Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery (ISAR-CLIP)

German Heart Center Munich

Status and phase

Unknown

Phase 4

Conditions

Mitral Regurgitation

Treatments

Device: percutaneous treatment by implanting a Mitra Clip device

Study type

Interventional

Funder types

Other

Identifiers

NCT01431222

IsarClip

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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