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:
- Diagnosis of paroxysmal atrial fibrillation (PAF), AND
- 2 or more episodes of AF during the 3 months preceding the
consent date, AND
- At least 1 episode of AF documented with a tracing within the 12
months preceding the Consent Date.
2. Age 18 years or older
3. Failure for the treatment of AF (effectiveness or intolerance) of at least
one membrane active AAD for rhythm control.