Status:
RECRUITING
Affera Global Registry
Lead Sponsor:
Medtronic Cardiac Ablation Solutions
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
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 pa...
Eligibility Criteria
Inclusion
- 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
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
- Subject with exclusion criteria required by local law
Key Trial Info
Start Date :
December 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT06026345
Start Date
December 22 2023
End Date
July 1 2028
Last Update
October 7 2025
Active Locations (12)
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1
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
2
IKEM - Institut Klinické a Experimentální Medicíny
Prague, Czechia, 14021
3
Nemocnice Na Homolce
Prague, Czechia, 15030
4
Hôpital Haut-Lévêque - CHU de Bordeaux
Bordeaux, France, 33604