RecruitingParoxysmal Atrial Fibrillation

STOP AF First Post-Approval Study

Eligible age

18+ yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

The STOP AF First PAS is a prospective, global, multi-center, observational trial.

Sponsor: Medtronic Cardiac Ablation Solutions

✓ 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

✕ History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1
✕ . Subjects under the following conditions may be included in the study:
✕ 1. 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)
✕ 2. 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
✕ 3. 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