Overview
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
Description
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the commercially available DiamondTemp™ Family of Cardiac Ablation Catheters (hereafter referred to as the DiamondTemp™ Ablation System) and followed according to the standard of care at each respective institution. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.
Eligibility
Inclusion Criteria:
- Subject is ≥ 18 years of age or minimum age as required by local regulations
- Planned procedure using commercially available DiamondTemp™ Ablation System
- Willing 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