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Active Not Recruiting
NCT05005949
STOP Persistent AF PAS
Conditions: Persistent Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 400
Sponsor: Medtronic Cardiac Ablation Solutions
Location: Hartford Hospital Hartford Connecticut
Summary
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
Eligibility Criteria
Inclusion Criteria:
* Subject has been diagnosed with persistent AF.
* Subject is ≥ 18 years of age or minimum age as required by local regulations.
* Planned pulmonary vein isolation (PVI) procedure using 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:
* 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.
Source: ClinicalTrials.gov (NCT05005949). StuddyBuddy aggregates publicly available trial information.