Mitral Valve ReplacementNCT06811662
Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement
A study testing mitral valve replacement in people with Mitral Valve Replacement and Mitral Insufficiency, run by Assiut University at 1 site in Egypt.
Trial summary
The purpose of this study is to evaluate the outcomes of complete (preservation of both anterior and posterior leaflets) versus partial (preservation of posterior leaflet only) preservation of subvalvular apparatus in cases of mitral valve replacement Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mitral Valve Replacement, Mitral Insufficiency
- What is being tested?
- mitral valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Age between 18 and 60 years
- Rheumatic mitral disease indicated for mitral valve replacement
- Concomitant other valve disease
Who cannot join
- - Patients who have undergone previous mitral valve surgery or other heart surgery.
- Patients with ischemic mitral disease.
- emergency operation.
- patients with significant comorbidities (severe pulmonary disease or end stage renal disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Heart Hosiptal
Asyut, 711
assiut university assiut university, +201000566770
About this study
The purpose of this study is to evaluate the outcomes of complete (preservation of both anterior and posterior leaflets) versus partial (preservation of posterior leaflet only) preservation of subvalvular apparatus in cases of mitral valve replacement
Read the detailed description
After mitral valve replacement (MVR), sudden increases in afterload and disruption of the annular-chordal-papillary-left-ventricular wall causes left ventricular (LV) dysfunction in the early postoperative period.
patients with LV dysfunction after MVR have a significantly lower 8-year survival rate compares with patients who did not have LV dysfunction Papillary muscles play an important role in the left ventricular contraction by drawing the mitral ring toward the apex, thereby causing shortening of the long axis and spherity of the chamber contribute for better ejection of blood.
preservation of papillary muscles and chordae tendineae in MVR reduces postoperative mortality, low cardiac output syndrome and improves haemodynamic function.
Partial preservation of the mitral apparatus through preservation of the posterior leaflet (MVR-P) has been proven to significantly reduce perioperative mortality.
The importance of complete preservation of the mitral apparatus remains controversial, but it is hypothesized that complete preservation with preservation of both the anterior and posterior leaflets may contribute to superior postoperative hemodynamic function as compared to partial preservation.
Due to the increased technical complexity of preserving both leaflets, concerns about longer bypass and cross-clamp times, the need to undersize prostheses, and the possibility of left ventricular outflow tract (LVOT) obstruction, the majority of cardiac surgeons currently prefer to preserve the posterior leaflet alone.
- Conditions
- Mitral Valve Replacement, Mitral Insufficiency
- Being tested
- mitral valve replacement
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve replacementProcedure or surgery
complete versus partial preservation of subvavular apparatus during mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatu | Active comparator | complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatus Receives: Procedure: mitral valve replacement |
| partial (preservation of posterior leaflet only) preservation of subvalvular apparatus | Active comparator | partial (preservation of posterior leaflet only) preservation of subvalvular apparatus Receives: Procedure: mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement regarding:
- Postoperative morbidity and mortality
- LV function and the change of cardiac chamber dimensions.
Measured: anticepated 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Mamdouh Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811662
- Sponsor's protocol ID
- preservation of MV leaflts
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT06811662
- Acronym / sponsor ID
- preservation of MV leaflts
- Conditions
- Mitral Valve Replacement, Mitral Insufficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2025 (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.
The purpose of this study is to evaluate the outcomes of complete (preservation of both anterior and posterior leaflets) versus partial (preservation of posterior leaflet only) preservation of subvalvular apparatus in cases of mitral valve replacement
Detailed description
After mitral valve replacement (MVR), sudden increases in afterload and disruption of the annular-chordal-papillary-left-ventricular wall causes left ventricular (LV) dysfunction in the early postoperative period.
patients with LV dysfunction after MVR have a significantly lower 8-year survival rate compares with patients who did not have LV dysfunction Papillary muscles play an important role in the left ventricular contraction by drawing the mitral ring toward the apex, thereby causing shortening of the long axis and spherity of the chamber contribute for better ejection of blood.
preservation of papillary muscles and chordae tendineae in MVR reduces postoperative mortality, low cardiac output syndrome and improves haemodynamic function.
Partial preservation of the mitral apparatus through preservation of the posterior leaflet (MVR-P) has been proven to significantly reduce perioperative mortality.
The importance of complete preservation of the mitral apparatus remains controversial, but it is hypothesized that complete preservation with preservation of both the anterior and posterior leaflets may contribute to superior postoperative hemodynamic function as compared to partial preservation.
Due to the increased technical complexity of preserving both leaflets, concerns about longer bypass and cross-clamp times, the need to undersize prostheses, and the possibility of left ventricular outflow tract (LVOT) obstruction, the majority of cardiac surgeons currently prefer to preserve the posterior leaflet alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatu | Active comparator | Procedure: mitral valve replacementcomplete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatus |
| partial (preservation of posterior leaflet only) preservation of subvalvular apparatus | Active comparator | Procedure: mitral valve replacementpartial (preservation of posterior leaflet only) preservation of subvalvular apparatus |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Age between 18 and 60 years
- Rheumatic mitral disease indicated for mitral valve replacement
- Concomitant other valve disease
Key exclusion criteria (4 listed)
- - Patients who have undergone previous mitral valve surgery or other heart surgery.
- Patients with ischemic mitral disease.
- emergency operation.
- patients with significant comorbidities (severe pulmonary disease or end stage renal disease).
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 |
|---|---|---|
| mitral valve replacementcomplete versus partial preservation of subvavular apparatus during mitral valve replacement | Procedure or surgery | complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatu, partial (preservation of posterior leaflet only) preservation of subvalvular apparatus |
Primary outcome
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement
Time frame: anticepated 3 years
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement regarding: * Postoperative morbidity and mortality * LV function and the change of cardiac chamber dimensions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
Related trials for Mitral Valve Replacement
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Recruiting
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Mitral Valve Regurgitation
RecruitingObservational study
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population
Mitral Valve Insufficiency
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral valve replacement in people with Mitral Valve Replacement and Mitral Insufficiency, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact amr mamdouh amr mamdouh, specialist (+201000566770, amrmamdouh_95@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement (time frame: anticepated 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2025.