Plasty or Prosthesis to Treat Functional Mitral Regurgitation
Not Applicable
Terminated
- Conditions
- Functional Mitral Regurgitation
- Interventions
- Procedure: ProsthesisProcedure: Plasty
- Registration Number
- NCT00947921
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prosthesis Prosthesis Patients treated with valve replacement Plasty Plasty Patients treated with restrictive Annuloplasty
- Primary Outcome Measures
Name Time Method Mortality 1 year of follow up after discharge from hospital
- Secondary Outcome Measures
Name Time Method Freedom from reintervention 1 year of follow-up after discharge from hospital
Trial Locations
- Locations (1)
Divisione di Cardiochirurgia, E.H.
🇮🇹Rome, Italy