Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Edwards Lifesciences
University of Michigan
Information provided by (Responsible Party):
Juan Crestanello, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00428103
First received: January 25, 2007
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Mitral Valve Regurgitation
Congestive Heart Failure
Cardiomyopathy
Procedure: 3 dimensional echocardiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Destiny Trial: Effects of Mitral Valve Annuloplasty With the Geoform Ring on Left Ventricular Geometry and Function in Patients With Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate effects on mitral valve annuloplasty with a Geoform ring on functional status. [ Time Frame: Postoperative Mitral Valve repair ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate effect of mitral valve annuloplasty with a Geoform ring on mortality. [ Time Frame: Postoperative ] [ Designated as safety issue: No ]
  • To evaluate effects on hospitalization for congestive heart failure. [ Time Frame: Hospital admissions that occur after intial postoperative discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 3 dimensional echocardiography
    Lab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428103

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Juan Crestanello, MD
Edwards Lifesciences
University of Michigan
Investigators
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
  More Information

Publications:

Responsible Party: Juan Crestanello, MD, Associate Professor of Surgery, The Ohio State University
ClinicalTrials.gov Identifier: NCT00428103     History of Changes
Other Study ID Numbers: 2006H0138, 0006378
Study First Received: January 25, 2007
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Mitral valve regurgitation

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on July 22, 2014