PulseMagic™ TrueForce™ PAF NMPA Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai MicroPort EP MedTech Co., Ltd.

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

Treatment groups

150 Participants
are divided into 1 treatment group