Plasty or Prosthesis to Treat Functional Mitral Regurgitation (POP)

Cardiochirurgia E.H.

Status: Terminated

Conditions: Functional Mitral Regurgitation

Treatments: Procedure: Prosthesis; Procedure: Plasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00947921

00-01

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Plasty

Active Comparator group

Description:

Patients treated with restrictive Annuloplasty

Treatment:

Procedure: Plasty

Prosthesis

Active Comparator group

Description:

Patients treated with valve replacement

Treatment:

Procedure: Prosthesis