Mitral TEER — Primary / Degenerative MR5
EVEREST II Endovascular Valve Edge-to-Edge Repair Study II TEER is safer upfront than surgery but less durable for reparable MR.
The first randomized TEER-vs-surgery trial: MitraClip was less effective than surgery for the composite efficacy endpoint but markedly safer early, with durable safety over 5 years.
Study overview
| Device | Abbott MitraClip |
|---|---|
| Intervention | TEER |
| Comparator | Surgical MV repair/replacement |
| Population | Mostly primary/degenerative MR, operable |
| Risk group | Operable |
| Sample size | 279 |
| Enrollment | 2005–2008 |
| Follow-up | 1, 4, and 5 years |
| Trial type | Randomized |
Inclusion criteria
—
Primary endpoint
Freedom from death, MV surgery/reoperation, or 3+/4+ MR at 12 months.
Secondary endpoints
- Major adverse events
- LV dimensions
- NYHA / quality of life
Key results
- Surgery more effective for the composite endpoint at 12 months
- MitraClip had markedly lower early major adverse events
- 5-year data: greater surgical durability but durable TEER safety
Why this trial matters
Established the US pivotal TEER pathway and the high-risk primary-MR niche.
Clinical pearls
- Residual/recurrent MR is the price of the less-invasive approach in reparable valves.
Limitations
- Less durable MR reduction than surgery
- Early-generation clip
Serial follow-ups & subanalyses 22
Click a follow-up to reveal its paper links.
Percutaneous mitral repair with the MitraClip system: safety and midterm durabil…
Surgical revision after percutaneous mitral
EVEREST II randomized clinical trial
Effects of atrial fibrillation on
Echocardiographic outcomes
5-year (vs surgery)
Fiveyear outcomes of transcatheter reduction
Comparison of Ranibizumab With or
PREDICTORS AND IMPORTANCE OF COMPLETE
Sixyear findings of polypoidal choroidal
The EVEREST II Trial: design and rationale for a randomized study of the evalve…
Acute and 12-month results with catheter-based mitral valve leaflet repair: the…
4-year results of a randomized controlled trial of percutaneous repair versus su…
One-Year Outcomes After MitraClip for Functional Mitral Regurgitation.
Impact of the MitraClip Procedure on Left Atrial Strain and Strain Rate.
Percutaneous mitral valve repair for mitral regurgitation in high-risk patients:…
Relationship between the magnitude of reduction in mitral regurgitation severity…
Percutaneous mitral valve repair in the initial EVEREST cohort: evidence of reve…
The acute hemodynamic effects of MitraClip therapy.
EVEREST II HRS EVEREST II High Surgical Risk Study / REALISM High-Risk Cohort TEER became viable for prohibitive-risk MR before the secondary-MR RCTs matured.
A high-/prohibitive-risk MitraClip cohort showing significant MR reduction, symptom improvement, and LV reverse remodeling through 12 months and beyond.
Study overview
| Device | Abbott MitraClip |
|---|---|
| Intervention | TEER |
| Comparator | No randomized comparator (benchmark) |
| Population | Severe MR, prohibitive / high surgical risk |
| Risk group | High / prohibitive |
| Sample size | 78 (HRS publication) |
| Enrollment | pre-2012 |
| Follow-up | 1 and 5 years |
| Trial type | Prospective single-arm / registry |
Inclusion criteria
—
Primary endpoint
Acute procedural safety and MR reduction.
Secondary endpoints
- Symptoms / functional class
- LV reverse remodeling
- Survival
Key results
- Significant MR reduction and symptom improvement
- LV reverse remodeling through 12 months
- Benefit sustained in longer follow-up
Why this trial matters
Supported high-risk primary-MR labeling and real-world adoption.
Clinical pearls
- Single-arm high-risk data preceded the randomized secondary-MR evidence.
Limitations
- No randomized comparator
- Selected high-risk population
Serial follow-ups & subanalyses 14
Click a follow-up to reveal its paper links.
Durability
The acute hemodynamic effects of
Pathological healing response of explanted
Percutaneous repair or surgery for
High Risk Study — acute & 12-month
Relationship between the magnitude of
Percutaneous mitral valve repair in
5-year
Impact of the MitraClip Procedure
Functional MR — 1-year
Fiveyear outcomes of transcatheter reduction
PASCAL CLASP Edwards PASCAL CLASP Study (first multicenter PASCAL experience) PASCAL emerged as the main TEER alternative to MitraClip.
The first prospective multicenter experience with the PASCAL TEER system across mixed MR etiologies, showing high survival, durable MR reduction, and functional improvement at 1 year.
Study overview
| Device | Edwards PASCAL |
|---|---|
| Intervention | TEER |
| Comparator | None (single-arm) |
| Population | Significant MR, mixed etiologies |
| Risk group | High risk |
| Sample size | not securely extracted |
| Enrollment | 2017–2019 |
| Follow-up | 30 days, 6 months, 1 year |
| Trial type | Prospective single-arm, multicenter |
Inclusion criteria
—
Primary endpoint
Safety and MR reduction.
Secondary endpoints
- Survival
- Durable MR grade
- NYHA / functional capacity
Key results
- High survival and durable MR reduction through 1 year
- Functional improvement across etiologies
Why this trial matters
Established feasibility for the commercial PASCAL program.
Clinical pearls
- Independent leaflet grasping and a central spacer distinguish PASCAL from MitraClip.
Limitations
- Single-arm
- Mixed etiologies
- NCT unconfirmed here
Serial follow-ups & subanalyses 4
Click a follow-up to reveal its paper links.
1-year
2-year
Early outcomes from the CLASP
CLASP IID Edwards PASCAL CLASP IID Pivotal Trial PASCAL is a credible alternative TEER platform in high-risk degenerative MR.
A randomized head-to-head of PASCAL vs MitraClip in prohibitive-risk degenerative MR; PASCAL was noninferior for safety and effectiveness, underpinning its FDA approval.
Study overview
| Device | Edwards PASCAL |
|---|---|
| Intervention | TEER |
| Comparator | Abbott MitraClip |
| Population | Prohibitive-risk degenerative MR |
| Risk group | Prohibitive surgical risk |
| Sample size | 180 (117 PASCAL / 63 MitraClip) |
| Enrollment | 2019–2022 |
| Follow-up | 6 months, 1 year, 2 years |
| Trial type | Randomized, noninferiority |
Inclusion criteria
—
Primary endpoint
30-day MAE and MR ≤2+ at 6 months (noninferiority).
Secondary endpoints
- MR ≤1+
- Gradient
- NYHA / KCCQ
- Durability
Key results
- PASCAL noninferior to MitraClip for safety and effectiveness
- Favorable 1-year outcomes; durable MR reduction
Why this trial matters
Provided the randomized basis for FDA approval of the PASCAL mitral repair system.
Clinical pearls
- Both devices perform well — platform choice can be anatomy- and operator-driven.
Limitations
- Prohibitive-risk DMR only
- Noninferiority design
Serial follow-ups & subanalyses 8
Click a follow-up to reveal its paper links.
Early outcomes from the CLASP
1-year
Anatomically complex DMR
2-year (trial & registry)
Sex differences
REPAIR MR Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Primary MR Could determine whether TEER enters earlier-risk primary-MR pathways.
A randomized trial of TEER versus surgical repair in severe primary MR at moderate surgical risk — testing whether TEER can move into earlier-risk degenerative disease.
Study overview
| Device | Abbott MitraClip |
|---|---|
| Intervention | TEER |
| Comparator | Surgical mitral repair |
| Population | Severe primary MR, moderate surgical risk |
| Risk group | Moderate surgical risk |
| Sample size | not fully extracted |
| Enrollment | ongoing |
| Follow-up | multi-year |
| Trial type | Randomized |
Inclusion criteria
—
Primary endpoint
Composite safety/effectiveness (see design paper).
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
A major ongoing primary-MR trial that could expand TEER indications.
Clinical pearls
- Watch for durability vs surgery in a lower-risk population.
Limitations
- Not yet reporting
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
Mitral TEER — Secondary / Functional MR5
COAPT Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for HF Patients With Functional MR The strongest RCT supporting TEER in carefully selected ventricular secondary MR.
In carefully selected symptomatic HF with severe secondary MR despite maximal GDMT, MitraClip reduced heart-failure hospitalizations and mortality and improved quality of life, with benefit sustained to 5 years.
Study overview
| Device | Abbott MitraClip + GDMT |
|---|---|
| Intervention | TEER + GDMT |
| Comparator | GDMT alone |
| Population | Symptomatic HF with 3+/4+ secondary MR despite maximal GDMT |
| Risk group | HFrEF on GDMT |
| Sample size | 614 |
| Enrollment | 2012–2017 |
| Follow-up | 2 and 5 years |
| Trial type | Randomized |
Inclusion criteria
—
Primary endpoint
Annualized heart-failure hospitalization through 24 months; 12-month safety.
Secondary endpoints
- All-cause mortality
- Quality of life (KCCQ)
- NYHA / 6-minute walk
Key results
- HF hospitalization markedly reduced (HR ~0.53)
- All-cause mortality reduced (HR ~0.62 at 2 years)
- Benefit sustained through 5 years
Why this trial matters
Practice-changing; underpinned 2019 FDA expansion to secondary MR and guideline upgrades.
Clinical pearls
- Selection matters: proportionate MR (high EROA, less-dilated LV) predicts benefit.
- Contrast with MITRA-FR explains the 'disproportionate MR' framework.
Limitations
- Highly selected population
- Requires optimized GDMT first
Serial follow-ups & subanalyses 36
Click a follow-up to reveal its paper links.
Health Status Changes and Outcomes in Patients With Heart Failure and Mitral Reg…
Implications of Atrial Fibrillation on the Mechanisms of Mitral Regurgitation an…
Predictors of clinical response
Residual MR & quality of life
Association of Effective Regurgitation Orifice
Hospitalizations & mortality
Prognostic implications of mitral valve
Changes in Left Ventricular Global
Impact of Peripheral Artery Disease
Transcatheter Mitral Valve Replacement Versus
Association between serum albumin and
Phenotypic Diversity and Outcomes of
Impact of Race and Ethnicity
3-Year Outcomes of Transcatheter Mitral Valve Repair in Patients With Heart Fail…
Impact of Natriuretic Peptide and Prior Hospitalization in Patients With Severe…
Left Atrial Improvement in Patients With Secondary Mitral Regurgitation and Hear…
Repeat Mitral Valve Interventions After Transcatheter Edge-to-Edge Repair: The C…
Regurgitant volume to LA volume ratio in patients with secondary MR: the COAPT t…
Incidence, Predictors, and Outcomes Associated With Worsening Renal Function in…
Cerebrovascular Events After Transcatheter Edge-to-Edge Repair and Guideline-Dir…
Impact of Malnutrition in Patients With Heart Failure and Secondary Mitral Regur…
Ventricular Remodeling and Outcomes After Mitral Transcatheter Edge-to-Edge Repa…
Prognostic Importance of Health Status Versus Functional Status in Heart Failure…
Impact of Diabetes on Outcomes After Transcatheter Mitral Valve Repair in Heart…
Impact of COPD on Outcomes After MitraClip for Secondary Mitral Regurgitation: T…
Transcatheter Mitral Valve Repair in Patients With and Without Cardiac Resynchro…
NYHA Functional Classification and Outcomes After Transcatheter Mitral Valve Rep…
Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial.
Echocardiographic Outcomes After Transcatheter Leaflet Approximation in Patients…
Cost-Effectiveness of Transcatheter Mitral Valve Repair Versus Medical Therapy i…
Health Status After Transcatheter Mitral-Valve Repair in Heart Failure and Secon…
Cardiovascular Outcomes Assessment of the MitraClip in Patients with Heart Failu…
Pulmonary Vein Systolic Flow Reversal and Outcomes in Patients From the Cardiova…
MITRA-FR Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary MR TEER is not uniformly beneficial across all secondary-MR phenotypes.
In severe secondary MR, adding MitraClip to medical therapy did not reduce death or unplanned heart-failure hospitalization at 1 year — the neutral counterpart to COAPT.
Study overview
| Device | Abbott MitraClip + medical therapy |
|---|---|
| Intervention | TEER + medical therapy |
| Comparator | Medical therapy alone |
| Population | Symptomatic severe secondary MR |
| Risk group | HFrEF |
| Sample size | 304 |
| Enrollment | 2013–2017 |
| Follow-up | 1 and 2 years |
| Trial type | Randomized |
Inclusion criteria
—
Primary endpoint
Death or unplanned heart-failure hospitalization at 12 months.
Secondary endpoints
- All-cause mortality
- HF hospitalization
- LV remodeling
Key results
- Neutral: no significant reduction in death or HF hospitalization at 1 year
- Result persisted at 2 years
Why this trial matters
Framed the COAPT-vs-MITRA-FR selection debate central to modern SMR practice.
Clinical pearls
- Enrolled more dilated ventricles / lower EROA than COAPT ('disproportionate' MR).
- Explains why patient selection dominates secondary-MR TEER decisions.
Limitations
- Smaller sample
- Less stringent GDMT optimization than COAPT
Serial follow-ups & subanalyses 9
Click a follow-up to reveal its paper links.
The MITRAFR study design and
2-year outcomes
Percutaneous mitral valve repair in
Delayed hospitalisation for heart failure
Impact of procedural success on
Percutaneous repair of moderatetosevere or
Phenotypic Diversity and Outcomes of
RESHAPE-HF2 Randomized Investigation of the MitraClip Device in HF With Clinically Significant Functional MR A modern positive SMR trial that extends TEER benefit toward moderate-to-severe functional MR.
The third MitraClip RCT in functional MR: adding TEER to medical therapy lowered cardiovascular death or heart-failure hospitalization and improved symptoms, in a moderate-to-severe FMR population.
Study overview
| Device | Abbott MitraClip + OMT |
|---|---|
| Intervention | TEER + optimal medical therapy |
| Comparator | Optimal medical therapy alone |
| Population | HF with moderate-to-severe functional MR, non-surgical |
| Risk group | HFrEF (mean LVEF ~31%) |
| Sample size | 505 |
| Enrollment | 2015–2024 |
| Follow-up | 24 months (KCCQ at 12 months) |
| Trial type | Randomized |
Inclusion criteria
—
Primary endpoint
Three co-primaries: total HF hospitalizations + CV death at 24 mo; total HF hospitalizations at 24 mo; change in KCCQ at 12 mo.
Secondary endpoints
- All-cause mortality
- MR grade
- Functional capacity
Key results
- Superior to medical therapy across all three primary endpoints
- CV death or HF hospitalization reduced (HR ~0.64, P=0.002)
- Better health status (KCCQ) at 12 months
Why this trial matters
Contemporary confirmatory SMR evidence, in a lower-EROA population than COAPT.
Clinical pearls
- Population sits between MITRA-FR and COAPT on MR severity — read alongside both.
Limitations
- Open-label
- Moderate-to-severe (not exclusively severe) MR
Serial follow-ups & subanalyses 5
Click a follow-up to reveal its paper links.
Baseline characteristics vs COAPT/MITRA-FR
Volume-based framework reconciling the 3 RCTs
Randomized investigation of the MitraClip
Hospitalization of Symptomatic Patients With
MATTERHORN Multicenter Mitral Valve Reconstruction for Advanced Insufficiency of Functional or Ischemic Origin In selected secondary MR, TEER now has randomized evidence against surgery, not just GDMT.
The first randomized TEER-vs-surgery trial in secondary MR: TEER was noninferior to surgery for the 1-year efficacy composite and had a markedly better 30-day safety profile.
Study overview
| Device | Abbott MitraClip |
|---|---|
| Intervention | TEER |
| Comparator | Surgical MV repair/replacement |
| Population | HF with secondary MR at elevated surgical risk |
| Risk group | High surgical risk |
| Sample size | 210 |
| Enrollment | 2015–2024 |
| Follow-up | 1 year |
| Trial type | Randomized, noninferiority |
Inclusion criteria
—
Primary endpoint
1-year composite of death, HF hospitalization, MV reintervention, assist-device implantation, or stroke; plus 30-day major-adverse-event safety endpoint.
Secondary endpoints
- Residual MR grade
- NYHA / quality of life
- Bleeding / new AF
Key results
- Efficacy composite 16.7% (TEER) vs 22.5% (surgery) — noninferior
- 30-day safety events 14.9% (TEER) vs 54.8% (surgery), P<0.001
- Comparable MR reduction at 1 year
Why this trial matters
First randomized TEER-vs-surgery trial in secondary MR; likely to influence guidelines.
Clinical pearls
- Safety advantage driven by less bleeding, reintervention, and new AF.
- High-surgical-risk selection — not a low-risk surgery comparison.
Limitations
- Modest sample
- High-risk population
- 1-year primary follow-up
CLASP IIF ⚠ Edwards PASCAL CLASP IIF Functional-MR Cohort The key unresolved PASCAL-vs-MitraClip functional-MR trial.
A head-to-head of PASCAL versus MitraClip (each with GDMT) in symptomatic functional MR — the key unresolved PASCAL-vs-MitraClip comparison in secondary MR.
Study overview
| Device | Edwards PASCAL + GDMT |
|---|---|
| Intervention | TEER + GDMT |
| Comparator | Abbott MitraClip + GDMT |
| Population | Symptomatic functional MR on GDMT |
| Risk group | HFrEF on GDMT |
| Sample size | ongoing |
| Enrollment | ongoing |
| Follow-up | ongoing |
| Trial type | Randomized |
Inclusion criteria
—
Primary endpoint
Safety and effectiveness vs MitraClip (see trial pages).
Secondary endpoints
—
Key results
- Pending — mature primary results not identified
Why this trial matters
Would define whether the two TEER platforms differ in functional MR.
Clinical pearls
- Device-vs-device in FMR is the main open TEER question.
Limitations
- Not yet reporting
- NCT unconfirmed here
Serial follow-ups & subanalyses 3
Click a follow-up to reveal its paper links.
Randomized Comparison of Transcatheter EdgetoEdge
Transcatheter EdgetoEdge Repair in Patients
Secondary MR — Direct Annuloplasty3
Mitralign ⚠ Mitralign Percutaneous Annuloplasty System (Bident) — First-in-Man / CE-mark Study Historically important as an early direct-annuloplasty device, but the evidence remained too limited for routine contemporary use.
A retrograde direct annuloplasty system that plicates the posterior annulus with paired pledgets; the first-in-man / CE-mark study met its 30-day safety and 6-month performance goals with reverse remodeling, but device success was modest and the platform is now historical.
Study overview
| Device | Mitralign Percutaneous Annuloplasty System (Bident) |
|---|---|
| Intervention | Direct annuloplasty (retrograde, transfemoral) |
| Comparator | None (single-arm) |
| Population | High-risk symptomatic functional MR |
| Risk group | High surgical risk, HFrEF |
| Sample size | 71 attempted (50 implanted) |
| Enrollment | 2013–2015 |
| Follow-up | 30 days / 6 months |
| Trial type | Prospective single-arm, first-in-man / CE |
Inclusion criteria
- Chronic functional MR
- Symptomatic heart failure
- High surgical risk
Primary endpoint
30-day safety and 6-month performance endpoints.
Secondary endpoints
- Device success
- LV dimensions / reverse remodeling
- 6-minute walk
- NYHA class
Key results
- Device success 70.4% (50/71); no intraprocedural deaths
- Cardiac tamponade in 8.9%
- Reverse LV remodeling and functional improvement through 6 months
- Met 30-day safety and 6-month performance goals (CE-mark 2016)
Why this trial matters
One of the first direct transcatheter annuloplasty systems to earn CE-mark, establishing feasibility of retrograde annular plication.
Clinical pearls
- Small footprint left other options open, but modest device success limited adoption.
- The sister Trialign system was explored for tricuspid regurgitation.
Limitations
- Single-arm, modest device success
- Tamponade risk
- Device no longer developed
ACTIVE ⚠ Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE The most important randomized direct-annuloplasty trial — but it was terminated, leaving the randomized evidence gap unfilled.
The US pivotal randomized trial of the Cardioband direct annuloplasty system plus GDMT versus GDMT alone in functional MR — designed to test both MR reduction and a clinical composite, but terminated before a primary publication.
Study overview
| Device | Edwards Cardioband + GDMT |
|---|---|
| Intervention | Direct annuloplasty + GDMT |
| Comparator | Guideline-directed medical therapy alone |
| Population | Clinically significant secondary (functional) MR with heart failure |
| Risk group | HFrEF on GDMT |
| Sample size | up to 375 planned (2:1) |
| Enrollment | 2017–2023 (terminated) |
| Follow-up | 1 year primary; 5-year planned |
| Trial type | Randomized, controlled, pivotal |
Inclusion criteria
- Clinically significant functional MR
- Symptomatic heart failure on GDMT
- Prior HF hospitalization or elevated natriuretic peptides
- Suitable anatomy
Primary endpoint
Co-primary: prevalence of MR ≤2+ and a hierarchical composite (CV death, HF hospitalization, 6-minute walk, KCCQ) at 1 year.
Secondary endpoints
- LV remodeling
- NYHA class
- Quality of life
- 5-year outcomes
Key results
- Pending — trial terminated before a primary results publication
Why this trial matters
Would have provided the first randomized clinical-outcome test of direct annuloplasty in functional MR; its termination is why the field still leans on single-arm data.
Clinical pearls
- Termination reflects the challenge of running device RCTs against a TEER-dominated landscape.
- Edwards subsequently emphasized the Cardioband platform for tricuspid disease.
Limitations
- Terminated
- No primary publication
- Enrollment challenges
Cardioband CE ⚠ Cardioband Adjustable Annuloplasty System for Transcatheter Repair of Mitral Regurgitation Direct transcatheter annuloplasty is feasible and reduces functional MR — but the evidence base is far smaller than TEER.
A transseptal direct annuloplasty band that cinches the posterior mitral annulus; the multicenter single-arm study showed high procedural success, meaningful annular and MR reduction, and symptomatic improvement in functional MR.
Study overview
| Device | Edwards (Valtech) Cardioband |
|---|---|
| Intervention | Direct annuloplasty (transseptal) |
| Comparator | None (single-arm) |
| Population | Symptomatic secondary (functional) MR with HFrEF |
| Risk group | High surgical risk, HFrEF |
| Sample size | 60 (1-yr cohort); 31 in feasibility |
| Enrollment | 2011–2016 |
| Follow-up | 6 months / 1 year |
| Trial type | Prospective single-arm, multicenter |
Inclusion criteria
- Moderate-to-severe / severe functional MR
- Symptomatic heart failure on GDMT
- Reduced LV ejection fraction
- Anatomy suitable for the band
Primary endpoint
Safety and device performance (procedural success, MR and annular reduction).
Secondary endpoints
- Septolateral annular dimension
- MR grade
- NYHA class / 6-minute walk
- Quality of life
Key results
- High procedural success with the entire device delivered
- >30% reduction in septolateral annular dimension
- MR reduced to ≤2+ in ~90% of early treated patients; ≤mild in a majority at 1 year
- Improved heart-failure symptoms and functional capacity
Why this trial matters
First direct transcatheter annuloplasty to reach CE-mark for functional MR, re-creating a surgical-style annuloplasty percutaneously.
Clinical pearls
- Preserves the leaflets and keeps future options (TEER, replacement) open.
- Single-arm data — not a substitute for the randomized TEER evidence base.
Limitations
- No randomized comparator
- Technically demanding, longer procedures
- Evidence base far smaller than TEER
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
Secondary MR — Indirect Annuloplasty2
EMPOWER Assessment of the Carillon Mitral Contour System in Treating Heart Failure With Functional MR The key unresolved trial for Carillon — the first indirect-annuloplasty study powered toward clinical outcomes.
The pivotal, blinded, randomized outcomes trial of the coronary-sinus Carillon device versus control in symptomatic heart failure with at least mild functional MR.
Study overview
| Device | Cardiac Dimensions Carillon Mitral Contour System |
|---|---|
| Intervention | Indirect (coronary-sinus) annuloplasty |
| Comparator | Control (GDMT; blinded) |
| Population | Symptomatic HF with functional MR ≥1+ |
| Risk group | HF (LVEF ≤50%) on GDMT |
| Sample size | 300 (1:1) |
| Enrollment | 2018–ongoing |
| Follow-up | 12–24 months primary; 5 years total |
| Trial type | Randomized, blinded, pivotal |
Inclusion criteria
- Ischemic or non-ischemic cardiomyopathy
- Functional MR ≥1+ (at least mild)
- NYHA II–IV
- LVEF ≤50%
- Elevated natriuretic peptides or recent HF hospitalization
Primary endpoint
Safety and efficacy composite (MR reduction and heart-failure clinical outcomes).
Secondary endpoints
- Heart-failure hospitalization
- Quality of life
- LV remodeling
- Functional capacity
Key results
- Pending — trial ongoing (recruiting)
Why this trial matters
If positive, EMPOWER would move indirect annuloplasty from proof-of-concept toward an outcomes-based indication.
Clinical pearls
- Enrolls milder MR (≥1+) than most device trials, reflecting a heart-failure emphasis.
- Leaflet-sparing approach preserves future TEER, direct annuloplasty, or replacement options.
Limitations
- Not yet reporting
- Long follow-up horizon
REDUCE-FMR Safety and Efficacy of the Carillon Mitral Contour System in Reducing Functional Mitral Regurgitation Carillon reduces MR burden and drives reverse remodeling — a clean proof-of-concept, though outcomes evidence remains limited.
The first blinded, sham-controlled randomized trial of a percutaneous mitral therapy: the coronary-sinus Carillon device significantly reduced mitral regurgitant volume and LV volumes versus sham in HFrEF with functional MR.
Study overview
| Device | Cardiac Dimensions Carillon Mitral Contour System |
|---|---|
| Intervention | Indirect (coronary-sinus) annuloplasty |
| Comparator | Sham procedure (both on GDMT) |
| Population | HFrEF with functional MR (grade 2+–4+) |
| Risk group | HFrEF (LVEF <50%) on GDMT |
| Sample size | 120 (87 device / 33 sham) |
| Enrollment | 2015–2018 |
| Follow-up | 12 months |
| Trial type | Randomized, double-blind, sham-controlled |
Inclusion criteria
- LVEF <50% and LV end-diastolic diameter >55 mm
- NYHA II–IV on ≥3 months GDMT
- Functional MR grade 2+–4+
- 6-minute walk 150–450 m
Primary endpoint
Change in mitral regurgitant volume at 12 months (quantitative echo, intention-to-treat).
Secondary endpoints
- LV volumes / reverse remodeling
- 6-minute walk
- NYHA class
- KCCQ quality of life
Key results
- Primary endpoint met: significant reduction in regurgitant volume vs sham
- Treatment −7.1 mL/beat vs an increase in the sham arm
- Reductions in LV end-diastolic and end-systolic volumes (reverse remodeling)
- Trends toward better 6-minute walk, NYHA, and KCCQ
Why this trial matters
First sham-controlled RCT of any percutaneous mitral therapy — validated indirect annuloplasty biology even though it was not powered for clinical outcomes.
Clinical pearls
- Coronary-sinus approach avoids transseptal access and spares the leaflets.
- Proof-of-concept, not a COAPT-style outcomes trial — EMPOWER is the pivotal test.
Limitations
- Proof-of-concept sample size
- Not powered for mortality / hospitalization
- Coronary-sinus anatomy and circumflex course limit some patients
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
Mitral Chordal Repair6
TACT (NeoChord) Safety and Performance Study of the NeoChord DS1000 Suturing Device Beating-heart chordal repair works in selected anatomy, but surgery still sets the durability benchmark.
Beating-heart transapical implantation of artificial neochordae for degenerative MR with leaflet prolapse; feasible and safe, supporting CE-mark, though durability vs surgery is unsettled.
Study overview
| Device | NeoChord DS1000 |
|---|---|
| Intervention | Transapical chordal repair |
| Comparator | None (single-arm) |
| Population | Degenerative MR, posterior-leaflet prolapse dominant |
| Risk group | Selected surgical candidates |
| Sample size | 30 (CE-mark cohort) |
| Enrollment | early 2010s |
| Follow-up | 30 days and observational |
| Trial type | Prospective single-arm |
Inclusion criteria
—
Primary endpoint
Composite procedural success / MR reduction and major-adverse-event framework.
Secondary endpoints
- MR grade
- Durability
- Reintervention
Key results
- Feasible and safe; acute success supported CE-mark
- Comparative durability remains uncertain
Why this trial matters
CE-mark device; not routine US therapy.
Clinical pearls
- Best in isolated posterior-leaflet prolapse with favorable anatomy.
Limitations
- No randomized comparator
- Durability vs surgery unproven
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
ReChord Randomized Trial of NeoChord DS1000 vs Open Surgical Repair Potentially pivotal if it can show durable noninferiority in selected leaflet prolapse.
A randomized comparison of transapical NeoChord repair against open surgical repair in degenerative mitral disease — the key trial to test durable noninferiority.
Study overview
| Device | NeoChord DS1000 |
|---|---|
| Intervention | Transapical chordal repair |
| Comparator | Open surgical repair |
| Population | Degenerative MV disease |
| Risk group | Surgical candidates |
| Sample size | not fully extracted |
| Enrollment | 2016–ongoing |
| Follow-up | ongoing |
| Trial type | Randomized |
Inclusion criteria
—
Primary endpoint
Safety/effectiveness vs surgery.
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
The key randomized chordal-repair study.
Clinical pearls
- Durability vs surgery is the crux.
Limitations
- Not yet reporting
HARPOON EFS Safety and Performance Study of the Harpoon Mitral Valve Repair System A second beating-heart chordal platform with promising anatomy-specific outcomes.
A transventricular beating-heart system that anchors ePTFE neochordae; early feasibility showed favorable 30-day and 1-year MR reduction in selected degenerative MR.
Study overview
| Device | Harpoon Mitral Valve Repair System |
|---|---|
| Intervention | Transventricular chordal repair |
| Comparator | None (single-arm) |
| Population | Degenerative MR |
| Risk group | Selected |
| Sample size | up to ~30 |
| Enrollment | 2016–ongoing |
| Follow-up | 30 days and 1 year |
| Trial type | Prospective single-arm (EFS) |
Inclusion criteria
—
Primary endpoint
Implantation success and MR ≤moderate at 30 days.
Secondary endpoints
- 1-year MR grade
- LV remodeling
- NYHA
Key results
- Feasible with favorable 30-day / 1-year MR reduction in selected DMR
Why this trial matters
CE-mark pathway; US investigational.
Clinical pearls
- Anatomy-specific (posterior prolapse) selection is key.
Limitations
- Small single-arm
- Durability data limited
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
HARPOON TRACER ⚠ CE-Mark Study for the Harpoon Mitral TRACER Trial Important historically, but with limited mature trial-level publication.
The CE-mark support study for the Harpoon system in severe degenerative MR (mainly posterior leaflet prolapse), evaluating 30-day performance and safety.
Study overview
| Device | Harpoon Mitral Valve Repair System |
|---|---|
| Intervention | Transventricular chordal repair |
| Comparator | None (single-arm) |
| Population | Severe DMR, mainly posterior-leaflet prolapse |
| Risk group | Selected |
| Sample size | 30 planned |
| Enrollment | late 2010s |
| Follow-up | planned long-term |
| Trial type | Prospective single-arm (CE) |
Inclusion criteria
—
Primary endpoint
30-day performance and safety.
Secondary endpoints
—
Key results
- Protocol available; mature indexed primary outcomes incompletely retrieved
Why this trial matters
Important CE-mark program for beating-heart chordal repair.
Clinical pearls
- Same platform as HARPOON EFS, CE-focused cohort.
Limitations
- Publication incomplete in the source set
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
RESTORE (Harpoon) Beating-Heart Mitral Valve Repair With the Harpoon System Ongoing validation of beating-heart chordal replacement.
The current Harpoon program evaluating beating-heart chordal replacement in severe degenerative MR.
Study overview
| Device | Harpoon Mitral Valve Repair System |
|---|---|
| Intervention | Transventricular chordal repair |
| Comparator | None (single-arm) |
| Population | Severe DMR |
| Risk group | Selected |
| Sample size | not fully extracted |
| Enrollment | 2020–ongoing |
| Follow-up | ongoing |
| Trial type | Single-arm |
Inclusion criteria
—
Primary endpoint
Safety / effectiveness.
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
Current Harpoon validation program.
Clinical pearls
- Watch durability and anatomy selection.
Limitations
- Not yet reporting
NeoChord Registry ⚠ TACT Post-Market Surveillance Registry (NeoChord DS1000) Useful for anatomy selection, not yet definitive vs surgery.
A post-market registry characterizing real-world CE-mark NeoChord experience and anatomy-based selection.
Study overview
| Device | NeoChord DS1000 |
|---|---|
| Intervention | Transapical chordal repair |
| Comparator | Registry |
| Population | Degenerative MR |
| Risk group | Selected |
| Sample size | not fully extracted |
| Enrollment | registry (ongoing) |
| Follow-up | longer term |
| Trial type | Post-market registry |
Inclusion criteria
—
Primary endpoint
Post-market effectiveness / safety.
Secondary endpoints
—
Key results
- Registry program active; heterogeneous published outputs
Why this trial matters
Defines real-world CE-mark experience.
Clinical pearls
- Registry data help refine patient selection.
Limitations
- Non-randomized
- Heterogeneous reporting
Transcatheter Mitral Replacement (TMVR)17
Tiara EFS ⚠ Neovasc Tiara Transapical TMVR Early Feasibility Study An important device concept, but mature peer-reviewed trial evidence is limited.
An early feasibility study of the D-shaped transapical Tiara valve, historically important though with limited mature peer-reviewed trial evidence.
Study overview
| Device | Neovasc Tiara |
|---|---|
| Intervention | Transapical TMVR |
| Comparator | None (single-arm) |
| Population | Severe symptomatic MR, high surgical risk |
| Risk group | High risk |
| Sample size | up to 30 |
| Enrollment | 2015–ongoing |
| Follow-up | through 5 years (planned) |
| Trial type | Single-arm (EFS) |
Inclusion criteria
—
Primary endpoint
Freedom from mortality/major adverse events with device performance.
Secondary endpoints
—
Key results
- Protocol available; mature full-cohort primary publication not clearly retrieved
Why this trial matters
Historically important D-shaped transapical TMVR platform.
Clinical pearls
- D-shaped frame aims to respect mitral anatomy and reduce LVOT interaction.
Limitations
- Limited mature publication
- Transapical access
Tendyne Feasibility Global Feasibility Study of the Tendyne Mitral Valve System Tendyne was the first dedicated TMVR platform with convincing native-MR feasibility.
The first convincing dedicated-TMVR feasibility experience: transapical Tendyne achieved high implant success with near-complete MR elimination at 30 days.
Study overview
| Device | Abbott Tendyne |
|---|---|
| Intervention | Transapical TMVR |
| Comparator | None (single-arm) |
| Population | Severe symptomatic native MR, high surgical risk |
| Risk group | High risk |
| Sample size | 30 (initial registry) |
| Enrollment | 2014–2016 |
| Follow-up | 30 days |
| Trial type | Prospective single-arm |
Inclusion criteria
—
Primary endpoint
Effectiveness and safety at 30 days.
Secondary endpoints
- MR elimination
- Stroke / MI
- Mortality
Key results
- 93.3% implant success; near-complete MR elimination
- Low early stroke/MI; 1 early death
Why this trial matters
Foundational dedicated-TMVR feasibility study.
Clinical pearls
- Repositionable, tetherable design anchored at the LV apex.
Limitations
- Small single-arm
- Transapical access morbidity
Serial follow-ups & subanalyses 3
Click a follow-up to reveal its paper links.
First 100 patients
2-year
Intrepid Pilot Intrepid Global Pilot Study (Transapical TMVR) Intrepid validated another transapical dedicated-TMVR route.
Early transapical Intrepid experience showed feasibility with high MR elimination, informing the later pivotal program.
Study overview
| Device | Medtronic Intrepid |
|---|---|
| Intervention | Transapical TMVR |
| Comparator | None (single-arm) |
| Population | Severe symptomatic MR, high/extreme risk |
| Risk group | High / extreme |
| Sample size | pilot cohort |
| Enrollment | mid-2010s |
| Follow-up | 30 days |
| Trial type | Prospective single-arm |
Inclusion criteria
—
Primary endpoint
Early safety and feasibility.
Secondary endpoints
- MR elimination
- Gradient
- Mortality
Key results
- Feasible with high MR elimination
- Informed later pivotal development
Why this trial matters
Foundational Medtronic native-TMVR program.
Clinical pearls
- Dual-stent self-expanding design conforms to the annulus.
Limitations
- Single-arm
- Transapical access
Serial follow-ups & subanalyses 4
Click a follow-up to reveal its paper links.
SAPIEN M3 FIH ⚠ First-in-Human Experience With the SAPIEN M3 Transseptal TMVR System SAPIEN M3 introduced a fully percutaneous replacement concept with a docking system.
The first-in-human transseptal SAPIEN M3 experience introduced a fully percutaneous replacement concept using a dock plus a balloon-expandable valve, enabling the ENCIRCLE pivotal.
Study overview
| Device | Edwards SAPIEN M3 |
|---|---|
| Intervention | Transseptal TMVR (dock + valve) |
| Comparator | None (single-arm) |
| Population | Severe MR, high-risk / unsuitable for surgery |
| Risk group | High risk |
| Sample size | early cohort |
| Enrollment | 2018–2019 |
| Follow-up | early |
| Trial type | First-in-human |
Inclusion criteria
—
Primary endpoint
Feasibility.
Secondary endpoints
—
Key results
- Favorable initial transseptal experience
- Enabled the ENCIRCLE pivotal
Why this trial matters
Key Edwards transseptal TMVR proof-of-concept.
Clinical pearls
- Two-step dock-then-valve approach adapts the SAPIEN platform to the mitral position.
Limitations
- Small early cohort
- NCT unconfirmed here
Cephea FIH Cephea Transseptal Mitral Valve System First-in-Human Cephea showed that fully transseptal native-TMVR was technically achievable.
The first-in-human Cephea implant demonstrated that fully transseptal native-TMVR is technically achievable.
Study overview
| Device | Abbott Cephea |
|---|---|
| Intervention | Transseptal TMVR |
| Comparator | None (single-arm FIH) |
| Population | Symptomatic moderate-severe degenerative or functional MR |
| Risk group | High risk |
| Sample size | 1 (FIH report) |
| Enrollment | 2019 |
| Follow-up | short-term |
| Trial type | First-in-human |
Inclusion criteria
—
Primary endpoint
Feasibility.
Secondary endpoints
—
Key results
- First-in-human implantation demonstrated technical feasibility
Why this trial matters
Important early Abbott TMVR concept study.
Clinical pearls
- Low-profile disc-shaped design intended for transfemoral-transseptal delivery.
Limitations
- Single case
- Early-stage
EVOQUE Eos MISCEND Edwards EVOQUE Eos Mitral Valve Replacement (MISCEND Study) The EVOQUE/CardiAQ platform demonstrated encouraging early and 1-year outcomes and remains one of the leading dedicated transseptal TMVR programs.
An active Edwards mitral TMVR program (EVOQUE/CardiAQ lineage) evaluating safety and performance across degenerative and functional MR; early feasibility demonstrated promising procedural success with sustained improvement through 1 year.
Study overview
| Device | Edwards EVOQUE Eos |
|---|---|
| Intervention | Transcatheter mitral replacement |
| Comparator | None (single-arm) |
| Population | Degenerative or functional mitral regurgitation |
| Risk group | High risk |
| Sample size | ~123 |
| Enrollment | 2015–ongoing |
| Follow-up | Ongoing |
| Trial type | Prospective single-arm |
Inclusion criteria
—
Primary endpoint
Safety and device performance.
Secondary endpoints
- Technical success
- MR reduction
- Functional improvement
- Mortality
Key results
- Early feasibility demonstrated high technical success with effective MR elimination
- Clinical improvement and valve performance remained favorable through 1 year
Why this trial matters
One of the earliest dedicated transseptal TMVR systems and the foundation of the Edwards EVOQUE mitral platform.
Clinical pearls
- Derived from the original CardiAQ TMVR technology.
- The mitral EVOQUE platform is distinct from the FDA-approved EVOQUE tricuspid valve.
Limitations
- Single-arm experience
- Limited long-term data
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
Tendyne Expanded Expanded Clinical Study of the Tendyne Mitral Valve System TMVR can abolish MR durably, but late mortality reflects the advanced substrate of treated patients.
Expanded Tendyne experience showing durable MR elimination and symptom benefit through 2–3 years, though late mortality remained substantial in a high-risk population.
Study overview
| Device | Abbott Tendyne |
|---|---|
| Intervention | Transapical TMVR |
| Comparator | None (single-arm) |
| Population | Severe MR |
| Risk group | High risk |
| Sample size | expanded cohort |
| Enrollment | later 2010s |
| Follow-up | 2, 3, and 5–6 years |
| Trial type | Prospective single-arm |
Inclusion criteria
—
Primary endpoint
Longer-term safety and performance.
Secondary endpoints
- Durable MR elimination
- NYHA / quality of life
- Mortality
Key results
- Durable MR elimination and symptom benefit through 2–3 years
- Substantial late mortality in this high-risk substrate
Why this trial matters
CE-marked in Europe; FDA-approved in 2025 for the MAC-related indication.
Clinical pearls
- Late mortality tracks comorbidity, not device failure.
Limitations
- Single-arm
- High-risk population confounds late mortality
Serial follow-ups & subanalyses 5
Click a follow-up to reveal its paper links.
Clinical outcomes and predictors
Five-year outcomes
Fiveyear outcomes of transcatheter mitral
Intrepid TS-EFS ⚠ Intrepid Transfemoral-Transseptal TMVR Early Feasibility Study Moving Intrepid from transapical to transseptal materially improved procedural appeal.
The transfemoral-transseptal Intrepid EFS showed excellent early safety — no death or stroke at 30 days and near-complete MR elimination — marking the shift away from transapical access.
Study overview
| Device | Medtronic Intrepid (transseptal) |
|---|---|
| Intervention | Transseptal TMVR |
| Comparator | None (single-arm) |
| Population | ≥moderate-severe MR, high surgical risk |
| Risk group | High risk |
| Sample size | 33 |
| Enrollment | 2020–2022 |
| Follow-up | 1 year |
| Trial type | Prospective single-arm (EFS) |
Inclusion criteria
—
Primary endpoint
30-day and 1-year MVARC-style safety/performance.
Secondary endpoints
- MR elimination
- Gradient
- Mortality
Key results
- 31/33 implanted; no death or stroke at 30 days
- 1-year mortality 6.7%; near-complete MR elimination with good gradients
Why this trial matters
Major transseptal-transition milestone for TMVR.
Clinical pearls
- Transseptal access avoids the morbidity of transapical delivery.
Limitations
- Small EFS
- NCT unconfirmed here
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
1-year outcomes
Cephea EFS Cephea Transseptal Mitral Valve System Early Feasibility Study Broader inclusion than pure MR may make Cephea especially interesting.
Abbott's early feasibility study of the transseptal Cephea system, with unusually broad inclusion spanning MR, mitral stenosis, and mixed disease.
Study overview
| Device | Abbott Cephea |
|---|---|
| Intervention | Transseptal TMVR |
| Comparator | None (single-arm) |
| Population | Symptomatic mitral valve disease incl. MR / MS / mixed |
| Risk group | High risk |
| Sample size | up to 50 |
| Enrollment | 2022–ongoing |
| Follow-up | 30 days+ |
| Trial type | Single-arm (EFS) |
Inclusion criteria
—
Primary endpoint
Safety: freedom from all-cause mortality at 30 days; effectiveness: MR ≤1+ at 30 days.
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
Major Abbott early-feasibility TMVR platform.
Clinical pearls
- Inclusion of stenosis/mixed disease broadens candidacy.
Limitations
- Not yet reporting
HighLife TSMVR HighLife Transseptal Mitral Valve Replacement Feasibility Study HighLife demonstrated the feasibility of a transseptal docking-ring TMVR system while highlighting the procedural complexity of multicomponent devices.
A transseptal, docking-ring-based TMVR concept; feasibility showed 90% implant success with 83% device success at 30 days, illustrating both the promise and complexity of multicomponent systems.
Study overview
| Device | HighLife TSMVR (two-component ring + valve) |
|---|---|
| Intervention | Transseptal TMVR |
| Comparator | None (single-arm) |
| Population | Symptomatic mitral regurgitation at high surgical risk |
| Risk group | High risk |
| Sample size | 30 |
| Enrollment | Early 2020s |
| Follow-up | 30 days |
| Trial type | Prospective single-arm |
Inclusion criteria
—
Primary endpoint
Feasibility, safety, and device performance.
Secondary endpoints
- Implant success
- Device success
- MR reduction
- Transmitral gradient
Key results
- Implant success 90%
- 30-day device success 83%
- Demonstrated feasibility of a fully transseptal docking-ring TMVR system
Why this trial matters
One of the earliest successful transseptal dedicated TMVR platforms using a subannular docking ring for secure anchoring.
Clinical pearls
- Two-component (subannular ring + valve) design provides dedicated anchoring independent of annular calcification.
- Demonstrated feasibility of fully transseptal TMVR without transapical access.
Limitations
- Small single-arm feasibility study
- Early experience with a technically complex multicomponent system
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
2-year outcomes
Intrepid TA (2-yr) ⚠ Two-Year Follow-Up of Intrepid Transapical TMVR (Pooled) Transapical Intrepid works, but patient selection remains the dominant challenge.
Pooled 2-year transapical Intrepid follow-up showed sustained MR elimination and valve performance, though mortality remained meaningful in high-risk patients.
Study overview
| Device | Medtronic Intrepid |
|---|---|
| Intervention | Transapical TMVR |
| Comparator | None (pooled single-arm) |
| Population | Symptomatic ≥moderate-severe MR |
| Risk group | High risk |
| Sample size | pooled cohort |
| Enrollment | later 2010s–2020s |
| Follow-up | 2 years (5-year emerging) |
| Trial type | Pooled single-arm follow-up |
Inclusion criteria
—
Primary endpoint
Safety and performance at 2 years.
Secondary endpoints
—
Key results
- Sustained MR elimination and valve performance
- Meaningful mortality in high-risk patients
Why this trial matters
Supports the longer-term durability concept for dedicated TMVR.
Clinical pearls
- Late mortality reflects substrate, not valve dysfunction.
Limitations
- Pooled/observational
- High-risk confounding
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
AltaValve Pivotal AltaValve Pivotal Trial Important next-phase trial for atrial-fixation TMVR.
The pivotal program for the atrial-fixation AltaValve in severe MR.
Study overview
| Device | AltaValve |
|---|---|
| Intervention | TMVR |
| Comparator | None (single-arm pivotal) |
| Population | Severe MR |
| Risk group | High risk |
| Sample size | not fully extracted |
| Enrollment | 2024–ongoing |
| Follow-up | ongoing |
| Trial type | Single-arm pivotal |
Inclusion criteria
—
Primary endpoint
Safety / performance.
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
Current pivotal path for AltaValve.
Clinical pearls
- Atrial fixation could suit MAC and LVOT-constrained anatomy.
Limitations
- Not yet reporting
ENCIRCLE SAPIEN M3 System Transcatheter Mitral Valve Replacement via Transseptal Access ENCIRCLE is the strongest evidence yet that fully percutaneous TMVR is becoming clinically scalable.
The first pivotal trial of a fully percutaneous transseptal TMVR system: SAPIEN M3 achieved very low 30-day mortality, near-complete MR elimination, and a 1-year event rate well below the performance goal — leading to CE-mark and FDA approval.
Study overview
| Device | Edwards SAPIEN M3 (dock + balloon-expandable valve) |
|---|---|
| Intervention | Transseptal TMVR |
| Comparator | Prespecified performance goal (single-arm) |
| Population | Symptomatic MR ≥3+ unsuitable for surgery or TEER |
| Risk group | High risk / unsuitable for repair |
| Sample size | 299 (287 implanted) |
| Enrollment | 2019–2025 |
| Follow-up | 1 year |
| Trial type | Prospective single-arm, pivotal |
Inclusion criteria
—
Primary endpoint
Non-hierarchical composite of all-cause mortality and HF rehospitalization at 1 year, vs a performance goal of 45%.
Secondary endpoints
- 30-day mortality
- MR ≤1+
- NYHA / quality of life
- Gradient
Key results
- Primary composite 25.2% vs 45% goal (P<0.0001)
- 30-day mortality 0.7% (STS predicted 6.6%)
- MR ≤1+ in ~96% at 30 days and 1 year; durable symptom/QoL improvement
Why this trial matters
Major contemporary TMVR milestone; supported CE-mark (Apr 2025) and FDA approval (Dec 2025).
Clinical pearls
- First transseptal TMVR approved in the US — a genuine access-route breakthrough.
- Reserved for anatomies unsuitable for TEER; not a TEER replacement.
Limitations
- Single-arm vs a performance goal
- Selected non-surgical / non-TEER anatomy
AltaValve EFS ⚠ AltaValve Atrial-Fixation TMVR Early Feasibility Study AltaValve may broaden TMVR candidacy by reducing LVOT constraints.
A supra-annular, atrial-fixation TMVR designed to minimize LVOT interaction; early and MAC-focused reports suggest low LVOT obstruction, durable MR reduction, and good gradients.
Study overview
| Device | AltaValve (atrial-fixation, supra-annular) |
|---|---|
| Intervention | TMVR |
| Comparator | None (single-arm) |
| Population | Severe MR, including MAC-enriched anatomies |
| Risk group | High risk |
| Sample size | early feasibility cohorts |
| Enrollment | 2020s |
| Follow-up | 6 months / 1 year |
| Trial type | Prospective single-arm (EFS) |
Inclusion criteria
—
Primary endpoint
Safety and hemodynamic performance.
Secondary endpoints
—
Key results
- Low LVOT interaction reported
- Durable MR reduction and good gradients in early cohorts
Why this trial matters
Innovative atrial-fixation concept; still investigational.
Clinical pearls
- Atrial-only fixation is designed to avoid the LVOT and subvalvular apparatus.
Limitations
- Small cohorts
- NCT unconfirmed here
SUMMIT ⚠ Clinical Trial to Evaluate the Safety and Effectiveness of the Tendyne TMVR System The key replacement trial for anatomies unsuitable for repair.
The Tendyne US pivotal program, including a randomized TEER-comparison arm and a mitral annular calcification (MAC) cohort; the MAC data supported Tendyne's 2025 FDA approval.
Study overview
| Device | Abbott Tendyne |
|---|---|
| Intervention | Transapical TMVR |
| Comparator | TEER or surgery strata; plus MAC single-arm cohort |
| Population | Symptomatic MR and TMVR-suitable MAC cohorts |
| Risk group | High risk / unsuitable for repair |
| Sample size | not fully extracted |
| Enrollment | 2018–ongoing |
| Follow-up | ongoing |
| Trial type | Randomized + single-arm pivotal |
Inclusion criteria
—
Primary endpoint
Safety and effectiveness of Tendyne in a pivotal framework.
Secondary endpoints
—
Key results
- MAC cohort supported FDA approval (2025)
- Randomized TEER-comparison results nuanced; full reporting evolving
Why this trial matters
Highest-profile Tendyne pivotal program.
Clinical pearls
- Approval landed first for MAC/unsuitable-for-TEER anatomy, not broad MR.
Limitations
- Complex multi-arm design
- Full randomized results still maturing
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
APOLLO Transcatheter Mitral Valve Replacement With the Intrepid System (APOLLO) Probably the most important ongoing dedicated-TMVR pivotal trial.
The flagship Medtronic Intrepid pivotal program, with a randomized surgical-comparison cohort and a single-arm nonsurgical cohort — probably the most important ongoing dedicated-TMVR trial.
Study overview
| Device | Medtronic Intrepid |
|---|---|
| Intervention | TMVR |
| Comparator | Surgery (randomized cohort) / single-arm nonsurgical |
| Population | Severe symptomatic MR unsuitable for approved repair or across surgical-risk strata |
| Risk group | Variable |
| Sample size | large pivotal target |
| Enrollment | 2017–ongoing |
| Follow-up | multi-year |
| Trial type | Randomized + single-arm pivotal |
Inclusion criteria
—
Primary endpoint
Pivotal safety/effectiveness.
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
Flagship Medtronic pivotal TMVR program.
Clinical pearls
- A positive randomized cohort would be a landmark for replacement.
Limitations
- Not yet reporting
APOLLO-EU / APOLTA Intrepid Transfemoral System in Severe Symptomatic MR (APOLLO-EU) Important for broader transseptal / intended-use anatomies.
European expansion of the transfemoral Intrepid program in symptomatic MR or MAC unsuitable for approved repair or surgery.
Study overview
| Device | Medtronic Intrepid (transfemoral) |
|---|---|
| Intervention | Transseptal TMVR |
| Comparator | None (single-arm) |
| Population | Symptomatic MR or MAC unsuitable for approved repair/surgery |
| Risk group | High risk |
| Sample size | not fully extracted |
| Enrollment | 2022–ongoing |
| Follow-up | ongoing |
| Trial type | Single-arm |
Inclusion criteria
—
Primary endpoint
Safety / effectiveness.
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
Broadens transseptal Intrepid evidence.
Clinical pearls
- Complements APOLLO for intended-use anatomies.
Limitations
- Not yet reporting
Mitral Valve-in-Valve / Ring / MAC5
LAMPOON IDE Intentional Laceration of the Anterior Mitral Leaflet to Prevent LVOT Obstruction During TMVR LAMPOON expanded TMVR eligibility for anatomies otherwise excluded by LVOT risk.
A TMVR-enabling technique that lacerates the anterior mitral leaflet to prevent LVOT obstruction; the IDE study achieved 100% procedure survival with acceptable LVOT gradients.
Study overview
| Device | LAMPOON technique + SAPIEN-based TMVR |
|---|---|
| Intervention | Leaflet laceration + TMVR |
| Comparator | None (single-arm) |
| Population | Valve-in-ring and native MAC at prohibitive LVOT-obstruction risk |
| Risk group | Prohibitive (LVOT risk) |
| Sample size | 30 |
| Enrollment | 2017–2018 |
| Follow-up | 30 days |
| Trial type | Prospective single-arm (IDE) |
Inclusion criteria
—
Primary endpoint
Procedure survival with successful LAMPOON/TMVR and acceptable LVOT gradient.
Secondary endpoints
- Stroke
- 30-day survival
- LVOT gradient
Key results
- 100% procedure survival; 30-day survival 93%; no strokes
Why this trial matters
Essential TMVR-enabling adjunctive study.
Clinical pearls
- Makes otherwise-excluded ViR/ViMAC anatomies treatable.
- A procedural technique, not a device — pairs with balloon-expandable TMVR.
Limitations
- Small single-arm
- Technically demanding
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
SAPIEN 3 MViV Registry ⚠ One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Valve (STS/ACC-TVT) Registry data strongly support MViV as the leading TMVR niche.
Real-world registry outcomes for SAPIEN 3 mitral valve-in-valve show high technical success and low 30-day and 1-year mortality.
Study overview
| Device | Edwards SAPIEN 3 |
|---|---|
| Intervention | Mitral valve-in-valve |
| Comparator | Registry |
| Population | Failed mitral bioprostheses |
| Risk group | High risk |
| Sample size | registry cohort |
| Enrollment | 2015–2019 |
| Follow-up | 1 year |
| Trial type | Registry |
Inclusion criteria
—
Primary endpoint
Registry-based effectiveness (mortality, MR/gradient).
Secondary endpoints
—
Key results
- High technical success
- Low 30-day and 1-year mortality
Why this trial matters
Reinforced real-world MViV adoption.
Clinical pearls
- Registry breadth complements the smaller prospective PARTNER 3 MViV cohort.
Limitations
- Non-randomized registry
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
MITRAL II MITRAL II Pivotal Trial (Valve-in-MAC) ViMAC remains the 'last frontier' re-replacement indication.
A dedicated pivotal attempt to formalize evidence for transcatheter mitral replacement in severe mitral annular calcification — the highest-risk re-replacement indication.
Study overview
| Device | Edwards SAPIEN 3 |
|---|---|
| Intervention | Valve-in-MAC |
| Comparator | None (single-arm pivotal) |
| Population | Severe symptomatic MAC, prohibitive surgical risk |
| Risk group | Prohibitive risk |
| Sample size | not fully extracted |
| Enrollment | 2020–ongoing |
| Follow-up | ongoing |
| Trial type | Single-arm pivotal |
Inclusion criteria
—
Primary endpoint
Safety / effectiveness.
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
Dedicated attempt to formalize ViMAC evidence.
Clinical pearls
- LVOT obstruction and paravalvular leak are the key ViMAC challenges.
Limitations
- Not yet reporting
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
MITRAL Mitral Implantation of Transcatheter Valves ViV is mature; ViR is feasible but harder; ViMAC remains highest-risk.
The foundational prospective dataset for transcatheter mitral re-replacement across three use-cases — failed surgical valves, rings, and severe mitral annular calcification.
Study overview
| Device | Edwards SAPIEN XT / SAPIEN 3 |
|---|---|
| Intervention | Valve-in-valve / ring / MAC |
| Comparator | None (single-arm, arm-specific) |
| Population | Failing surgical mitral prostheses, rings, or severe MAC |
| Risk group | High / prohibitive |
| Sample size | arm-specific cohorts |
| Enrollment | 2015–ongoing |
| Follow-up | 1 year (arm-specific) |
| Trial type | Prospective single-arm |
Inclusion criteria
—
Primary endpoint
Feasibility / safety across ViV, ViR, and ViMAC.
Secondary endpoints
- Mortality by arm
- Residual gradient / MR
- LVOT obstruction
Key results
- Feasibility established across all three use-cases
- ViMAC carried the highest mortality and technical risk
Why this trial matters
Foundational transcatheter mitral re-replacement dataset.
Clinical pearls
- Risk gradient: ViV < ViR < ViMAC.
- ViMAC LVOT obstruction risk drives LAMPOON and dedicated ViMAC trials.
Limitations
- Single-arm
- Small arm-specific cohorts
Serial follow-ups & subanalyses 5
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Transcatheter Mitral Valve Replacement inNativeMitral
Transatrial implantation of a transcatheter
Valve-in-valve arm — 1-year
PARTNER 3 MVIV PARTNER 3 Trial — Mitral Valve-in-Valve Transseptal MViV with SAPIEN 3 is now a highly credible alternative in failing bioprostheses.
A prospective transseptal SAPIEN 3 mitral valve-in-valve cohort in failing surgical bioprostheses recorded no death or stroke through 1 year, with good hemodynamics.
Study overview
| Device | Edwards SAPIEN 3 |
|---|---|
| Intervention | Transseptal mitral valve-in-valve |
| Comparator | None (single-arm) |
| Population | Failing surgical mitral bioprostheses, intermediate surgical risk |
| Risk group | Intermediate risk |
| Sample size | 50 |
| Enrollment | 2018–2021 |
| Follow-up | 1 year |
| Trial type | Prospective single-arm |
Inclusion criteria
—
Primary endpoint
Composite of all-cause mortality and stroke at 1 year.
Secondary endpoints
- Residual gradient / MR
- NYHA / quality of life
Key results
- No primary endpoint events through 1 year
- Good hemodynamics and symptom improvement
Why this trial matters
Best contemporary prospective MViV dataset.
Clinical pearls
- Transseptal access is now standard for mitral ViV.
- Watch residual gradients in small surgical valves.
Limitations
- Single-arm
- Small sample
- Selected bioprosthetic failures
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