This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Pulsed field ablation using a ultra-compliant endoscopic PFA balloon.
Na Homolce Hospital
Prague, Czech Republic, Czechia
RECRUITINGPrimary Effectiveness Endpoint - Acute Procedure Success
Pulmonary vein isolation at the end of the index procedure
Time frame: During procedure
Primary Safety Endpoint - Rate of Primary Serious Adverse Events
The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * AE fistula (assessed at \>=60 days) * Cardiac perforation, tamponade, or pericardial effusion * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * MI * Pericarditis * PNI resulting in persistent diaphragmatic paralysis (assessed at \<=60 days) * PV stenosis (assessed at \<=60 days) * Stroke/CVA * Thromboembolism * TIA * Vagal nerve injury/gastroparesis
Time frame: 7 days (unless otherwise specified)
Secondary Effectiveness Endpoint - Chronic Durability
Percentage of treated PVs with documented PVI at the remapping procedure
Time frame: 90 days
Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia
Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes of \> 30 seconds duration after 60-day blanking period documented by TTM or Holter monitor
Time frame: 12 months
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