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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07032948

Enrollment

300

Registered

2025-06-24

Start date

2025-08-31

Completion date

2025-08-31

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), Paroxysmal Supraventricular Tachycardia (PSVT), Rapid Arrhythmia

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.

Interventions

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

All patients were treated withFireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter and Columbus™ 3D EP Navigation System for rapid arrhythmia.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1\. Inclusion Criteria 1. Patient age between 18 and 75 years old, male or non-pregnant female; 2. Confirmed diagnosis of supraventricular tachycardia or atrial fibrillation requiring catheter radiofrequency ablation surgery; 3. Signed informed consent form approved by the ethics committee; 4. Willingness to undergo follow-up and evaluation as required by the protocol. 2\.

Exclusion criteria

Include: 1.

Design outcomes

Primary

Measure	Time frame	Description
major evaluation indicators--Efficacy indicators	On the day of the surgery	Immediate success rate of the investigational device in treating rapid arrhythmias;
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

Secondary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026