CoreMedic has announced the start of the first-in-man Chagall study to evaluate the new minimally-invasive valve repair technology ChordArt. A press release reports that the device is a novel transfemoral chordal repair system designed to address unmet needs in the treatment of degenerative heart disease with mitral valve insufficiency. It adds that the Chagall trial is a prospective, multicentre trial that is intended to establish the safety and effectiveness of the system.
The ChordArt implant is used to replace the ruptured or elongated chordae of the valve and re-establishes the connection of the valve leaflets with the papillary muscle to restore the proper function. As the goal with ChordArt is to reduce the complexity of the procedure, according to the press release, both patients and physicians will benefit.
Chagall study was approved to enrol up to 40 patients at up to 6 European centres. This study is the first trial of its kind to treat patients that have ruptured or elongated mitral chords with the ChordArt system. The first-in-man case using ChordArt was treated by the Heart Team led by Kęstutis Ručinskas (Vilnius University Hospital, Lithuania). The ChordArt treatment was aimed at improving procedural outcomes and allowing standardised placement of the artificial chords with a dedicated, reproducible technique. The patient recovered very well from the intervention and is continuously doing well. A 30 day follow-up showed no complications.
Alberto Weber (Herzzentrum Hirslanden, Zurich, Switzerland), who proctored the procedure, comments: “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.”
Thomas Bauer, CEO of CoreMedic, notes: “The first clinical use of ChordArt is a major milestone in our path towards developing the best in class transfemoral mitral valve chordal repair system”.