Edwards PASCAL TrAnScatheter Mitral Valve RePair System Pivotal Clinical Trial (CLASP IID): A prospective multicenter randomized controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Mitral Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR)

Brief description of study

The goal of this study is to assess the safety and performance of the PASCAL System in patients with symptomatic degenerative mitral regurgitation (DMR) who are at prohibitive risk for mitral valve surgery (the risk to you is so high that surgery is not an option). Mitral valve regurgitation is a condition in which the mitral valve does not close completely, causing blood to leak back into the left atrium of the heart. This increases the workload on the heart and if left untreated, can increase the risk of heart failure. The PASCAL and MitraClip Systems are designed to reduce the amount of mitral regurgitation without the need for surgery (less invasive). It is unknown whether the amount of reduction in regurgitation that is achieved using either device implant system will result in a comparable benefit to you. The PASCAL System is an investigational (experimental) device. This means it has not yet approved by the U.S. Food and Drug Administration (FDA). The MitraClip System is approved in the United States to treat patients with DMR who are determined to be at prohibitive risk for surgery.


Clinical Study Identifier: s18-01570
ClinicalTrials.gov Identifier: NCT03706833
Principal Investigator: Mathew R. Williams.
Other Investigators: Alan F Vainrib, Muhamed Saric, Daniel G Bamira, Alex Reyentovich, Cezar S Staniloae, Shaline D Rao.


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