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

Abbott

Status and phase

Completed

Phase 2

Phase 1

Conditions

Mitral Valve Regurgitation

Mitral Valve Insufficiency

Mitral Insufficiency

Mitral Regurgitation

Mitral Valve Incompetence

Treatments

Device: Percutaneous mitral valve repair (MitraClip Implant)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00209339

Protocol #0301

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction;
Experience regurgitation origination from the central two-thirds of the valve;
Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass.

Exclusion criteria