Surgical Correction of Moderate Ischemic Mitral Regurgitation

This study is not yet open for participant recruitment.

Verified by Shaare Zedek Medical Center, July 2006

Sponsored by:	Shaare Zedek Medical Center
Information provided by:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT00394797

Purpose

The purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.Patients will be randomized to CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Secondary endpoints include event free survival, symptoms, and echocardiographic outcomes.

Condition	Intervention
Moderate Ischemic Mitral Regurgitation	Procedure: mitral valve annuloplasty

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

survival at 1,5 and 10 years

Secondary Outcome Measures:

event free survival
syptoms
echocardiographic parameters

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

patients undergoing coronary bypass surgery who have moderate degree of ischemic MR

Exclusion Criteria:

etiology of mitral regurgitation other than ischemic, degree of regurgitation other thatn moderate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394797

Locations

Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators

Principal Investigator:

Shuli Silberman, MD

Shaare Zedek Medical Center

More Information

Study ID Numbers:	IMR001
Study First Received:	October 31, 2006
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00394797
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Heart Diseases
Ischemia
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009