About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- PFA Ablation catheter