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

History of Changes

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:

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 Cardiovascular Diseases Heart Diseases Heart Valve Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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