Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation

Not currently recruiting at 22 trial locations

Overseen By TMTT Clinical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Tricuspid valve contraindications, Hemodynamic instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for tricuspid regurgitation, a condition where the heart's tricuspid valve doesn't close properly, causing blood flow issues. The study tests the safety and effectiveness of the Edwards EVOQUE Tricuspid Valve Replacement System, a device designed to replace the faulty valve without traditional surgery. Suitable candidates for this trial have moderate or severe symptoms despite medication or have been hospitalized for heart failure related to their condition. Participants must not require immediate heart surgery or have certain heart valve issues. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for tricuspid regurgitation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Edwards EVOQUE Tricuspid Valve Replacement System is safe?

Research has shown that the Edwards EVOQUE Tricuspid Valve Replacement System has been tested for safety and effectiveness in individuals with severe tricuspid regurgitation, a condition where the heart valve fails to close properly, causing blood to flow backward. In one study, some side effects occurred, mostly during the procedure. About 13.8% of issues appeared within two days, and 6.9% within three months after the procedure.

Despite some side effects, the treatment improved the health of many patients, with a significant number experiencing no remaining tricuspid regurgitation one year later. This suggests the treatment can be effective, but potential risks should be considered. Prospective trial participants should consult their doctor to understand what this might mean for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Edwards EVOQUE Tricuspid Valve Replacement System is unique because it offers a minimally invasive approach to treating tricuspid regurgitation, a condition where the heart's tricuspid valve does not close tightly, causing blood to flow backward. Unlike traditional surgical valve repair or replacement, which requires open-heart surgery, this system is delivered via a catheter, meaning it's less invasive and generally involves a shorter recovery time. Researchers are excited about this treatment because it could provide a safer and more effective option for patients who are not good candidates for surgery, potentially improving their quality of life with fewer complications.

What evidence suggests that the Edwards EVOQUE Tricuspid Valve Replacement System is effective for tricuspid regurgitation?

Research has shown that the Edwards EVOQUE Tricuspid Valve Replacement System, which participants in this trial will receive, effectively treats tricuspid regurgitation, a heart valve issue where blood flows in the wrong direction. In over 95% of patients, this treatment reduced the problem to a mild level or better. Early results indicate that this improvement persists, with 92% of patients experiencing a significant reduction immediately after the procedure. A large study involving more than 1,000 patients confirmed both the safety and effectiveness of this treatment in real-world situations. These consistent findings suggest that the EVOQUE system could be a promising option for those with severe tricuspid regurgitation. ^{2 3 5 6 7}

Who Is on the Research Team?

Susheel Kodali, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for people with a heart condition called tricuspid regurgitation who still have symptoms despite medication or have been hospitalized for heart failure. They must be considered suitable for a non-surgical valve replacement by their medical team, and not in need of urgent surgery or other cardiac procedures within the next year.

Inclusion Criteria

My heart team has approved me for a specific heart valve replacement procedure.

I still have symptoms despite treatment, or I was hospitalized for heart failure.

You have a moderate or severe problem with your tricuspid valve.

Exclusion Criteria

My heart's tricuspid valve has a physical issue preventing certain treatments.

My blood pressure and heart rate are stable.

I do not need any urgent surgery or have any planned heart surgery in the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Edwards EVOQUE Tricuspid Valve Replacement System

Up to 7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Edwards EVOQUE Tricuspid Valve Replacement System

Trial Overview The TRISCEND study is testing the safety and effectiveness of a new procedure called Transcatheter Tricuspid Valve Replacement using the Edwards EVOQUE system. It's done without open-heart surgery to see if it can help patients with tricuspid valve issues.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

Transcatheter tricuspid valve-in-valve (VIV) replacement using balloon-expandable valves showed significant improvements in heart function, including increased tricuspid valve area and reduced right atrial pressure, in a small group of 4 patients.

At a median follow-up of 32 months, all patients remained alive and experienced improved functional status, with low rates of complications and well-maintained valve performance, indicating the procedure's potential safety and efficacy for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up after trans-catheter tricuspid valve-in-valve replacement with balloon-expandable aortic valves. Scarsini, R., Lunardi, M., Pesarini, G., et al.[2017]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2401918

Transcatheter Valve Replacement in Severe Tricuspid ... Transcatheter tricuspid-valve replacement reduces tricuspid regurgitation to a level that is deemed to be mild or less in more than 95% of patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879825016176

Early Outcomes of Real-World Transcatheter Tricuspid ... The aim of this study was to investigate the real-world safety and efficacy of the EVOQUE TTVR system in patients with severe TR treated at 12 ...

3. businesswire.com businesswire.com/news/home/20251027759798/en/Successful-Patient-Outcomes-Demonstrated-With-Edwards-SAPIEN-M3-and-EVOQUE-Systems-New-Data-Presented-at-TCT-2025

Successful Patient Outcomes Demonstrated With Edwards' ... With data from 1,034 patients evaluated, findings from the EVOQUE TTVR system STS/ACC TVT Registry demonstrated a positive real-world safety ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2023.04.014

2-Year Outcomes Following Transcatheter Tricuspid Valve ... The early compassionate use report of the EVOQUE TTVR system showed TR reduction to ≤1+ intraprocedurally in 92% and maintained in 88% and 87% ...

5. edwards.com edwards.com/healthcare-professionals/products-services/transcatheter-mitral-tricuspid-technologies/evoque-tricuspid-valve-replacement-system

EVOQUE Tricuspid Valve Replacement System The TRISCEND II trial successfully met the composite primary safety and effectiveness endpoint at 1 year. 1 / 2 ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230013B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The EVOQUE system, as shown in Figure 1, is designed to replace the native tricuspid heart valve without open heart surgery and without ...

7. tctmd.com tctmd.com/news/sobering-adverse-event-rate-evoque-seen-real-world-use

'Sobering' Adverse Event Rate With Evoque Seen in Real- ... Three-quarters of these events were diagnosed during the procedure, with 13.8% and 6.9% found within 2 days and 3 months, respectively. Ten of ...