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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00947921
Acronym
POP
Enrollment
20
Registered
2009-07-28
Start date
2009-08-31
Completion date
2017-08-31
Last updated
2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Mitral Regurgitation

Keywords

Functional MItral regurgitation

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.

Interventions

PROCEDUREPlasty

Restrictive Annuloplasty

PROCEDUREProsthesis

Valve replacement

Sponsors

Cardiochirurgia E.H.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mortality1 year of follow up after discharge from hospital

Secondary

MeasureTime frame
Freedom from reintervention1 year of follow-up after discharge from hospital

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026