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

ConditionsAllograft Bioprosthesis Tricuspid Valve Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-70

SponsorChelyabinsk Regional Clinical Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

Pregnancy

Confirmed active drug addiction

Progressive HIV-infection

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

Trial design

Treatments tested in this trial

tricuspid valve replacement

Treatment groups

56 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Chelyabinsk Regional Clinical Hospital

Lead sponsor

Source ClinicalTrials.gov