Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT00428103
Status:
WITHDRAWN
Last Update Posted:
2013-02-28
First Post:
2007-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
Sponsor:
Juan Crestanello, MD
Organization:
Study Overview
Official Title:
Destiny Trial: Effects of Mitral Valve Annuloplasty With the Geoform Ring on Left Ventricular Geometry and Function in Patients With Cardiomyopathy
Status:
WITHDRAWN
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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) 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:
1. 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.
2. To evaluate the effects on mitral valve annuloplasty with a Geoform ring on functional status.
Secondary endpoints will be:
3. To evaluate the effect of mitral valve annuloplasty with a Geoform ring on mortality.
4. To evaluate its effects on hospitalization for congestive heart failure.
5. To evaluate the effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
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:
1. 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.
2. To evaluate the effects on mitral valve annuloplasty with a Geoform ring on functional status.
Secondary endpoints will be:
3. To evaluate the effect of mitral valve annuloplasty with a Geoform ring on mortality.
4. To evaluate its effects on hospitalization for congestive heart failure.
5. To evaluate the effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 0006378 | OTHER | OSU surgery dept | View |