Lifetech KONAR-MF™ VSD Occluder Post-Market Clinical Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Accurate success rate
研究概览
简要总结
The purpose of the study is to collect real-world data on patient outcomes and evaluate the procedural success and performance of the Lifetech KONAR-MF™ VSD Occluder for patients with ventricular septal defect (VSD).
详细描述
This is a non-randomized prospective post-marketing clinical follow-up study (PMCFS) in order to evaluate the feasibility and safety of the Lifetech KONAR-MF™ VSD Occluder device used for patients with ventricular septal defect. The implantation should be performed in accordance with the instructions for use (IFU).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have a clinically relevant ventricular septum defect (VSD) by Echocardiography and/or X-ray examination according to current clinical standards and center-specific protocols.
- •The patient should be older than 6 months of age and a bodyweight heavier than 8kg.
- •Defect diameter (by 2D Echocardiography): The size of the VSD is larger than or equal to 2mm and less than 10mm.
- •Upper margin of VSD to aortic valve distance >2 mm for models 6-4, 8-6, 10-8, 12-10, 14-12 and >2.5mm for models 5-3, 7-5, 9-7, in case of PmVSD.
- •Only left to right shunt of the ventricular shunt.
排除标准
- •Any contraindication mentioned in the corresponding IFU*.
- •Note: In IFU, contraindications for The KONAR-MFTM VSD Occluder are as follows:
- •Patient has extensive congenital cardinal anomaly which can only be adequately repaired by cardiac surgery.
- •Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained.
- •Active endocarditis or other infections-producing bacteria.
- •The implant of KONAR-MFTM VSD Occluder would cause an obvious interference with the aortic valve or the atrioventricular valve.
- •Patients with severely increased pulmonary vascular resistance and a right-to-left shunt and patients with documented irreversible pulmonary vascular disease.
- •Patients with contraindications to anti-platelet therapy or agents.
- •The patient does present with an aortic valve prolapsing into the VSD.
- •Currently participating in other investigational drugs- or device studies.
- •The patient who is pregnant, planning to become pregnant, or breastfeeding.
- •Patients don't give informed written consent for the procedure.
- •Patient with other cardiac anomalies by surgery therapy.
结局指标
主要结局
Accurate success rate
时间窗: From implant attempt to 12-month post-procedure.
VSD closure without complication (dislocation, hemolysis, AVB, device-related valve dysfunction, thrombosis, infection, or endocarditis) and no or only mild residual shunt after 12 months of follow-up.
Procedure successful
时间窗: From implant attempt to 12-month post-procedure.
The optimal position of the VSD with appropriate closure rate at echocardiographic examination. No or only tiny or without residual shunt and absence of device-related aortic or atrioventricular valve reflux.
次要结局
- Rate of incomplete closure at the 12-month follow-up.(At 12-month follow-up.)
- Rate of complete atrioventricular block (cAVB) or any arrhythmia needed for pacemaker implantation, device removal, or any kind of medical treatment.(From implant attempt to 12-month post-procedure.)
- Rate of device deficiencies.(From implant attempt to 12-month post-procedure.)
- Rate of device and procedure-related serious adverse events (SAE).(From implant attempt to 12-month post-procedure.)
- Incidence within 12 months post-implantation(From implant attempt to 12-month post-procedure.)