STOP AF First Post-Approval Study

Recruiting now

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT05227053

Run by

Medtronic Cardiac Ablation Solutions

People needed

200

Starts

2022-04-28

Expected to finish

2028-04-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• 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)
• 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

Where it is running

• Stern Cardiovascular Foundation — Germantown, Tennessee, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Texas Health Research and Education Institute — Dallas, Texas, United States (enrolling)
• BayCare Medical Group Cardiology — Clearwater, Florida, United States (enrolling)
• Heart Rhythm Solutions — Davie, Florida, United States (enrolling)
• Iowa Heart — West Des Moines, Iowa, United States (enrolling)
• Cardiology Associates of Fairfield County — Stamford, Connecticut, United States (enrolling)
• Southcoast Health System — North Dartmouth, Massachusetts, United States (enrolling)
• Henry Ford Heart & Vascular — Detroit, Michigan, United States (enrolling)
• The Lindner Research Center — Cincinnati, Ohio, United States (enrolling)
• Our Lady of the Lake — Baton Rouge, Louisiana, United States
• Alaska Heart Institute — Anchorage, Alaska, United States
• University of Tennessee Methodist Physicians — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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