Persistent Atrial Fibrillation
Conditions
Brief summary
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
Detailed description
The STOP Persistent AF Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The PAS is a prospective, global, multicenter, observational trial. The purpose of the PAS is to describe long-term clinical performance and safety data in the Persistent AF population treated with Arctic Front™ and Freezor™ MAX Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System). This PAS is a condition of the Pre-Market Approval order (P100010/S098) by the U.S. Food and Drug Administration. Up to 400 subjects will be enrolled to ensure 355 are treated. A minimum of 50% of patients will be enrolled and treated in the US. The follow-up duration for this post-approval study will be 36-months.
Interventions
DEVICEArctic Front™ Cardiac Cryoablation Catheter System
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 persistent AF. * Subject is ≥ 18 years of age or minimum age as required by local regulations. * Planned pulmonary vein isolation (PVI) procedure using 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
* 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
Austria, Germany, Italy, Poland, United Kingdom, United States
Contacts
STUDY_DIRECTORKhaldoun Tarakji, MD
Medtronic CAS Chief Medical Officer
Outcome results
None listed