Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

Last updated: September 7, 2024
Sponsor: Chelyabinsk Regional Clinical Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Organ Transplant

Heart Valve Disease

Treatment

tricuspid valve replacement

Clinical Study ID

NCT06591000
14012016
  • Ages 18-70
  • All Genders

Study Summary

The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis 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 40%

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: tricuspid valve replacement
Phase:
Study Start date:
January 14, 2016
Estimated Completion Date:
June 14, 2025

Study Description

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.

Connect with a study center

  • Department of Cardiac Surgery

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.