PulseMagic™ TrueForce™ PAF NMPA Study

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.

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.