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

NCT ID: NCT07032948

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rapid Arrhythmia（Paroxysmal supraventricular tachycardia and Atrial Fibrillation）

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

FireMagic™ 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

Exclusion Criteria

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);
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort EP MedTech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Shanghai MicroPort EP MedTech

Identifier Type: -

Identifier Source: org_study_id