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PulseMagic™ TrueForce™ PAF NMPA Study
Sponsor: Shanghai MicroPort EP MedTech Co., Ltd.
Summary
This clinical investigation is intended to demonstrate safety and effectiveness of the PulseMagic™ TrueForce™ Ablation Catheter and the PulseMagic™Pulse Field Ablation (PFA) Generator, and Columbus™ 3D EP Navigation System with Pulsed Field Ablation Software for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).
Official title: A Study of Pulsed Field Ablation With the PulseMagic™ TrueForce™ Catheter and PulseMagic™ PFA Generator for the Treatment of Paroxysmal Atrial Fibrillation (PFATrueForce)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-07-10
Completion Date
2028-11-30
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
PFA Ablation catheter
Deliver PF energy using the PulseMagic™ PFA system
Locations (1)
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China