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

NCT ID: NCT01431222

Last Updated: 2011-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-09-30

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 default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.

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 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.

Conditions

Mitral Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

percutaneous treatment

Group Type: ACTIVE_COMPARATOR

percutaneous treatment by implanting a Mitra Clip device

Intervention Type: DEVICE

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.

optimal medical treatment

Group Type: NO_INTERVENTION

percutaneous treatment by implanting a Mitra Clip device

Intervention Type: DEVICE

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.

Interventions

percutaneous treatment by implanting a Mitra Clip device

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.

Intervention Type: DEVICE

Other Intervention Names

Mitra Clip system

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Muenchen

Principal Investigators

Joerg Hausleiter, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Steffen Massberg, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Juergen Pache, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Hasema Lesevic, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

Deutsches Herzzentrum Muenchen

Munich, Bavaria, Germany

Countries

Germany

Central Contacts

Joerg Hausleiter, MD

Role: CONTACT

hausleiter@dhm.mhn.de

+49-89-1218-0 ext. 4018

Hasema Lesevic, MD

Role: CONTACT

lesevic@dhm.mhn.de

+49-89-1218-0

Facility Contacts

Joerg Hausleiter, MD

Role: primary

hausleiter@dhm.mhn.de

+49-89-1218-0 ext. 4018

Hasema Lesevic, MD

Role: backup

lesevic@dhm.mhn.de

+49-89-1218-0

Other Identifiers

IsarClip

Identifier Type: -

Identifier Source: org_study_id