PULSED AF Post-Approval Study
Start Date
11/4/2024
Completion Date
4/30/2030
Summary
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
Detailed Description
PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PulseSelect™ PFA system
Conditions
Locations
University of South Florida Health (USF)
Tampa, Florida 33606-3603
United States
Piedmont Heart Institute
Atlanta, Georgia 30309
United States
Endeavor Health Swedish Hospital
Chicago, Illinois 60625
United States
Pikeville Medical Center
Whitesburg, Kentucky 41858-7428
United States
Southcoast Health System
Fall River, Massachusetts 02720
United States
Beaumont Health System
Royal Oak, Michigan 48073
United States
Nebraska Medical Center
Omaha, Nebraska 68198
United States
The Valley Hospital
New York, New York 10025
United States
Northwell Health Lenox Hill Hospital
New York, New York 10075
United States
Duke University Medical Center (DUMC)
Durham, North Carolina 27710
United States
Bethesda North Hospital
Cincinnati, Ohio 45220
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio 045218
United States
Mount Carmel Grove City Medical Center
Grove City, Ohio 43123
United States
Doylestown Health Cardiology a division of Doylestown Health Physicians
Doylestown, Pennsylvania 18901-2554
United States
AnMed Health Center
Anderson, South Carolina 29621
United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina 29425-8908
United States
Texas Health Research & Education Institute
Dallas, Texas 75231-3815
United States
University of Virginia Medical Center
Charlottesville, Virginia 22908
United States