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NCT07720557
PulseMagic™ TrueForce™ PAF NMPA Study
Conditions: Atrial Fibrillation (AF), Paroxysmal AF, Drug Refractory Paroxysmal Atrial Fibrillation, Atrial Arrhythmia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.
Location: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Beijing Municipality
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07720557). StuddyBuddy aggregates publicly available trial information.