clinical trial · NCT06858306
SPHERE Per-AF Post-Approval Study
Medtronic Cardiac Ablation Solutions·—·recruiting·n = 200
Persistent Atrial FibrillationSphere-9™ Catheter and Affera™ Ablation System
brief 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.
started
Sep 25, 2025
primary completion
Oct 1, 2030
completion
Oct 1, 2030
last updated
Apr 1, 2026
detailed description
The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).
official title
SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol