This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
Confirmed diagnosis of supraventricular tachycardia or atrial fibrillation requiring catheter radiofrequency ablation surgery;
Signed informed consent form approved by the ethics committee;
Willingness to undergo follow-up and evaluation as required by the protocol.
Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%;
Left atrial thrombus;
History of atrial septal repair or atrial myxoma;
History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);
Single group
FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System
DeviceAll patients were treated withFireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter and Columbus™ 3D EP Navigation System for rapid arrhythmia.
major evaluation indicators--Efficacy indicators
Immediate success rate of the investigational device in treating rapid arrhythmias;
Major evaluation indicators--Monitoring methods
Radiofrequency ablation treatment of rapid arrhythmias (such as supraventricular tachycardia and atrial fibrillation) using the trial device, with immediate ablation success determined based on the operator's professional experience combined with real-time intracardiac electrocardiogram display, followed by statistical analysis;
Major evaluation indicators--Safety indicators：Perioperative study of the incidence of adverse events related to medical devices
Statistics on the incidence of adverse events related to surgical instruments during the perioperative period
Changes in the surface temperature of the ablated tissue
extract multiple surface temperature data through tissue temperature measurement catheter microelectrodes and perform statistical analysis;
Changes in ablation point impedance
evaluate secondary indicators of tissue temperature measurement catheters, observe the impedance display of the radiofrequency ablation device, and record whether the impedance decreases during ablation
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