Design and manufacture of heart valve bioprostheses and vascular grafts

UNILINE

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.