Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- major evaluation indicators--Efficacy indicators
研究概览
简要总结
This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
详细描述
This project will conduct a clinical demonstration application study involving 300 cases, with the aim of evaluating the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Patient age between 18 and 75 years old, male or non-pregnant female;
- •Confirmed diagnosis of supraventricular tachycardia or atrial fibrillation requiring catheter radiofrequency ablation surgery;
- •Signed informed consent form approved by the ethics committee;
- •Willingness to undergo follow-up and evaluation as required by the protocol.
排除标准
- •Exclusion criteria for atrial fibrillation patients:
- •Patients should not participate in this study if any of the following conditions apply:
- •Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%;
- •Left atrial thrombus;
- •History of atrial septal repair or atrial myxoma;
- •History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);
- •Cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);
- •Acute or severe systemic infection;
- •Severe liver or kidney disease;
- •Significant bleeding tendency or haematological disorders;
- •Patients with other conditions deemed inappropriate for participation in this trial by the investigators.
- •Exclusion criteria for patients with ventricular tachycardia and supraventricular tachycardia:
- •Patients should not participate in this study if any of the following conditions apply:
- •Left atrial size ≥50 mm and left ventricular ejection fraction ≤40%;
- •History of atrial septal defect repair or atrial myxoma;
- •Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);
- •Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);
- •Patients with acute or severe systemic infection;
- •Patients with severe liver or kidney disease;
- •Patients with a significant tendency to bleed or haematological disorders;
- •Patients with other conditions deemed by the investigator to be unsuitable for participation in this trial.
结局指标
主要结局
major evaluation indicators--Efficacy indicators
时间窗: On the day of the surgery
Immediate success rate of the investigational device in treating rapid arrhythmias;
Major evaluation indicators--Monitoring methods
时间窗: On the day of the surgery
Radiofrequency ablation treatment of rapid arrhythmias (such as supraventricular tachycardia and atrial fibrillation) using the trial device, with immediate ablation success determined based on the operator's professional experience combined with real-time intracardiac electrocardiogram display, followed by statistical analysis;
Major evaluation indicators--Safety indicators：Perioperative study of the incidence of adverse events related to medical devices
时间窗: perioperative period
Statistics on the incidence of adverse events related to surgical instruments during the perioperative period
次要结局
- Changes in the surface temperature of the ablated tissue(During surgery)
- Changes in ablation point impedance(During surgery)