| NCT ID | NCT05227053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Cardiac Ablation Solutions |
| Condition | Paroxysmal Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-04-28 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-04-28 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: 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: 1. 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) 2. 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 3. 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 * Subject with exclusion criteria required by local law
Contact & Investigator
Khaldoun Tarakji, MD
STUDY DIRECTOR
Medtronic CAS Chief Medical Officer
Frequently Asked Questions
Who can join the NCT05227053 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paroxysmal Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05227053 currently recruiting?
Yes, NCT05227053 is actively recruiting participants. Contact the research team at libby.bergmann@medtronic.com for enrollment information.
Where is the NCT05227053 trial being conducted?
This trial is being conducted at Anchorage, United States, Stamford, United States, Washington D.C., United States, Clearwater, United States and 9 additional locations.
Who is sponsoring the NCT05227053 clinical trial?
NCT05227053 is sponsored by Medtronic Cardiac Ablation Solutions. The principal investigator is Khaldoun Tarakji, MD at Medtronic CAS Chief Medical Officer. The trial plans to enroll 200 participants.
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