Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (NCT03706833)
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): 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 Mitral Regurgitation
🩺 Plain-English Summary (8th-Grade Level)
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)
Who can join: Review the eligibility criteria below.
Location: Banner University Medical Center — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (81 Sites)
Showing the first 25 of 81 sites.
- Banner University Medical Center — Phoenix, Arizona
- TMC Healthcare — Tucson, Arizona
- Scripps Memorial Hospital La Jolla — La Jolla, California
- Cedars Sinai Medical Center — Los Angeles, California
- UC Irvine — Orange, California
- Sutter Medical Center-Sacramento — Sacramento, California
- Kaiser Permanente San Francisco — San Francisco, California
- University of California, San Francisco — San Francisco, California
- Stanford University — Stanford, California
- Los Robles Hospital and Medical Center — Thousand Oaks, California
- Medical Center of the Rockies — Loveland, Colorado
- Medstar Washington Hospital Center — Washington D.C., District of Columbia
- The Cardiac and Vascular Institute Research Foundation — Gainesville, Florida
- Mount Sinai — Miami Beach, Florida
- NCH Rooney Heart Institute — Naples, Florida
- AdventHealth Orlando — Orlando, Florida
- Piedmont Healthcare — Atlanta, Georgia
- Emory University Hospital and Emory University Hospital Midtown — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- St. Vincent Heart Center — Carmel, Indiana
- University of Iowa Hospitals & Clinics — Iowa City, Iowa
- Massachusetts General Hospital — Boston, Massachusetts
- Brigham and Woman's Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Degenerative Mitral Valve Disease
- Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation — Los Angeles, California
Explore by condition: All Degenerative Mitral Valve Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.