NCT06591000 Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)
| NCT ID | NCT06591000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chelyabinsk Regional Clinical Hospital |
| Condition | Allograft |
| Study Type | OBSERVATIONAL |
| Enrollment | 56 participants |
| Start Date | 2016-01-14 |
| Primary Completion | 2024-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 56 participants in total. It began in 2016-01-14 with a primary completion date of 2024-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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%
Contact & Investigator
Yuri Malinovsky, PhD
STUDY CHAIR
Department of Cardiac Surgery
Frequently Asked Questions
Who can join the NCT06591000 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Allograft. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06591000 currently recruiting?
Yes, NCT06591000 is actively recruiting participants. Contact the research team at austesla2022@gmail.com for enrollment information.
Where is the NCT06591000 trial being conducted?
This trial is being conducted at Chelyabinsk, Russia.
Who is sponsoring the NCT06591000 clinical trial?
NCT06591000 is sponsored by Chelyabinsk Regional Clinical Hospital. The principal investigator is Yuri Malinovsky, PhD at Department of Cardiac Surgery. The trial plans to enroll 56 participants.