Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: amr mamdouh amr mamdouh, specialist
- Phone Number: +201000566770
- Email: amrmamdouh_95@yahoo.com
Study Locations
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-
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Assiut, Egypt, 711
- Assiut University Heart Hosiptal
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Contact:
- assiut university assiut university
- Phone Number: +201000566770
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Age between 18 and 60 years
- Rheumatic mitral disease indicated for mitral valve replacement
- Concomitant other valve disease
Exclusion Criteria:
- - 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatu
complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatus
|
complete versus partial preservation of subvavular apparatus during mitral valve replacement
|
|
Active Comparator: partial (preservation of posterior leaflet only) preservation of subvalvular apparatus
|
complete versus partial preservation of subvavular apparatus during mitral valve replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement
Time Frame: anticepated 3 years
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To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement regarding:
|
anticepated 3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- preservation of MV leaflts
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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