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.

NCT ID: NCT07039032

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-centre, post-marketing study

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort EP MedTech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Gao Henggan

Gao henggan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Qing NA Yang, PhD

Role: CONTACT

yangq@cd120.com

028-85422114

Facility Contacts

Qing NA Yang, PhD

Role: primary

yangq@cd120.com

028-85422114

Other Identifiers

A.1

Identifier Type: -

Identifier Source: org_study_id