Prospective and Non-randomized Registry of CardioCel 3D

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D

Conditions
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Intracardiac and Septal Defects, Valve and Anulus Repair, Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing

Intervention / Treatment
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* Device: CardioCel implantation


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria; patients treated per standard clinical practice
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CardioCel group<br>Patients who require repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing | Device: CardioCel implantation<br>* treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of graft related reintervention | capture the rate of graft related reintervention | 30 days post procedure. | 
| Incidence of patch related morbidity | capture the rate of patch related morbidity | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of graft related reinterventions | capture the rate of graft related reinterventions | at 1 and 2 years post-procedure | 
| Rates of Valvular Regurgitation Grade > Moderate | for Valve and annulus repair | 30 days post procedure | 
| Rates of re-stenosis | for Great vessel reconstruction | at 30 days and 1 and 2 years follow-up | 
| Rates of recoarctation | for Great vessel reconstruction | at 30 days and 1 and 2 years follow-up | 
| Rates of measurement of the dynamic flow by facility standard of care ≥110-175* cm/sec for peripheral vascular locations | for Peripheral vascular reconstruction | at 30 days and 1 and 2 years follow-up | 
| incidence of Patch dehiscence | capturing the rate of patch dehiscence | at 30 days and 1 and 2 years follow-up | 
| Incidence of Patch calcification | capturing the rate of patch calcification | at 30 days and 1 and 2 years follow-up | 
| Incidence of Patch retraction | capturing the rate of patch retraction | at 30 days and 1 and 2 years follow-up | 
| Incidence of Unanticipated events | capturing the rate of unanticipated events | at 30 days and 1 and 2 years follow-up |