Prospective and Non-randomized Registry of CardioCel 3D

Condition(s) studied

Investigational drug(s) / intervention(s)

CardioCel implantation: treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing

Study summary

Post-market, prospective, multi-centre, open-label, registry designed to collect prospective safety and performance data on the use of CardioCel in patients with cardiovascular disorders and in accordance with local standard of care.

The Registry will collect data with a minimum of 50 subjects per major indication (minimum total of 200) in 5-10 sites in Europe. The clinical investigation will maintain data for each patient from the date of implant through 2 years post-implantation.

Eligibility

Primary outcome measure(s)

• Incidence of graft related reintervention — 30 days post procedure.
  capture the rate of graft related reintervention
• Incidence of patch related morbidity — 30 days post procedure
  capture the rate of patch related morbidity

Trial sites (6)

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