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

ConditionsRapid Arrhythmia Atrial Fibrillation (AF)Paroxysmal Supraventricular Tachycardia (PSVT)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai MicroPort EP MedTech Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%;

Left atrial thrombus;

History of atrial septal repair or atrial myxoma;

History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);

Trial design

Treatments tested in this trial

FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System

Treatment groups

300 Participants

are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Shanghai MicroPort EP MedTech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov