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SPHERE Per-AF Post-Approval Study

Name: SPHERE Per-AF Post-Approval Study — clinical trial record (NCT06858306)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusActive, Not Recruiting

PhaseNot specified

SponsorMedtronic Cardiac Ablation Solutions

Started2025-09-25

View on ClinicalTrials.gov ↗

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.

Amendment history 1 change detected by DataLookout

2026-05-09

Trial status changed: Recruiting → Active, Not Recruiting

Trial Details

NCT Number	NCT06858306
Lead Sponsor	Medtronic Cardiac Ablation Solutions
Conditions	Persistent Atrial Fibrillation
Enrollment	200 participants
Start Date	2025-09-25
Primary Completion	2030-10 (estimated)
Study Completion	2030-10 (estimated)
Updated on ClinicalTrials.gov	2026-06-18