Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

Last updated: September 30, 2025
Sponsor: Chelyabinsk Regional Clinical Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Mitral allograft implantation

Clinical Study ID

NCT06196684
26122023
  • Ages 18-70
  • All Genders

Study Summary

The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failurescheduled for tricuspid valve intervention.

  • Intraoperative findings suggested for tricuspid valve replacement rather thanrepair.

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Confirmed active drug addiction

  • Progressive HIV-infection

  • HIV-infected patients with CD4-cells count less than 250

  • Patients with secondary tricuspid valve pathology (left-sided valve disease)

  • LV Ejection fraction less than 50%

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Mitral allograft implantation
Phase:
Study Start date:
September 29, 2021
Estimated Completion Date:
October 30, 2026

Study Description

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication ) is going to be evaluated.

Connect with a study center

  • Department of Cardiac Surgery

    Chelyabinsk 1508291, Chelyabinsk Oblast 1508290 454076
    Russia

    Site Not Available

  • Department of Cardiac Surgery

    Chelyabinsk, 454076
    Russian Federation

    Site Not Available

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