PulseMagic™ TrueForce™ PAF NMPA Study
Condition(s) studied
Investigational drug(s) / intervention(s)
PFA Ablation catheter: Deliver PF energy using the PulseMagic™ PFA system
Study 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).
Eligibility
Primary outcome measure(s)
- The success rate within 12 months after operation treatment without AADs — 12 months
Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07720557 on ClinicalTrials.gov ↗ ← All trials in China