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 | Not Yet Recruiting

• 1 other identifier: A.1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Keywords

PFA; PeAF; PFA/RF

Outcome Measures

Primary Outcomes (1)

• Three-month follow-up success rate after surgery

  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.

  Postoperative 3-month

Secondary Outcomes (1)

• Immediate ablation success rate

  On the day of the surgery

Study Arms (1)

Single-centre, post-marketing study

EXPERIMENTAL

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

Device: FireMagic™ Magbot Ablation Catheter 、FireMagic™ TrueForce™ Ablation Catheter

Interventions

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

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.

Single-centre, post-marketing study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai MicroPort EP MedTech Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qing NA Yang, PhD

CONTACT

028-85422114; yangq@cd120.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gao henggan

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: September 30, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

CN (1)