Status:
RECRUITING
STOP AF First Post-Approval Study
Lead Sponsor:
Medtronic Cardiac Ablation Solutions
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05227053
Start Date
April 28 2022
End Date
April 1 2028
Last Update
November 14 2025
Active Locations (13)
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1
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
2
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States, 06905-5522
3
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
BayCare Medical Group Cardiology
Clearwater, Florida, United States, 33756