PulseMagic™ TrueForce™ PAF NMPA Study
NCT07720557 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-07-22
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).
Conditions
- Atrial Fibrillation (AF)
- Paroxysmal AF
- Drug Refractory Paroxysmal Atrial Fibrillation
- Atrial Arrhythmia
Interventions
- DEVICE
-
PFA Ablation catheter
Deliver PF energy using the PulseMagic™ PFA system
Sponsors & Collaborators
-
Shanghai MicroPort EP MedTech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-10
- Primary Completion
- 2028-07-01
- Completion
- 2028-11-30
Countries
- China
Study Locations
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