Feasibility Study on the VERAFEYE System

Study Overview
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Brief Summary
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The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure. Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.

Official Title
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Luma Vision's Feasibility Study on the VERAFEYE System

Conditions
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Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure

Intervention / Treatment
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* Device: VERAFEYE System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter-ablation and closure procedures arm<br>Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter or atrial fibrillation and subjects entitled to undergo a left atrial appendage/atrial septal defect closure procedure | Device: VERAFEYE System<br>* The VERAFEYE System will be used during standard of care, catheter-based treatments for atrial flutter or atrial fibrillation; or left atrial appendage/atrial septal defect closure procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Feedback on VERAFEYE System | The objective of the study is to collect physician feedback by means of a questionnaire on the VERAFEYE System. Results from this study may be used to guide development and refinement of the VERAFEYE System. | During the procedure |