Clinical Trials Directory

Trials / Completed

CompletedNCT00209339

Feasibility Study of a Percutaneous Mitral Valve Repair System.

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

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Abbott Medical Devices · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICEPercutaneous mitral valve repair (MitraClip Implant)Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.

Timeline

Start date
2003-07-01
Primary completion
2006-02-01
Completion
2011-10-01
First posted
2005-09-21
Last updated
2018-11-07
Results posted
2016-08-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00209339. Inclusion in this directory is not an endorsement.