PFA Ablation catheter: Deliver PF energy using the PulseMagic™ PFA system
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
The success rate within 12 months after operation treatment without AADs — 12 months 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
Trial sites (1)
Facility
City
Region
Status
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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