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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Valtech Cardio Ltd
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01519050
First received: January 23, 2012
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Severe Degenerative Mitral Regurgitation
Behavioral: mitral valve repair
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Zurich:

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: mitral valve repair
    Mitral valve repair in patients with degenerative mitral regurgitation
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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: 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
Valtech Cardio Ltd
Investigators
Principal Investigator: Patric Biaggi, MD, Senior physican University Hospital Zurich, Division of Cardiology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01519050     History of Changes
Other Study ID Numbers: KEK ZH 2011- 0274
Study First Received: January 23, 2012
Last Updated: January 25, 2012
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on September 22, 2014