Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Running, not enrolling · Not applicable

Conditions studied: Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation

In brief

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)

Key facts

Study ID

NCT03706833

Run by

Edwards Lifesciences

People needed

1247

Starts

2018-11-30

Expected to finish

2031-06-30

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• TMC Healthcare — Tucson, Arizona, United States
• Scripps Memorial Hospital La Jolla — La Jolla, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• UC Irvine — Orange, California, United States
• Sutter Medical Center-Sacramento — Sacramento, California, United States
• Kaiser Permanente San Francisco — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Los Robles Hospital and Medical Center — Thousand Oaks, California, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida, United States
• Mount Sinai — Miami Beach, Florida, United States
• NCH Rooney Heart Institute — Naples, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• Emory University Hospital and Emory University Hospital Midtown — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• St. Vincent Heart Center — Carmel, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Woman's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Banner University Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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