Not Yet RecruitingNot Applicable

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

300 participantsStarted 2025-08-31

Plain-language summary

This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Patient age between 18 and 75 years old, male or non-pregnant female;
✓. 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.

Exclusion criteria

✕. Exclusion criteria for atrial fibrillation patients:
✕. Exclusion criteria for patients with ventricular tachycardia and supraventricular tachycardia:

What they're measuring

major evaluation indicators--Efficacy indicators

Timeframe: On the day of the surgery

Major evaluation indicators--Monitoring methods

Timeframe: On the day of the surgery

Major evaluation indicators--Safety indicators：Perioperative study of the incidence of adverse events related to medical devices

Timeframe: perioperative period

Trial details

NCT IDNCT07032948

SponsorShanghai MicroPort EP MedTech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Rapid Arrhythmia trials