Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function
- Conditions
- Rapid ArrhythmiaAtrial Fibrillation (AF)Paroxysmal Supraventricular Tachycardia (PSVT)
- Registration Number
- NCT07032948
- Lead Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
- Brief Summary
This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Major evaluation indicators--Monitoring methods On the day of the surgery 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 perioperative period Statistics on the incidence of adverse events related to surgical instruments during the perioperative period
major evaluation indicators--Efficacy indicators On the day of the surgery Immediate success rate of the investigational device in treating rapid arrhythmias;
- Secondary Outcome Measures
Name Time Method Changes in the surface temperature of the ablated tissue During surgery extract multiple surface temperature data through tissue temperature measurement catheter microelectrodes and perform statistical analysis;
Changes in ablation point impedance During surgery 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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