Status:
WITHDRAWN
Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
Lead Sponsor:
Juan Crestanello, MD
Collaborating Sponsors:
Edwards Lifesciences
University of Michigan
Conditions:
Mitral Valve Regurgitation
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary aim of this study is to assess the changes on the shape and function of the left ventricle in patients with severe mitral valve regurgitation due to congestive heart failure and cardiomyop...
Detailed Description
Congestive heart failure is a leading cause of hospitalization and mortality with an estimated 5 million people affected in the United States of America. Ischemic and idiopathic (dilated) cardiomyopat...
Eligibility Criteria
Inclusion
- Patients would be at least 18 years old.
- They will have history of congestive heart failure and be in New York Heart Association Class III or IV.
- Their left ventricular ejection fraction will be less or equal to 30%.
- They will have moderate or severe mitral regurgitation as determined by echocardiogram. Echocardiogram's criteria for severe mitral regurgitation will be:
- regurgitant volume greater than 50 ml,
- regurgitant fraction greater than 50% and
- effective regurgitant orifice greater than 40 mm2.
- If the quantitative criteria are not available, severity of the MR will be graded qualitative in grades I, II, III, and IV. Patients with mitral regurgitation in grade III and IV will be eligible to be included in the study.
Exclusion
- Cancer - Metastatic or any cancer within five years except patients with non- melanoma skin cancer.
- Recent stroke (less than six months).
- Severe COPD (patients with an FEV1 less than .8 liters).
- Patients on inotropic infusion preoperatively.
- Patients in atrial fibrillation.
- Pregnant patients.
- Patients with any other valvular disease that required surgical intervention except tricuspid valve disease.
- Patients that will require surgical ventricular restoration.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00428103
Start Date
October 1 2006
End Date
December 1 2012
Last Update
February 28 2013
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210