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

NCT ID: NCT06811662

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Mitral Valve Replacement Mitral Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatu

complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatus

Group Type ACTIVE_COMPARATOR

mitral valve replacement

Intervention Type PROCEDURE

complete versus partial preservation of subvavular apparatus during mitral valve replacement

partial (preservation of posterior leaflet only) preservation of subvalvular apparatus

partial (preservation of posterior leaflet only) preservation of subvalvular apparatus

Group Type ACTIVE_COMPARATOR

mitral valve replacement

Intervention Type PROCEDURE

complete versus partial preservation of subvavular apparatus during mitral valve replacement

Interventions

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mitral valve replacement

complete versus partial preservation of subvavular apparatus during mitral valve replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Amr Mohamed Mamdouh Hussein

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Heart Hosiptal

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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amr mamdouh amr mamdouh, specialist

Role: CONTACT

+201000566770

Facility Contacts

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assiut university assiut university

Role: primary

+201000566770

Other Identifiers

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preservation of MV leaflts

Identifier Type: -

Identifier Source: org_study_id

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