Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00428103|
Recruitment Status : Withdrawn
First Posted : January 29, 2007
Last Update Posted : February 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Mitral Valve Regurgitation Congestive Heart Failure Cardiomyopathy||Procedure: 3 dimensional echocardiography||Not Applicable|
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) cardiomyopathies are the two most common etiologies. As the left ventricle fails, changes in ventricular geometry and function occurs that leads to functional mitral regurgitation. Mitral regurgitation is a complication of end stage cardiomyopathy that adversely affects survival and patient's functional status. Mitral regurgitation in these patients is not an intrinsic disease of the mitral valve but rather results from mitral annular dilatation and ventricular dilatation.
Geoform mitral annuloplasty ring reduces the antero-posterior diameter of the mitral valve and elevates the posterior mitral annulus. Although it has been very effective on eliminating mitral regurgitation its effects on ventricular geometry have not been fully elucidated. Evaluation of ventricular and mitral valve geometry and function and their interactions has been difficult. The availability of three dimensional echocardiogram with sophisticated finite volume analysis allows us to evaluate the changes in ventricular geometry associated with the implantation of the Geoform ring. We have then designed this study with the purpose of evaluating the changes in left ventricular geometry and function resulting from mitral valve annuloplasty with the Geoform ring in patients with left ventricular dysfunction and congestive heart failure.
The two primary endpoints of this study will be:
- To assess the changes on left ventricular geometry and function as assessed by 3D echocardiography in patients with cardiomyopathy and severe mitral regurgitation who undergo mitral valve annuloplasty with a Geoform ring. This assessment will be done preoperatively, at three months, at six months, at one year, and at two years after the procedure.
To evaluate the effects on mitral valve annuloplasty with a Geoform ring on functional status.
Secondary endpoints will be:
- To evaluate the effect of mitral valve annuloplasty with a Geoform ring on mortality.
- To evaluate its effects on hospitalization for congestive heart failure.
- To evaluate the effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Destiny Trial: Effects of Mitral Valve Annuloplasty With the Geoform Ring on Left Ventricular Geometry and Function in Patients With Cardiomyopathy|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- Procedure: 3 dimensional echocardiography
Lab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram
- To assess changes on left ventricular geometry and function using 3D echocardiography in patients with cardiomyopathy and severe mitral regurgitation who undergo mitral valve annuloplasty with a Geoform ring. [ Time Frame: Post operative Mitral Valve repair ]
- To evaluate effects on mitral valve annuloplasty with a Geoform ring on functional status. [ Time Frame: Postoperative Mitral Valve repair ]
- To evaluate effect of mitral valve annuloplasty with a Geoform ring on mortality. [ Time Frame: Postoperative ]
- To evaluate effects on hospitalization for congestive heart failure. [ Time Frame: Hospital admissions that occur after intial postoperative discharge ]
- To evaluate effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy). [ Time Frame: Postoperative Mitral Valve repair ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428103
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Juan Crestanello, MD||Ohio State University|
|Principal Investigator:||Nadia Nathan, MD||Ohio State University|
|Principal Investigator:||Subha Raman, MD||Ohio State University|
|Principal Investigator:||Steven Bolling, MD||University of Michigan|
|Principal Investigator:||Min Pu, MD||Ohio State University|