Mitral Regurgitation Functional

Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.

To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.

Transcatheter Edge-to-Edge Repair (TEER) has become an established alternative for the treatment of severe mitral regurgitation (MR). RESHAPE trial indicated that patients with moderate functional MR (FMR) and heart failure (HF) might benefit from TEER. However, it still not clear that TEER is effective for which subset of patients with FMR. Hand-Gripping (HG), characterized with an increased venous return, preservation or increase of left ventricular (LV) afterload and systemic vascular resistance, has been identified as a means of stress test to identify exertion-induced mitral regurgitation. Most importantly, compared to exercise stress testing via treadmill running or cycling in patients with moderate FMR, HG demonstrates significantly higher feasibility and safety. HG-induced severe MR reflects the reversibility of the regurgitation under stress, suggesting that reducing MR through TEER might alleviate LV volume overload, improve cardiac efficiency, and mitigate symptoms, which need to be validated in this trial. TIMER is a multi-center, randomized, double blind, placebo-controlled trial. A total of 300 patients with moderate and exertional-induced severe MR will be randomized in a 1:1 ratio to the treatment with TEER and guideline-directed medical therapy (GDMT) or GDMT only. The primary endpoint of this study is rehospitalization within 24 months.

A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.

To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.