Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Condition: Mitral valve regurgitation

Eligibility

Key Inclusion Criteria:

  • At least 18 years old
  • Functional or degenerative mitral regurgitation (MR ≥3+) by echo measurement
  • Left ventricular ejection fraction (LVEF) is ≥20%

Key Exclusion Criteria:

  • Patient in whom transesophageal echocardiogram (TEE) is contraindicated or screening TEE is unsuccessful
  • Mitral valve anatomy which might limit PASCAL System or MitraClip System access, use, and/or deployment or sufficient reduction in mitral regurgitation will be evaluated on a case-by-case basis

Full Study Name

Edwards PASCAL Transcatheter Mitral 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 Mitral Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation (IRB no. PRO00055414)

Summary

The purpose of this study is to determine the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System (PASCAL System) compared to the Abbott MitraClip Transcatheter Mitral Valve Repair System (MitraClip System) in patients with mitral regurgitation. 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.

Participants in this study have symptoms due to heart failure, despite medical therapy for mitral regurgitation, and are being considered for transcatheter mitral valve treatment. The PASCAL and MitraClip Systems are designed to reduce the amount of mitral regurgitation without the need for surgery and are thus less invasive.

The Edwards PASCAL Transcatheter Valve Repair System (PASCAL System) is investigational. The MitraClip System is approved in the U.S. to treat patients with moderate to severe degenerative mitral regurgitation who are determined to be at prohibitive risk for surgery, as well as symptomatic heart failure patients with moderate to severe functional mitral regurgitation.

Principal Investigator

Raj Makkar, MD