STOP AF First Post-Approval Study
1 other identifier
observational
200
1 country
13
Brief Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Start
First participant enrolled
April 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
November 14, 2025
November 1, 2025
5.9 years
January 27, 2022
November 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)
Estimate the 36-month freedom from Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ cardiac cryoablation catheter System.
36 months
Freedom from Primary Safety Events
Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months.
12 months
Interventions
Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system
Eligibility Criteria
Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for a pulmonary vein ablation with the Arctic Front™ cardiac cryoablation catheter System.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Alaska Heart Institute
Anchorage, Alaska, 99508, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, 06905-5522, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
BayCare Medical Group Cardiology
Clearwater, Florida, 33756, United States
Heart Rhythm Solutions
Davie, Florida, 33328, United States
Iowa Heart
West Des Moines, Iowa, 50266, United States
Our Lady of the Lake
Baton Rouge, Louisiana, 70808, United States
Southcoast Health System
North Dartmouth, Massachusetts, 02747, United States
Henry Ford Heart & Vascular
Detroit, Michigan, 48202-2608, United States
The Lindner Research Center
Cincinnati, Ohio, 45219, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
University of Tennessee Methodist Physicians
Memphis, Tennessee, 38104-6638, United States
Texas Health Research and Education Institute
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Khaldoun Tarakji, MD
Medtronic CAS Chief Medical Officer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 7, 2022
Study Start
April 28, 2022
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
November 14, 2025
Record last verified: 2025-11