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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
50
The VERAFEYE Imaging and Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation.
ADEs
• Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure
Time frame: within 7 days of the index procedure
VERAFEYE Performance
• Ability of VERAFEYE Imaging and Guidance System to: * Visualize major cardiac structures (e.g. RA, septum, LA, PVs) * Create 3D anatomical model with the VERAFEYE Imaging and Guidance System
Time frame: during procedure
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