Cardiac Dimensions’ Carillon Mitral Contour System Will Be Evaluated in EMPOWER Pivotal Trial to Treat Early Stage FMR

August 20, 2021—Cardiac Dimensions announced the launch of the EMPOWER trial, a United States pivotal trial for the company’s Carillon mitral contour system for the treatment of heart failure patients with early stage functional mitral regurgitation (FMR). Currently, the Carillon mitral contour system is an investigational device in the United States. It has gained CE Mark approval for sale in Europe.

The company stated that the blinded, randomized trial will compare the Carillon treatment to a sham-controlled group treated with optimal medical management according to established heart failure guidelines. The international trial is expected to randomize 300 patients at up to 75 sites. The study has primary safety and efficacy endpoints at 12 months and will follow the randomized patients out to 5 years to document long-term safety and clinical status.

The EMPOWER trial will be led by national Principal Investigator Samir Kapadia, MD, who is an interventional cardiologist and professor of medicine and Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic in Cleveland, Ohio.

According to Cardiac Dimensions, during development of the trial design, the company analyzed an extensive amount of data from more than 250 study patients previously enrolled in more than four similar trials. Based on these analyses, the device safety profile, and the company’s recent publications, the trial will focus on this extremely large patient population with limited other therapeutic alternatives.

Consistent with previous trials, Cardiac Dimensions will use third-party monitoring, core lab review, and external safety reviews to produce scientifically rigorous clinical data.

“I am very excited to launch the EMPOWER trial,” commented Dr. Kapadia in the company’s press release. “This will be the first time where we are able to study early intervention with a device in heart failure. The Carillon device will be used to treat heart failure patients with mild and moderate FMR. This is an extremely large patient population that is currently not being studied by other novel therapies. It will be phenomenal to study the efficacy of the Carillon device in the EMPOWER trial—a rigorously designed, randomized, double blinded, and sham-controlled multicenter clinical trial.”