NCT04211441

Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias

An Initial Assessment of Safety and Performance of the Sphere-9™ Catheter and System for Mapping and Ablation of Atrial and Ventricular Arrhythmias

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and RF Ablation System to treat Atrial Arrhythmias

Conditions

• Atrial Fibrillation
• Atrial Flutter
• Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System	Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-09-02
• Completion: 2020-09-18
• First posted: 2019-12-26
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

2 sites across 1 country: Czechia

Regulatory

• FDA-regulated device study