NCT01519050

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

2.5 years

First QC Date

January 23, 2012

Last Update Submit

January 25, 2012

Conditions

Severe Degenerative Mitral Regurgitation

Interventions

mitral valve repairBEHAVIORAL

Mitral valve repair in patients with degenerative mitral regurgitation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 patients with mitral valve proplapse ondergoing mitral valve repair for severe mitral regurgitation

You may qualify if:

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

You may not qualify if:

  • Functional or ischemic mitral regurgitation
  • Presence of relevant (symptomatic) Coronary Artery Disease
  • Inability of exercising on semi supine bicycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Cardiology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Interventions

Mitral Valve Annuloplasty

Intervention Hierarchy (Ancestors)

Cardiac Valve AnnuloplastyCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Patric Biaggi, MD, Senior physican

    University Hospital Zurich, Division of Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Bühler, Study Coordinator

CONTACT

+41 (0)44 255 11 11ines.buehler@usz.ch

Patric Biaggi, MD

CONTACT

patric.biaggi@usz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 26, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

CH(1)