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Trials / Completed

CompletedNCT04210622

An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System

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

Status
Completed
Phase
Study type
Interventional
Enrollment
16 (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 Ablation System to treat Atrial Arrhythmias

Conditions

Interventions

TypeNameDescription
DEVICECatheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation SystemCatheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

Timeline

Start date
2018-05-01
Primary completion
2019-07-04
Completion
2020-06-18
First posted
2019-12-26
Last updated
2025-05-16
Results posted
2025-05-16

Locations

1 site across 1 country: Lithuania

Source: ClinicalTrials.gov record NCT04210622. Inclusion in this directory is not an endorsement.

An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System (NCT04210622) · Clinical Trials Directory