The study evaluates the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System for focal catheter ablation of persistent atrial fibrillation (PerAF).
Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND
At least one documented episode of AF captured continuously on 12-lead ECG, or for at least 30 seconds on transtelephonic monitor (TTM), Holter monitor, telemetry strip, or similar within 12 months prior to enrollment
Physician's note indicating symptoms consistent with recurrent symptomatic PerAF AND
Any 24-hour ECG recording of continuous AF within 12 months prior to enrollment OR
Long-standing persistent AF (continuous AF sustained > 1 year)
AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
Prior cardiac ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion, or valvular cardiac procedure)
Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during study participation
Single group
pulsed field ablation
Devicepulsed field ablation with a large-area focal catheter
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: * Atrio-esophageal fistula (assessed at ≥60 days) * Cardiac perforation, tamponade, or pericardial effusion * Cerebrovascular accident (CVA)/stroke * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in persistent diaphragmatic paralysis (assessed at ≥60 days) * Pulmonary vein stenosis (assessed at ≥60 days) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury/gastroparesis
Primary Effectiveness Endpoint - Acute Procedure Success
Percentage of treated pulmonary veins with documented PVI at the end of the index procedure using the study device only. Acute PVI will be assessed by the confirmation of entrance and/or exit block. • Inability to isolate a targeted pulmonary vein with the study device and requiring use of a non-study ablation device to complete PVI will count as an acute procedure failure.
Chronic PVI Durability
Percentage of treated pulmonary veins with documented PVI at the remapping procedure. Chronic PVI will be assessed by the confirmation of entrance and/or exit block for all pulmonary veins treated at the index procedure.
Acute Success of Additional Atrial Lesion Sets
Percentage of additional atrial lesion sets (PWI, CTI, mitral isthmus) with documented acute procedural success using the study device only.
12-Month Freedom from Atrial Arrhythmia
Freedom from documented atrial arrhythmia (AF/AFL/AT) episodes ≥30 seconds duration, after the 60-day Blanking Period following the index ablation procedure, documented by trans-telephonic monitoring (TTM) or Holter monitor through 12 months follow-up.
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