STOP Persistent AF PAS (NCT05005949) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
STOP Persistent AF PAS
United States, Austria, Germany400 participantsStarted 2021-08-19
Plain-language summary
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking whether patients stay free from atrial fibrillation, atrial flutter, and atrial tachycardia after treatment — how does my own history of persistent AF affect whether results from this study would be relevant to my situation?
2Since this trial is listed as 'active not recruiting,' it sounds like enrollment is already closed — does that mean I've missed the chance to participate, or are there similar studies still enrolling that my care team could look into for me?
3This appears to be a post-approval study, meaning the device or procedure being studied has already received regulatory clearance — does that change how we should think about the safety profile compared to an early-phase trial, and what does the existing safety data show so far?
4The study is measuring 'freedom from primary safety events' as a key outcome — what kinds of safety events are they specifically tracking, and how do those risks compare to other treatment options for persistent AF that I might consider?
5Given that this is a study for persistent AF specifically rather than other types, can you help me understand whether the findings would apply to my particular pattern of AF, and whether catheter ablation or another approach studied here makes sense as a next step for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.