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NCT Number: NCT07039032

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.

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location contact

Qing NA Yang, PhD

CONTACT

[email protected]

028-85422114

About this study

This trial will select appropriate clinical cases at clinical centres, where authorised investigators will perform ablation surgery for paroxysmal atrial fibrillation using the trial product. Indicators such as immediate ablation success rate and treatment success rate within three months post-surgery will be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age between 18 and 80 years old, male or non-pregnant female.
  • Confirmed diagnosis of paroxysmal atrial fibrillation requiring catheter radiofrequency ablation surgery.
  • 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

  • Post-ablation for atrial fibrillation
  • Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
  • Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
  • Left atrial thrombus
  • History of atrial septal defect repair or atrial myxoma
  • History of cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
  • 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)
  • Patients with acute or severe systemic infection
  • Patients with severe liver or kidney disease
  • Patients with significant bleeding tendencies or haematological disorders
  • Patients with malignant tumours or end-stage diseases
  • Patients deemed ineligible for this trial by the investigator

Treatment and study plan

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

Device
  • 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.
  • 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.

Primary outcomes

  1. Three-month follow-up success rate after surgery

    Time frame: 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.

Secondary outcomes

  1. Immediate ablation success rate

    Time frame: On the day of the surgery

    This refers to the proportion of subjects who achieved electrical isolation after surgery among the total number of patients enrolled in the study. The verification method involves waiting for 20 minutes after successful pulmonary vein electrical isolation and then reconfirming pulmonary vein conduction block.

Study contacts

Contact information is provided by the study sponsor or research team.

Qing NA Yang, PhD

CONTACT

[email protected]

028-85422114

Sponsors and collaborators

Lead sponsor

Shanghai MicroPort EP MedTech Co., Ltd.

Industry

Registry information

Acronym: paroxysmal at

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
Jun 26, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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