STOP Persistent AF PAS
- Conditions
- Persistent Atrial Fibrillation
- Registration Number
- NCT05005949
- Lead Sponsor
- Medtronic Cardiac Ablation Solutions
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (17)
Texas Health Research & Education Institute
🇺🇸Dallas, Texas, United States
Kepler Universitätsklinikum Med Campus III.
🇦🇹Linz, Austria
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz
🇵🇱Łódź, Poland
Cardiology Associates of Fairfield County
🇺🇸Stamford, Connecticut, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Henry Ford Heart & Vascular
🇺🇸Detroit, Michigan, United States
The Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
Spectrum Health Hospitals
🇺🇸Grand Rapids, Michigan, United States
Heart Rhythms Solutions
🇺🇸Davie, Florida, United States
MVZ CCB Frankfurt und Main Taunus
🇩🇪Frankfurt am Main, Germany
St. Vinzenz-Hospital Köln
🇩🇪Köln, Germany
Städtische Kliniken München GmbH - Klinikum Bogenhausen
🇩🇪München, Germany
Universitaria Pisana - Stabilimento di Cisanello
🇮🇹Pisa, Italy
Liverpool Heart and Chest Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
BayCare Medical Group Cardiology
🇺🇸Clearwater, Florida, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States