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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid Arrhythmia(Paroxysmal supraventricular tachycardia and Atrial Fibrillation) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System | Device | All patients were treated withFireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter and Columbus™ 3D EP Navigation System for rapid arrhythmia. |
| Measure | Description | Time Frame |
|---|---|---|
| major evaluation indicators--Efficacy indicators | Immediate success rate of the investigational device in treating rapid arrhythmias; | 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; | 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 | perioperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the surface temperature of the ablated tissue | extract multiple surface temperature data through tissue temperature measurement catheter microelectrodes and perform statistical analysis; | During surgery |
| Changes in ablation point impedance |
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1. Inclusion Criteria
2. Exclusion Criteria Include:
Exclusion criteria for atrial fibrillation patients:
Patients should not participate in this study if any of the following conditions apply:
Exclusion criteria for patients with ventricular tachycardia and supraventricular tachycardia:
Patients should not participate in this study if any of the following conditions apply:
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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
| During surgery |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
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