Atrial Fibrillation
Conditions
Brief summary
The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.
Interventions
DEVICEAffera Platform
A cardiac ablation will be performed using the Affera Platform
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 18 years of age or minimum age as required by local regulations * Planned procedure using the commercially available Affera Platform * Willing and able to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
Exclusion criteria
* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager * Subject with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective #1 (Efficacy) | 12 Month Post Proceedure | Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective #2 (Safety) | 90 Days Post Proceedure | Estimate serious device and serious procedure-related adverse events for the Affera Platform. |
Countries
Belgium, Czechia, France, Germany, Ireland, Switzerland, United Kingdom
Contacts
Primary ContactLibby Bergmann
Backup ContactSusan Knols
Outcome results
None listed