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.

Brief description of study

The Edwards PASCAL provides a transcatheter treatment for patients suffering from mitral regurgitation.The Edwards PASCAL System was designed to provide physicians a system that is safe, easy to use, and designed to maximize MR reduction. 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 when treating patients with symptomatic degenerative mitral regurgitation (despite medical therapy) and who are considered to be candidates (by the Heart Team) for transcatheter mitral valve repair. Specifically, transcatheter mitral valve repair using the PASCAL System will be compared to the MitraClip System.


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.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.