STOP AF First Post-Approval Study

Korábbi kezelés

• History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1
• Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for a period of <4 weeks prior to the index PVI procedure)
• Recent treatment with a class I or III AAD (within 6 months of the index PVI procedure) at a dose below therapeutic threshold according to the AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation
• A subject who has received a chemical cardioversion may be included in the study. This includes a chemical cardioversion prior to enrollment and between enrollment and ablation.
  • Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
  • Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
  • Subject with exclusion criteria required by local law

Más betegség

• . Subjects under the following conditions may be included in the study:

• Subject has been diagnosed with symptomatic paroxysmal AF
• Subject is ≥ 18 years of age or minimum age as required by local regulations
• Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System.
• Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements