PulseMagic™ TrueForce™ PAF NMPA Study (PFATrueForce)
2026年7月19日 更新者：Shanghai MicroPort EP MedTech Co., Ltd.
A Study of Pulsed Field Ablation With the PulseMagic™ TrueForce™ Catheter and PulseMagic™ PFA Generator for the Treatment of Paroxysmal Atrial Fibrillation (PFATrueForce)
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).
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yan Yao
- 电话号码：010-88392405
- 邮箱：ianyao@263.net.cn
学习地点
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：PulseMagic™ TrueForce™ Ablation catheter
A single use catheter that is designed to facilitate electrophysiological mapping of the heart chambers and PFA therapy to the catheter's flexible tip electrode for intracardiac ablation purposes.
|
Deliver PF energy using the PulseMagic™ PFA system
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The success rate within 12 months after operation treatment without AADs
大体时间：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
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute procedural success
大体时间：after a 20 min observation period following the last ablation
|
Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation.
|
after a 20 min observation period following the last ablation
|
|
Primary safety endpoint
大体时间：Up to 7 days post ablation procedure
|
The incidence of primary adverse events refers to the rate of early-onset adverse events occurring within 7 days after ablation, including: vagal reflex complicated with severe bradycardia, acute coronary injury/occlusion, acute kidney injury, myocardial infarction, phrenic nerve injury/paralysis, left atrial-esophageal fistula, transient ischaemic attack, stroke/cerebrovascular accident/thromboembolism, pericarditis requiring intervention, cardiac tamponade/perforation, pneumothorax, severe vascular access complications and death.
|
Up to 7 days post ablation procedure
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月10日
初级完成 (估计的)
2028年7月1日
研究完成 (估计的)
2028年11月30日
研究注册日期
首次提交
2026年7月19日
首先提交符合 QC 标准的
2026年7月19日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月19日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.