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

Mitral Regurgitation Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

• NCT number: NCT01431222
• Study type: Interventional
• Source: Deutsches Herzzentrum Muenchen
• Contact: Joerg Hausleiter, MD
• Phone: +49-89-1218-0
• Email: hausleiter@dhm.mhn.de
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2011
• Completion date: September 2014