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Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy

NCT00428103 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-02-28

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

3 dimensional echocardiography

Lab tests: BNP, 6 minute walk test Transthoracic 3D echocardiogram

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • University of Michigan

    collaborator OTHER

  • Juan Crestanello, MD

    lead OTHER

Principal Investigators

  • Juan Crestanello, MD · Ohio State University

  • Nadia Nathan, MD · Ohio State University

  • Subha Raman, MD · Ohio State University

  • Steven Bolling, MD · University of Michigan

  • Min Pu, MD · Ohio State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428103 on ClinicalTrials.gov