Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
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 default medical treatment - in a study population who is not amenable for the
 conventional surgical approach as current gold standard.
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 mitral valve repair or replacement - is the current gold standard. However
 mere half of the patients with a severe and symptomatic MR actually undergo an operative
 treatment (EURO-HEART-SURVEY) due to restricted left ventricular ejection fraction, elderly
 patients with co-morbidities and high perioperative morbidity and mortality. In contrast,
 patients with severe and symptomatic MR not suitable for operation are treated with
 palliative medical therapy (heart insufficiency therapy). With the development of the
 MitraClip device - a minimal-invasive, percutaneous catheter-based technique - high-risk
 patients not suitable for surgery may receive a promising alternative treatment by
 approximating the mitral leaflets, thus creating a permanent leaflet coaptation and reducing
 or even abrogating the MR. The current data support the assumption of a safe and effective MR
 reduction with the MitraClip-System in inoperable high-risk patients with severe MR. But the
 feasibility still has to be proven in this special patient population.
Inclusion Criteria:

 -  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 Criteria:

 -  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