NCT05438433

Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives: The aim is to compare outcome of modified preservation of mitral valve apparatus during prosthetic mitral replacement for rheumatic versus myocardial ischemia \&mitral valve disease. Methods ;This prospective cross-sectional comparative study will include 50 patients with isolated rheumatic mitral valve disease (group A) and 50 patients with mitral disease and myocardial ischemia (group B), surgery is expected to be performed between 2017 and 2020 at one center. All patients will have modified preservation of mitral apparatus during prosthetic mitral replacement. Additionally, group B patients will have bypass grafts to left anterior descending and/or posterior descending / right coronary artery. Data will be collected and analyzed. The Institutional Review Board (IRB), Ethics Committee (EC)-approval and consent of each patient were obtained. Criteria for inclusion of patients and exclusion of others were determined according to the guide lines. Statistical analysis:: Qualitative variables and their association among both groups were studied by applying Chi-square test and Fisher Exact test. Quantitative variables among both groups were compared by applying independent samples t-test. P \< 0.05 values mean statistically-significant results.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-12-28
• Primary completion: 2020-01-01
• Completion: 2021-12-28
• First posted: 2022-06-30
• Last updated: 2022-06-30

Locations

2 sites across 1 country: Egypt

Regulatory

• FDA-regulated device study