A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Study Evaluating the Safety and Efficacy of the AThrough Radiofrequency Transseptal Puncture System in Atrial Septal Puncture.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 4
- 主要终点
- Transseptal puncture success rate.
研究概览
简要总结
This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥ 18 years;
- •Subjects scheduled to undergo cardiology interventional treatment via the transseptal puncture route;
- •Subjects have been informed about the nature of the study, understand the purpose of the clinical trial, and voluntarily participate and sign the informed consent form.
排除标准
- •Echocardiogram indicates the presence of intracardiac masses, thrombi, or vegetations; left atrial myxoma;
- •Subjects with an atrial septal defect occluder or atrial septal patch implant;
- •Hemorrhagic disease or coagulopathy; or contraindications to antithrombotic medication treatment;
- •Acute myocardial infarction occurred within the last 4 weeks;
- •End-stage heart failure (ACC/AHA stage D); post-heart transplant; or awaiting heart transplant;
- •Pregnant or breastfeeding women;
- •Acute systemic infection or sepsis;
- •Participation in any drug and/or medical device clinical trial within the last month;
- •Researchers judge the patient's compliance to be poor, unable to complete the study as required; or other situations deemed by the researchers as making the subject unsuitable for participation in the study.
结局指标
主要结局
Transseptal puncture success rate.
时间窗: Intraprocedural assessment
Defined as successfully completing the puncture in the atrial septum and establishing a pathway from the right atrium to the left atrium (with the sheath entering the left atrium) using the transseptal puncture system
次要结局
- Initial transseptal puncture success rate.(Intraprocedural assessment)
- Number of attempts needed to successfully complete the transseptal puncture.(Intraprocedural assessment)
- Time required to successfully complete the transseptal puncture.(Intraprocedural assessment)
- Ratio of atrial septal puncture failures that cross over to the opposite group.(Intraprocedural assessment)