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Plasty or Prosthesis to Treat Functional Mitral Regurgitation (POP)

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947921
First Posted: July 28, 2009
Last Update Posted: May 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.
  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
Intervention Model: Parallel Assignment
Masking: None (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 Luca Weltert, Cardiochirurgia E.H.:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 year of follow up after discharge from hospital ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT00947921     History of Changes
Other Study ID Numbers: 00-01
First Submitted: July 23, 2009
First Posted: July 28, 2009
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Luca Weltert, Cardiochirurgia E.H.:
Functional MItral regurgitation

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