What side effects are associated with this type of intervention?

The most common side effects of transcatheter tricuspid valve repair, such as the Edwards PASCAL Transcatheter Repair System, include bleeding, infection, and vascular complications at the catheter insertion site. Other potential risks are arrhythmias, device embolization, and residual tricuspid regurgitation. Additionally, there may be procedural complications like valve leaflet damage or perforation, and in rare cases, stroke or myocardial infarction.

What prior FDA approvals exist?

The FDA has approved several transcatheter devices for the treatment of tricuspid regurgitation, focusing on minimally invasive approaches. One notable approval is the MitraClip, initially designed for mitral valve repair but also used off-label for tricuspid valve repair. The Edwards PASCAL Transcatheter Repair System is currently under investigation for its safety and effectiveness in treating symptomatic severe tricuspid regurgitation, representing a similar transcatheter approach aimed at reducing the risks associated with traditional surgical methods.

What other types of research exist?

Promising alternatives to the Edwards PASCAL Transcatheter Repair System for tricuspid regurgitation include the following: 1) The TriClip device by Abbott, which is a transcatheter edge-to-edge repair system similar to the MitraClip but designed for the tricuspid valve. 2) The Cardioband Tricuspid System by Edwards Lifesciences, which is an annuloplasty device that cinches the tricuspid annulus to reduce regurgitation. 3) The FORMA Repair System by Edwards Lifesciences, which uses a spacer to reduce the regurgitant orifice area. 4) The EVOQUE tricuspid valve replacement system by Edwards Lifesciences, which is a transcatheter valve replacement option currently under investigation.

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Transcatheter Valve Repair System

Edwards PASCAL System for Tricuspid Regurgitation (CLASP II TR Trial)

N/A

Recruiting

Led By Laura Davidson, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

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

Must have

Eighteen (18) years of age or older

New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months

Must not have

Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment

Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new device that fixes a leaky heart valve without surgery in patients who are too risky for traditional surgery. The device helps the valve close properly to stop blood from leaking backward. The first device specifically designed for this purpose is the paravalvular leak device (PLD - Occlutech).

Who is the study for?

This trial is for adults with severe tricuspid regurgitation, a heart valve disease causing symptoms or hospitalization despite medical treatment. Candidates must be at intermediate or higher risk for surgery complications as assessed by a Heart Team and willing to follow the study's procedures.

What is being tested?

The Edwards PASCAL Transcatheter Valve Repair System is being tested against Optimal Medical Therapy in patients with symptomatic severe tricuspid regurgitation who are not good candidates for surgery due to high risk of mortality.

What are the potential side effects?

Potential side effects may include bleeding, infection risks associated with catheter-based procedures, possible damage to the heart or vessels where the device is implanted, irregular heartbeats, and in rare cases stroke or death.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have moderate to severe heart issues or was hospitalized for heart failure in the last year.

Exclusion Criteria

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

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I had a leadless pacemaker for my heart implanted within the last 30 days.

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I haven't had heart infection or needed antibiotics for any infection in the last 2 weeks.

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I need oxygen regularly or all the time at home.

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I have serious heart issues that haven't been treated.

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I have a serious heart condition, such as cardiomyopathy or significant congenital heart disease.

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I have severe heart failure and may need a device or transplant.

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I have had a tricuspid valve repair or replacement that may affect new treatments.

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I have a severe narrowing of my neck arteries, treated or not.

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I have severe heart valve issues.

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I am currently experiencing bleeding in my digestive tract.

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I have had a stroke recently.

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My heart condition is not due to aging or wear and tear.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months 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, and Quality of Life improvement (measured by KCCQ score)

Secondary study objectives

1 Grade Reduction in TR Severity

All Cause Mortality

All cause mortality or the first heart failure hospitalization for patients with massive or torrential TR at baseline

+11 more

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 repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

Group II: Edwards PASCAL System & OMTExperimental Treatment1 Intervention

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Group III: Continued Access StudyExperimental Treatment1 Intervention

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

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

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

0 / 14Eligibility 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 treatments for tricuspid regurgitation, especially those similar to the Edwards PASCAL Transcatheter Repair System, involve transcatheter approaches to repair the tricuspid valve. These treatments work by using a catheter-based system to place a device that can either clip the leaflets of the tricuspid valve together or provide structural support to improve valve function. This minimally invasive approach is crucial for patients who are at intermediate or greater risk of mortality with traditional surgical methods. By reducing the regurgitation, these treatments help alleviate symptoms, improve heart function, and enhance the quality of life for patients with severe tricuspid regurgitation.