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

MicroPort

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07032948

Shanghai MicroPort EP MedTech

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria

2. Patient age between 18 and 75 years old, male or non-pregnant female;

3. Confirmed diagnosis of supraventricular tachycardia or atrial fibrillation requiring catheter radiofrequency ablation surgery;

4. Signed informed consent form approved by the ethics committee;

5. Willingness to undergo follow-up and evaluation as required by the protocol.

6. Exclusion Criteria Include:

7. 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.

8. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Rapid Arrhythmia（Paroxysmal supraventricular tachycardia and Atrial Fibrillation）

Experimental group

Treatment:

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