Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
Withdrawn before enrolling · Not applicable
Conditions studied: Mitral Valve Regurgitation, Congestive Heart Failure, Cardiomyopathy
In brief
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 cardiomyopathy who undergo mitral valve reconstruction with a Geoform ring. Three-dimensional echocardiogram will be used for precise evaluation of the shape and function of the ventricle.
Key facts
- Study ID
- NCT00428103
- Run by
- Juan Crestanello, MD
- People needed
- 0
- Starts
- 2006-10-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2013-02-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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