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).
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.
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.).
Single group
PFA Ablation catheter
DeviceDeliver PF energy using the PulseMagic™ PFA system
The success rate within 12 months after operation treatment without AADs
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
Acute procedural success
Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation.
Primary safety endpoint
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.
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