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Plasty or Prosthesis to Treat Functional Mitral Regurgitation

NCT00947921 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-01-26

No results posted yet for this study

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.

Conditions

  • Functional Mitral Regurgitation

Interventions

PROCEDURE

Plasty

Restrictive Annuloplasty

PROCEDURE

Prosthesis

Valve replacement

Sponsors & Collaborators

  • Cardiochirurgia E.H.

    lead OTHER

Principal Investigators

  • Luca Weltert, MD · Cardiochirurgia E.H.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2016-08-31
Completion
2017-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947921 on ClinicalTrials.gov