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Plasty or Prosthesis to Treat Functional Mitral Regurgitation (POP)

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. Identifier: NCT00947921
Recruitment Status : Terminated
First Posted : July 28, 2009
Last Update Posted : January 26, 2018
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.

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.

Condition or disease Intervention/treatment Phase
Functional Mitral Regurgitation Procedure: Plasty Procedure: Prosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Active Comparator: Plasty
Patients treated with restrictive Annuloplasty
Procedure: Plasty
Restrictive Annuloplasty

Active Comparator: Prosthesis
Patients treated with valve replacement
Procedure: Prosthesis
Valve replacement

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00947921

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Divisione di Cardiochirurgia, E.H.
Rome, Italy, 00149
Sponsors and Collaborators
Cardiochirurgia E.H.
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Principal Investigator: Luca Weltert, MD Cardiochirurgia E.H.
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Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H. Identifier: NCT00947921    
Other Study ID Numbers: 00-01
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Keywords provided by Luca Weltert, Cardiochirurgia E.H.:
Functional MItral regurgitation
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases