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| Name | Class |
|---|---|
| Factory CRO for Medical Devices B.V. | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CardioCel group | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioCel implantation | Device | treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- no study specific exclusion criteria; patients treated per standard clinical practice
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CardioCel, CardioCel Neo and CardioCel 3D are indicated for the 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.
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| Name | Affiliation | Role |
|---|---|---|
| Ioana Ghiu | Anteris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Leipzig | Leipzig | 04289 | Germany | |||
| Policlinico San Donato |
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| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| 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 |
| San Donato Milanese |
| MI |
| 20097 |
| Italy |
| A.O.U. Città della Salute e della Scienza | Turin | 10126 | Italy |
| Hospital Universitario "Doce de Octubre" | Madrid | 28041 | Spain |
| Bristol Children's Hospital and the Heart Institute | Bristol | United Kingdom |
| The Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle | NE7 7DN | United Kingdom |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |