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SPHERE Per-AF Post-Approval Study
Sponsor: Medtronic Cardiac Ablation Solutions
Summary
SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
Official title: SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2025-09-25
Completion Date
2030-10
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Sphere-9™ Catheter and Affera™ Ablation System
De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System
Locations (14)
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Montefiore Medical Center
New York, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
OhioHealth
Columbus, Ohio, United States
Doylestown Health Cardiology
Doylestown, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Texas Health Resources
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia, United States