Evanston, Illinois 60201

  • Mitral Insufficiency

Purpose:

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.


Study summary:

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.


Criteria:

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: - Ejection fraction < 30% - Endocarditis - Rheumatic heart disease - Renal insufficiency


NCT ID:

NCT00209339


Primary Contact:

Principal Investigator
Ted Feldman, M.D.
NorthShore University HealthSystem Research Institute


Backup Contact:

N/A


Location Contact:

Evanston, Illinois 60201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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