Clinical Study on the Safety and Efficacy of FireMagic™ Magbot Ablation Catheter for Rapid Arrhythmia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Immediate success rate of surgery
研究概览
简要总结
Clinical study on the safety and efficacy of FireMagic™ Magbot Ablation Catheter for rapid arrhythmia
详细描述
Explore the safety and efficacy of ireMagic™ Magbot Ablation Catheter for rapid arrhythmia in clinical studies, establish standards for standardised catheter use after market launch, and provide evaluation indicators that meet the requirements for nationwide multi-centre promotion.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years old, with no gender restrictions; 2) Patients clinically diagnosed with paroxysmal atrial fibrillation or symptomatic supraventricular tachycardia: i. For patients with paroxysmal atrial fibrillation, atrial fibrillation was recorded by surface electrocardiogram or Holter monitoring (including single-lead electrocardiogram) within one year prior to enrolment; ii. For patients with symptomatic supraventricular tachycardia, PSVT (AVNRT or AVRT) was recorded by electrocardiogram, Holter monitoring, or electrophysiological examination; 3) Patients who have not responded adequately to or are intolerant of at least one antiarrhythmic drug, or who are willing to undergo ablation surgery without prior medication; 4) Patients who fully understand the treatment plan, voluntarily sign the informed consent form, and are willing to undergo the examinations, surgery, and follow-up required by the plan.
排除标准
- •Left atrial thrombus (not applicable for PSVT); 2) Left atrial anteroposterior diameter ≥55 mm (not applicable for PSVT); 3) Left ventricular ejection fraction (LVEF) ≤40%; 4) Previous history of atrial septal defect repair or atrial myxoma (not applicable for PSVT); 5) Presence of active implantable devices (e.g., pacemaker, ICD, etc.); 6) NYHA functional class III-IV; 7) History of cerebrovascular disease within the past 6 months (including cerebral haemorrhage, stroke, transient ischaemic attack); 8) History of cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, atrial or ventricular incision); 9) Acute or severe systemic infection; 10) Patients with severe liver or kidney disease, malignant tumours, or end-stage diseases, or those whom the investigator believes may interfere with the treatment, evaluation, or compliance of this trial; 11) Patients with a significant tendency to bleed, hypercoagulable states, or severe haematological disorders.
结局指标
主要结局
Immediate success rate of surgery
时间窗: On the day of the surgery
1. For patients with supraventricular tachycardia: Following the procedure, the following criteria are used to evaluate whether catheter ablation has achieved the intended surgical objectives:Ⅰ. AVNRT: AVNRT cannot be induced after ablation. If skipped beats or 1-2 atrial echoes are present, induction stimulation must be performed concurrently with an isoproterenol challenge test, and AVNRT still cannot be induced. Ⅱ.AVRT: ① AVRT cannot be induced after ablation; ② ventricular stimulation shows central VA Wenckebach conduction or VA dissociation; ③ atrial stimulation shows central AV Wenckebach conduction. 2. For patients with paroxysmal atrial fibrillation: Observe for 20-30 minutes after initial pulmonary vein isolation and verify successful bidirectional block.
次要结局
未报告次要终点
研究者
Gao Henggan
Shanghai MicroPort EP MedTech Co., Ltd.
Ruijin-Hainan Hospital Shanghai Jiao Tong University School Of Medicine