Tricuspid TEER9
MitraClip in TR (early) ⚠ Transcatheter Treatment of Severe Tricuspid Regurgitation With the Edge-to-Edge MitraClip Technique The proof-of-concept that launched tricuspid TEER, using the mitral clip off-label.
The foundational multicenter experience showing that edge-to-edge repair with the MitraClip could be applied to the tricuspid valve, reducing TR and improving symptoms and opening the T-TEER field.
Study overview
| Device | Abbott MitraClip (off-label) |
|---|---|
| Intervention | TEER |
| Comparator | None (observational) |
| Population | Severe symptomatic TR, high surgical risk |
| Risk group | High surgical risk |
| Sample size | 64 |
| Enrollment | 2015–2016 |
| Follow-up | 30 days |
| Trial type | Multicenter observational |
Inclusion criteria
—
Primary endpoint
Feasibility, procedural success, and TR reduction.
Secondary endpoints
—
Key results
- Procedural success with significant acute TR reduction
- Symptomatic improvement; established feasibility of the edge-to-edge concept in the tricuspid position
Why this trial matters
Opened the dedicated T-TEER field (TRILUMINATE, CLASP TR) that followed.
Clinical pearls
- Repurposing the mitral clip proved the anatomy was tractable before dedicated devices existed.
Limitations
- Off-label device
- Observational, no comparator
- Early-generation hardware
Serial follow-ups & subanalyses 3
Click a follow-up to reveal its paper links.
Impact of baseline tricuspid regurgitation
TRILUMINATE Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR (Single-Arm) Proved tricuspid TEER was feasible and safe, launching the modern T-TEER era.
The single-arm feasibility study that established transcatheter edge-to-edge repair of the tricuspid valve as feasible and safe, reducing TR and improving symptoms — the basis for CE mark.
Study overview
| Device | Abbott TriClip |
|---|---|
| Intervention | TEER |
| Comparator | None (single-arm) |
| Population | Moderate or greater symptomatic TR, high surgical risk |
| Risk group | High surgical risk |
| Sample size | 85 |
| Enrollment | 2017–2018 |
| Follow-up | 30 days, 1 year, 3 years |
| Trial type | Prospective single-arm, multicenter |
Inclusion criteria
—
Primary endpoint
Safety and reduction in TR severity.
Secondary endpoints
- NYHA class
- 6-minute walk
- Quality of life
- Right-heart remodeling
Key results
- Significant TR reduction with a strong safety profile
- Durable symptom and functional improvement through 3 years
Why this trial matters
First convincing tricuspid TEER dataset; led to CE mark (2020).
Clinical pearls
- Used the first-generation clip in a highly selected population.
Limitations
- Single-arm
- Selected anatomy
- First-generation device
Serial follow-ups & subanalyses 3
Click a follow-up to reveal its paper links.
TriValve Registry ⚠ International Multisite Transcatheter Tricuspid Valve Therapies (TriValve) Registry The registry that first suggested a survival signal for transcatheter TR therapy — later tempered by randomized data.
The landmark international registry of transcatheter tricuspid therapies; its propensity-matched comparison suggested a survival and heart-failure benefit of intervention over medical therapy, and its edge-to-edge subset defined early real-world TEER outcomes.
Study overview
| Device | Multiple (MitraClip/PASCAL TEER, Cardioband, others) |
|---|---|
| Intervention | Transcatheter tricuspid intervention |
| Comparator | Medical therapy (propensity-matched) |
| Population | Severe symptomatic TR |
| Risk group | High surgical risk |
| Sample size | 472 vs 1,179 (matched) |
| Enrollment | 2016–2018 |
| Follow-up | 1–2 years |
| Trial type | International registry / propensity-matched |
Inclusion criteria
—
Primary endpoint
Survival and heart-failure rehospitalization vs medical therapy.
Secondary endpoints
—
Key results
- Transcatheter intervention associated with improved survival and fewer HF hospitalizations vs matched medical therapy
- Edge-to-edge subset: 1-year TR ≤2+ in ~72%, NYHA ≤II in ~69%
Why this trial matters
Framed the rationale for randomized T-TEER trials; benefit later only partly confirmed by TRILUMINATE Pivotal.
Clinical pearls
- Registry survival signal exceeded what the randomized trials later showed — selection bias matters.
Limitations
- Non-randomized
- Propensity-matched
- Device-heterogeneous
Serial follow-ups & subanalyses 11
Click a follow-up to reveal its paper links.
Which patients are treated
Mid-term (all devices)
Conduction/pacemaker
Impact of Massive or Torrential
Transcatheter Tricuspid Valve Intervention in
Right VentricularPulmonary Arterial Coupling and
Mitral regurgitation evolution after transcatheter
Effects of tricuspid transcatheter edgetoedge
TRIVALVE Score A Risk Score
TRILUMINATE Pivotal TRILUMINATE Pivotal Trial of Tricuspid TEER vs Medical Therapy Established tricuspid TEER as an FDA-approved therapy; benefit is real but largely symptomatic/QoL.
The first randomized tricuspid TEER trial: TriClip beat medical therapy on a hierarchical composite driven mainly by quality-of-life improvement, with excellent safety and durable TR reduction — the basis for FDA approval.
Study overview
| Device | Abbott TriClip |
|---|---|
| Intervention | TEER |
| Comparator | Guideline-directed medical therapy |
| Population | Severe symptomatic TR, intermediate-or-greater surgical risk |
| Risk group | Intermediate+ surgical risk |
| Sample size | 350 (175 / 175) + single-arm |
| Enrollment | 2019–2021 |
| Follow-up | 1 and 2 years |
| Trial type | Randomized, open-label |
Inclusion criteria
—
Primary endpoint
Hierarchical composite (win ratio) of death/tricuspid surgery, HF hospitalization, and KCCQ change at 1 year.
Secondary endpoints
- TR grade ≤moderate
- KCCQ
- NYHA / 6-minute walk
- Safety (MAE)
Key results
- Win ratio 1.48 (95% CI 1.06–2.13, P=0.02), driven by quality of life
- TR reduced to moderate-or-less in ~90% at 30 days, sustained at 1 year
- >98% free from major adverse events at 30 days
- No significant reduction in death or HF hospitalization
Why this trial matters
Practice-changing: basis for FDA approval of TriClip (April 2024).
Clinical pearls
- Benefit is predominantly symptomatic/QoL — counsel expectations accordingly.
- TR reduction is durable and the procedure is remarkably safe.
Limitations
- Open-label
- Composite driven by KCCQ, not hard outcomes
Serial follow-ups & subanalyses 7
Click a follow-up to reveal its paper links.
Transcatheter EdgetoEdge Repair inPatients With
Imaging / cardiac remodeling substudy
CLASP TR EFS Edwards PASCAL Tricuspid Repair System Early Feasibility Study PASCAL is the second viable tricuspid TEER platform.
Early feasibility of the PASCAL system for tricuspid TEER, showing durable TR reduction and functional improvement — the PASCAL counterpart to the TriClip program.
Study overview
| Device | Edwards PASCAL / PASCAL Ace |
|---|---|
| Intervention | TEER |
| Comparator | None (single-arm) |
| Population | Severe symptomatic TR, high surgical risk |
| Risk group | High surgical risk |
| Sample size | early feasibility cohort |
| Enrollment | 2019–2021 |
| Follow-up | 30 days, 1 year, 2 years |
| Trial type | Prospective single-arm (EFS) |
Inclusion criteria
—
Primary endpoint
Safety and performance / TR reduction.
Secondary endpoints
- TR grade
- NYHA / 6-minute walk
- KCCQ
Key results
- Durable TR reduction and functional improvement with good safety
Why this trial matters
Feasibility basis for the PASCAL tricuspid pivotal (CLASP II TR).
Clinical pearls
- Independent leaflet grasping and a central spacer suit large tricuspid gaps.
Limitations
- Single-arm
- Small cohort
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
bRIGHT ⚠ Real-World Outcomes of Tricuspid TEER With TriClip (bRIGHT Study) Real-world data confirm the safety and TR-reduction seen in the randomized trials.
A European post-market registry showing that tricuspid TEER reduces TR safely and durably across a broad range of real-world anatomies and centers.
Study overview
| Device | Abbott TriClip / TriClip G4 |
|---|---|
| Intervention | TEER |
| Comparator | Registry |
| Population | Severe symptomatic TR in routine practice |
| Risk group | Mixed / high risk |
| Sample size | registry cohort |
| Enrollment | 2020–2023 |
| Follow-up | 30 days, 1 year, 2 years |
| Trial type | Prospective post-market registry |
Inclusion criteria
—
Primary endpoint
Real-world safety and TR reduction.
Secondary endpoints
- NYHA / KCCQ
- Durability
- Procedural success
Key results
- Significant, durable TR reduction across broad anatomies
- Safety consistent with the randomized trials
Why this trial matters
Provides generalizability for the RCT findings.
Clinical pearls
- Broader/less-selected patients and centers than TRILUMINATE.
Limitations
- Non-randomized registry
- Shorter-term outcomes
Serial follow-ups & subanalyses 5
Click a follow-up to reveal its paper links.
Characterization of Tricuspid Valve Anatomy
Outcomes of tricuspid transcatheter edgetoedge
Bivalirudin Versus Heparin in Low
TRI-FR Multicentric Randomized Evaluation of Tricuspid TEER in Severe Secondary TR (Tri.Fr) Independent randomized confirmation that tricuspid TEER improves symptoms and functional status.
A French/Belgian investigator-led RCT: tricuspid TEER plus medical therapy improved a clinical composite (symptoms, TR, functional status) versus medical therapy alone — the second positive randomized T-TEER trial.
Study overview
| Device | Abbott TriClip G4 |
|---|---|
| Intervention | TEER + GDMT |
| Comparator | GDMT alone |
| Population | Severe isolated secondary TR, ineligible for surgery |
| Risk group | High surgical risk |
| Sample size | 300 |
| Enrollment | 2021–2023 |
| Follow-up | 1 year |
| Trial type | Randomized, open-label |
Inclusion criteria
—
Primary endpoint
Packer clinical composite score (improved / unchanged / worse) at 1 year.
Secondary endpoints
- Patient global assessment
- TR grade
- 6-minute walk
- KCCQ
Key results
- Composite improvement 74.6% (TEER) vs 39.5% (GDMT); effect estimate 0.68 (P<0.0001)
- Technical success 97.3%; in-hospital mortality 0.6%
- Most patients required 2 devices
Why this trial matters
Sponsor-independent confirmation of TRILUMINATE Pivotal's QoL/functional benefit.
Clinical pearls
- Government-funded trial — reduces industry-sponsorship concerns.
- Reinforces that the benefit is symptomatic/functional.
Limitations
- Open-label
- Composite is symptom/QoL-weighted
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
EuroTR Registry European Real-World Registry of Transcatheter Leaflet Repair for Tricuspid Regurgitation (EuroTR) The biggest real-world European T-TEER dataset — generalizes the trial findings across both devices.
A large European real-world registry of tricuspid leaflet-repair (TEER) with both MitraClip and PASCAL, confirming durable TR reduction and symptom benefit across routine practice, and identifying residual TR as a key prognostic marker.
Study overview
| Device | MitraClip and PASCAL |
|---|---|
| Intervention | TEER (leaflet repair) |
| Comparator | Registry |
| Population | Severe symptomatic TR in routine practice |
| Risk group | Mixed / high risk |
| Sample size | large multicenter cohort |
| Enrollment | 2016–2023 |
| Follow-up | 30 days, 1 year |
| Trial type | Prospective multicenter registry |
Inclusion criteria
—
Primary endpoint
Real-world procedural success, TR reduction, and 1-year outcomes.
Secondary endpoints
—
Key results
- Durable TR reduction and symptom improvement across both devices
- Residual TR severity independently associated with 1-year outcome
Why this trial matters
Cross-device generalizability for T-TEER outside the pivotal trials.
Clinical pearls
- Includes both leaflet-repair platforms, unlike the device-specific pivotal trials.
Limitations
- Non-randomized registry
- Device-heterogeneous
Serial follow-ups & subanalyses 4
Click a follow-up to reveal its paper links.
Residual tricuspid regurgitation after tricuspid
Invasive Hemodynamics and Risk Stratification
CLASP II TR Edwards PASCAL Tricuspid Repair System Pivotal Trial The key pivotal that could bring PASCAL to FDA approval for tricuspid TEER.
The pivotal randomized trial of PASCAL tricuspid TEER plus medical therapy versus medical therapy — the trial that would confirm a second TEER platform for approval.
Study overview
| Device | Edwards PASCAL |
|---|---|
| Intervention | TEER + GDMT |
| Comparator | GDMT alone |
| Population | Severe symptomatic TR |
| Risk group | High surgical risk |
| Sample size | pivotal target |
| Enrollment | ongoing |
| Follow-up | 1 year+ |
| Trial type | Randomized |
Inclusion criteria
—
Primary endpoint
Safety/effectiveness vs medical therapy.
Secondary endpoints
—
Key results
- Pending — trial ongoing
Why this trial matters
Would establish PASCAL as an approved T-TEER option.
Clinical pearls
- Watch how PASCAL vs TriClip outcomes compare in tricuspid anatomy.
Limitations
- Not yet reporting
- NCT unconfirmed here
Tricuspid Transcatheter Replacement (TTVR)3
TRISCEND II Edwards EVOQUE Tricuspid Valve Replacement Pivotal Trial EVOQUE is the first FDA-approved tricuspid replacement, with the strongest win ratio in the field.
The first randomized TTVR trial: EVOQUE plus medical therapy was superior to medical therapy on a hierarchical composite (win ratio ~2.0), with near-complete TR elimination — basis for the first FDA-approved tricuspid replacement.
Study overview
| Device | Edwards EVOQUE |
|---|---|
| Intervention | TTVR + GDMT |
| Comparator | Optimal medical therapy |
| Population | Severe or torrential TR, symptomatic |
| Risk group | High surgical risk |
| Sample size | 400 (392 randomized) |
| Enrollment | 2021–2023 |
| Follow-up | 6 months primary; 1 year |
| Trial type | Randomized, open-label |
Inclusion criteria
—
Primary endpoint
Hierarchical composite (win ratio) of death, RVAD/transplant, tricuspid intervention, HF hospitalization, KCCQ, NYHA, and 6-minute walk at 1 year.
Secondary endpoints
- TR grade ≤mild
- KCCQ
- NYHA / 6-minute walk
- Safety (MAE)
Key results
- Win ratio 2.02 (95% CI 1.56–2.62, P<0.001) favoring EVOQUE
- ~95–99% achieved TR ≤mild
- More new pacemakers and bleeding with EVOQUE
Why this trial matters
Basis for the first FDA-approved transcatheter tricuspid replacement (Feb 2024).
Clinical pearls
- Largest treatment effect in tricuspid trials — but weigh pacemaker/anticoagulation trade-offs.
- Approved without an FDA advisory panel, on a prespecified 6-month analysis of the first 150 patients.
Limitations
- Open-label
- Pacemaker and bleeding risk
- Composite includes softer endpoints
Serial follow-ups & subanalyses 7
Click a follow-up to reveal its paper links.
TRISCEND II Novel Randomized Trial
Outcomes by baseline TR severity
LuX-Valve LuX-Valve / LuX-Valve Plus Transcatheter Tricuspid Replacement Program A distinct TTVR design worth tracking as it moves toward transfemoral delivery and wider study.
A non-radial-force tricuspid replacement anchored to the interventricular septum; early (mainly Chinese) experience shows high TR elimination, with transfemoral (LuX-Valve Plus) iterations advancing.
Study overview
| Device | Jenscare LuX-Valve / LuX-Valve Plus |
|---|---|
| Intervention | Transcatheter tricuspid replacement |
| Comparator | None (single-arm) |
| Population | Severe symptomatic TR, high surgical risk |
| Risk group | High surgical risk |
| Sample size | not fully extracted |
| Enrollment | 2020-2021 |
| Follow-up | ongoing |
| Trial type | Single-arm / early studies |
Inclusion criteria
—
Primary endpoint
Safety and TR reduction.
Secondary endpoints
—
Key results
- High TR elimination in early series; broader/Western data still limited
Why this trial matters
Septal-anchoring design avoids radial force on the annulus.
Clinical pearls
- LuX-Valve Plus moves to transjugular/transfemoral delivery.
Limitations
- Limited Western data
Serial follow-ups & subanalyses 2
Click a follow-up to reveal its paper links.
TVT Registry — TTVR ⚠ Real-World Outcomes of Transcatheter Tricuspid Valve Replacement: Analysis From the STS/ACC TVT Registry Real-world confirmation that TTVR translates from trial to routine US practice — with lower-than-trial pacemaker and bleeding rates.
The first US real-world report of commercial EVOQUE tricuspid replacement — 1,034 consecutive patients in the first year after FDA approval — showing near-complete TR elimination and rapid health-status improvement, with 30-day outcomes consistent with (and pacemaker/bleeding rates lower than) the TRISCEND II trial.
Study overview
| Device | Edwards EVOQUE |
|---|---|
| Intervention | Transcatheter tricuspid replacement (commercial) |
| Comparator | None (registry) |
| Population | Severe symptomatic TR undergoing commercial TTVR |
| Risk group | Older, medically complex (mean age 77; 69% female) |
| Sample size | 1,034 (82 US centers) |
| Enrollment | Feb 2024–Mar 2025 |
| Follow-up | 30 days |
| Trial type | Retrospective real-world registry |
Inclusion criteria
—
Primary endpoint
30-day clinical, echocardiographic, and health-status (KCCQ) outcomes.
Secondary endpoints
- TR reduction to ≤mild
- New pacemaker implantation
- Bleeding
- Procedural success
Key results
- High procedural success with near-complete TR elimination
- Rapid, significant KCCQ health-status improvement at 30 days
- New-pacemaker and bleeding rates lower than in the randomized trials
- 30-day outcomes consistent with TRISCEND II
Why this trial matters
First large-scale real-world validation of EVOQUE after US approval; supports generalizability of the pivotal-trial findings.
Clinical pearls
- Real-world pacemaker/bleeding rates ran below the trial — reassuring as adoption widens.
- Only 30-day data so far; durability and 1-year outcomes are the next question.
Limitations
- Retrospective, no comparator
- 30-day follow-up only
- Early adopter centers
Tricuspid Annuloplasty2
SCOUT ⚠ Percutaneous Tricuspid Valve Annuloplasty System for Symptomatic Chronic Functional TR (Trialign) An early proof-of-concept for suture-based tricuspid annuloplasty.
An early feasibility study of the Trialign system, which plicates the annulus to mimic a surgical Kay bicuspidization, showing reduced annular area and TR.
Study overview
| Device | Mitralign Trialign |
|---|---|
| Intervention | Direct annuloplasty (bicuspidization) |
| Comparator | None (single-arm) |
| Population | Symptomatic chronic functional TR |
| Risk group | High surgical risk |
| Sample size | 15 (SCOUT I) |
| Enrollment | 2015–2016 |
| Follow-up | 30 days, 6 months |
| Trial type | Prospective single-arm (early feasibility) |
Inclusion criteria
—
Primary endpoint
Feasibility, safety, and annular/TR reduction.
Secondary endpoints
- Annular area
- TR grade
- 6-minute walk
- Quality of life
Key results
- Reduced annular area and TR with functional improvement
- Single-leaflet dehiscence observed in some patients
Why this trial matters
One of the first transcatheter tricuspid annuloplasty concepts.
Clinical pearls
- Recreates a surgical Kay-type annuloplasty percutaneously.
Limitations
- Very small
- Durability/dehiscence concerns
- Limited ongoing development
TRI-REPAIR TrIcuspid Regurgitation RePAIr With Cardioband Device Study Direct annuloplasty can remodel the tricuspid annulus, but the evidence base is smaller than TEER.
Direct transcatheter annuloplasty of the tricuspid annulus with Cardioband reduced annular size and TR with durable symptom improvement — a repair-based alternative to TEER and replacement.
Study overview
| Device | Edwards Cardioband (tricuspid) |
|---|---|
| Intervention | Direct annuloplasty |
| Comparator | None (single-arm) |
| Population | Symptomatic functional TR, high surgical risk |
| Risk group | High surgical risk |
| Sample size | 30 |
| Enrollment | 2016–2017 |
| Follow-up | 6 months, 1 year, 2 years |
| Trial type | Prospective single-arm, multicenter |
Inclusion criteria
—
Primary endpoint
Safety and annular/TR reduction.
Secondary endpoints
- Septolateral annular diameter
- TR grade
- NYHA / 6-minute walk
- KCCQ
Key results
- Significant annular reduction and TR improvement
- Durable functional gains through 2 years
Why this trial matters
CE-mark tricuspid annuloplasty option; leaflet- and anatomy-preserving.
Clinical pearls
- Preserves future TEER/replacement options.
- Right coronary artery course is a key procedural consideration.
Limitations
- Small single-arm
- Technically demanding
Serial follow-ups & subanalyses 4
Click a follow-up to reveal its paper links.
Cardioband TR EFS (US) — 30-day
Cardioband TR EFS (US) — 1-year
Tricuspid Heterotopic / Caval2
HOVER ⚠ Heterotopic Implantation of the SAPIEN Valve in the Inferior Vena Cava for Severe TR Proof-of-concept that an off-the-shelf valve in the IVC can palliate TR-related congestion.
A feasibility study implanting a balloon-expandable SAPIEN valve in the inferior vena cava to palliate right-heart congestion from severe TR in inoperable patients.
Study overview
| Device | Edwards SAPIEN (in IVC) |
|---|---|
| Intervention | Single-site caval valve implantation |
| Comparator | None (single-arm) |
| Population | Severe TR, inoperable / very high risk |
| Risk group | Prohibitive surgical risk |
| Sample size | 15 (planned) |
| Enrollment | 2015–2019 |
| Follow-up | 30 days, 6 months |
| Trial type | Prospective single-arm feasibility |
Inclusion criteria
—
Primary endpoint
30-day safety; 6-month symptom palliation.
Secondary endpoints
- NYHA class
- Congestion symptoms
Key results
- Feasible IVC implantation with symptom palliation in selected patients
Why this trial matters
Early demonstration of single-site caval valve implantation.
Clinical pearls
- Palliative — addresses congestion, not the tricuspid valve.
Limitations
- Very small
- Off-label device use
- Palliative intent
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
Trial design and rationale
TRICUS EURO Safety and Efficacy of the TricValve Transcatheter Bicaval Valves System (TRICUS EURO) Caval valve implantation palliates congestion when the valve itself can't be repaired or replaced.
A dedicated bicaval valve system (SVC + IVC) that treats the congestive consequences of severe TR rather than the valve itself; improved symptoms and quality of life at 6–12 months in high-risk patients — the basis for CE mark.
Study overview
| Device | P+F TricValve |
|---|---|
| Intervention | Bicaval valve implantation (CAVI) |
| Comparator | None (single-arm) |
| Population | Severe symptomatic TR, high surgical risk, significant caval backflow |
| Risk group | High surgical risk |
| Sample size | 35 (44 pooled with first-in-human) |
| Enrollment | 2019–2021 |
| Follow-up | 30 days, 6 months, 1 year |
| Trial type | Prospective single-arm, multicenter |
Inclusion criteria
—
Primary endpoint
30-day safety; 6-month quality-of-life and functional status.
Secondary endpoints
- NYHA class
- KCCQ
- Caval backflow
- Right-heart congestion markers
Key results
- Significant quality-of-life and functional improvement at 6–12 months
- Does not reduce true tricuspid TR — treats caval backflow/congestion
- Mortality aligned with baseline TRI-SCORE
Why this trial matters
Offers a palliative option for patients unsuitable for TEER or orthotopic replacement.
Clinical pearls
- Treats symptoms of congestion, not the regurgitation — set expectations accordingly.
- Useful when coaptation gaps or anatomy preclude TEER/replacement.
Limitations
- Small single-arm
- Does not correct TR
- Palliative intent
Serial follow-ups & subanalyses 1
Click a follow-up to reveal its paper links.
Tricuspid Frontier / Next-Gen Device1
TANDEM I (CroíValve) European Feasibility Study of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System A novel coaptation-valve concept to watch in the crowded tricuspid frontier.
An early feasibility study of a coaptation-valve system that anchors in the SVC and places a spacer at the tricuspid annulus — a hybrid concept between caval and orthotopic approaches.
Study overview
| Device | CroíValve DUO |
|---|---|
| Intervention | Transcatheter tricuspid coaptation valve |
| Comparator | None (single-arm) |
| Population | Severe symptomatic TR |
| Risk group | High surgical risk |
| Sample size | early feasibility |
| Enrollment | 2022–ongoing |
| Follow-up | ongoing |
| Trial type | Prospective single-arm (EFS) |
Inclusion criteria
—
Primary endpoint
Safety and performance.
Secondary endpoints
—
Key results
- Pending — early feasibility ongoing
Why this trial matters
Represents the diversity of next-generation tricuspid approaches.
Clinical pearls
- Combines a caval anchor with an annular coaptation element.
Limitations
- Very early stage
- Not yet reporting
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