Paroxysmal Atrial Fibrillation (PAF) Clinical Trial
Official title:
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic 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 have been previously used
to demonstrate safety and effectiveness 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 procedure attempt have reached 12 months of
follow-up post-cryoablation procedure. The analyses for the secondary objectives will take
place once all subjects with a study cryoablation attempt have reached 36 months of follow-up
post-cryoablation procedure.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01687166 -
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
|
N/A | |
| Completed |
NCT03539302 -
INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
|
Phase 2 |