TIARA Clinical Study
Post-market clinical study to confirm the performance and safety of TiAra heart valve bioprosthesis
Short name (TIARA)
Study design:
Sites: 10 health care centres in Russia
Full design, cohort study
Prospective: 5 years (2019-2024)
Number of patients: 200-250
Study endpoints:
- Primary endpoint: fatal case.
- The secondary endpoint: non-lethal complications: bleeding, thromboembolism, biological prosthesis dysfunction, reoperation.
Patients' follow-up:
- In-Hospital phase: life history, past medical history, the nature and scope of operative intervention, the results of pre- and postoperative echo-cardiogram
- Follow-up phases: 3, 6, 12, 24, 36, 48, 60 months after the surgery, each visit includes history taking and an echo-cardiogram
We are currently recruiting health care centres to participate in this clinical trial. For more information visit the website of our partner, ST Medical Contract research organization https://www.ctmedical.ru/
Phone: +7 913 433 7669; Mikhail Karelin, Director General, ST Medical
