NCT01431222

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2014-09-01
• First posted: 2011-09-09
• Last updated: 2011-09-09

Locations

1 site across 1 country: Germany