Clinical Study on the Safety and Efficacy of a New Magnetic Navigation Radiofrequency Ablation Catheter for Rapid Arrhythmia

Not Applicable

Not yet recruiting

• Conditions: Rapid Arrhythmia; PFA; Symptomatic Supraventricular Tachycardia

• Registration Number: NCT07067372
• Lead Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.

Brief Summary

Clinical study on the safety and efficacy of FireMagic™ Magbot Ablation Catheter for rapid arrhythmia

Detailed Description

Explore the safety and efficacy of ireMagic™ Magbot Ablation Catheter for rapid arrhythmia in clinical studies, establish standards for standardised catheter use after market launch, and provide evaluation indicators that meet the requirements for nationwide multi-centre promotion.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Study Start: 2025-12-31
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1. Patients aged 18 to 80 years old, with no gender restrictions; 2) Patients clinically diagnosed with paroxysmal atrial fibrillation or symptomatic supraventricular tachycardia: i. For patients with paroxysmal atrial fibrillation, atrial fibrillation was recorded by surface electrocardiogram or Holter monitoring (including single-lead electrocardiogram) within one year prior to enrolment; ii. For patients with symptomatic supraventricular tachycardia, PSVT (AVNRT or AVRT) was recorded by electrocardiogram, Holter monitoring, or electrophysiological examination; 3) Patients who have not responded adequately to or are intolerant of at least one antiarrhythmic drug, or who are willing to undergo ablation surgery without prior medication; 4) Patients who fully understand the treatment plan, voluntarily sign the informed consent form, and are willing to undergo the examinations, surgery, and follow-up required by the plan.

Exclusion Criteria

• 1. Left atrial thrombus (not applicable for PSVT); 2) Left atrial anteroposterior diameter ≥55 mm (not applicable for PSVT); 3) Left ventricular ejection fraction (LVEF) ≤40%; 4) Previous history of atrial septal defect repair or atrial myxoma (not applicable for PSVT); 5) Presence of active implantable devices (e.g., pacemaker, ICD, etc.); 6) NYHA functional class III-IV; 7) History of cerebrovascular disease within the past 6 months (including cerebral haemorrhage, stroke, transient ischaemic attack); 8) History of cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, atrial or ventricular incision); 9) Acute or severe systemic infection; 10) Patients with severe liver or kidney disease, malignant tumours, or end-stage diseases, or those whom the investigator believes may interfere with the treatment, evaluation, or compliance of this trial; 11) Patients with a significant tendency to bleed, hypercoagulable states, or severe haematological disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Immediate success rate of surgery	On the day of the surgery	1. For patients with supraventricular tachycardia: Following the procedure, the following criteria are used to evaluate whether catheter ablation has achieved the intended surgical objectives:Ⅰ. AVNRT: AVNRT cannot be induced after ablation. If skipped beats or 1-2 atrial echoes are present, induction stimulation must be performed concurrently with an isoproterenol challenge test, and AVNRT still cannot be induced. Ⅱ.AVRT: ① AVRT cannot be induced after ablation; ② ventricular stimulation shows central VA Wenckebach conduction or VA dissociation; ③ atrial stimulation shows central AV Wenckebach conduction.; 2. For patients with paroxysmal atrial fibrillation: Observe for 20-30 minutes after initial pulmonary vein isolation and verify successful bidirectional block.

Trial Locations

Locations (1)

Ruijin Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China