This study is a prospective, single-arm, open-label 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 is intended for 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) or short-duration (\<1 year) persistent AF (PeAF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation
University Hospital of Split
Split, Croatia
RECRUITINGRate of device and procedure related serious adverse events
The rate of system-related and procedure-related serious adverse events (SAEs)
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 Feasibility: Proportion of patients with documented electrical isolation of the pulmonary veins
Proportion of patients with documented electrical isolation of the pulmonary veins
Time frame: 90 days
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