Back to resultsPlasty or Prosthesis to Treat Functional Mitral Regurgitation (POP)
Primary Purpose
Functional Mitral Regurgitation
Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Plasty
Prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring Functional MItral regurgitation
Eligibility 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
Sites / Locations
- Divisione di Cardiochirurgia, E.H.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Plasty
Prosthesis
Arm Description
Patients treated with restrictive Annuloplasty
Patients treated with valve replacement
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Freedom from reintervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00947921
Brief Title
Plasty or Prosthesis to Treat Functional Mitral Regurgitation
Acronym
POP
Official Title
POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiochirurgia E.H.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Mitral Regurgitation
Keywords
Functional MItral regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasty
Arm Type
Active Comparator
Arm Description
Patients treated with restrictive Annuloplasty
Arm Title
Prosthesis
Arm Type
Active Comparator
Arm Description
Patients treated with valve replacement
Intervention Type
Procedure
Intervention Name(s)
Plasty
Intervention Description
Restrictive Annuloplasty
Intervention Type
Procedure
Intervention Name(s)
Prosthesis
Intervention Description
Valve replacement
Primary Outcome Measure Information:
Title
Mortality
Time Frame
1 year of follow up after discharge from hospital
Secondary Outcome Measure Information:
Title
Freedom from reintervention
Time Frame
1 year of follow-up after discharge from hospital
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Weltert, MD
Organizational Affiliation
Cardiochirurgia E.H.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Divisione di Cardiochirurgia, E.H.
City
Rome
ZIP/Postal Code
00149
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Plasty or Prosthesis to Treat Functional Mitral Regurgitation
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