Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures

Inclusion Criteria:

• 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 procedureto treat AFL/AF, according to current international and local guidelines and perphysician 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 withthis clinical study at an approved clinical study site

Exclusion Criteria:

• EC1: Subject where placement of VERAFEYE Imaging Catheter is technically notfeasible per physician discretion

• EC2: Pregnant women or women who plan to become pregnant during the course of theirparticipation in the study (women should either be of non- childbearing potential atthe time of enrolment (as documented in the medical file) or have a negativepregnancy test within the previous 7 days prior to the procedure)

• EC3: Subject implanted with an active cardiac rhythm management device (e.g.pacemaker, CRT, ICD)

• EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure

• EC5: Any planned surgical or endovascular intervention within 30 days before orafter the ablation procedure

• EC6: Life expectancy less than 12 months

• EC7: Current LA thrombus Note: Screening for LA thrombus is required to be performedwithin 48 hours prior to or during the index procedure. Method of screening perphysician discretion. If an atrial thrombus is observed prior to or during theplanned index procedure, the index procedure will not begin or will be terminatedbefore accessing the left atrium, and no ablation will be performed. The indexprocedure for this subject may be rescheduled to be performed within 30 days postICF signature, provided that the thrombus is no longer present.

• EC8: Subjects who are currently enrolled in another study