This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
This project will conduct a clinical demonstration application study involving 300 cases, with the aim of evaluating the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
All 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;
Time frame: On the day of the surgery
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;
Time frame: On the day of the surgery
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
Time frame: 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;
Time frame: During surgery
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
Time frame: During surgery
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