Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 14
- 主要终点
- Effective Closure Rate at 360-day Post Operation
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
详细描述
Atrial Septal Defect (hereinafter referred to as "ASD") is a common congenital heart disease (hereinafter referred to as "CHD"), accounting for about 10% of CHD in children.Initially，ASD was treated by surgical operation. Nowdays transcatheter ASD closure, characterized by minimal invasion, definite curative effect, short recovery period, and no need for cardiopulmonary bypass, provides a new safe and effective therapy for CHD. According to a large number of clinical reports, the use of transcatheter closure devices for ASD closure has a high success rate, good closure effect and low risk of complications.
Absnow absorbable ASD closure system has undergone implantation experiments that implant it into animal (pig) ASD models, with the implantation success rate being 100%. Up to 2 years' observation indicated that the cardiomyocytes and endothelial cells covering the implanted device were not different from those of the control group (nickel-titanium alloy occluder) and were of a great number, and the inflammatory response was remarkably lower than that of the control group. During the observation period, all occluders in the trial did not fall off or were displaced, no evident postoperative complications and therefore, this occluder has the feasibility of local application and system safety.
Absnow absorbable ASD closure system developed by LifeTech Scientific passed the registration inspection of CFDA Shenzhen Medical Device Quality Monitoring and Inspection Center, verifying that this closure system conforms to the product technical specification in mechanical strength, physiochemical properties and biological properties. According to the provisions in Measures for Administration of Medical Device Registration (No. 4 Order) and Regulation on Quality Management of Medical Device Clinical Trial (No. 25) issued by CFDA, this product has the conditions for clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥3 , weight ≥10Kg
- •Secundum left-to-right shunt ASD with hemodynamic significance
- •Distance from the defect edge to coronary vein sinus, superior and inferior vena cava, pulmonary vein≥5mm and AV valve should be ≥7mm
- •The atrial septum length (stretched diameter) should be greater than the diameter of left disk
排除标准
- •Patients of primum, venous sinus and coronary sinus ASD
- •Patients with atrial septum defect ≥26mm
- •Patients with other structural heart disease in addition to ASD
- •Patients with complication of obstructive pulmonary arterial hypertension, Eisenmenger syndrome
- •Infective endocarditis patients
- •Patients with hemolysis or hemorrhagic disease, unhealed ulcer or any taboo about aspirin (except being able to take other anti-platelet agent for consecutive six months) within one month before implantation
- •Patients with thrombosis(especially in left atrium or left atrial appendage thrombus) as shown by echocardiography
- •Patients with known condition of hypercoagulation status
- •Patients who have undergone heart surgery in the past
- •Patients allergic to PLLA
- •Patients refusing to sign the informed consent form
- •Patients with poor compliance on disease-related treatment and poor cooperation on follow-up visits
- •Patients that are in pregnancy or lactation, or planned for pregnancy or get a positive pregnancy test result during the screening period
- •Patients that have participated in any clinical trial that may affect the evaluation of the device in this trial and not completed or withdrawn from the previous clinical trial within 3 months prior to this trial screening period
- •The patients considered to be not eligible for this clinical trial by the investigator
研究组 & 干预措施
Absnow Absorbable ASD Closure System
All subjects are implanted with Absnow Absorbable ASD Occluder
干预措施: Absnow Absorbable ASD Closure System (Device)
结局指标
主要结局
Effective Closure Rate at 360-day Post Operation
时间窗: 360-day post ASD closure operative
Effective closure rate refers to proportion of patient without or with only mild-small residual shunt in TTE or TEE observation after device implantation
The Rate of Common Complication During 360-day Post ASD Closure Operative
时间窗: 360-day post operation
Rate of common complication refers to proportion of subject with common complication during the 360day of follow up, common complications include Occluder dislocation, Moderate or larger residual shunt, High-grade atrioventricular block, Intractable headache or migraine, Cardiac tamponade, Cerebral embolism and Air embolism.
次要结局
- Immediate Operation Success Rate(Immediate postoperative)
- Device-related AE (Adverse Event) Rate(5 years post operation)
- Device-related SAE (Serious Adverse Event) Rate(5 years post operation)