RecruitingNCT05227053
STOP AF First Post-Approval Study
STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry
Sponsor
Medtronic Cardiac Ablation Solutions
Enrollment
200 participants
Start Date
Apr 28, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This post-approval study is following patients who undergo a heart procedure called cryoablation — which uses freezing to destroy abnormal electrical tissue causing atrial fibrillation (AFib), an irregular heartbeat. It is collecting real-world safety and effectiveness data after the device received approval.
**You may be eligible if...**
- You are 18 or older
- You have been diagnosed with symptomatic paroxysmal AFib (AFib that comes and goes with symptoms)
- You are planning to have a pulmonary vein isolation procedure using the Arctic Front cryoablation catheter system
- You are willing to complete follow-up visits
**You may NOT be eligible if...**
- You have persistent or permanent AFib (not the intermittent type)
- You have had a prior AFib ablation procedure
- You have serious structural heart disease
- You are pregnant
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DEVICEArctic Front™ Cardiac Cryoablation Catheter
Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system
Locations(13)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05227053
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