Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
The PaS is a prospective, multi-center, non-randomized, single arm, controlled, unblinded clinical study designed to provide long-term safety and effectiveness of the artic Front Cardiac Cryoablation System.
Safety and effectiveness will be evaluated against pre-specified performance criteria as determined by the sponsor and FDa. The criteria set in this study whave been previously used to demonstrate safety and effectivenesss in cryoablation and radio-frequency ablation for the treatment of paroxysmal atrial fibrillation.
The analyses of the primary effectiveness objective will take place once all the subjects with a study cryoablation procedure attempt have reached 36 months of follow-up post-cryoablation procedure. The analysis of the primary safety objective will take place once all the subjects with a study cryoablation attempt have reached 60 months of follow-up post-cryoablation procedure.
For inclusion in the study, subjects must fulfill ALL of the following criteria:
1) Documented PAF:
2) Diagnosis of paroxysmal atrial fibrillation (PAF), AND 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a
3) Age 18 years or older
4) Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.