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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Interventional Strategy to Abrogate Mitral Regurgitation Using the MitraClip System in High-Risk Patients Considered Unsuitable for Surgery (ISAR-CLIP)

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Device: percutaneous treatment by implanting a Mitra Clip device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: percutaneous treatment<br> | Device: percutaneous treatment by implanting a Mitra Clip device<br>* With a minimal-invasive, percutaneous catheter-based technique and trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance, the MitraClip device grasps and approximates the mitral leaflets thus creating a double-orifice mitral valve with a permanent leaflet coaptation and a reduction or even abrogation of mitral regurgitation.<br>* Other names: Mitra Clip system;|
| No Intervention: optimal medical treatment<br> | Device: percutaneous treatment by implanting a Mitra Clip device<br>* With a minimal-invasive, percutaneous catheter-based technique and trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance, the MitraClip device grasps and approximates the mitral leaflets thus creating a double-orifice mitral valve with a permanent leaflet coaptation and a reduction or even abrogation of mitral regurgitation.<br>* Other names: Mitra Clip system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Dyspnoea of at least one class (NYHA-Classification) |  | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite endpoint and clinical outcome measured by NYHA-classification | composite endpoint (death of any cause, myocardial infarction, stroke, sepsis, TIMI major bleeding, clip embolisation, partial clip detachement, acute renal failure) unscheduled hospitalization due to increased heart insuffiecency changes in quality of life echocardiographic parameters loboratory parameters resiliance measured by spiroergometry | 1 year and 2 years after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe mitral regurgitation, interventional mitral valve reconstruction, inoperable, EuroSCORE, STS Risk Score, MitraClip, fluoroscopy, echocardiography, percutaneous treatment of mitral regurgitation