AltaValve Pivotal Trial for Treatment of Moderate-to-Severe or Severe Mitral Regurgitation Using the AltaValve System

What this Trial Is About

Researchers are evaluating the safety and performance of the AltaValve System to treat moderate-to-severe or severe mitral regurgitation (MR) in patients who are not suitable for surgery or other transcatheter repair options. This clinical trial focuses on adults with symptoms classified in New York Heart Association (NYHA) class II-IV, aiming to address mitral valve incompetence in targeted patient groups, including those with and without moderate to severe mitral annular calcification (MAC). The trial uses the AltaValve System, a transcatheter device designed for mitral valve replacement. Participants receive treatment through one of two groups: those without moderate mitral annular calcification and those with moderate to severe MAC. The study is non-randomized and open-label, with the device implanted to assess its safety and effectiveness in these specific populations. Participants will be monitored for at least 12 months, with key outcomes including all-cause mortality and heart failure hospitalizations. Additional assessments involve stroke, kidney injury, bleeding events, mitral valve re-intervention, technical success on the day of the procedure, changes in heart failure symptoms, walking ability, and pacemaker rates. Follow-up visits occur at various intervals up to five years, ensuring comprehensive evaluation of safety and performance over time.

AltaValve Pivotal Trial