Paroxysmal Atrial Fibrillation
Conditions
Brief summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Detailed description
The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.
Interventions
DEVICEArctic Front™ Cardiac Cryoablation Catheter
Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTLibby Bergmann
CONTACTJennifer Diouf
STUDY_DIRECTORKhaldoun Tarakji, MD
Medtronic CAS Chief Medical Officer
Outcome results
None listed