THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
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This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
Condition or disease
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Device: THERMOCOOL® SMARTTOUCH™ Catheter
The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.
Freedom from atrial tachyarrhythmias [ Time Frame: Day 91-361 ]
Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361).
Secondary Outcome Measures
Acute Success [ Time Frame: End of procedure ]
Peri-procedural SAEs [ Time Frame: Less than or equal to 30 days post procedure ]
Late onset SAEs [ Time Frame: Greater than 30 days post procedure ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Have had at least 3 atrial fibrillation episodes within 6 months of this study
Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
18 years of age or older
Exclusion Criteria including, but not limited to:
Have had previous ablation for atrial fibrillation
Have take amiodarone within 6 months of this study
Have had any heart surgery within the last 60 days