Cardiac Dimensions has launched the pivotal EMPOWER trial to evaluate its Carillon Mitral Contour System to treat heart failure patients suffering from early-stage functional mitral regurgitation (FMR).
The non-surgical device is developed to address mitral valve insufficiency safely and effectively.
It is claimed to be the only indirect transcatheter mitral valve repair (TMVr) treatment device intended to generate an annuloplasty effect, start left ventricular remodelling and improve long-term survival for patients.
The blinded, randomised EMPOWER study will assess the device compared to a sham-controlled group receiving optimal medical management according to established heart failure guidelines.
Based on evaluations of results from more than 250 participants, who were part of four similar trials, and Cardiac Dimensions’ recent publications, the trial targets a large population of heart failure patients with FMR who have limited treatment options.
The company plans to use third-party monitoring, core lab reviews and external safety reviews similar to previous trials.
This approach is expected to help gather the most rigorous clinical data so far in this patient population.
EMPOWER national principal investigator and Cleveland Clinic Department of Cardiovascular Medicine chairman Samir Kapadia said: “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 functional mitral regurgitation.
“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, randomised, double-blinded and sham-controlled multicentre clinical trial.”
Cardiac Dimensions expects to enrol 300 patients at up to 75 sites for the EMPOWER trial.
The study will assess primary safety and efficacy goals at 12 months as well as involving a follow-up of five years to capture long-term safety and clinical status.