The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
This clinical study is designed to evaluate the safety and performance of the PFA System in the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory submissions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
All subjects will be treated using the Acutus Medical Pulsed Field Ablation System (PFA System) to treat their atrial fibrillation.
Na Homolce Hospital
Prague, Czechia
Proportion of subjects who are free from device/procedure related Major Adverse Events
The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 6-months.
Time frame: 6 months
Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)
The Primary Endpoint for efficacy is the number of subjects where ablation of each accessible pulmonary vein (PV) resulted in confirmation of electrical isolation of the pulmonary vein (PVI) 20 minutes following the last index PFA/RF application with the investigational device
Time frame: 20 minutes post ablation
Analysis of all identified SAEs, SADEs, and UADEs
The Secondary Endpoint for Safety is a recording and analysis of all identified serious adverse events (SAEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs).
Time frame: 12 months
Subjects with freedom from an atrial arrhythmia
The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 12-months post index procedure
Time frame: 12 months
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