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Feasibility Study of a Percutaneous Mitral Valve Repair System. — EVEREST(I)  

Mitral Regurgitation Clinical Trial

Official title:
A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).

Clinical Trial Summary

Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.

Clinical Trial Description

Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System.

The study is a prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. A minimum of 20 patients will be enrolled (an additional maximum of 12 roll in-patients, a maximum of 2 per site, may be enrolled and analyzed separately). Patients will undergo 30-day, 6 month and 12 month clinical follow-up.

Up to 12 clinical sites throughout the US may participate.

The primary endpoint is acute safety at thirty days, with a secondary efficacy endpoint of reduction of MR. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00209339
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2003
Completion date October 2011
View Details
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