NCT06858306

SPHERE Per-AF Post-Approval Study

SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Sphere-9™ Catheter and Affera™ Ablation System	De novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera™ Ablation System

Timeline

• Start date: 2025-09-25
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2025-03-05
• Last updated: 2026-04-01

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study