NCT06232798已完成不适用
A Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Immediate success rate
研究概览
简要总结
The goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with PFA/RFA. 10 patients will be treated by PFA/RFA catheter or PFA catheter only.
Participants will followed 1、3 month after catheter ablation
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
- •Aged 18-75 years old;
- •Documented symptomatic persistent atrial fibrillation, defined as persistent atrial fibrillation lasting more than 7 days and less than 1 year；
- •Ineffective or intolerable after treatment with at least one Class I or Class III antiarrhythmic drug;
- •Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.
排除标准
- •Patients who have undergone left atrial surgery
- •Left atrial thrombosis
- •Patients with combined atrial tachycardia and atypical atrial flutter
- •Patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment
- •Anterior and posterior left atrial diameter ≥ 55mm
- •Left ventricular ejection fraction (LVEF) ≤ 40%
- •Previous atrial septal repair or atrial mucinous tumor
- •Active implants (e.g. pacemakers, ICDs, etc.) in the body
- •NYHA class III-IV cardiac function
- •Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
- •Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)
- •Those with acute or severe systemic infections
- •Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial
- •Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
- •Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
- •Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
研究组 & 干预措施
A prospective, singlecenter, single-arm clinical study
Experimental
干预措施: a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter (Other)
A prospective, singlecenter, single-arm clinical study
Experimental
干预措施: catheter ablation (Other)
结局指标
主要结局
Immediate success rate
时间窗: 1 Day of catheter ablation
Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled.
次要结局
- Ablation success at 3-month after the catheter ablation(3 months)
研究者
研究点 (1)
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