Clinical Trial: Plasty or Prosthesis to Treat Functional Mitral Regurgitation

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Cardiochirurgia E.H.

Current Primary Outcome: Mortality [ Time Frame: 1 year of follow up after discharge from hospital ]

Original Primary Outcome: Mortality [ Time Frame: 1 year ]

Current Secondary Outcome: Freedom from reintervention [ Time Frame: 1 year of follow-up after discharge from hospital ]

Original Secondary Outcome: Freedom from reintervention [ Time Frame: 1 year ]

Information By: Cardiochirurgia E.H.

Dates:
Date Received: July 23, 2009
Date Started: August 2009
Date Completion: August 2015
Last Updated: May 20, 2013
Last Verified: May 2013