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
Inclusion Criteria4
- 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 Criteria7
- 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
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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