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Clinical Trials/NCT00947921
NCT00947921
Terminated
Not Applicable

POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study

Cardiochirurgia E.H.1 site in 1 country20 target enrollmentAugust 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Mitral Regurgitation
Sponsor
Cardiochirurgia E.H.
Enrollment
20
Locations
1
Primary Endpoint
Mortality
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

Functional Mitral regurgitation is a now well known entity due to tethering of the valve either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis remains controversial in terms of mid and long term benefit for the patient. The investigators propose a randomized controlled study to compare the efficacy of both technique in terms of mortality and freedom from reintervention.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cardiochirurgia E.H.
Responsible Party
Principal Investigator
Principal Investigator

Luca Weltert

Project Leader Luca Weltert

Cardiochirurgia E.H.

Eligibility Criteria

Inclusion Criteria

  • All patients presenting for surgery due to functional mitral regurgitation

Exclusion Criteria

  • Associated Heart Surgery procedures other than CABG, Tricuspid Regurgitation correction, Atrial Fibrillation Correction

Outcomes

Primary Outcomes

Mortality

Time Frame: 1 year of follow up after discharge from hospital

Secondary Outcomes

  • Freedom from reintervention(1 year of follow-up after discharge from hospital)

Study Sites (1)

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