RecruitingNCT06591000

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

Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease


Sponsor

Chelyabinsk Regional Clinical Hospital

Enrollment

56 participants

Start Date

Jan 14, 2016

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
  • Intraoperative findings suggested for tricuspid valve replacement rather than repair.

Exclusion Criteria6

  • 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%

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREtricuspid valve replacement

Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis


Locations(1)

Department of Cardiac Surgery

Chelyabinsk, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06591000


Related Trials