Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 6
- 主要终点
- Procedural success
研究概览
简要总结
The objective of this post-market study is to:
- collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder
- identify previously unknown side-effects
详细描述
Atrial Septal Defect (ASD) is a type of Congenital Heart Defects (CHD) that have the potential to be closed without open-heart surgery. The treatment of choice for ASD closure has long been surgical closure. An alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for ASD. With percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. The Lifetech Cera™ ASD occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. In order to collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 139 subjects. The anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
- •Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
- •Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.
排除标准
- •Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
- •Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.
- •Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.
- •Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
- •Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
- •Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.
- •Patients did not conduct any follow up visit after hospital discharge.
结局指标
主要结局
Procedural success
时间窗: 6 months post-implantation
1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/procedure related death, assessed at 6 months post-implantation. 2. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation.
次要结局
- Successful closure of the defects(at procedure, discharge（up to 2 days）and 12 months post-implantation)
- Incidence of new onset arrhythmia requiring medical treatment(From attempted procedure to 2 years post-implantation)
- Incidence of device or procedure related Adverse Events (AEs)(From attempted procedure to 2 years post-implantation)
- Incidence of device or procedure related Serious Adverse Events (SAEs)(From attempted procedure to 2 years post-implantation)
- Incidence of death(From attempted procedure to 2 years post-implantation)