An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
NCT04210622 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-05-16
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
- Atrial Fibrillation
- Atrial Flutter
Interventions
- 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
Sponsors & Collaborators
-
Medtronic Cardiac Ablation Solutions
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-01
- Primary Completion
- 2019-07-04
- Completion
- 2020-06-18
Countries
- Lithuania
Study Locations
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