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)
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) — 36 months Estimate the 36-month freedom from Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ cardiac cryoablation catheter System.
Freedom from Primary Safety Events — 12 months Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months.
Trial sites (13)
Facility
City
Region
Status
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.
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