Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

NCT ID: NCT05438433

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-28
• Study Completion Date: 2021-12-28

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

50 patients with isolated rheumatic mitral valve disease (group A)

Group Type: SHAM_COMPARATOR

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

Intervention Type: DEVICE

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)

Group Type: OTHER

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

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

St.Jude bi leaflet prosthesis to replace diseased valve with preservation of leaflets with Myocardial re-vascularization; St.Jude prosthetic mitral replacement with preservation of valve apparatus and bypass grafts for associated coronary artery disease

Eligibility Criteria

Inclusion Criteria

Mitral stenosis (MS)

• 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

• Patients showing good response to medical therapy, and Cases complicated by:
• ineffective endocarditis,
• previous myocardial re-vascularization
• ischemic ventricular septal defect,
• left ventricular aneurysm,
• Ruptured papillary muscles of mitral apparatus.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Centre, Egypt

OTHER

Sponsor Role: collaborator

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Hamdy Dosoky Ibraheem Elayouty

Prof. of Cardio-thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A. allaban, PhD

Role: STUDY_DIRECTOR

Suez Canal University, FOM- Research Ethics Committee

Locations

Suez Canal University

Ismailia, , Egypt

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2796#

Identifier Type: -

Identifier Source: org_study_id