First-in-Human Study of the Novel Transcatheter Mitral Valve Repair Systemfor Mitral Regurgitation.

Abstract

Transcatheter mitral valve intervention treatment is a promising alternative therapy for patients with severe mitral regurgitation (MR). This is a multicenter, prospective, first-in-human study of transcatheter edge-to-edge repair (TEER) using a novel device for severe MR. Safety and efficacy were assessed immediately after the procedure and at 30-day follow-up. Twenty-three patients (age 70.0 ± 5.2 years) who were at high/prohibitive surgical risk underwent successful procedures without major periprocedural complications. All patients achieved residual MR≤2+ at discharge, with 73.9% with 1+ residual MR. The left ventricular end-systolic diameter improved from 4.1cm at baseline to 3.4cm at 30-day follow-up. New York Heart Association functional class I/II after TEER was achieved in 87% of patients. This study demonstrated that TEER with the device was feasible and safe for the treatment of patients with severe MR. (Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study; NCT04528576).