Plasty or Prosthesis to Treat Functional Mitral Regurgitation

Cardiochirurgia E.H.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Functional Mitral Regurgitation

Interventions

PlastyPROCEDURE

Restrictive Annuloplasty

ProsthesisPROCEDURE

Valve replacement

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Divisione di Cardiochirurgia, E.H.

Rome, Italy

Outcomes

Primary Outcomes

Mortality

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

Secondary Outcomes

Freedom from reintervention

Time frame: 1 year of follow-up after discharge from hospital

Data from ClinicalTrials.gov

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