FireMagic™ Magbot Ablation Catheter: All patients signed informed consent forms, enrolled in the trial, underwent surgical treatment for rapid arrhythmia using XX, and were discharged after follow-up data collection. The total duration for each subject is estimated to be approximately 7 days.
Study summary
Clinical study on the safety and efficacy of FireMagic™ Magbot Ablation Catheter for rapid arrhythmia
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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 sites (1)
Facility
City
Region
Status
Ruijin Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
More Shanghai MicroPort EP MedTech Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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