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NCT Number: NCT06811662

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Heart Hosiptal

Asyut, 711, Egypt

Location contact

assiut university assiut university

CONTACT

+201000566770

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mitral valve replacement

Procedure

complete versus partial preservation of subvavular apparatus during mitral valve replacement

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

amr mamdouh amr mamdouh, specialist

CONTACT

[email protected]

+201000566770

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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