A Clinical Study on the Use of a Domestically Produced Three-dimensional Cardiac Electrophysiological Mapping System Combined With Pressure Monitoring Technology and Star Mapping Technology for the Treatment of Paroxysmal Atrial Fibrillation.

NCT07039032 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai MicroPort EP MedTech Co., Ltd

Phase

Not applicable

Started

2025-09-30

Last updated

2025-06-27

Condition(s) studied

Paroxysmal Atrial Fibrillation (PAF)

Investigational drug(s) / intervention(s)

FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter

FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter: 1. The pressure-sensing catheter primarily consists of electrodes, a catheter body, and a control handle. The catheter body comprises a high-torque body and a flexible tip, divided into an adjustable bending segment and a main segment. By pushing or pulling the handle at the proximal end of the catheter, the internal traction wire at the catheter tip can be activated to control the bending of the tip. The adjustable bending segment is fixed with four electrodes at regular intervals, including one tip electrode and three ring electrodes. 2. The disposable star-shaped magnetoelectric positioning catheter is specifically designed for cardiac electrophysiological mapping. The distal end of the catheter has multiple 3F branches, each with multiple platinum-iridium electrodes for collecting cardiac electrophysiological signals. The distal end of the catheter features an adjustable bend design; pushing the button on the catheter forward will cause the distal end of the catheter to bend.

Study summary

Validating the safety and efficacy of pressure monitoring technology and star-shaped marking technology for the treatment of paroxysmal atrial fibrillation

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Patient age between 18 and 80 years old, male or non-pregnant female. 2. Confirmed diagnosis of paroxysmal atrial fibrillation requiring catheter radiofrequency ablation surgery. 3. Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan. Exclusion Criteria: 1. Post-ablation for atrial fibrillation 2. Reproductive-age patients who cannot use effective contraception within 12 months of enrolment 3. Left atrial size ≥50 mm, left ventricular ejection fraction ≤40% 4. Left atrial thrombus 5. History of atrial septal defect repair or atrial myxoma 6. History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack) 7. History of 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) 8. Patients with acute or severe systemic infection 9. Patients with severe liver or kidney disease 10. Patients with significant bleeding tendencies or haematological disorders 11. Patients with malignant tumours or end-stage diseases 12. Patients deemed ineligible for this trial by the investigator

Primary outcome measure(s)

Three-month follow-up success rate after surgery — Postoperative 3-month
Postoperative 3-month treatment success rate: Specifically refers to the proportion of participants who, during the 3-month follow-up period (after the washout period), did not experience any episodes of atrial fibrillation/atrial flutter/atrial tachycardia lasting ≥30 seconds, as confirmed by electrocardiogram (ECG), Holter monitoring, or equivalent rhythm monitoring methods (including single-lead ECG), without the use of Class I or Class III antiarrhythmic drugs, relative to the total number of enrolled participants.

Trial sites (1)

Facility	City	Region	Status
West China Hospital of Sichuan University	Chengdu	Sichuan

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Other trials for the same condition

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Official registry record

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.

View NCT07039032 on ClinicalTrials.gov ↗ ← All trials in China