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

NCT07032948 | Not Yet Recruiting

• 1 other identifier: Shanghai MicroPort EP MedTech
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• major evaluation indicators--Efficacy indicators

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

  On the day of the surgery

• Major evaluation indicators--Monitoring methods

  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;

  On the day of the surgery

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

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

  perioperative period

Secondary Outcomes (2)

• Changes in the surface temperature of the ablated tissue

  During surgery

• Changes in ablation point impedance

  During surgery

Study Arms (1)

Rapid Arrhythmia（Paroxysmal supraventricular tachycardia and Atrial Fibrillation）

EXPERIMENTAL

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

Interventions

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.

Rapid Arrhythmia（Paroxysmal supraventricular tachycardia and Atrial Fibrillation）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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);

Sponsors & Collaborators

• Shanghai MicroPort EP MedTech Co., Ltd.: lead

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 24, 2025
• Study Start: August 31, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06