About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- pulsed field ablation