Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Success rate of atrial septum
研究概览
简要总结
To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum.
Evaluation indicators:
Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the contralateral group; Performance evaluation of an RF transseptal puncture system; The incidence of complications related to atrial septal puncture; Rates of adverse events; Rates of serious adverse events.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants scheduled to undergo transseptal access interventional cardiology procedure; The subjects were informed of the nature of the study, understood the purpose of the clinical trial, voluntarily participated and signed an informed consent form.
排除标准
- •The presence of an intracardiac mass, thrombus or vegetation on echocardiography; Left atrial myxoma;
- •subjects with ASD occluder or patch implantation;
- •hemorrhagic or coagulopathy; Or there is contraindication to antithrombotic drugs;
- •acute myocardial infarction within 4 weeks;
- •end-stage heart failure (ACC/AHAD stage); Or after heart transplantation; Or waiting for a heart transplant;
- •history of cerebrovascular accident within 30 days;
- •pregnant and lactating women;
- •acute systemic infection or sepsis;
- •patients who have participated in any drug and/or medical device clinical trial within 1 month before this trial;
- •atrial septal puncture within 3 months;
- •life expectancy less than one year;
- •The investigator judged that the patient had poor compliance and could not complete the study according to the requirements; Or other circumstances in which the researcher considers the subject to be unsuitable for the study
研究组 & 干预措施
Test Group
RF Cross
干预措施: Radiofrequency Transseptal Puncture System and Auxiliary Device (Device)
Control Group
Braidin Cross
干预措施: Radiofrequency Transseptal Puncture System and Auxiliary Device (Device)
结局指标
主要结局
Success rate of atrial septum
时间窗: It is expected to last 18 months
次要结局
未报告次要终点
研究者
Yibo Yu
Associate chief physician
First Affiliated Hospital of Ningbo University