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Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function

Not Applicable
Not yet recruiting
Conditions
Rapid Arrhythmia
Atrial 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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Major evaluation indicators--Monitoring methodsOn 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 devicesperioperative period

Statistics on the incidence of adverse events related to surgical instruments during the perioperative period

major evaluation indicators--Efficacy indicatorsOn the day of the surgery

Immediate success rate of the investigational device in treating rapid arrhythmias;

Secondary Outcome Measures
NameTimeMethod
Changes in the surface temperature of the ablated tissueDuring surgery

extract multiple surface temperature data through tissue temperature measurement catheter microelectrodes and perform statistical analysis;

Changes in ablation point impedanceDuring 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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