First-in-Human Study Begins for CoreMedic's ChordArt Mitral Valve Repair System

May 18, 2018—CoreMedic announced the start of the CHAGALL trial, a prospective, multicenter, first-in-human study intended to establish the safety and effectiveness of the company's ChordArt mitral valve repair system. The study was approved to enroll up to 40 patients at up to six European centers. In the study, patients who have ruptured or elongated mitral chords will be treated with the ChordArt system.

According to the company, the ChordArt transfemoral chordal repair system is designed to reduce the complexity of the procedure to treat degenerative heart disease with mitral valve insufficiency. The ChordArt implant is used to replace the ruptured or elongated chordae of the valve, re-establishing the connection of the valve leaflets with the papillary muscle to restore the proper function.

The ChordArt treatment was aimed at improving procedural outcomes and allowing standardized placement of the artificial chords with a dedicated, reproducible technique.

The initial patient in the study was treated by the heart team led by Prof. Kęstutis Ručinskas, MD, at the Vilnius University Hospital in Vilnius, Lithuania. The patient recovered well from the intervention and continues to do well with no complications at 30-day follow-up.

Alberto Weber, MD, of Herzzentrum Hirslanden in Zurich, Switzerland, proctored the procedure. In the company's announcement, Dr. Weber commented, “Using the ChordArt reduced the invasiveness and duration of the procedure by repairing the valve in a fast, precise, and safe way. This allowed the heart team to focus on the procedure and timing rather than manually placing the artificial chords to resolve the mitral insufficiency. Thanks to the ease of the ChordArt deployment technique, this was the fastest mitral valve chordal repair I have ever witnessed.”