NCT02534155

High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Trial Comparing MitraClip® to Surgical Therapy

High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: A Randomized Controlled Trial Comparing MitraClip® to Surgical Therapy

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is comparing MitraClip® to Surgical therapy in high and intermediate risk patients, who should be older than 18 years, and shall evaluate safety and efficacy of MitraClip® vs. surgery in high or intermediate risk patients. The patients will be randomised (MitraClip® or Surgery). The Study Follow-Up includes 4 visits after procedure (hospital discharge, 1, 6, 12 months post-procedure).

Detailed description

Two-arm, multi-centre, randomised prospective study comparing MitraClip® to Surgical therapy in high and intermediate risk patients. Patients should be older than 18 years and high and intermediate risk is defined by a score (for MV repair) \>= 3% and \<= 10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify all possible risk factors. Patients are selected upon clinical conditions and severity of MR. Anatomical feasibility is assessed by ECHO, according to the IFU (information for use). The purpose of the trial is to evaluate safety and efficacy of MitraClip® vs. surgery in high and intermediate risk patients with DMR. Study Follow-Up includes the following visits after procedure: Hospital discharge, 1, 6, 12 months post-procedure. Primary Endpoints are the 30-day safety superiority (ITT analysis) and the 12-month efficacy non-inferiority (ITT analysis) of the MitraClip®. The overall rate of Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) until 12 months and the MR Severity reduction at 6 and 12 month in the MitraClip® and Surgery groups are Secondary Endpoints

Conditions

• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	MitraClip®	one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory
PROCEDURE	Mitral valve Surgery	Repair or replace mitral valve

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-09-01
• Completion: 2018-09-01
• First posted: 2015-08-27
• Last updated: 2016-09-09

Locations

12 sites across 3 countries: Germany, Italy, Switzerland