Design and manufacture of heart valve bioprostheses and vascular grafts

TIARA

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