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

Launched by CHELYABINSK REGIONAL CLINICAL HOSPITAL · Sep 7, 2024

Keywords

ClinConnect Summary

The ALLOTRI clinical trial is looking at two different types of heart valve replacements for people with primary tricuspid valve disease, which is a condition affecting a specific valve in the heart. The study aims to compare the safety and effectiveness of using allografts (which are donated human tissue) versus stented biological prostheses (which are man-made valves) for patients who need to have their tricuspid valve replaced. The trial is currently recruiting participants, and eligible individuals are typically between the ages of 65 and 75 who have been diagnosed with this heart condition and are scheduled for surgery.

To take part in the study, patients must have primary tricuspid valve disease or a failed previous valve replacement and show that valve replacement is necessary based on their surgical findings. However, some groups of people cannot participate, such as those who are pregnant, have certain infections or drug addictions, or have severe heart issues. Participants in the trial can expect to be closely monitored for their health and the outcomes of their surgery over time, which will help doctors understand which treatment works better for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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%