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

NCT06811662 | Not Yet Recruiting DMC

• 1 other identifier: preservation of MV leaflts
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Mitral Valve Replacement; Mitral Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  anticepated 3 years

Study Arms (2)

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

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

Procedure: mitral valve replacement

Interventions

mitral valve replacement PROCEDURE

complete versus partial preservation of subvavular apparatus during mitral valve replacement

complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatu; partial (preservation of posterior leaflet only) preservation of subvalvular apparatus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Age between 18 and 60 years
• Rheumatic mitral disease indicated for mitral valve replacement
• Concomitant other valve disease

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Heart Hosiptal

Asyut, 711, Egypt

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

amr mamdouh amr mamdouh, specialist

CONTACT

+201000566770; amrmamdouh_95@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: February 6, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

EG (1)