AHEAD US Study Will Evaluate Cardiovalve's Transcatheter Mitral Valve Replacement System

September 20, 2018—Cardiovalve announced that it has commenced the multicenter AHEAD US trial, the early feasibility study of patients at high surgical risk with severe mitral regurgitation treated with the company's Cardiovalve transfemoral mitral valve system. Recruitment in the trial will start in early Q4 2018.

According to the company, the primary endpoint of the study is the safety and feasibility of the Cardiovalve system in reducing mitral regurgitation, with evaluation at 30 days after the procedure and continuing for 2 years. A multicenter European study, AHEAD EU, also has initiated recruitment starting in Switzerland, with later expansion to Italy, France, and Germany.

The AHEAD US study is being conducted in collaboration with the Clinical Trials Center and the Cardiovascular Research Foundation in New York, New York, led by Ori Ben-Yehuda, MD. In the announcement, Dr. Ben-Yehuda commented, “We are delighted to have received approval from regulatory agencies to commence the Early Feasibility Study for the Cardiovalve. The design of this valve and its delivery system shows significant promise in reducing the complexity of transcatheter mitral valve replacement and enhancing the safety and outcomes of these procedures."