Transcatheter Valve Repair for Mitral Regurgitation

(CLASP IID/IIF Trial)

Recruiting at 89 trial locations

Overseen By Wally Omar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Edwards Lifesciences

Must be taking: Heart failure medications

Disqualifiers: Stroke, Severe COPD, Pregnancy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are in the CLASP IIF cohort, you must be on stable heart failure medications.

What data supports the effectiveness of the treatment for mitral regurgitation?

Research shows that the PASCAL transcatheter valve repair system is effective in treating mitral regurgitation, with studies reporting positive early results and extending treatment options for patients. The CLASP study and other real-world experiences have demonstrated its potential benefits in improving heart valve function. ^{1 2 3 4 5}

How is the Edwards PASCAL System treatment for mitral regurgitation different from other treatments?

The Edwards PASCAL System is unique because it uses a transcatheter approach, meaning it repairs the mitral valve without open-heart surgery, and it is based on the edge-to-edge repair concept, which is a novel method for treating mitral regurgitation. ^{1 2 3 4 6}

Research Team

Robert L. Smith, MD

Principal Investigator

The Heart Hospital Baylor Plano

Brian Whisenant, MD

Principal Investigator

Intermountain Medical Center

Scott Lim, MD

Principal Investigator

University of Virginia

Vinod Thourani, MD

Principal Investigator

Piedmont Healthcare

Linda Gillam, MD

Principal Investigator

Morristown Medical Center

Ralph Stephan von Bardeleben, MD

Principal Investigator

/ Universitätsmedizin Mainz- Zentrum für Kardiologie

Paul Grayburn, MD

Principal Investigator

The Heart Hospital Baylor Plano

Jörg Hausleiter, MD

Principal Investigator

LMU München, Campus Gorsshadern

Eligibility Criteria

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.

Inclusion Criteria

My heart valve and its function are suitable for the study.

Your heart's pumping ability is between 20% and 50%.

Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements

Exclusion Criteria

Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator

Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment

I have severe chronic obstructive pulmonary disease.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Transcatheter mitral valve repair with the Edwards PASCAL or Abbott MitraClip System

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at discharge, 30 days, 6 months, and annually through 5 years

Treatment Details

Interventions

• Abbott Mitraclip System (Transcatheter Valve Repair System)
• Edwards PASCAL System (Transcatheter Valve Repair System)

Trial Overview 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.

Participant Groups

Group I: Edwards PASCAL System - Single-Arm Registry Experimental Treatment 1 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 IIF Experimental Treatment 1 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 IID Experimental Treatment 1 Intervention

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

Group IV: Abbott Mitraclip System - CLASP IID Active Control 1 Intervention

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

Group V: Abbott Mitraclip System - CLASP IIF Active Control 1 Intervention

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

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

The PASCAL Transcatheter Valve Repair System demonstrated a low major adverse event rate of 6.5% and an all-cause mortality rate of only 1.6% in 62 patients with severe mitral regurgitation, indicating its safety for use in this population.

At 30 days post-procedure, 98% of patients experienced a significant reduction in mitral regurgitation severity, and there were notable improvements in functional status and quality of life, as evidenced by increased walking distance and higher scores on quality of life assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. Lim, DS., Kar, S., Spargias, K., et al.[2020]

The PASCAL system for transcatheter mitral valve repair demonstrated a high technical success rate of 96% in 68 patients, with all patients achieving a reduction in mitral regurgitation (MR) to ≤2+ at discharge.

At 30 days post-procedure, the major adverse event rate was low at 5.9%, and 98% of patients improved to New York Heart Association functional class ≤II, indicating both safety and significant improvement in patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation. Li, CP., Estévez-Loureiro, R., Freixa, X., et al.[2022]

The PASCAL transcatheter valve repair system was used in 18 patients with severe mitral regurgitation, resulting in significant reductions in the severity of the condition, with 22.2% achieving complete resolution (grade 0) and 61.1% showing mild improvement (grade I).

The procedure was safe, with no periprocedural complications reported, and the device's unique features allowed for tailored repairs based on individual patient anatomy, demonstrating its efficacy in treating severe mitral regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience. Kriechbaum, SD., Boeder, NF., Gaede, L., et al.[2021]

The PASCAL transcatheter valve repair system achieved a high procedural success rate of 96.9% in treating mitral regurgitation under conscious sedation in a study of 211 patients, indicating its efficacy as a treatment option.

The procedure resulted in significant improvements in mitral regurgitation and functional class, with a low mortality rate of 2.8% and a short hospital stay, suggesting it is a safe and efficient alternative to general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patients undergoing edge-to-edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation. Geisler, T., Schreieck, J., Euper, M., et al.[2023]

The Edwards PASCAL transcatheter valve repair system provides a new treatment option for patients with mitral and tricuspid regurgitation who cannot undergo surgery, allowing for personalized approaches based on individual anatomy.

Early evidence suggests that the PASCAL device has similar safety and efficacy to the Abbott MitraClip system, but further randomized studies and long-term data are necessary to validate these initial findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PASCAL Device-Early Experience with a Leaflet Approximation Device: What Are the Benefits/Limitations Compared with the MitraClip? Corpataux, N., Winkel, MG., Kassar, M., et al.[2021]

In a study involving 17 high-risk patients with symptomatic mitral regurgitation, the PASCAL Ace implant system achieved a technical success rate of 100% and a procedural success rate of 94%, indicating its effectiveness in treating this condition.

After one year, 93% of patients had a significant reduction in mitral regurgitation severity (to grade ≤2+), with an 88% survival rate and 94% free from heart failure hospitalization, demonstrating both safety and efficacy of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair. Moonen, A., Chuang, A., Simmons, L., et al.[2023]

References

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

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study. [2020]

2. Spain pubmed.ncbi.nlm.nih.gov

Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience. [2021]

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

Outcomes of patients undergoing edge-to-edge mitral valve repair with the Edwards PASCAL transcatheter valve repair system under conscious sedation. [2023]

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

The PASCAL Device-Early Experience with a Leaflet Approximation Device: What Are the Benefits/Limitations Compared with the MitraClip? [2021]

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

One-Year Outcomes of Early, Compassionate Use of the PASCAL Ace Implant System for Transcatheter Mitral Valve Repair. [2023]