A Clinical Study on the Use of a Domestically Produced Three-dimensional Cardiac Electrophysiological Mapping System Combined With Pressure Monitoring Technology and Star Mapping Technology for the Treatment of Paroxysmal Atrial Fibrillation.
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
- Three-month follow-up success rate after surgery
研究概览
简要总结
Validating the safety and efficacy of pressure monitoring technology and star-shaped marking technology for the treatment of paroxysmal atrial fibrillation
详细描述
This trial will select appropriate clinical cases at clinical centres, where authorised investigators will perform ablation surgery for paroxysmal atrial fibrillation using the trial product. Indicators such as immediate ablation success rate and treatment success rate within three months post-surgery will be collected.
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
- •Patient age between 18 and 80 years old, male or non-pregnant female.
- •Confirmed diagnosis of paroxysmal atrial fibrillation requiring catheter radiofrequency ablation surgery.
- •Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.
排除标准
- •Post-ablation for atrial fibrillation
- •Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
- •Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
- •Left atrial thrombus
- •History of atrial septal defect repair or atrial myxoma
- •History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
- •History of 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 significant bleeding tendencies or haematological disorders
- •Patients with malignant tumours or end-stage diseases
- •Patients deemed ineligible for this trial by the investigator
结局指标
主要结局
Three-month follow-up success rate after surgery
时间窗: Postoperative 3-month
Postoperative 3-month treatment success rate: Specifically refers to the proportion of participants who, during the 3-month follow-up period (after the washout period), did not experience any episodes of atrial fibrillation/atrial flutter/atrial tachycardia lasting ≥30 seconds, as confirmed by electrocardiogram (ECG), Holter monitoring, or equivalent rhythm monitoring methods (including single-lead ECG), without the use of Class I or Class III antiarrhythmic drugs, relative to the total number of enrolled participants.
次要结局
- Immediate ablation success rate(On the day of the surgery)
研究者
Gao Henggan
Gao henggan
Shanghai MicroPort EP MedTech Co., Ltd.