STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry
Medtronic Cardiac Ablation Solutions
Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Description
The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: History of AF treatm…
Interventions
- DeviceArctic Front™ Cardiac Cryoablation Catheter
Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system
Locations (13)
- Alaska Heart InstituteAnchorage, Alaska
- Cardiology Associates of Fairfield CountyStamford, Connecticut
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- BayCare Medical Group CardiologyClearwater, Florida
- Heart Rhythm SolutionsDavie, Florida
- Iowa HeartWest Des Moines, Iowa