Great Vessel Reconstruction, Intracardiac and Septal Defects, Peripheral Vessel Reconstruction, Suture Line Buttressing, Valve and Anulus Repair
Conditions
Brief 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.
Detailed description
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 has been designed to collect prospective product safety and performance data after the CardioCel line extension for CardioCel 3D and the indication expansion to include great vessel and peripheral reconstruction and suture line buttressing and will collect safety and performance data up to 2 years following implantation. The CardioCel 3D Registry will collect data on the use of the CardioCel, CardioCel Neo and CardioCel 3D for the following major indications: * Intracardiac and septal defects * Valve and annulus repair * Great vessel reconstruction * Peripheral vascular reconstruction As suture line buttressing is a procedure that does not consistently use tissue, data on this indication will only be included if available. Data will be prospectively collected by the sites on registry-specific electronic case report forms (eCRFs). The primary endpoints will assess devices' safety and performance through measures and images obtained via the facility's standard of care at the respective registry site. Additional data will also be collected from the implant procedure to assess user (surgeon) satisfaction with the devices' handling and performance.
Interventions
DEVICECardioCel implantation
treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
Sponsors
Factory CRO for Medical Devices B.V.
LeMaitre Vascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patient has signed the informed consent * patient is a candidate for treatment with CardioCel/CardioCel Neo/CardioCel 3D per approved device indications.
Exclusion criteria
\- no study specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of re-stenosis | at 30 days and 1 and 2 years follow-up | for Great vessel reconstruction |
| Rates of recoarctation | at 30 days and 1 and 2 years follow-up | for Great vessel reconstruction |
| Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular locations | at 30 days and 1 and 2 years follow-up | for Peripheral vascular reconstruction |
| Incidence of graft related reinterventions | at 1 and 2 years post-procedure | capture the rate of graft related reinterventions |
| Incidence of Patch calcification | at 30 days and 1 and 2 years follow-up | capturing the rate of patch calcification |
| Incidence of Patch retraction | at 30 days and 1 and 2 years follow-up | capturing the rate of patch retraction |
| Incidence of Unanticipated events | at 30 days and 1 and 2 years follow-up | capturing the rate of unanticipated events |
| incidence of Patch dehiscence | at 30 days and 1 and 2 years follow-up | capturing the rate of patch dehiscence |
| Rates of Valvular Regurgitation Grade > Moderate | 30 days post procedure | for Valve and annulus repair |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed