What side effects are associated with this type of intervention?

Common side effects of tricuspid valve replacement procedures, such as those similar to the Edwards EVOQUE tricuspid valve replacement system, include surgical risks like infection, bleeding, and thromboembolic events. Specific complications related to the valve replacement can involve valve malfunction, paravalvular leak, and positioning issues. Long-term complications may include valve degeneration and the potential need for reoperation.

What prior FDA approvals exist?

FDA approvals for the treatment of Tricuspid Valve Disease have primarily focused on surgical interventions and transcatheter valve replacement systems. The Edwards EVOQUE tricuspid valve replacement system is an investigational device designed to replace a malfunctioning tricuspid valve, aiming to restore proper valve function. While specific FDA-approved drugs for tricuspid valve disease are limited, the focus has been on developing and approving devices that can be implanted via minimally invasive procedures to improve patient outcomes. Broader treatments for tricuspid valve disease include surgical repair or replacement and the use of medications to manage symptoms and underlying conditions.

What other types of research exist?

Promising alternatives to the Edwards EVOQUE tricuspid valve replacement system for tricuspid valve disease include: 1) The TriClip device, which is a transcatheter edge-to-edge repair system designed to treat tricuspid regurgitation. 2) The PASCAL transcatheter valve repair system, which offers a minimally invasive option for tricuspid valve repair. 3) The Cardioband tricuspid system, which is an adjustable annuloplasty device for tricuspid valve repair. These devices have shown positive outcomes in clinical trials and are expected to be viable options for patients in 2024.

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Tricuspid Valve Replacement System

Edwards EVOQUE System for Tricuspid Valve Disease

N/A

Recruiting

Led By James Gammie, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

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

Must have

TR graded as severe or greater

Symptomatic tricuspid regurgitation (TR) despite medical therapy

Must not have

Tricuspid valve anatomic contraindications

Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the Edwards EVOQUE system, which replaces a faulty heart valve. It targets patients with severe tricuspid regurgitation, a condition where the heart valve does not close properly. The new valve helps blood flow correctly through the heart, improving its function and reducing symptoms. The EVOQUE system has shown promise in initial studies for treating severe tricuspid regurgitation.

Who is the study for?

This trial is for individuals with severe symptoms of tricuspid regurgitation who haven't improved with medical therapy. Candidates should be suitable for a non-surgical valve replacement as determined by their heart care team. People are excluded if they have certain tricuspid valve issues, need urgent heart surgery, are hemodynamically unstable, require advanced treatment for heart failure, or are in another study.

What is being tested?

The TRISCEND II Pivotal Trial is testing the safety and effectiveness of the Edwards EVOQUE system which replaces the tricuspid valve without needing open-heart surgery against Optimal Medical Therapy alone in managing heart valve disease.

What are the potential side effects?

Potential side effects may include complications related to catheter insertion such as bleeding or infection, adverse reactions to materials in the device, irregular heartbeat patterns (arrhythmias), and possible deterioration of the new valve function over time.

Eligibility Criteria

Inclusion Criteria

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

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My condition is considered severe or worse.

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I have symptoms from a leaky tricuspid heart valve despite taking medication.

Exclusion Criteria

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

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

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I don't need urgent surgery or any heart surgery in the next year.

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My heart failure needs advanced treatment.

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My blood pressure and heart rate are stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement

Rate of Major Adverse Events (MAE)

TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement

Secondary study objectives

Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Single-Arm RegistryExperimental Treatment1 Intervention

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

Group II: Edwards EVOQUE System & OMTExperimental Treatment1 Intervention

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation

Group III: Continued Access StudyExperimental Treatment1 Intervention

Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.

Group IV: Optimal Medical Therapy (OMT)Active Control1 Intervention

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

0 / 6Eligibility 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

The most common treatment for severe Tricuspid Valve Disease, particularly when the valve is malfunctioning, is valve replacement. The Edwards EVOQUE tricuspid valve replacement system, for example, involves the surgical implantation of a new valve to replace the damaged one. This procedure restores proper valve function by ensuring unidirectional blood flow from the right atrium to the right ventricle, thereby preventing regurgitation and improving cardiac efficiency. This is crucial for patients as it alleviates symptoms such as fatigue, swelling, and liver congestion, and reduces the risk of heart failure and other complications associated with tricuspid valve dysfunction.