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

July 23, 2009
May 20, 2013
August 2009
August 2014   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 1 year of follow up after discharge from hospital ] [ Designated as safety issue: Yes ]
Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00947921 on ClinicalTrials.gov Archive Site
Freedom from reintervention [ Time Frame: 1 year of follow-up after discharge from hospital ] [ Designated as safety issue: Yes ]
Freedom from reintervention [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Plasty or Prosthesis to Treat Functional Mitral Regurgitation
POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Functional Mitral Regurgitation
  • Procedure: Plasty
    Restrictive Annuloplasty
  • Procedure: Prosthesis
    Valve replacement
  • Active Comparator: Plasty
    Patients treated with restrictive Annuloplasty
    Intervention: Procedure: Plasty
  • Active Comparator: Prosthesis
    Patients treated with valve replacement
    Intervention: Procedure: Prosthesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
August 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00947921
00-01
Yes
Luca Weltert, Cardiochirurgia E.H.
Cardiochirurgia E.H.
Not Provided
Principal Investigator: Luca Weltert, MD Cardiochirurgia E.H.
Cardiochirurgia E.H.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP