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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Sponsor: Medtronic Cardiac Ablation Solutions
Summary
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.
Official title: Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Prospective, Single Arm, Unblinded Pre-market Clinical Study to Evaluate the Safety and Effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for Treating Paroxysmal Atrial Fibrillation (PAF)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-01-15
Completion Date
2027-11-22
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
Pulmonary Vein Isolation using the Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
Locations (22)
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Scripps Memorial Hospital
La Jolla, California, United States
NCH Rooney Heart Institute
Naples, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Southcoast Health System
Fall River, Massachusetts, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
The Valley Hospital
Paramus, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Northwell Health Lenox Hill Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Ohio Health Research and Innovation Institute
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States