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

Launched by SHANGHAI MICROPORT EP MEDTECH CO., LTD. · Jul 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the FireMagic™ Magbot Ablation Catheter, which is designed to treat rapid arrhythmias—abnormal heart rhythms that happen quickly. The study aims to see if this new catheter is safe and effective for patients who have certain types of fast heartbeats, specifically paroxysmal atrial fibrillation (a kind of irregular heartbeat that starts and stops suddenly) or symptomatic supraventricular tachycardia (a rapid heartbeat that comes from the upper chambers of the heart).

People who may join this study are adults between 18 and 80 years old who have been diagnosed with one of these heart rhythm problems and have either not responded well to medication or prefer to try this catheter treatment instead. Before joining, participants will need to understand and agree to the treatment plan, which includes surgery using the catheter and follow-up check-ups. The study is not yet recruiting participants. Some people won’t be able to take part, including those with certain heart conditions, recent serious strokes or heart attacks, implanted devices like pacemakers, or other serious health issues. If you qualify and join, you can expect careful monitoring to see how well the new catheter works and to ensure it is safe for treating your heart rhythm problem.

Gender

ALL

Eligibility criteria

• 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.