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Not yet recruiting NCT07067372

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

No phase Interventional Rapid Arrhythmia PFA Symptomatic Supraventricular Tachycardia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FireMagic™ Magbot Ablation Catheter.
Who it may be relevant to
Registry conditions: Rapid Arrhythmia, PFA, Symptomatic Supraventricular Tachycardia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Study on the Safety and Efficacy of FireMagic™ Magbot Ablation Catheter for Rapid Arrhythmia

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Immediate success rate of surgery [Time frame: On the day of the surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07067372 · 20240710

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗