Feasibility Study of a Percutaneous Mitral Valve Repair System.

NCT ID: NCT00209339

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2011-10-31

Brief 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

Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MitraClip

Percutaneous mitral valve repair (MitraClip Implant)

Group Type: EXPERIMENTAL

Percutaneous mitral valve repair (MitraClip Implant)

Intervention Type: DEVICE

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.

Interventions

Percutaneous 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.

Intervention Type: DEVICE

Other Intervention Names

EVEREST I, MitraClip

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott Vascular Structural Heart (Evalve, Inc)

Principal Investigators

Ted Feldman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

Evanston Northwestern Healthcare

Evanston, Illinois, United States

Countries

United States

References

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Other Identifiers

Protocol #0301

Identifier Type: -

Identifier Source: secondary_id

Protocol #0301

Identifier Type: -

Identifier Source: org_study_id