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The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arctic Front™ Cardiac Cryoablation Catheter System | Device | Pulmonary vein isolation will be performed with the Arctic Front™ 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 Front™ Cardiac Cryoablation Catheter System. | 36 months |
| Freedom from Primary Safety Events | Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12-months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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 may be approached regarding enrollment in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Khaldoun Tarakji, MD | Medtronic CAS Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States | ||
| Cardiology Associates of Fairfield County |
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| Stamford |
| Connecticut |
| 06905-5522 |
| United States |
| BayCare Medical Group Cardiology | Clearwater | Florida | 33756 | United States |
| Heart Rhythms Solutions | Davie | Florida | 33328 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801-2500 | United States |
| Henry Ford Heart & Vascular | Detroit | Michigan | 48202-2608 | United States |
| Spectrum Health Hospitals | Grand Rapids | Michigan | 49525-6427 | United States |
| The Lindner Research Center | Cincinnati | Ohio | 45219-2906 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705-1852 | United States |
| Texas Health Research & Education Institute | Dallas | Texas | 75231 | United States |
| Kepler Universitätsklinikum Med Campus III. | Linz | 4020 | Austria |
| St. Vinzenz-Hospital Köln | Cologne | 50733 | Germany |
| MVZ CCB Frankfurt und Main Taunus | Frankfurt am Main | 60431 | Germany |
| Städtische Kliniken München GmbH - Klinikum Bogenhausen | München | 81925 | Germany |
| Universitaria Pisana - Stabilimento di Cisanello | Pisa | 56124 | Italy |
| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz | Lodz | 92-213 | Poland |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | L14 3PE | United Kingdom |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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