Post-Market Registry in Europe for the Use of CardioCel®, CardioCel® Neo and CardioCel® 3D
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Incidence of graft related reintervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient has signed the informed consent
- •patient is a candidate for treatment with CardioCel/CardioCel Neo/CardioCel 3D per approved device indications.
排除标准
- •no study specific exclusion criteria; patients treated per standard clinical practice
结局指标
主要结局
Incidence of graft related reintervention
时间窗: 30 days post procedure.
capture the rate of graft related reintervention
Incidence of patch related morbidity
时间窗: 30 days post procedure
capture the rate of patch related morbidity
次要结局
- Incidence of graft related reinterventions(at 1 and 2 years post-procedure)
- incidence of Patch dehiscence(at 30 days and 1 and 2 years follow-up)
- Rates of recoarctation(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(at 30 days and 1 and 2 years follow-up)
- Incidence of Unanticipated events(at 30 days and 1 and 2 years follow-up)
- Rates of Valvular Regurgitation Grade > Moderate(30 days post procedure)
- Rates of re-stenosis(at 30 days and 1 and 2 years follow-up)
- Incidence of Patch calcification(at 30 days and 1 and 2 years follow-up)
- Incidence of Patch retraction(at 30 days and 1 and 2 years follow-up)