Clinical Trials Logo
  1. Home
  2. Functional Mitral Regurgitation
  3. NCT00947921
  4. Details
NCT00947921 Clinical Trial

Plasty or Prosthesis to Treat Functional Mitral Regurgitation

Functional Mitral Regurgitation Clinical Trial

— POP  

Official title:
POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00947921
Other study ID # 00-01
Secondary ID
Status Terminated
Phase N/A
First received July 23, 2009
Last updated January 24, 2018
Start date August 2009
Est. completion date August 2017

Study information
Verified date January 2018
Source Cardiochirurgia E.H.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date August 2017
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Plasty
Restrictive Annuloplasty
• Prosthesis
Valve replacement

Locations
Country Name City State
Italy Divisione di Cardiochirurgia, E.H. Rome

Sponsors (1)
Lead Sponsor Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality 1 year of follow up after discharge from hospital
Secondary Freedom from reintervention 1 year of follow-up after discharge from hospital
See also
  Status Clinical Trial Phase
Completed NCT02520310 - AVJ-514 Japan Trial N/A
Not yet recruiting NCT04396379 - Epicardial Mitral Touch System for Mitral Insufficiency N/A
Not yet recruiting NCT05566340 - Treatment of Moderate FMR During AVR
Completed NCT01899573 - Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function N/A
Terminated NCT04529928 - An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation N/A
Recruiting NCT03706833 - Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial N/A
Completed NCT00800046 - A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study N/A
Active, not recruiting NCT03929913 - NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study N/A
Active, not recruiting NCT05988450 - Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation N/A
Recruiting NCT03616678 - VenTouch OUS Feasibility Study N/A
Not yet recruiting NCT04679714 - EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation N/A
Active, not recruiting NCT02701972 - Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR N/A
Enrolling by invitation NCT04776798 - Biomechanical Taping on Low Back Pain With Increased Foot Pronation N/A
Enrolling by invitation NCT05677568 - The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
Recruiting NCT03433274 - Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation N/A
Completed NCT05865938 - PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair
Terminated NCT03016975 - Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) N/A
Completed NCT02471664 - Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation N/A
Active, not recruiting NCT02671799 - Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR) N/A
Recruiting NCT03142152 - The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR N/A