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The STOP AF First PAS is a prospective, global, multi-center, observational trial.
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 Frontâ„¢ and Freezorâ„¢ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Frontâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Frontâ„¢ Cardiac Cryoablation Catheter | Device | Pulmonary vein isolation will be performed with the Arctic Frontâ„¢ cardiac cryoablation catheter system |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) | Estimate the 36-month freedom from Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Frontâ„¢ cardiac cryoablation catheter System. | 36 months |
| Freedom from Primary Safety Events | Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Frontâ„¢ cardiac cryoablation catheter System through 12-months. | 12 months |
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Inclusion Criteria:
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.
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Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for a pulmonary vein ablation with the Arctic Front™ cardiac cryoablation catheter System.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Sauline | Contact | 800-633-8766 | mary.k.sauline@medtronic.com | |
| Jennifer Diouf | Contact | jen.r.diouf@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Tarakji, MD | Medtronic CAS Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Heart Institute | Active, not recruiting | Anchorage | Alaska | 99508 | United States | |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Cardiology Associates of Fairfield County |
| Recruiting |
| Stamford |
| Connecticut |
| 06905-5522 |
| United States |
|
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| BayCare Medical Group Cardiology | Recruiting | Clearwater | Florida | 33756 | United States |
|
| Heart Rhythm Solutions | Recruiting | Davie | Florida | 33328 | United States |
|
| Iowa Heart | Recruiting | West Des Moines | Iowa | 50266 | United States |
|
| Our Lady of the Lake | Withdrawn | Baton Rouge | Louisiana | 70808 | United States |
| Southcoast Health System | Recruiting | North Dartmouth | Massachusetts | 02747 | United States |
|
| Henry Ford Heart & Vascular | Recruiting | Detroit | Michigan | 48202-2608 | United States |
|
| The Lindner Research Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| Stern Cardiovascular Foundation | Recruiting | Germantown | Tennessee | 38138 | United States |
|
| University of Tennessee Methodist Physicians | Withdrawn | Memphis | Tennessee | 38104-6638 | United States |
| Texas Health Research and Education Institute | Recruiting | Dallas | Texas | 75231 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |