Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
United States250 participantsStarted 2019-07-14
Plain-language summary
A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a:
1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to ,
2. an approach of pulmonary vein isolation (PVI) alone.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Non-Paroxysmal Atrial Fibrillation.
✓. Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
✓. 18-85 year of age at time of consent.
✓. Scheduled to undergo a clinically indicated AF ablation procedure.
✓. Able and willing to comply with all protocol visit requirements.
✓. Signed Patient Informed Consent (ICF).
✓. Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure
Exclusion criteria
✕. History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
✕. Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
✕. Ejection Fraction \< 0.20.
✕. Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
✕. Left atrial size \> 60 mm diameter on echocardiogram.
✕. "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment.
✕
What they're measuring
1
Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia.
Timeframe: Any event between the 3 month blanking period and 1 year post-ablation.