Plasty or Prosthesis to Treat Functional Mitral Regurgitation

NCT ID: NCT00947921

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Functional Mitral Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plasty

Patients treated with restrictive Annuloplasty

Group Type ACTIVE_COMPARATOR

Plasty

Intervention Type PROCEDURE

Restrictive Annuloplasty

Prosthesis

Patients treated with valve replacement

Group Type ACTIVE_COMPARATOR

Prosthesis

Intervention Type PROCEDURE

Valve replacement

Interventions

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Plasty

Restrictive Annuloplasty

Intervention Type PROCEDURE

Prosthesis

Valve replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiochirurgia E.H.

OTHER

Sponsor Role lead

Responsible Party

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Luca Weltert

Project Leader Luca Weltert

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luca Weltert, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiochirurgia E.H.

Locations

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Divisione di Cardiochirurgia, E.H.

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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00-01

Identifier Type: -

Identifier Source: org_study_id

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