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

NCT07067372 | Not Yet Recruiting

• 1 other identifier: 20240710
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rapid Arrhythmia; PFA; Symptomatic Supraventricular Tachycardia

Keywords

Paroxysmal atrial fibrillation; Symptomatic supraventricular tachycardia

Outcome Measures

Primary Outcomes (1)

• Immediate success rate of 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.

  On the day of the surgery

Other Outcomes (1)

• Safety metrics: Calculate the incidence rate of adverse events associated with the use of the study device during the perioperative period.

  Statistics Perioperative

Study Arms (1)

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

EXPERIMENTAL

Multicentre, target value method, single-arm

Device: FireMagic™ Magbot Ablation Catheter

Interventions

FireMagic™ Magbot Ablation Catheter DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Shanghai MicroPort EP MedTech Co., Ltd.: lead

Study Sites (1)

Ruijin Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qi NA Jin, PhD

CONTACT

021-64370045; ruijin@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai MicroPort EP MedTech Co., Ltd.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 16, 2025
• Study Start: December 31, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-06

Locations

CN (1)