Percutaneous or Surgical Repair in Mitral Prolapse and Regurgitation for 60 Year-olds (PRIMARY) Ancillary Substudy

What this Trial Is About

Researchers are studying patients aged 60 and older with mitral valve prolapse (MVP) and degenerative mitral regurgitation (MR) to understand how two treatments, mitral valve repair (MVr) and transcatheter edge-to-edge repair (TEER), affect heart muscle structure and function. This study aims to explore how these treatments impact left ventricular biomechanics, fibrosis, arrhythmias, and heart failure risks, helping to identify the best therapy for different patient groups. It is an ancillary study of a larger randomized clinical trial involving up to 250 patients from centers in the U.S., Canada, Germany, the U.K., and Spain, with outcomes measured up to 12 months after treatment. Participants will receive either MVr surgery involving general anesthesia and cardiopulmonary bypass or TEER using an approved edge-to-edge repair device. Up to 200 patients will have cardiac magnetic resonance imaging (CMR) before and after intervention, all will have rhythm monitoring and echocardiograms, and 60 surgical patients will have myocardial tissue biopsies during surgery. The study combines imaging, rhythm monitoring, tissue analysis, and computational modeling to assess treatment effects on the heart. During the study, patients will undergo heart rhythm monitoring using wearable devices, echocardiograms, and CMR scans at baseline and one year after treatment. Surgical patients will provide tissue samples to study gene and structural changes. Researchers will evaluate myocardial fibrosis, ventricular arrhythmias, and proteomic profiles one year post-treatment, along with computational models predicting treatment outcomes. Safety and heart function will be closely monitored throughout the 12-month study period.

PRIMARY Ancillary Substudy