What side effects are associated with this type of intervention?

The most common treatments for Tricuspid Valve Regurgitation, particularly valve replacement procedures like the Edwards EVOQUE Tricuspid Valve Replacement System, can have several side effects. These include surgical risks such as infection, bleeding, and thromboembolic events. Specific complications related to the valve replacement may involve valve malfunction, paravalvular leak, and issues with valve positioning. Long-term risks include valve degeneration and the potential need for reoperation.

What prior FDA approvals exist?

As of now, there have been limited FDA approvals specifically for tricuspid valve replacement systems. Traditional treatments for tricuspid valve regurgitation have included medical management with diuretics and other heart failure medications, as well as surgical interventions such as tricuspid valve repair or replacement using bioprosthetic or mechanical valves. The Edwards EVOQUE Tricuspid Valve Replacement System represents a newer, investigational approach aimed at improving valve function through transcatheter valve replacement, which is currently being studied for safety and performance.

What other types of research exist?

Promising novel alternatives to the Edwards EVOQUE Tricuspid Valve Replacement System for treating Tricuspid Valve Regurgitation in 2024 include: 1) The Cardioband Tricuspid System, which offers an adjustable annuloplasty solution for tricuspid valve repair. 2) The TriClip device, a transcatheter edge-to-edge repair system specifically designed for the tricuspid valve. 3) The PASCAL Tricuspid Valve Repair System, which provides a minimally invasive option for tricuspid valve repair. These alternatives have shown positive outcomes in clinical trials and are expected to be viable options for patients by 2024.

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Transcatheter Valve Replacement

Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation

N/A

Waitlist Available

Led By Susheel Kodali, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic despite medical therapy or prior HF hospitalization from TR

Be older than 18 years old

Must not have

Tricuspid valve anatomic contraindications

Hemodynamic instability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days, 6 months, 12 months, annual for five years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include bleeding, infection at the catheter insertion site, irregular heartbeats, kidney problems, stroke, or device-related complications like dislodgement or malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My blood pressure and heart rate are stable.

Select...

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

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My heart failure needs advanced treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 6 months, 12 months, annual for five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 6 months, 12 months, annual for five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 6 months, 12 months, annual for five years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freedom from device or procedure-related adverse events [Time Frame: 30 days]

Secondary study objectives

Health Status - KCCQ

Health Status - SF-36

NYHA Functional Class

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Tricuspid Valve Regurgitation (TVR) occurs when the tricuspid valve fails to close properly, causing blood to flow backward into the right atrium. The most common treatment, particularly in severe cases, is tricuspid valve replacement. This procedure involves replacing the dysfunctional valve with a prosthetic one, which restores proper valve function and prevents regurgitation. The Edwards EVOQUE Tricuspid Valve Replacement System, for example, is designed to improve valve function by ensuring a tight seal and reducing the backward flow of blood. This is crucial for TVR patients as it alleviates symptoms such as fatigue and swelling, improves heart function, and reduces the risk of complications like heart failure.