Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy

February 26, 2013 updated by: Juan Crestanello, MD

Destiny Trial: Effects of Mitral Valve Annuloplasty With the Geoform Ring on Left Ventricular Geometry and Function in Patients With Cardiomyopathy

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Postoperative Mitral Valve repair

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate effect of mitral valve annuloplasty with a Geoform ring on mortality.
Time Frame: Postoperative
Postoperative
To evaluate effects on hospitalization for congestive heart failure.
Time Frame: Hospital admissions that occur after intial postoperative discharge
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
Postoperative Mitral Valve repair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan Crestanello, MD

Collaborators

University of Michigan
Edwards Lifesciences

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 26, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Estimate)

February 28, 2013

Last Update Submitted That Met QC Criteria

February 26, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006H0138
  • 0006378 (Other Identifier: OSU surgery dept)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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