Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

Study ID
STU 052012-085

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • UT Southwestern University Hospital—St. Paul

Contact
Dana Red
214-590-5015
dana.red@utsouthwestern.edu

Principal Investigator
Richard Wu

Summary

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.

Participant Eligibility

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
tracing
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.