CLASP IID/IIF: 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.
Summary: The CLASP IID/IIF study focuses on patients with heart failure who have leaky mitral valves that do not close properly. The study offers patients a procedure using a clip device that grabs onto the leaflets of the mitral valve to stabilize and realign them so that the valve becomes less leaky. In turn, patients typically experience improved heart function and alleviation of their heart failure symptoms. The procedure is done using catheters that are fed into the heart through vessels in the groin, which is a less invasive approach than open-heart surgery.
- Primary Investigator: Ignacio Inglessis, MD
- Study Population or Disease Focus: Patients with moderate to severe or severe mitral regurgitation
- Status: Enrolling
- Source: Industry-sponsored