STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry
| Registry | NCT05005949 |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 400 (Estimated) |
| Sponsor | Medtronic Cardiac Ablation Solutions (Industry) |
| Conditions | Persistent Atrial Fibrillation |
| Interventions | Arctic Front™ Cardiac Cryoablation Catheter System (Device) |
| Dates | start 2021-08-19, primary completion 2028-07-01 (estimated), completion 2028-07-01 (estimated), first posted 2021-08-16, last updated 2026-07-22 |
| Locations | 17 sites in United States, Austria, Germany, Italy, Poland, United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Persistent Atrial Fibrillation All trials of Arctic Front™ Cardiac Cryoablation Catheter System
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.
Sex: All, ages: 18 Years to any
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 exclusion criteria required by local law.
| Facility | City | Country | Status |
|---|---|---|---|
| Hartford Hospital | Hartford, Connecticut | United States | |
| Cardiology Associates of Fairfield County | Stamford, Connecticut | United States | |
| BayCare Medical Group Cardiology | Clearwater, Florida | United States | |
| Heart Rhythms Solutions | Davie, Florida | United States | |
| Carle Foundation Hospital | Urbana, Illinois | United States | |
| Henry Ford Heart & Vascular | Detroit, Michigan | United States | |
| Spectrum Health Hospitals | Grand Rapids, Michigan | United States | |
| The Lindner Research Center | Cincinnati, Ohio | United States | |
| Texas Cardiac Arrhythmia Research Foundation | Austin, Texas | United States | |
| Texas Health Research & Education Institute | Dallas, Texas | United States | |
| Kepler Universitätsklinikum Med Campus III. | Linz | Austria | |
| St. Vinzenz-Hospital Köln | Cologne | Germany | |
| MVZ CCB Frankfurt und Main Taunus | Frankfurt am Main | Germany | |
| Städtische Kliniken München GmbH - Klinikum Bogenhausen | München | Germany | |
| Universitaria Pisana - Stabilimento di Cisanello | Pisa | Italy | |
| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz | Lodz | Poland | |
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | United Kingdom |