Diseases of Mitral ValvesEarlyOutcomeNCT05438433

Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement

A study testing St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets in people with Diseases of Mitral Valves and Abnormality of Mitral Valve Annulus (Disorder), run by Suez Canal University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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?. Read more about this study

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Diseases of Mitral Valves, Abnormality of Mitral Valve Annulus (Disorder), Mitral Valve Replacement
What is being tested?: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 2 sitesEgypt
Study dates: 28 Dec 2016to 28 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

Suez Canal University
Ismailia, +064
Suez Canal University
Ismailia, 002-064

Other trials in Egypt

About this study

Official title: Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement

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.

Read the 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
Being tested: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
Keywords: : Preservation of mitral apparatus ,, mitral valve replacement, Rheumatic valve disease and ischemia
Medical subject headings: Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leafletsDevice
Also called 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
St.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts

Study groups in NCT05438433
Study group	Role	What they receive
Group A	Sham comparator	50 patients with isolated rheumatic mitral valve disease (group A) Receives: Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
Group B	Other	50 patients with mitral disease and myocardial ischemia (group B) Receives: Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets

What is being measured

The primary outcome is the main question the study is designed to answer.

Smoking index
Number of Packs every day X number of years of smoking= Pack.year,
Measured: One week before surgery(or during first clinical visit) .
Age and gender for each participant
Males above 40 years and Females above 45 years need pre-operative coronary angio-graph
Measured: One week before surgery .
For each participant: pathological:type of mitral valve lesion
severe stenosis with mitral area < 1 cm square, severe regurgitation, or mixed lesions
Measured: Seven days before surgery .
For each participant: etiological :type of mitral valve lesion
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
Measured: Seven days before surgery .
For each participant: etiological :type of mitral valve lesion
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence
Measured: Seven days before surgery- echo-cardiograph.
For each participant:, assessing sub-valvular apparatus
Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.
Measured: One week before surgery. with Echo-cardiograph.
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
Measured: One week before surgery.with Echo-cardiograph
left ventricular wall motion abnormality
hypokinesia, Akinesia, Dyskinesia of certain segment(s)
Measured: one week before surgery - with an echo-cardiograph
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
Measured: seven days before surgery echo-cardiograph examination
Number of participants with pre-operative coronary artery disease
Expected on clinical bases and .proved by Echo-cardiograph-findings
Measured: seven days before surgery, coronary angio-graph
Number of participants with pre-operative ischemic complications
left ventricular thrombi, septal and left ventricular wall thickness in mm .
Measured: seven days before surgery echo-cardiograph examination
Assessment of any evolving new prosthetic valve dysfunction
Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus
Measured: intra-operative trans-esophageal echo-cardiograph examination
Change in post-operative left ventricular functions
: Low Fractional Shortening < 28% , Ejection fraction < 40%,, increased left ventricular dimensions and volume
Measured: 5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
Change of Prosthetic mitral valve functions
Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus
Measured: Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph

Secondary outcomes (3)

changes on Clinical examination
local and general Examination,: a new murmur, evolving heart failure
Measured: Monthly up to 12 months after surgery)
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.
Measured: .Monthly through study completion up to 12 months.
Mortality and Morbidity
cause of mortality, type of morbidity: wound infection, hypertrophied scar, Kiloid Formation
Measured: Monthly through study completion up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 201628 Dec 2021

First posted30 Jun 2022
Study start28 Dec 2016
Primary completion1 Jan 2020
Study completion28 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diseases of Mitral ValvesStudies of the same condition, open and under way.
More trials run by Suez Canal UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: both groups of patients received surgical treatment parallel to each other.
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05438433
Sponsor's protocol ID: 2796#
Acronym: EarlyOutcome
Status last verified: Jun 2022
First submitted: 1 Jun 2022
Last updated: 30 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diseases of Mitral Valves trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outcome of Preservation of Mitral Valve Leaflets During Mitral Replacement
ClinicalTrials.gov ID: NCT05438433
Acronym / sponsor ID: EarlyOutcome / 2796#
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Suez Canal UniversityUniversity, hospital or other
Collaborators: National Research Centre, Egypt
Study start: 28 Dec 2016 (actual)
Primary completion: 1 Jan 2020 (actual)
Study completion: 28 Dec 2021 (actual)
First posted: 30 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?.

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.

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::

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: both groups of patients received surgical treatment parallel to each other.

Arm	Type	Receives
Group A	Sham comparator	Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets50 patients with isolated rheumatic mitral valve disease (group A)
Group B	Other	Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets50 patients with mitral disease and myocardial ischemia (group B)

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Mitral stenosis (MS)
symptoms are severely limiting and cannot be managed with diuresis and heart rate control.
acute severe MR require surgical correction for hemo-dynamics and relief of symptoms .
rheumatic heart disease: replacement before irreversible changes occur can be curative.
If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms.

Key exclusion criteria (6 listed)

Patients showing good response to medical therapy, and Cases complicated by:
ineffective endocarditis,
previous myocardial re-vascularization
ischemic ventricular septal defect,
left ventricular aneurysm,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leafletsAlso: 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 diseaseSt.Jude prosthetic(FDA approved) mitral valve replacement with or without coronary artery bypass grafts	Device	Group A, Group B

Primary outcome

Smoking index
Time frame: One week before surgery(or during first clinical visit) .
Number of Packs every day X number of years of smoking= Pack.year,
Age and gender for each participant
Time frame: One week before surgery .
Males above 40 years and Females above 45 years need pre-operative coronary angio-graph
For each participant: pathological:type of mitral valve lesion
Time frame: Seven days before surgery .
severe stenosis with mitral area < 1 cm square, severe regurgitation, or mixed lesions
For each participant: etiological :type of mitral valve lesion
Time frame: Seven days before surgery .
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae
For each participant: etiological :type of mitral valve lesion
Time frame: Seven days before surgery- echo-cardiograph.
Rheumatic: distorted thickened leaflets,thickened fibrosed chordae or ischemic incompetence
For each participant:, assessing sub-valvular apparatus
Time frame: One week before surgery. with Echo-cardiograph.
Thickened chordae, ruptured chordae, ischemia of papillary muscles or lateral ventricular wall.
Abascal echo-cardiographic mitral valve score (Wilkins score)
Time frame: One week before surgery.with Echo-cardiograph
: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
Time frame: one week before surgery - with an echo-cardiograph
hypokinesia, Akinesia, Dyskinesia of certain segment(s)
Number of participants with Signs of left ventricular dysfunction
Time frame: seven days before surgery echo-cardiograph examination
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
Time frame: seven days before surgery, coronary angio-graph
Expected on clinical bases and .proved by Echo-cardiograph-findings
Number of participants with pre-operative ischemic complications
Time frame: seven days before surgery echo-cardiograph examination
left ventricular thrombi, septal and left ventricular wall thickness in mm .
Assessment of any evolving new prosthetic valve dysfunction
Time frame: intra-operative trans-esophageal echo-cardiograph examination
Left atrioventricular outflow stenosis, prosthetic dysfunction due to preservation of valve apparatus
Change in post-operative left ventricular functions
Time frame: 5 days post-operatively and end of 6th and 12 months after surgery with Echo-Cardiograph
: Low Fractional Shortening < 28% , Ejection fraction < 40%,, increased left ventricular dimensions and volume
Change of Prosthetic mitral valve functions
Time frame: Monthly through study completion up to 12 months after surgery..... with Echo-cardiograph
Development of para-valvular leak or central jet of regurgitation or stuck valve by a thrombus

3 secondary outcomes

changes on Clinical examination
Time frame: Monthly up to 12 months after surgery)
Changes in Results of Prothrombin time, concentration and.International normalized ratio
Time frame: .Monthly through study completion up to 12 months.
Mortality and Morbidity
Time frame: Monthly through study completion up to 12 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
Individual participant dataSharing planned: Yes. 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.

Related trials for Diseases of Mitral Valves

Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
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Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
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Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamed A. allaban, PhD study director

Suez Canal University, FOM- Research Ethics Committee

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking index (time frame: One week before surgery(or during first clinical visit) .). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05438433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.