Feasibility Study on the VERAFEYE System

Key Inclusion Criteria:

• Subject is 18 to 80 years of age at the time of consent
• Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure
• Subject is able to understand and willing to provide written informed consent

Key Exclusion Criteria:

• Any of the following within 6 months prior to enrolment:

• Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
• Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances
• Myocardial infarction
• Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
• Dilated or hypertropic cardiomyopathy
• Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure.
• Any of the following cardiac conditions:

• New York Heart Association (NYHA) class IV
• Left ventricular ejection fraction (LVEF) < 30%
• Implanted with a cardiac rhythm management device (pacemaker, CRT, ICD, loop recorder)
• Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
• Body mass index (BMI) > 40 kg/m2
• Body weight < 50kg
• Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the ablation, or LAA/ASD closure procedure)
• Life expectancy less than 12 months
• Subjects who are currently enrolled in another study
• Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging