This is a prospective, single-arm, open-label clinical study following patients to 1 year, to evaluate the safety and performance of the Centauri system for catheter ablation of atrial fibrillation (AF). The study will include adult patients (age 18-75 years) who are indicated for a first-time catheter ablation of AF where the pre-procedure treatment plan contemplates pulmonary vein isolation (PVI) in patients with paroxysmal AF (PAF), and PVI - with or without additional left atrial ablations - in patients with Persistent AF (PeAF) of short duration (\< 1 year).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation; cavo-tricuspid isthmus (CTI) line ablation may be performed as needed
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Device and Procedure related serious adverse event rate
The rate of system-related and procedure-related serious adverse events of interest
Time frame: 30 days
Acute Procedural Success
Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure
Time frame: During treatment procedure
Chronic Success
Proportion of patients with freedom from AF recurrence after a single procedure
Time frame: 12 months
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