Plasty or Prosthesis to Treat Functional Mitral Regurgitation

Not Applicable

Terminated

• Conditions: Functional Mitral Regurgitation

• Registration Number: NCT00947921
• Lead Sponsor: Cardiochirurgia E.H.

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 Description

Not available

Study Timeline

• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Study Start: 2009-08
• Primary Completion: 2016-08
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality	1 year of follow up after discharge from hospital

Secondary Outcome Measures

Name	Time	Method
Freedom from reintervention	1 year of follow-up after discharge from hospital

Trial Locations

Locations (1)

Divisione di Cardiochirurgia, E.H.; 🇮🇹 Rome, Italy