Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

Mitral Valve Replacement Clinical Trial

— EarlyOutcome  

Official title:

Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438433
• Other study ID #: 2796#
• Status: Completed
• Phase: N/A
• Start date: December 28, 2016
• Est. completion date: December 28, 2021

Study information

• Verified date: June 2022
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 28, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Mitral Valve Replacement

Intervention

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

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia
Egypt	Suez Canal University	Ismailia

Sponsors (2)

Lead Sponsor	Collaborator
Suez Canal University	National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking index	Number of Packs every day X number of years of smoking= Pack.year,	One week before surgery(or during first clinical visit) .
Primary	Age and gender for each participant	Males above 40 years and Females above 45 years need pre-operative coronary angio-graph	One week before surgery .
Primary	For each participant: pathological:type of mitral valve lesion	severe stenosis with mitral area < 1 cm square, severe regurgitation, or mixed lesions	Seven days before surgery .
Primary	For each participant: etiological :type of mitral valve lesion	Rheumatic: distorted thickened leaflets,thickened fibrosed chordae	Seven days before surgery .
Primary	For each participant: etiological :type of mitral valve lesion	Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence	Seven days before surgery- echo-cardiograph.
Primary	For each participant:, assessing sub-valvular apparatus	Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.	One week before surgery. with Echo-cardiograph.
Primary	Abascal echo-cardiographic mitral valve score (Wilkins score)	:if score is 8 or less it is good for balloon valvo-plasty, if > 8 surgery is recommended ( leaflet mobility, thickness and calcification. Fourthly, sub-valvular thickening., higher scores = more deterioration	One week before surgery.with Echo-cardiograph
Primary	left ventricular wall motion abnormality	hypokinesia, Akinesia, Dyskinesia of certain segment(s)	one week before surgery - with an echo-cardiograph
Primary	Number of participants with Signs of left ventricular dysfunction	low ejection fraction <52%, low stroke volume< 70 ml, low cardiac output <5 litres per minute	seven days before surgery echo-cardiograph examination
Primary	Number of participants with pre-operative coronary artery disease	Expected on clinical bases and .proved by Echo-cardiograph-findings	seven days before surgery, coronary angio-graph
Primary	Number of participants with pre-operative ischemic complications	left ventricular thrombi, septal and left ventricular wall thickness in mm .	seven days before surgery echo-cardiograph examination
Primary	Assessment of any evolving new prosthetic valve dysfunction	Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus	intra-operative trans-esophageal echo-cardiograph examination
Primary	Change in post-operative left ventricular functions	: Low Fractional Shortening < 28% , Ejection fraction < 40%,, increased left ventricular dimensions and volume	5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
Primary	Change of Prosthetic mitral valve functions	Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus	Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph
Secondary	changes on Clinical examination	local and general Examination,: a new murmur, evolving heart failure	Monthly up to 12 months after surgery)
Secondary	Changes in Results of Prothrombin time, concentration and.International normalized ratio	Adjust dose of oral anticoagulant.( between double and half to three times the control) Dose usually ranges between 1 and 11 mg warfarin tablet daily.	.Monthly through study completion up to 12 months.
Secondary	Mortality and Morbidity	cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation	Monthly through study completion up to 12 months.