Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement (EarlyOutcome)
Primary Purpose
Diseases of Mitral Valves, Abnormality of Mitral Valve Annulus (Disorder), Mitral Valve Replacement
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
Sponsored by
About this trial
This is an interventional treatment trial for Diseases of Mitral Valves focused on measuring : Preservation of mitral apparatus ,, mitral valve replacement, Rheumatic valve disease and ischemia
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.
Sites / Locations
- Suez Canal University
- Suez Canal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Other
Arm Label
Group A
Group B
Arm Description
50 patients with isolated rheumatic mitral valve disease (group A)
50 patients with mitral disease and myocardial ischemia (group B)
Outcomes
Primary Outcome Measures
Smoking index
Number of Packs every day X number of years of smoking= Pack.year,
Age and gender for each participant
Males above 40 years and Females above 45 years need pre-operative coronary angio-graph
For each participant: pathological:type of mitral valve lesion
severe stenosis with mitral area < 1 cm square, severe regurgitation, or mixed lesions
For each participant: etiological :type of mitral valve lesion
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
For each participant: etiological :type of mitral valve lesion
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence
For each participant:, assessing sub-valvular apparatus
Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.
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
left ventricular wall motion abnormality
hypokinesia, Akinesia, Dyskinesia of certain segment(s)
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
Number of participants with pre-operative coronary artery disease
Expected on clinical bases and .proved by Echo-cardiograph-findings
Number of participants with pre-operative ischemic complications
left ventricular thrombi, septal and left ventricular wall thickness in mm .
Assessment of any evolving new prosthetic valve dysfunction
Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus
Change in post-operative left ventricular functions
: Low Fractional Shortening < 28% , Ejection fraction < 40%,, increased left ventricular dimensions and volume
Change of Prosthetic mitral valve functions
Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus
Secondary Outcome Measures
changes on Clinical examination
local and general Examination,: a new murmur, evolving heart failure
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.
Mortality and Morbidity
cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation
Full Information
NCT ID
NCT05438433
First Posted
June 1, 2022
Last Updated
June 23, 2022
Sponsor
Suez Canal University
Collaborators
National Research Centre, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05438433
Brief Title
Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement
Acronym
EarlyOutcome
Official Title
Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 28, 2016 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
December 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University
Collaborators
National Research Centre, Egypt
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
both groups of patients received surgical treatment parallel to each other.
Masking
None (Open Label)
Masking Description
All roles were unmasked
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Sham Comparator
Arm Description
50 patients with isolated rheumatic mitral valve disease (group A)
Arm Title
Group B
Arm Type
Other
Arm Description
50 patients with mitral disease and myocardial ischemia (group B)
Intervention Type
Device
Intervention Name(s)
St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
Other Intervention Name(s)
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
Intervention Description
St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts
Primary Outcome Measure Information:
Title
Smoking index
Description
Number of Packs every day X number of years of smoking= Pack.year,
Time Frame
One week before surgery(or during first clinical visit) .
Title
Age and gender for each participant
Description
Males above 40 years and Females above 45 years need pre-operative coronary angio-graph
Time Frame
One week before surgery .
Title
For each participant: pathological:type of mitral valve lesion
Description
severe stenosis with mitral area < 1 cm square, severe regurgitation, or mixed lesions
Time Frame
Seven days before surgery .
Title
For each participant: etiological :type of mitral valve lesion
Description
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
Time Frame
Seven days before surgery .
Title
For each participant: etiological :type of mitral valve lesion
Description
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence
Time Frame
Seven days before surgery- echo-cardiograph.
Title
For each participant:, assessing sub-valvular apparatus
Description
Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.
Time Frame
One week before surgery. with Echo-cardiograph.
Title
Abascal echo-cardiographic mitral valve score (Wilkins score)
Description
: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
Time Frame
One week before surgery.with Echo-cardiograph
Title
left ventricular wall motion abnormality
Description
hypokinesia, Akinesia, Dyskinesia of certain segment(s)
Time Frame
one week before surgery - with an echo-cardiograph
Title
Number of participants with Signs of left ventricular dysfunction
Description
low ejection fraction <52%, low stroke volume< 70 ml, low cardiac output <5 litres per minute
Time Frame
seven days before surgery echo-cardiograph examination
Title
Number of participants with pre-operative coronary artery disease
Description
Expected on clinical bases and .proved by Echo-cardiograph-findings
Time Frame
seven days before surgery, coronary angio-graph
Title
Number of participants with pre-operative ischemic complications
Description
left ventricular thrombi, septal and left ventricular wall thickness in mm .
Time Frame
seven days before surgery echo-cardiograph examination
Title
Assessment of any evolving new prosthetic valve dysfunction
Description
Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus
Time Frame
intra-operative trans-esophageal echo-cardiograph examination
Title
Change in post-operative left ventricular functions
Description
: Low Fractional Shortening < 28% , Ejection fraction < 40%,, increased left ventricular dimensions and volume
Time Frame
5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
Title
Change of Prosthetic mitral valve functions
Description
Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus
Time Frame
Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph
Secondary Outcome Measure Information:
Title
changes on Clinical examination
Description
local and general Examination,: a new murmur, evolving heart failure
Time Frame
Monthly up to 12 months after surgery)
Title
Changes in Results of Prothrombin time, concentration and.International normalized ratio
Description
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.
Time Frame
.Monthly through study completion up to 12 months.
Title
Mortality and Morbidity
Description
cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation
Time Frame
Monthly through study completion up to 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A. allaban, PhD
Organizational Affiliation
Suez Canal University, FOM- Research Ethics Committee
Official's Role
Study Director
Facility Information:
Facility Name
Suez Canal University
City
Ismailia
ZIP/Postal Code
+064
Country
Egypt
Facility Name
Suez Canal University
City
Ismailia
ZIP/Postal Code
002-064
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by H. D. Elayouty, H. S. Hassan and S.A. Elhafeez. The first draft of the manuscript was written by A. H.Elayouty and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
IPD Sharing Time Frame
Within 360 days
IPD Sharing Access Criteria
h.dosoky@yahoo.com
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Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement
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