Safety and Effectiveness of Edwards SAPIEN 3 Valves for Severe Calcific Mitral Valve Disease in High-Risk Patients Not Suitable for Standard Surgery

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves using the Commander delivery system in patients with severe mitral annular calcification MAC and symptomatic mitral valve dysfunction who are at high risk for standard mitral valve surgery. The study includes patients with severe mitral stenosis, moderate to severe mitral regurgitation, or a combination of both, focusing on those who are not candidates for traditional surgery due to their surgical risk. Participants are divided into two groups one group receives the transseptal Valve-in-MAC ViMAC procedure using balloon-expandable aortic transcatheter valves, while the other group is a natural history registry of patients treated with medical management alone due to anatomical or other exclusion criteria. The study also includes a registry for patients who undergo preemptive septal ablation procedures but do not proceed with the ViMAC procedure. The treatment arm plans to enroll 110 patients, and the medically managed arm up to 100 patients. During the study, participants will be monitored through follow-up visits including annual visits for up to five years. Researchers will assess safety outcomes such as all-cause mortality and hospitalization for heart failure over one year. Effectiveness measures will also be evaluated at one year. Patients will undergo clinical evaluations and imaging to track valve function and overall heart health. The study spans from the screening and treatment phases through long-term follow-up to gather comprehensive data on patient outcomes.

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).