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Not yet recruiting NCT07032948

Safety and Efficacy Study of the First Domestically Produced FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter Therapy for Rapid Arrhythmia With Tissue Temperature Measurement Function

No phase Interventional Rapid Arrhythmia Atrial Fibrillation (AF) Paroxysmal Supraventricular Tachycardia (PSVT)

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™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System.
Who it may be relevant to
Registry conditions: Rapid Arrhythmia, Atrial Fibrillation (AF), Paroxysmal Supraventricular Tachycardia (PSVT). Basic parameters: 18 years — 75 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
Center list to be confirmed — check the primary protocol.
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 →

Overview

This project aims to evaluate the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.

Detailed description

This project will conduct a clinical demonstration application study involving 300 cases, with the aim of evaluating the safety, efficacy, and cost-effectiveness of using FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter to treat rapid arrhythmias.

Interventions

  • Device FireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter、Columbus™ 3D EP Navigation System
    All patients were treated withFireMagic™ PreciSense™ 3D Microelectrode Ablation Catheter、EasyStars™ High Density Mapping Catheter and Columbus™ 3D EP Navigation System for rapid arrhythmia.

Primary outcome measures

  • major evaluation indicators--Efficacy indicators [Time frame: On the day of the surgery]
  • Major evaluation indicators--Monitoring methods [Time frame: On the day of the surgery]
  • Major evaluation indicators--Safety indicators：Perioperative study of the incidence of adverse events related to medical devices [Time frame: perioperative period]
Secondary outcome measures (2)
  • Changes in the surface temperature of the ablated tissue [Time frame: During surgery]
  • Changes in ablation point impedance [Time frame: During surgery]

Eligibility criteria

1\. Inclusion Criteria

  • Patient age between 18 and 75 years old, male or non-pregnant female;
  • Confirmed diagnosis of supraventricular tachycardia or atrial fibrillation requiring catheter radiofrequency ablation surgery;
  • Signed informed consent form approved by the ethics committee;
  • Willingness to undergo follow-up and evaluation as required by the protocol.

2\. Exclusion Criteria Include:

  • Exclusion criteria for atrial fibrillation patients:

Patients should not participate in this study if any of the following conditions apply:

  • Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%;
  • Left atrial thrombus;
  • History of atrial septal repair or atrial myxoma;
  • History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);
  • Cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);
  • Acute or severe systemic infection;
  • Severe liver or kidney disease;
  • Significant bleeding tendency or haematological disorders;
  • Patients with other conditions deemed inappropriate for participation in this trial by the investigators.
  • Exclusion criteria for patients with ventricular tachycardia and supraventricular tachycardia:

Patients should not participate in this study if any of the following conditions apply:

  • Left atrial size ≥50 mm and left ventricular ejection fraction ≤40%;
  • History of atrial septal defect repair or atrial myxoma;
  • Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack);
  • Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision);
  • Patients with acute or severe systemic infection;
  • Patients with severe liver or kidney disease;
  • Patients with a significant tendency to bleed or haematological disorders;
  • Patients with other conditions deemed by the investigator to be unsuitable for participation in this trial.

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07032948 · Shanghai MicroPort EP MedTech

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗