Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Not Applicable

Recruiting

• Conditions: Degenerative Mitral Valve Disease; Mitral Regurgitation; Mitral Insufficiency; Functional Mitral Regurgitation

• Registration Number: NCT03706833
• Lead Sponsor: Edwards Lifesciences

Brief Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Detailed Description

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-16
• Study Start: 2018-11-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-06-30
• Study Completion: 2031-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1247

Inclusion Criteria

• Eighteen (18) years of age or older
• Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
• Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
• Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
• Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
• Mitral regurgitation (3+ to 4+) by echo
• Suitable valve and regurgitant jet morphology
• 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)
• LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)

Exclusion Criteria

• Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
• Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
• Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
• Clinically significant, untreated coronary artery disease
• Recent stroke
• Other severe valve disorders requiring intervention
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
• Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
• Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
• Active rheumatic heart disease or rheumatic etiology for MR
• Severe aortic stenosis or regurgitation
• Known history of untreated, severe carotid stenosis
• Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
• Severe COPD
• Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
• 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
• Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.	From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).	30 days.
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.	6 months

Secondary Outcome Measures

Name	Time	Method
Functional Improvement (increase in 6 minute walk test in meters)	30 days , 6 months, 1 year	Increase in 6 minute walk test in meters
Rates of various adverse events	6 months; 12 months	Rates of various adverse events at 6 and 12 months
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years	30 days , 6 months, 1 year, 2 year	Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through	30 days, 6 months, 1 year, 2 year	Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life
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	30 days, 6 months, 1 year, 2 year	Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life

Trial Locations

Locations (103)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

Abrazo Arizona Heart Hospital; 🇺🇸 Phoenix, Arizona, United States

Arizona Cardiovascular Research Center; 🇺🇸 Phoenix, Arizona, United States

TMC Healthcare; 🇺🇸 Tucson, Arizona, United States

Scripps Memorial Hospital La Jolla; 🇺🇸 La Jolla, California, United States

PIH Health Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

St. Joseph Hospital; 🇺🇸 Orange, California, United States

UC Irvine; 🇺🇸 Orange, California, United States

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