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Mitral Valve Repair CLASP IID/IIF

Status: Closed to Enrollment

Study Details

View study details on clinicaltrials.gov.

Locations

  • Sacramento
  • San Francisco

Clinical Trial FAQs

Information for patients and study volunteers, including frequently asked questions.

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF)

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)

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).

Pei-Hsiu Huang
Pei-Hsiu Huang
Principal investigator
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Dr. Christian Spies
Dr. Christian Spies
Principal investigator
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