Overview
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.
Eligibility
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 exclusion criteria required by local law