A Study of Pulsed Field Ablation With the PulseMagic™ TrueForce™ Catheter and PulseMagic™ PFA Generator for the Treatment of Paroxysmal Atrial Fibrillation (PFATrueForce)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The success rate within 12 months after operation treatment without AADs
研究概览
简要总结
This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with Pulsed Field Ablation Software for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).
详细描述
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years old.
- •Clinically diagnosed with symptomatic paroxysmal atrial fibrillation.
- •Atrial fibrillation documented by surface electrocardiogram (ECG), or ambulatory electrocardiogram (including single-lead ECG recorder).
- •Poor response or intolerance to at least one Class I or Class III antiarrhythmic drug.
- •Fully informed of the treatment regimen, voluntarily signed the informed consent form, and agreed to undergo all examinations, procedures and follow-up visits specified in the study protocol.
排除标准
- •Patients with a history of atrial fibrillation ablation.
- •Left atrial thrombus.
- •Left atrial anteroposterior diameter ≥ 60 mm, and left ventricular ejection fraction (LVEF) ≤ 40%.
- •Patients with active implantable devices in situ (e.g., cardiac pacemaker, ICD, etc.).
- •Women of childbearing potential who cannot use effective contraception throughout the 12-month study period after enrollment.
- •Atrial fibrillation caused by hyperthyroidism or other transient factors.
- •Patients with prior atrial septal repair, atrial septal occlusion, or left atrial myxoma.
- •Patients with confirmed cerebrovascular diseases within the past 6 months (including cerebral hemorrhage, stroke and transient ischaemic attack).
- •Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary intervention, coronary artery bypass grafting, prosthetic valve replacement or repair, atrial or ventricular incision).
- •Patients deemed ineligible for this trial by the investigator for any other reason.
结局指标
主要结局
The success rate within 12 months after operation treatment without AADs
时间窗: 12 months
Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure
次要结局
- Acute procedural success(after a 20 min observation period following the last ablation)
- Primary safety endpoint(Up to 7 days post ablation procedure)