Post-approval study of Mitra Clip shows improved heart performance after transcatheter mitral valve repair.- Abbott.

The post-approval study evaluating the safety and efficacy of Mitra Clip, from Abbott, in a real-world, commercial setting in transcatheter mitral valve repair was presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2018 Scientific Sessions. The prospective, single-arm, multi-center, observational study entitled, The Abbott Post-Approval Study 1 Mitra Clip Registry: 1-year Results of the First 2,000 Patients in the Transcatheter Valve Therapy Registry, is the first to include echocardiographic, functional and quality of life outcomes. At one-year, 86.8 percent of patients had post-procedural mitral regurgitation (MR) of 2+ and there was 81.7 percent freedom from all-cause mortality. Measurements of the left ventricle by echocardiogram showed improvement in left ventricular end-diastolic volume (LVEDV) and left ventricular internal diameter end diastole and end systole (LVIDd) with 8.5 ml and 0.2 cm mean reduction, respectively. Clinical measures show mean improvement of 37.9 m in the six-minute walk test and 83.4 percent improvement with NYHA I/II at the one-year mark.

There is an additional randomized study being conducted in the field of mitral valve regurgitation which will further study the Mitra Clip device in symptomatic functional mitral valve regurgitation (FMR) patients with heart failure, called the COAPT study. Primary results from the study are expected to be shared in 2018 and, if successful, will provide evidence for expanded indication for MitraClip to treat FMR.