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

NCT ID: NCT07067372

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

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.

Conditions

Rapid Arrhythmia; PFA; Symptomatic Supraventricular Tachycardia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Multicentre, target value method, single-arm

Group Type: EXPERIMENTAL

FireMagic™ Magbot Ablation Catheter

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort EP MedTech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Gao Henggan

Shanghai MicroPort EP MedTech Co., Ltd.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Qi NA Jin, PhD

Role: CONTACT

ruijin@rjh.com.cn

021-64370045

Facility Contacts

Qi NA Jin

Role: primary

ruijin@rjh.com.cn

021-64370045

Other Identifiers

20240710

Identifier Type: -

Identifier Source: org_study_id