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 PASC

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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 PASC

Brief description of study

The goal of this study is to assess the safety and performance of the PASCAL System compared to the MitraClip System in patients with symptomatic moderate to severe mitral regurgitation who may not be ideal candidates for mitral valve surgery and may be eligible for transcatheter mitral valve repair. Mitral regurgitation (MR) is a condition when your heart’s mitral valve does not close tightly which causes blood to flow backwards in your heart. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure.

Clinical Study Identifier: s20-00791

ClinicalTrials.gov Identifier: NCT03706833

Principal Investigator: Richard K Schwartz.

Other Investigators: Aasha S Gopal, Khaled F Salhab.

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