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STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 19, 2021
Primary Completion Date
July 1, 2028
Completion Date
July 1, 2028
Last Updated
November 13, 2025
400
ESTIMATED participants
Arctic Front™ Cardiac Cryoablation Catheter System
DEVICE
Lead Sponsor
Medtronic Cardiac Ablation Solutions
NCT03546374
NCT07301190
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05411614