Feasibility Study of a Percutaneous Mitral Valve Repair System. - Full Text View

Sponsored by:	Evalve
Information provided by:	Evalve
ClinicalTrials.gov Identifier:	NCT00209339

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 and 12 month clinical follow-up.

Condition	Intervention	Phase
Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency	Device: Percutaneous mitral valve repair	Phase I

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).

Further study details as provided by Evalve:

Primary Outcome Measures:

Acute safety at 30 days, defined as freedom from major adverse events (MAE), defined as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed Clip, Clip detachment, stroke and septicemia. [ Time Frame: Prospective ]

Secondary Outcome Measures:

30 day and 6-month assessment of mitral regurgitation severity determined by echocardiography. [ Time Frame: Prospective ]

Enrollment:	55
Study Start Date:	July 2003
Estimated Study Completion Date:	March 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209339

Locations

United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201

Sponsors and Collaborators

Evalve

Investigators

Principal Investigator:

Ted Feldman, M.D.

Evanston Northwestern Healthcare

More Information

Evalve corporate web site This link exits the ClinicalTrials.gov site

Web site listing study sites and describing mitral regurgitation, symptoms, clinical consequences and treatments This link exits the ClinicalTrials.gov site

Publications:

St Goar FG, Fann JI, Komtebedde J, Foster E, Oz MC, Fogarty TJ, Feldman T, Block PC. Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model. Circulation. 2003 Oct 21;108(16):1990-3. Epub 2003 Oct 6.

Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response. Circulation. 2004 Aug 24;110(8):988-93. Epub 2004 Aug 9.

Study ID Numbers:	Protocol #0301, Protocol #0301
Study First Received:	September 13, 2005
Last Updated:	June 27, 2007
ClinicalTrials.gov Identifier:	NCT00209339
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Evalve:

Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve
Mitral Regurgitation
MR
Mitral Valve Prolapse
E2E - Edge to Edge
Alfieri Technique

MitraClip
Functional MR
Degenerative MR
Echocardiogram
CAD - Coronary Artery Disease
Heart Failure
Heart Attack
EVEREST
EVEREST I
EVEREST II

Study placed in the following topic categories:

Coronary Disease
Heart Failure
Heart Diseases
Orthostatic intolerance
Mitral Valve Prolapse
Prolapse

Myocardial Infarction
Coronary Artery Disease
Heart Valve Diseases
Neurocirculatory Asthenia
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009