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).
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Deliver PF energy using the PulseMagic™ PFA system
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
The success rate within 12 months after operation treatment without AADs
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
Time frame: 12 months
Acute procedural success
Acute procedural success is defined as the isolation of each PV after a 20 min observation period following the last ablation.
Time frame: after a 20 min observation period following the last ablation
Primary safety endpoint
The incidence of primary adverse events refers to the rate of early-onset adverse events occurring within 7 days after ablation, including: vagal reflex complicated with severe bradycardia, acute coronary injury/occlusion, acute kidney injury, myocardial infarction, phrenic nerve injury/paralysis, left atrial-esophageal fistula, transient ischaemic attack, stroke/cerebrovascular accident/thromboembolism, pericarditis requiring intervention, cardiac tamponade/perforation, pneumothorax, severe vascular access complications and death.
Time frame: Up to 7 days post ablation procedure
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