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.

NANot yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

December 31, 2028

Conditions
Paroxysmal Atrial Fibrillation (PAF)
Interventions
DEVICE

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."

Trial Locations (1)

610041

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
lead

Shanghai MicroPort EP MedTech Co., Ltd.

INDUSTRY