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Plasty or Prosthesis to Treat Functional Mitral Regurgitation (POP)

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier:
NCT00947921
First received: July 23, 2009
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Functional Mitral Regurgitation
 Procedure: Plasty
Procedure: Prosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study

Further study details as provided by Cardiochirurgia E.H.:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year of follow up after discharge from hospital ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Freedom from reintervention [ Time Frame: 1 year of follow-up after discharge from hospital ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plasty
Patients treated with restrictive Annuloplasty
 Procedure: Plasty
Restrictive Annuloplasty
Active Comparator: Prosthesis
Patients treated with valve replacement
 Procedure: Prosthesis
Valve replacement

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947921

Locations
Italy
Divisione di Cardiochirurgia, E.H.
Rome, Italy, 00149
Sponsors and Collaborators
Cardiochirurgia E.H.
Investigators
Principal Investigator: Luca Weltert, MD Cardiochirurgia E.H.
  More Information

No publications provided

Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT00947921     History of Changes
Other Study ID Numbers: 00-01
Study First Received: July 23, 2009
Last Updated: May 20, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Cardiochirurgia E.H.:
Functional MItral regurgitation

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013