STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry
Status: Active_not_recruiting
Location: See all (17) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Connecticut
Hartford Hospital
Hartford
Cardiology Associates of Fairfield County
Stamford
Florida
BayCare Medical Group Cardiology
Clearwater
Heart Rhythms Solutions
Davie
Illinois
Carle Foundation Hospital
Urbana
Michigan
Henry Ford Heart & Vascular
Detroit
Spectrum Health Hospitals
Grand Rapids
Ohio
The Lindner Research Center
Cincinnati
Texas
Texas Cardiac Arrhythmia Research Foundation
Austin
Texas Health Research & Education Institute
Dallas
Other Locations
Austria
Kepler Universitätsklinikum Med Campus III.
Linz
Germany
St. Vinzenz-Hospital Köln
Cologne
MVZ CCB Frankfurt und Main Taunus
Frankfurt Am Main
Städtische Kliniken München GmbH - Klinikum Bogenhausen
München
Italy
Universitaria Pisana - Stabilimento di Cisanello
Pisa
Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz
Lodz
United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
Time Frame
Start Date: 2021-08-19
Completion Date: 2028-07
Participants
Target number of participants: 400
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiac Ablation Solutions