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Recruiting
NCT05227053
STOP AF First Post-Approval Study
Conditions: Paroxysmal Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Medtronic Cardiac Ablation Solutions
Location: Alaska Heart Institute Anchorage Alaska
Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Eligibility Criteria
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 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 \
Source: ClinicalTrials.gov (NCT05227053). StuddyBuddy aggregates publicly available trial information.