Comparing MitraClip and PASCAL Devices for Treating Mitral Regurgitation in Adults

What this Trial Is About

Researchers are evaluating the outcomes of two commercially available devices, MitraClip and PASCAL, used for transcatheter edge-to-edge mitral valve repair M-TEER in patients with mitral regurgitation. This study aims to compare procedural results of these devices in a real-world, all-comer patient population, particularly focusing on patients with complex or highly complex anatomy to see if the devices perform similarly outside of simple cases. The study involves performing M-TEER via a transfemoral venous approach where the mitral valve is repaired using either the PASCAL or MitraClip device. Participants are randomly assigned to receive one of these two devices. The study will measure outcomes during the procedure and at follow-up visits, including the degree of residual mitral regurgitation, valve opening area, inflow gradient, and clinical endpoints such as need for surgery or repeat intervention. Participants will be monitored during the procedure and followed up at 30 days and one year to assess mitral valve function, safety outcomes, quality of life, and symptoms such as exertional breathlessness. Researchers will use imaging and clinical assessments to compare device performance and patient health status over time. The study is expected to continue until 2028, with detailed evaluations conducted at multiple timepoints.

Efficacy of MitraCLip Vs. PASCAL for the TrEAtment of MitraL REgurgiTation in an All-comer Population