First Human Study Evaluating the Capstan TMVR System for Adults with Moderate to Severe Mitral Regurgitation Unsuitable for Surgery

What this Trial Is About

Researchers are conducting a first-in-human, multi-center study to assess the safety and feasibility of the Capstan Medical TMVR System in adults with moderate-severe or greater mitral regurgitation who cannot undergo surgery. This trial focuses on patients who are symptomatic despite optimal medical treatment and for whom transcatheter mitral valve replacement TMVR is considered the preferred option over surgery or other treatments. Participants will undergo a minimally invasive procedure to implant the Capstan System transcatheter mitral valve replacement device. This novel device and its electro-mechanical delivery system aim to provide an alternative treatment for those ineligible for surgical intervention. After implantation, participants will be followed for up to five years to monitor safety and feasibility outcomes. During the study, participants will have regular follow-up visits to assess procedural success within 30 days and technical success at 30 days. They will also be monitored for major adverse events at 30 days, 90 days, 6 months, 1 year, and annually up to five years. Researchers will collect clinical evaluations, imaging, and other assessments to track the devices performance and patient health over time.

Capstan Medical TMVR Study: FIH