Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.
• IC1: Subject is at least 18 years of age at the time of consent
• IC2: Subject is scheduled to undergo a standard of care catheter-ablation procedure to treat AFL/AF, according to current international and local guidelines and per physician discretion
• IC3: Subject is able to understand and willing to provide written informed consent
• IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site