A Multicenter, Randomized, Parallel-controlled Clinical Trial to Evaluate the Efficacy and Safety of a New Atrial Septal Defect Occluder, ReAces®, and Delivery System for the Treatment of Atrial Septal Defect Occlusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Successful rate of complete closure of atrial septal defect
研究概览
简要总结
A multicenter, randomized, parallel-controlled clinical trial to evaluate the efficacy and safety of a new atrial septal defect occluder, ReAces®, and delivery system for the treatment of atrial septal defect occlusion. Compared with the traditional atrial septal occluder, this new atrial septal occluder supports re-puncture after occluder implantation. Thus those patients who have undergone atrial septal defect closure with the novel device may be eligible for future radiofrequency ablation of atrial fibrillation or mitral valve intervention.
The trial is expected to enroll 128 patients who will be randomly assigned to the test group or control group in a 1:1 ratio. Patients in test group will received ReAces occluder，and the others the regular occluder.The experiment is scheduled to enroll 128 patients who will be randomly allocated to one of two groups: test or control. Patients in the test group will receive a ReAces occluder, while those in the control group will receive a standard occluder.The safety and efficacy of the two groups at 1 year after surgery will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-70 years;
- •with congenital secundum atrial septal defect;
- •the maximal ASD diameter was ≤38 mm;
- •with atrial-level left-to-right shunt, with Qp/Qs shunt ratio ≥1.5:1, or TTE or clinical manifestations indicated the existence of defect that inducing overfilling of right atrium;
- •the distance from the margin of defect to coronary sinus, atrioventricular (AV) valve, and right superior pulmonary vein (RSPV) was ≥5 mm, according to the echocardiography measurements;
- •volunteered to participate in this study, and signed informed consents.
排除标准
- •ostium primordium ASD and sinus venosus ASD.
- •infective endocarditis and hemorrhagic disorders.
- •active thrombosis.
- •patients with severe pulmonary hypertension (mean pulmonary artery pressure measured by catheter > 30 mmHg) who are not taking targeted drugs
- •patients with a porous atrial septal defect that cannot be completely occluded by a single occluder.
- •with severe myocardial disorders or valvular disease not associated with ASD
- •infectious disease within the last 1 month, or uncontrolled infectious disease
- •bleeding disorders, untreated gastric or duodenal ulcers
- •thrombosis in left atrium
- •partial or total pulmonary vein ectopic drainage
- •left atrial septum, left atrial or left ventricular dysplasia
- •Patients whose size (too small for TEE probe, catheter size, etc.) or physical condition (active infection, etc.) makes them unsuitable for cardiac catheterization
- •Patients who are allergic to nickel
- •Patients with any contraindication to aspirin therapy (except for those able to take other antiplatelet agents for 6 consecutive months).
- •Pregnant or lactating women and those who plan to become pregnant during the trial
- •Patients with a life expectancy of <12 months or those who are unable to complete the study's prescribed follow-up schedule
- •Participation in another clinical trial of a drug or medical device within 30 days prior to screening.
- •Patients who have previously undergone surgical atrial septal defect repair or percutaneous interventional atrial septal defect closure.
- •Patients who, in the opinion of the investigator, are not suitable for participation in this study.
结局指标
主要结局
Successful rate of complete closure of atrial septal defect
时间窗: 0-360 days
The success rate of complete closure at 12 months after the procedure was used as the main efficacy index to evaluate the effectiveness of the novel atrial septal defect occluder ReAces, reflecting the long-term implantation effect of the device.
次要结局
- Adverse events(0-360 days)
研究者
Junbo Ge
Principal Investigator
Shanghai Zhongshan Hospital