Pulsed field ablation catheter for paroxysmal atrial fibrillation not controlled by medicine
Tests a pulsed field ablation catheter in adults with paroxysmal atrial fibrillation.
Plain-language title generated from the registry record
Registry title: PulseMagic™ TrueForce™ PAF NMPA Study
Key facts
- Where
- Beijing, ChinaSee the site
Where in China
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai MicroPort EP MedTech Co., Ltd.
- Trial code
- NCT07720557
- Record updated
- 22 July 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: Patients with prior atrial septal repair, atrial septal occlusion, or left atrial myxoma; Patients with a history of atrial fibrillation ablation; Patients with active implantable devices in situ (e.g., cardiac pacemaker, ICD, etc.); 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); Left atrial anteroposterior diameter ≥ 60 mm, and left ventricular ejection fraction (LVEF) ≤ 40%; Left atrial thrombus; 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 deemed ineligible for this trial by the investigator for any other reason.