NeoCor is currently conducting a multicentre clinical study:
Post-market confirmation of safety and efficiency of
UniLine PRESERVED XENOPERICARDIUM BIOLOGICAL HEART VALVE PROSTHESIS, MOUNTED ON A FLEXIBLE STENT used for mitral, aortic and tricuspid valves failure treatment
Short name (UNILINE)
Study design:
Sites: 10 health care centres in Russia
Full-design, cohort study
Prospective (2018-2021)
Number of patients: 200
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 months after the surgery, each visit includes history taking and an echo-cardiogram.
