Clinical trial NCT00428103: Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy
Official title: Destiny Trial: Effects of Mitral Valve Annuloplasty With the Geoform Ring on Left Ventricular Geometry and Function in Patients With Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mitral Valve Regurgitation
Congestive Heart Failure
Cardiomyopathy
Keywords: Mitral valve regurgitation
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
name: University of Michigan
First posted: 2007-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: Post operative Mitral Valve repair
measure: To evaluate effects on mitral valve annuloplasty with a Geoform ring on functional status.
timeFrame: Postoperative Mitral Valve repair
Secondary outcomes:
measure: To evaluate effect of mitral valve annuloplasty with a Geoform ring on mortality.
timeFrame: Postoperative
measure: To evaluate effects on hospitalization for congestive heart failure.
timeFrame: Hospital admissions that occur after intial postoperative discharge
measure: To evaluate effect on the need of further interventions for congestive heart failure (insertion of ventricular assist device, transplantation, cardiac resynchronization therapy).
timeFrame: Postoperative Mitral Valve repair
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Juan Crestanello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Nadia Nathan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Subha Raman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Steven Bolling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Min Pu, MD
role: PRINCIPAL_INVESTIGATOR
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