Evaluating the Carillon Mitral Contour System Device for Treating Heart Failure with Functional Mitral Regurgitation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Carillon Mitral Contour System CMCS in treating patients with heart failure who also have functional mitral regurgitation FMR. This prospective, randomized, double-blinded, sham-controlled trial aims to better understand how this device may impact heart function and symptoms in people with this condition. Participants will be randomly assigned to one of two groups one group will receive the Carillon implant along with guideline-directed heart failure medications, while the other group will receive only the heart failure medications and a sham procedure to preserve blinding. Before randomization, patients will undergo specific heart imaging tests and evaluations to determine eligibility and suitability for the device placement. After the procedure, participants will have follow-up visits at 1, 6, 12, 18, and 24 months to monitor safety and heart function. After 24 months, all participants will be informed of their group assignment and followed annually for an additional three years. During the study, researchers will assess various health outcomes including freedom from major adverse events at 12 months and clinical improvement at 24 months. Additional measures will include changes in heart valve function, heart size, walking ability, heart failure symptoms, hospitalizations, and quality of life. Participants will have regular heart imaging, clinical evaluations, and questionnaires to track these outcomes. The total participation time may extend up to five years with long-term monitoring to better understand the devices impact over time.

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR