Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for 60 Year-olds and Older

What this Trial Is About

The trial investigates treatment options for adults aged 60 and older with severe primary degenerative mitral regurgitation MR. It compares two approaches transcatheter edge-to-edge repair TEER and surgical mitral valve repair. The study aims to evaluate long-term effectiveness and safety, along with patient-centered outcomes such as quality of life and functional status, over a follow-up period of up to 10 years. This research is conducted across multiple countries and includes patients considered suitable for both treatment methods by their heart team. Participants are randomly assigned to one of two treatment groups surgical mitral valve repair or TEER. Surgical repair involves heart surgery under general anesthesia, possibly using a sternotomy or thoracotomy approach with techniques to correct valve issues. TEER uses a catheter-based device inserted through the femoral vein to repair the valve with image guidance. Both procedures are performed according to standard medical practices and device instructions. The study includes an enrollment period of about three years, with follow-up assessments extending up to a decade. During the study, patients undergo regular evaluations including echocardiograms, heart failure assessments, and quality of life questionnaires such as the Kansas City Cardiomyopathy Questionnaire and 6-minute walk test. Outcomes measured include mortality, hospitalizations, valve function, and adverse events. Data collection also involves administrative records to track long-term clinical events. The primary outcome focuses on a composite of mortality, heart failure events, valve re-intervention, and mitral regurgitation severity at three years post intervention.

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)