ATLAS Pivotal Trial Evaluating the AltaValve System for Treating Moderate-to-Severe or Severe Mitral Regurgitation in Adults

What this Trial Is About

Researchers are evaluating the safety and performance of the AltaValve System for treating moderate-to-severe or severe mitral regurgitation in patients who are not suitable for surgery or other catheter-based repair methods. This prospective, single-arm, multicenter clinical trial focuses on two patient groups those with and without moderate to severe mitral annular calcification MAC. Participants will receive the AltaValve System, a transcatheter mitral valve replacement device designed to improve heart valve function. The study includes two cohorts based on the presence of MAC. The trial assesses outcomes such as all-cause mortality, heart failure hospitalizations, valve function, and quality of life over a long period extending up to five years after implantation. During the study, participants undergo various evaluations including mortality and stroke monitoring, kidney function tests, bleeding assessments, and technical success of the device. Quality of life and exercise capacity are measured using questionnaires and walk tests at 6 months and 1 year. Follow-up includes monitoring for pacemaker use and any need for additional valve interventions. The primary outcome is a composite measure of death or heart failure hospitalization within 12 months, with continued assessments up to 5 years.

ATLAS (AltaValve) Pivotal Trial