Clinical Trial

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Study Description

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

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)

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Device - Edwards PASCAL System

Transcatheter mitral valve repair with the Edwards PASCAL System

Device - Abbott Mitraclip System

Transcatheter mitral valve repair with the Abbott Mitraclip System

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03706833

ParticipAid ID

eXD5We