STOP AF First Post-Approval Study
ConditionParoxysmal Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Cardiac Ablation Solutions
About this trial
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Arctic Front™ Cardiac Cryoablation Catheter
Treatment groups
No treatment groups listed
Locations
13Alaska
Alaska Heart Institute99508, Anchorage United States
Connecticut
Cardiology Associates of Fairfield County06905-5522, Stamford United States
District of Columbia
MedStar Washington Hospital Center20010, Washington D.C. United States
Florida
BayCare Medical Group Cardiology33756, Clearwater United States
Sponsors and collaborators
Medtronic Cardiac Ablation Solutions
Lead sponsor
Source ClinicalTrials.gov