What side effects are associated with this type of intervention?

Common side effects of transcatheter mitral valve repair systems, such as the Edwards PASCAL Transcatheter Valve Repair System, include bleeding at the catheter insertion site, infection, arrhythmias, and potential damage to blood vessels. There is also a risk of stroke, kidney complications from contrast dye, and residual or recurrent mitral regurgitation. Complications related to anesthesia may also occur.

What prior FDA approvals exist?

The FDA has previously approved several transcatheter mitral valve repair systems for the treatment of mitral valve regurgitation. One notable example is the MitraClip device, which was approved for patients with significant symptomatic degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery. The MitraClip device works by clipping together a portion of the mitral valve leaflets to reduce regurgitation. Other related devices and therapies are continually being studied and developed to provide less invasive options for patients with mitral valve regurgitation.

What other types of research exist?

Promising alternatives to the Edwards PASCAL Transcatheter Valve Repair System for mitral valve regurgitation include the MitraClip system, which has been widely used and has a strong track record of safety and efficacy. Additionally, the Cardioband system, which allows for annular reduction and has shown positive outcomes in clinical trials, is another viable option. Both of these systems are expected to be significant options for patients in 2024.

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Transcatheter Valve Repair System

Transcatheter Valve Repair for Mitral Regurgitation (CLASP IID/IIF Trial)

N/A

Recruiting

Led By Robert Smith, 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

Elevated corrected BNP > 400 pg/ml or corrected NT-pro BNP of > 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)

Must not have

Severe COPD

Recent stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months; 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new device called Edwards PASCAL that fixes leaky heart valves without surgery. It is for patients who can't have surgery or haven't improved with other treatments. The device helps the valve close better, stopping blood from leaking backward.

Who is the study for?

This trial is for adults with severe mitral valve regurgitation who are at high risk for surgery. Candidates must be on stable heart medications, able to consent and comply with follow-up visits, have suitable valve morphology, and not be pregnant. Exclusions include prior mitral procedures (except some repairs), significant untreated coronary disease, recent stroke or DVT/PE, severe lung disease, or life expectancy under 12 months.

What is being tested?

The trial tests the Edwards PASCAL Transcatheter Valve Repair System against the Abbott MitraClip System in patients with degenerative or functional mitral regurgitation deemed too risky for surgery. It aims to establish safety and effectiveness of these minimally invasive heart valve repair options.

What are the potential side effects?

Potential side effects may include complications related to catheter insertion such as bleeding or infection, adverse reactions to anesthesia used during the procedure, damage to the heart valves from device placement or operation failure leading to inadequate reduction of regurgitation.

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 had heart failure or high heart stress levels recently.

Exclusion Criteria

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

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I have severe chronic obstructive pulmonary disease.

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I have had a stroke recently.

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I have active rheumatic heart disease.

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I have a severe narrowing in my neck arteries that hasn't been treated.

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My heart's mitral valve shape may not allow certain treatments.

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

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I have had surgery or a procedure on my mitral valve, but not for chord replacement or annuloplasty.

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I have severe heart valve issues needing surgery.

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I have had a recent blood clot in my leg or lung.

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I have severe heart failure needing advanced treatment like a heart pump or transplant.

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I have serious heart artery problems that haven't been treated.

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I need treatment for a severe heart valve problem.

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I have a severe heart valve problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months; 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months; 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months; 12 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Functional Improvement (increase in 6 minute walk test in meters)

Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through

Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Edwards PASCAL System - Single-Arm RegistryExperimental Treatment1 Intervention

Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.

Group II: Edwards PASCAL System - CLASP IIFExperimental Treatment1 Intervention

Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation

Group III: Edwards PASCAL System - CLASP IIDExperimental Treatment1 Intervention

Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation

Group IV: Abbott Mitraclip System - CLASP IIDActive Control1 Intervention

Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation

Group V: Abbott Mitraclip System - CLASP IIFActive Control1 Intervention

Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation

0 / 15Eligibility 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 Edwards PASCAL Transcatheter Valve Repair System and similar transcatheter repair systems work by addressing the backflow of blood in Mitral Valve Regurgitation (MVR) through minimally invasive means. These devices are inserted via a catheter to either clip the mitral valve leaflets together or provide structural support, improving valve function and reducing regurgitation. This approach is crucial for high-risk patients who cannot undergo traditional open-heart surgery, offering a safer alternative with faster recovery.