The 120-patient Reduce FMR study is a prospective, double-blind, randomized multi-center trial, Kirkland, Wash.-based Cardiac Dimensions said. Patients are slated to be randomized on a 3:1 basis to receive the Carillon device and optimal drug treatment, or optimal drug treatment alone, the company said.
The trial is also to include a cross-over registry for control patients to receive the Carillon device after 12 months, Cardiac Dimensions said. A sub-study is designed to evaluate the Carillon device both at rest and during exercise, according to a press release.
“The outcomes from Reduce FMR will be added to the positive data already collected from nearly 100 treated patients evaluated during the three previous prospective trials,” CEO Rick Stewart said in prepared remarks. “This is the first randomized, blinded study in the field of FMR, making its results of critical importance in understanding the clinical significance of the Carillon device in this underserved patient population.”
“My experiences with Carillon have been extremely positive. As an investigator in the last two multi-center trials involving the Carillon therapy I’ve seen significant clinical improvement in patients who receive the device,” added Dr. Janusz Lipiecki of Clinique Pôle Santé République in Clermont Ferrand, France. “In this latest landmark trial, we expect to firmly establish the magnitude of benefit that patients receive from Carillon.”
Cardiac Dimensions raised $15.2 million in March to back the Reduce FMR trial.