Cardiac Dimensions has commenced the clinical trial of Carillon mitral contour system to treat functional mitral regurgitation (FMR) associated with heart failure (HF).
The company randomized its first patient in the US pivotal Carillon trial.
The study has been designed to assess the Carillon mitral contour system to treat FMR associated with HF as compared to a randomized control group treated with optimal medical management according to established heart failure guidelines.
FMR takes place when the left ventricle of the heart is enlarged and dilates the valve opening, making backward flow of blood into the atrium. If untreated, it will lead to heart failure.
Cardiac Dimensions president and CEO Gregory Casciaro said: “The initiation of the CARILLON Trial is the pinnacle of our clinical program, which includes positive data from three previous clinical trials, and is the final step on our path to bringing the Carillon System to patients in the United States.”
Carillon mitral contour system is a minimally invasive treatment for people diagnosed with FMR, and is designed to allow physicians treat patients earlier in their disease diagnosis.
Carillon system, which secured CE mark approval, is available in certain European markets and other key geographies such as Turkey.
The system is said to solve the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery.
Cardiac Dimensions is planning to randomize 450 patients in multi-center, double-blinded and randomized controlled trial at up to 75 centers in North America and Europe.
According to the company, the study has primary safety and efficacy endpoints at 12 months and will follow the randomized patients out to five years to document long-term safety and clinical status.
The trail will also comprise cross-over feature, which allows patients originally randomized to the control group to secure the Carillon system after their one year follow-up visit.
Poznan University of Medical Sciences cardiology professor Tomasz Siminiak has randomized the first patient in the study.
Siminiak said: “These patients need access to less invasive treatment options, and to be able to contribute to advancements that have the potential to slow the progression of this chronic disease, is very important to us.”