Trials / Terminated
TerminatedNCT00947921
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Cardiochirurgia E.H. · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Plasty | Restrictive Annuloplasty |
| PROCEDURE | Prosthesis | Valve replacement |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2016-08-01
- Completion
- 2017-08-01
- First posted
- 2009-07-28
- Last updated
- 2018-01-26
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00947921. Inclusion in this directory is not an endorsement.