GISE Registry Study on MitraClip G4 for Treating Severe Mitral Valve Regurgitation

What this Trial Is About

The trial focuses on patients with symptomatic severe mitral regurgitation MR, either functional or degenerative, who have undergone or are undergoing Transcatheter Edge-to-Edge Repair TEER using the MitraClip G4 device. The aim is to confirm the safety of the MitraClip and improve its effectiveness in a broad group of patients with severe MR. This observational study involves participants with both ischemic and non-ischemic causes of MR on optimal medical therapy. Participants are divided into two groups based on their MR type functional MR with severe secondary MR and degenerative MR with severe primary MR. Eligibility for each group is determined using a multiparametric study algorithm assessing MR severity and other heart function measures. The study tracks the outcomes after the MitraClip procedure, focusing on MR severity and clinical events over several years. Throughout the study, participants will be monitored for MR severity at 30 days and one year, alongside longer-term outcomes such as death and hospitalizations for heart failure over up to five years. Data will be collected to evaluate device safety and effectiveness in real-world settings. Participants will undergo heart function evaluations and follow-ups as part of the registry to assess the impact of the MitraClip treatment.

GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4