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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014