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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.

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IID: The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip System in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team. IIF: The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System and GDMT compared to the MitraClip System and GDMT for the treatment of moderate-to-severe (3+) or severe (4+) FMR in symptomatic heart failure patients who have been determined by the site’s local multidisciplinary heart team to be eligible for transcatheter mitral valve repair.

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This study is NOT accepting healthy volunteers

Degenerative Mitral Valve Disease, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Regurgitation

Sierra Behr-Holewinski - sierra.behr-holewinski@fairview.org
Mudassar Ahmed
Pivotal
STUDY00011277
NCT03706833
See this study on ClinicalTrials.gov

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