STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject has been diagnosed with symptomatic paroxysmal AF
• Subject is ≥ 18 years of age or minimum age as required by local regulations
• Planned pulmonary vein isolation (PVI) procedure using the 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
Alaska
Alaska Heart Institute
ACTIVE_NOT_RECRUITING
Anchorage
Connecticut
Cardiology Associates of Fairfield County
RECRUITING
Stamford
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
BayCare Medical Group Cardiology
RECRUITING
Clearwater
Heart Rhythm Solutions
RECRUITING
Davie
Iowa
Iowa Heart
RECRUITING
West Des Moines
Louisiana
Our Lady of the Lake
RECRUITING
Baton Rouge
Massachusetts
Southcoast Health System
RECRUITING
North Dartmouth
Michigan
Henry Ford Heart & Vascular
RECRUITING
Detroit
Ohio
The Lindner Research Center
RECRUITING
Cincinnati
Tennessee
Stern Cardiovascular Foundation
RECRUITING
Germantown
University of Tennessee Methodist Physicians
RECRUITING
Memphis
Texas
Texas Health Research and Education Institute
RECRUITING
Dallas
Contact Information
Primary
Mary Sauline
mary.k.sauline@medtronic.com
800-633-8766
Backup
Jennifer Diouf
jen.r.diouf@medtronic.com
Time Frame
Start Date: 2022-04-28
Estimated Completion Date: 2028-04
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiac Ablation Solutions