NCT00947921

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

7 years

First QC Date

July 23, 2009

Last Update Submit

January 24, 2018

Conditions

Functional Mitral Regurgitation

Keywords

Functional MItral regurgitation

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 year of follow up after discharge from hospital

Secondary Outcomes (1)

  • Freedom from reintervention

    1 year of follow-up after discharge from hospital

Study Arms (2)

Plasty

ACTIVE COMPARATOR

Patients treated with restrictive Annuloplasty

Procedure: Plasty

Prosthesis

ACTIVE COMPARATOR

Patients treated with valve replacement

Procedure: Prosthesis

Interventions

PlastyPROCEDURE

Restrictive Annuloplasty

Plasty
ProsthesisPROCEDURE

Valve replacement

Prosthesis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting for surgery due to functional mitral regurgitation

You may not qualify if:

  • Associated Heart Surgery procedures other than CABG, Tricuspid Regurgitation correction, Atrial Fibrillation Correction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Divisione di Cardiochirurgia, E.H.

Rome, 00149, Italy

Location

MeSH Terms

Interventions

Prostheses and Implants

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Luca Weltert, MD

    Cardiochirurgia E.H.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Leader Luca Weltert

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 28, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

IT(1)