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Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

NCT05438433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-06-30

No results posted yet for this study

Summary

Are there differences in outcome of mitral valve replacement with preservation of mitral apparatus among rheumatic and/or ischemic mitral lesions?.

Mitral valve replacement with preservation of leaflets, and added coronary artery-bypass surgery, when indicated, is it a feasible and reproducible procedure?.

The study was designed to compare outcome after prosthetic mitral replacement with preservation of mitral apparatus for rheumatic valve disease with outcome of replacement for ischemic myocardium and mitral valve disease, The outcomes will be guided by clinical assessment. and echo-cardiograph.

Conditions

  • Diseases of Mitral Valves
  • Abnormality of Mitral Valve Annulus (Disorder)
  • Mitral Valve Replacement

Interventions

DEVICE

St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets

St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts

Sponsors & Collaborators

  • National Research Centre, Egypt

    collaborator OTHER

  • Suez Canal University

    lead OTHER

Principal Investigators

  • Mohamed A. allaban, PhD · Suez Canal University, FOM- Research Ethics Committee

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-28
Primary Completion
2020-01-01
Completion
2021-12-28
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438433 on ClinicalTrials.gov