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

Severe Degenerative Mitral Regurgitation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01519050
• Other study ID #: KEK ZH 2011- 0274
• Status: Recruiting
• Phase: Phase 3
• First received: January 23, 2012
• Last updated: January 25, 2012
• Start date: November 2011
• Est. completion date: May 2014

Study information

• Verified date: January 2012
• Source: University of Zurich
• Contact: Ines Bühler, Study Coordinator
• Phone: +41 (0)44 255 11 11
• Email: ines.buehler[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Severe Degenerative Mitral Regurgitation

Intervention

Behavioral:
• mitral valve repair
Mitral valve repair in patients with degenerative mitral regurgitation

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Cardiology	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Valtech Cardio Ltd

Country where clinical trial is conducted

Switzerland,