Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS) (NCT01456949) | Clinical Trial Compass
CompletedNot Applicable
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
United States, Canada402 participantsStarted 2012-06-26
Plain-language summary
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
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
. Documented PAF:
. Age 18 years or older
. Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.
Exclusion criteria
. Any previous left atrial (LA) ablation (except permissible retreatment subjects)
. Any previous LA surgery
. Current intracardiac thrombus (can be treated after thrombus is resolved)
. Presence of any pulmonary vein stents
. Presence of any pre-existing pulmonary vein stenosis
. Pre-existing hemidiaphragmatic paralysis
. Anteroposterior LA diameter \> 5.5 cm by TTE
. Presence of any cardiac valve prosthesis
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months
Timeframe: Through 36 months
2
Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months