Actively Recruiting

Age: 18Years - 70Years
All Genders
NCT06591000

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

Led by Chelyabinsk Regional Clinical Hospital · Updated on 2024-09-19

56

Participants Needed

1

Research Sites

491 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention
  • Intraoperative findings suggesting tricuspid valve replacement rather than repair
  • Age between 18 and 70 years
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Confirmed active drug addiction
  • Progressive HIV infection
  • HIV-infected patients with CD4 cell count less than 250
  • Patients with secondary tricuspid valve pathology (left-sided valve disease)
  • Left ventricular ejection fraction less than 40%

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Cardiac Surgery

Chelyabinsk, Russia

Actively Recruiting

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Research Team

M

Mikhail Nuzhdin, PhD

CONTACT

Y

Yuri Malinovsky, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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