Safety & Effectiveness of the CardioWave Pulsed Field Ablation System With the QuickShot Nav Large-Area Focal Catheter for Ablation of Persistent Atrial Fibrillation
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).
• Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation:
• Paroxysmal AF (Phase A participants)
⁃ 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
• Persistent AF (Phase A, B, and C participants)
⁃ 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
⁃ Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR
⁃ History of ≥2 direct current cardioversion (DCCV) performed within 12 months prior to enrollment
• Failure or intolerance of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic PerAF or intolerable side effects due to the AAD
• Age 18 through 75 years-old on the day of enrollment
• Patient is indicated for an ablation procedure according to society guidelines or study site practice
• Patient is willing and able to give informed consent and is willing, able, and committed to participate in baseline and follow-up evaluations for the full duration of the study