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Clinical Trials in the USA / NCT05227053
Recruiting Observational

STOP AF First Post-Approval Study

NCT05227053 · tracked via the Priya Life Science USA tracker
Sponsor
Medtronic Cardiac Ablation Solutions
Phase
Observational
Started
2022-04-28
Last updated
2026-07-22

Condition(s) studied

Paroxysmal Atrial Fibrillation

Investigational drug(s) / intervention(s)

Arctic Front™ Cardiac Cryoablation Catheter

Arctic Front™ Cardiac Cryoablation Catheter: Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system

Study summary

The STOP AF First PAS is a prospective, global, multi-center, observational trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Alaska Heart Institute Anchorage Alaska Active Not Recruiting
Cardiology Associates of Fairfield County Stamford Connecticut Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
BayCare Medical Group Cardiology Clearwater Florida Recruiting
Heart Rhythm Solutions Davie Florida Recruiting
Iowa Heart West Des Moines Iowa Recruiting
Our Lady of the Lake Baton Rouge Louisiana Withdrawn
Southcoast Health System North Dartmouth Massachusetts Recruiting
Henry Ford Heart & Vascular Detroit Michigan Recruiting
The Lindner Research Center Cincinnati Ohio Recruiting
Stern Cardiovascular Foundation Germantown Tennessee Recruiting
University of Tennessee Methodist Physicians Memphis Tennessee Withdrawn
Texas Health Research and Education Institute Dallas Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05227053 on ClinicalTrials.gov ↗ ← All trials in the USA