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NCT Number: NCT07032948

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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 Include:
  • Exclusion criteria for atrial fibrillation patients:

Patients should not participate in this study if any of the following conditions apply:

  • 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);
  • Cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);
  • Acute or severe systemic infection;
  • Severe liver or kidney disease;
  • Significant bleeding tendency or haematological disorders;
  • Patients with other conditions deemed inappropriate for participation in this trial by the investigators.
  • Exclusion criteria for patients with ventricular tachycardia and supraventricular tachycardia:

Patients should not participate in this study if any of the following conditions apply:

  • Left atrial size ≥50 mm and left ventricular ejection fraction ≤40%;
  • History of atrial septal defect repair or atrial myxoma;
  • Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);
  • Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);
  • Patients with acute or severe systemic infection;
  • Patients with severe liver or kidney disease;
  • Patients with a significant tendency to bleed or haematological disorders;
  • Patients with other conditions deemed by the investigator to be unsuitable for participation in this trial.

Treatment and study plan

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.

Primary outcomes

  1. major evaluation indicators--Efficacy indicators

    Time frame: On the day of the surgery

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

  2. Major evaluation indicators--Monitoring methods

    Time frame: 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;

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

    Time frame: perioperative period

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

Secondary outcomes

  1. Changes in the surface temperature of the ablated tissue

    Time frame: During surgery

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

  2. Changes in ablation point impedance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort EP MedTech Co., Ltd.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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