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Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement

Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06811662
Enrollment
80
Registered
2025-02-06
Start date
2025-02-01
Completion date
2027-12-31
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Insufficiency, Mitral Valve Replacement

Brief 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

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.

Interventions

PROCEDUREmitral valve replacement

complete versus partial preservation of subvavular apparatus during mitral valve replacement

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacementanticepated 3 yearsTo 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.

Countries

Egypt

Contacts

Primary Contactamr mamdouh amr mamdouh, specialist
amrmamdouh_95@yahoo.com+201000566770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026