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).
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or persistent AF (PerAF) with the following documentation:
✓. 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
✓. 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
Exclusion criteria
✕. 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)
What they're measuring
1
Primary Safety Endpoint - Rate of Primary Serious Adverse Events
✕. 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
✕. Presence of any permanent pacemaker, biventricular pacemaker, or implantable cardiac defibrillator (with or without biventricular pacing function) that cannot be programmed, per the manufacturer's recommendations, during the ablation procedure
✕. Patient cannot be removed from AADs for reasons other than AF, which includes participants with Wolff-Parkinson-White (WPW) Syndrome and participants with a history of ventricular tachycardia (VT)