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Predictors of Postoperative Left Ventricular Function in Patients Undergoing Mitral Valve Repair for Severe Degenerative Mitral Regurgitation

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ClinicalTrials.gov Identifier: NCT01519050
Recruitment Status : Unknown
Verified January 2012 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
University of Zurich

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The aim of the study is to investigate whether a predictive score (combination of several validated predictors) better predicts postoperative left ventricular function than any single predictor in patients undergoing mitral valve repair for degenerative mitral regurgitation.

A single center, prospective cohort study


Condition or disease Intervention/treatment
Severe Degenerative Mitral Regurgitation Behavioral: mitral valve repair

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014
Groups and Cohorts
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Intervention Details:
    Behavioral: mitral valve repair
    Mitral valve repair in patients with degenerative mitral regurgitation

Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
100 patients with mitral valve proplapse ondergoing mitral valve repair for severe mitral regurgitation
Criteria

Inclusion criteria:

  • Age 18- 85 years
  • Patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution

Exclusion criteria:

  • Functional or ischemic mitral regurgitation
  • Presence of relevant (symptomatic) Coronary Artery Disease
  • Inability of exercising on semi supine bicycle
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519050


Contacts
Contact: Ines Bühler, Study Coordinator +41 (0)44 255 11 11 ines.buehler@usz.ch
Contact: Patric Biaggi, MD patric.biaggi@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Cardiology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Edwards Lifesciences
Investigators
Principal Investigator: Patric Biaggi, MD, Senior physican University Hospital Zurich, Division of Cardiology
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01519050     History of Changes
Other Study ID Numbers: KEK ZH 2011- 0274
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

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