Focal Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia: A Prospective, Multicenter, Single-Arm Study in Mainland China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Primary efficacy and safety endpoints
研究概览
简要总结
The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter
详细描述
The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs . The primary safety endpoints were to assess the incidences of serious adverse events (SAEs) at the end of the procedure , discharge and during the 6-month follow-up period.
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
- •age from 18 to 80 years,
- •episode of PSVT recorded by a 12-lead surface electrocardiogram (ECG), 24-hour Holter monitoring, or esophageal electrophysiologic study (EES) before hospitalization
- •reproducible clinical tachycardia confirmed by the electrophysiological study (EPS).
排除标准
- •Previous failure or recurrence of radiofrequency ablation
- •Left ventricular ejection fraction (LVEF) ≤ 40%
- •Combined with atrial flutter or atrial fibrillation
- •Combination of thromboembolic disease
- •Women who are breastfeeding, pregnant or planning to become pregnant during the study period
- •Carrying active implants in the body (e.g., pacemakers, ICDs, etc.)
- •Patients with second-degree (type II) or third-degree atrioventricular block
- •NYHA Class III-IV cardiac function [Appendix 1]
- •Patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale)
- •Patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month
- •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)
- •Acute or severe systemic infection
- •Patients with severe liver and kidney diseases, malignant tumors and end-stage diseases
- •Patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders
- •Patients who have participated or are participating in other clinical trials within 3 months before enrollment
- •Patients who have other conditions that the investigator considers inappropriate for participation in this trial.
研究组 & 干预措施
Experiment group
Patients of PSVT treated with PFA catheter.
干预措施: Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter (Device)
结局指标
主要结局
Primary efficacy and safety endpoints
时间窗: at end of the procedure, 1-month follow-up, 3-month follow-up, 6-month follow-up
The primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after PFA without the use of antiarrhythmic drugs. The primary safety endpoints were to assess the incidences of SAEs at the end of the procedure and during the 6-month follow-up period.
次要结局
- Interim analysis(Refers to the postoperative phase after 6 months.)