A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Success rate of atrial septal puncture
研究概览
简要总结
This study aims to evaluate the safety and efficacy of a three-dimensional navigation intracardiac guidance kit to perform atrial septal puncture in patients requiring catheter ablation, which will be compared with procedures using traditional kit for atrial septal puncture.
详细描述
Atrial septal puncture has become a key technique in cardiac interventional procedures. Traditional septal punctures are routinely perfomed under two-dimensioanl guidance, whic are likely to be not acurate sometimes.
This study is aimed to study the safety and efficacy of a novel designed three-dimensional navigation Intracardiac guidance kit for atrial septal puncture in patients with atrial fibrillation requiring catheter ablation and to explore the possibility of transseptal without fluoroscopy using the three-dimensional positioning intracardiac guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with atrial fibrillation.
- •Requiring catheter ablation therapy.
- •Voluntarily sign the informed consent.
排除标准
- •Previous atrial septal puncture.
- •Blood clots in the left atrium or left atrial appendage
- •Left atrial mucinous tumor.
- •Atrial septal defect, including previous surgical correction or interventional occlusion.
- •Acute or severe systemic infection.
- •Cardiac function (NYHA classification) Ⅲ-Ⅳ.
- •Contraindications to anticoagulation.
- •Left ventricular ejection fraction <35%.
- •Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
- •Patients with malignancy with expected survival of less than 1 year.
- •Myocardial infarction or any cardiac intervention or open procedure within the last 3 months
- •Stroke and other cerebrovascular disease or thromboembolic disease within the last 3 months.
- •Participated in clinical trials of other drugs or devices in the past 3 months.
- •Any other condition that the investigator deems inappropriate for participation in this trial.
结局指标
主要结局
Success rate of atrial septal puncture
时间窗: one day
Successful atrial septal puncture is defined as the right and left interatrial pathways are established and the ablation catheter can enter the left atrium smoothly for subsequent ablation operations.
X-Ray exposure time
时间窗: one day
X-ray exposure time from the successful femoral vein puncture to the entry of the external sheath into the left atrium (ending with heparin saline flushing of the sheath).
次要结局
- First puncture success rate of atrial septum(one day)
- Total operation time(one day)
- Performance evaluation of a three-dimensional positioning intracardiac guidance kit(one day)
- Atrial septal puncture duration(one day)