STOP AF First Post-Approval Study
Recruiting · NCT05227053 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Arctic Front™ Cardiac Cryoablation Catheter
What this trial is about
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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:
- 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
- Subject with exclusion criteria required by local law
Where it is running
13 locations listed across 11 US states.
- Alaska Heart Institute - Anchorage, Alaska, United States
- Cardiology Associates of Fairfield County - Stamford, Connecticut, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- BayCare Medical Group Cardiology - Clearwater, Florida, United States
- Heart Rhythm Solutions - Davie, Florida, United States
- Iowa Heart - West Des Moines, Iowa, United States
- Our Lady of the Lake - Baton Rouge, Louisiana, United States
- Southcoast Health System - North Dartmouth, Massachusetts, United States
- Henry Ford Heart & Vascular - Detroit, Michigan, United States
- The Lindner Research Center - Cincinnati, Ohio, United States
- Stern Cardiovascular Foundation - Germantown, Tennessee, United States
- University of Tennessee Methodist Physicians - Memphis, Tennessee, United States
- Texas Health Research and Education Institute - Dallas, Texas, United States