Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement
NCT ID: NCT05438433
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2016-12-28
2021-12-28
Brief Summary
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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
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
50 patients with isolated rheumatic mitral valve disease (group A)
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
Group B
50 patients with mitral disease and myocardial ischemia (group B)
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* symptoms are severely limiting and cannot be managed with diuresis and heart rate control.
Mitral regurgitation(MR):
\* acute severe MR require surgical correction for hemo-dynamics and relief of symptoms .
Chronic primary mitral regurgitation:
\* rheumatic heart disease: replacement before irreversible changes occur can be curative.
Mixed Mitral Stenosis and Mitral Regurgitation:
* If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms.
* Myocardial ischemia associating or complicated with miral valve disease.
Exclusion Criteria
* ineffective endocarditis,
* previous myocardial re-vascularization
* ischemic ventricular septal defect,
* left ventricular aneurysm,
* Ruptured papillary muscles of mitral apparatus.
30 Years
65 Years
ALL
No
Sponsors
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National Research Centre, Egypt
OTHER
Suez Canal University
OTHER
Responsible Party
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Hamdy Dosoky Ibraheem Elayouty
Prof. of Cardio-thoracic Surgery
Principal Investigators
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Mohamed A. allaban, PhD
Role: STUDY_DIRECTOR
Suez Canal University, FOM- Research Ethics Committee
Locations
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Suez Canal University
Ismailia, , Egypt
Suez Canal University
Ismailia, , Egypt
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2796#
Identifier Type: -
Identifier Source: org_study_id