PulseMagic™ TrueForce™ PAF NMPA Study

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia

In brief

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).

Key facts

Study ID

NCT07720557

Run by

Shanghai MicroPort EP MedTech Co., Ltd.

People needed

150

Starts

2026-07-10

Expected to finish

2028-11-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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