Clinical trial NCT05438433: Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement
Official title: Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diseases of Mitral Valves
Abnormality of Mitral Valve Annulus (Disorder)
Mitral Valve Replacement
Keywords: : Preservation of mitral apparatus ,
mitral valve replacement
Rheumatic valve disease and ischemia
Lead sponsor: Suez Canal University
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2022-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: both groups of patients received surgical treatment parallel to each other.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Smoking index
timeFrame: One week before surgery(or during first clinical visit) .
measure: Age and gender for each participant
timeFrame: One week before surgery .
measure: For each participant: pathological:type of mitral valve lesion
timeFrame: Seven days before surgery .
measure: For each participant: etiological :type of mitral valve lesion
timeFrame: Seven days before surgery .
measure: For each participant: etiological :type of mitral valve lesion
timeFrame: Seven days before surgery- echo-cardiograph.
measure: For each participant:, assessing sub-valvular apparatus
timeFrame: One week before surgery. with Echo-cardiograph.
measure: Abascal echo-cardiographic mitral valve score (Wilkins score)
timeFrame: One week before surgery.with Echo-cardiograph
measure: left ventricular wall motion abnormality
timeFrame: one week before surgery - with an echo-cardiograph
measure: Number of participants with Signs of left ventricular dysfunction
timeFrame: seven days before surgery echo-cardiograph examination
measure: Number of participants with pre-operative coronary artery disease
timeFrame: seven days before surgery, coronary angio-graph
measure: Number of participants with pre-operative ischemic complications
timeFrame: seven days before surgery echo-cardiograph examination
measure: Assessment of any evolving new prosthetic valve dysfunction
timeFrame: intra-operative trans-esophageal echo-cardiograph examination
measure: Change in post-operative left ventricular functions
timeFrame: 5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
measure: Change of Prosthetic mitral valve functions
timeFrame: Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph
Secondary outcomes:
measure: changes on Clinical examination
timeFrame: Monthly up to 12 months after surgery)
measure: Changes in Results of Prothrombin time, concentration and.International normalized ratio
timeFrame: .Monthly through study completion up to 12 months.
measure: Mortality and Morbidity
timeFrame: Monthly through study completion up to 12 months.
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez Canal University, FOM- Research Ethics Committee
name: Mohamed A. allaban, PhD
role: STUDY_DIRECTOR
References: