Clinical Trial

Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Study acronym: Horizon 360
Recruiting
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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.
Protocol Amendment History 1 change
notable Trial sites expanded: 15 -> 22 locations 2026-06-13
Trial Details
NCT Number NCT07308847
Lead Sponsor Medtronic Cardiac Ablation Solutions
Conditions Paroxysmal AF
Enrollment 300 participants
Start Date 2026-01-15
Primary Completion 2027-11-22 (estimated)
Study Completion 2027-11-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-24