Status:
UNKNOWN
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous de...
Detailed Description
The presence of a significant mitral regurgitation (MR) seriously effects the patient's quality of life and is associated with an increased mortality rate. The operative treatment of MR - either mitra...
Eligibility Criteria
Inclusion
- age ≥ 18 years
- signed written consent
- symptomatic patients (NYHA-stadium ≥ III) for at least 3 months with an exploited medical heart insufficiency therapy
- increased perioperative risk with a logistic EuroScore ≥ 15 or STS-Score ≥ 15
- MR grade ≥ 2, amenable for MitraClip intervention assessed by an experienced interventional cardiologist
- Affirmation of in-operability by a "Heart-Team" consisting of either 1 cardiac surgeon and 1 cardiologist or 3 cardiologists
Exclusion
- one essential cardiovascular event in the past 6 weeks; i. e. myocardial infarction, stroke, shock, cardiac decompensation, or the necessity of catecholamine therapy for haemodynamic stabilisation
- implantation of a biventricular pacemaker-device for cardiac resynchronisation therapy in the past 3 months
- solid tumor with a live expectancy \< 1 year
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01431222
Start Date
September 1 2011
End Date
September 1 2014
Last Update
September 9 2011
Active Locations (1)
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1
Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, 80636