Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting at 21 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

228 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new heart valve replacement device for patients with tricuspid valve problems. The device replaces the damaged valve to improve heart function.

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 data supports the effectiveness of the treatment Edwards EVOQUE Tricuspid Valve Replacement System for tricuspid regurgitation?

The EVOQUE system has shown promising results in early studies, with patients experiencing improved heart valve function and uneventful recovery up to 18 months after the procedure. It is considered a potential solution for patients at high risk for traditional surgery, offering a less invasive option with positive short-term outcomes. ^{1 2 3 4 5}

Is the Edwards EVOQUE Tricuspid Valve Replacement System safe for humans?

The Edwards EVOQUE Tricuspid Valve Replacement System has been studied for safety in humans, showing positive short-term and midterm outcomes. In one study, patients experienced uneventful recovery and well-functioning valve performance up to 18 months after the procedure, indicating it is generally safe. ^{1 2 3 4 6}

How is the Edwards EVOQUE Tricuspid Valve Replacement System treatment different from other treatments for tricuspid regurgitation?

The Edwards EVOQUE Tricuspid Valve Replacement System is unique because it is a transcatheter procedure, meaning it is done through a small incision in the leg (transfemoral), which is less invasive than traditional open-heart surgery. This makes it a suitable option for patients who are at high risk for surgery or not eligible for other repair methods. ^{2 3 4 5 7}

Research Team

Susheel Kodali, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System: A Multicenter, Observational, First-in-Human Experience. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Transfemoral Transcatheter Tricuspid Valve Replacement Using the EVOQUE System in an Octogenarian for Severe Tricuspid Valve Regurgitation. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term follow-up after trans-catheter tricuspid valve-in-valve replacement with balloon-expandable aortic valves. [2017]

6. France pubmed.ncbi.nlm.nih.gov

Percutaneous Edwards SAPIEN valve implantation in the tricuspid position: case report and review of literature. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric Tricuspid Valve Replacement With Transcatheter Bioprosthetic Valve: An Alternative Option in High-Risk Patients. [2021]