Luma Vision's Feasibility Study on the VERAFEYE System
Phase: NA
Conditions: Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
Sponsor: LUMA Vision Ltd.

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1. TABLE OF CONTENTS
1. Table of Contents....................................................................................................................................1
2. Signatures...............................................................................................................................................3
3. Template Version History (filled in by QA) ..............................................................................................3
4. Document Version History ......................................................................................................................3
5. Protocol...................................................................................................................................................5
5.1. Contact Information ..........................................................................................................................6
5.2. Protocol Synopsis.............................................................................................................................7
5.3. Background ....................................................................................................................................10
5.3.1. Rationale for the clinical study .................................................................................................12
5.4. Device Description..........................................................................................................................12
5.4.1. General ....................................................................................................................................12
5.4.2. VERAFEYE Imaging Catheter .................................................................................................13
5.4.3. VERAFEYE Imaging System...................................................................................................14
5.4.4.  Indications for Use/Contraindications .....................................................................................16
5.5. Study Objective ..............................................................................................................................16
5.6. Study Endpoints .............................................................................................................................17
5.7. Study Design ..................................................................................................................................17
5.8. Subject Selection............................................................................................................................18
5.9. Subject Accountability ....................................................................................................................20
5.9.1. Point of Enrolment ...................................................................................................................20
5.9.2. Subject Classification...............................................................................................................21
5.9.3. End of Study ............................................................................................................................22
5.9.4. Withdrawal ...............................................................................................................................22
5.9.5. Lost-to-follow up.......................................................................................................................23

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5.10. Study Assessments......................................................................................................................23
5.10.1. Informed Consent ..................................................................................................................23
5.10.2. Baseline Visit .........................................................................................................................23
5.10.3. Procedure ..............................................................................................................................24
5.10.4. Post-Procedure Visit ..............................................................................................................27
5.10.5. 7-Day Follow-Up ....................................................................................................................28
5.10.6. Data Collection Schedule.......................................................................................................28
5.11. Potential Risks and Benefits.........................................................................................................29
5.11.1. Risks associated with the Procedure.....................................................................................29
5.11.2. Risks associated with the Study Device ................................................................................30
5.11.3. Potential Adverse Events.......................................................................................................30
5.11.4. Risks associated with Study Participation..............................................................................33
5.11.5. Benefits associated with Study Participation .........................................................................33
5.12. Statistical Design and Analysis.....................................................................................................34
5.13. Safety Reporting...........................................................................................................................34
5.13.1. Reportable Events .................................................................................................................34
5.13.2. Reporting Requirements........................................................................................................36
5.13.3. Death Reporting.....................................................................................................................41
5.14. Regulatory and Ethical Aspects....................................................................................................41
5.14.1. Study Financing .....................................................................................................................41
5.14.2. General Duties of Sponsor and Principal Investigator ...........................................................41
5.14.3. Role of LUMA Vision Representative(s) ................................................................................43
5.14.4. Ethics Committee...................................................................................................................44
5.14.5. Study Registration..................................................................................................................44
5.14.6. Study Insurance.....................................................................................................................44
5.14.7. Patient Confidentiality ............................................................................................................44
5.14.8. Protocol Deviations................................................................................................................44
5.14.9. Protocol Amendments............................................................................................................44
5.14.10. Early Termination.................................................................................................................45
5.15. Study Documentation ...................................................................................................................45
5.15.1. Data Management .................................................................................................................45

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5.15.2. Source Documents ................................................................................................................45
5.15.3. Technical Source Forms........................................................................................................46
5.15.4. Investigator Files/Retention of Documents ............................................................................47
5.15.5. Device Accountability.............................................................................................................47
5.15.6. Monitoring ..............................................................................................................................48
5.15.7. Audits and Inspections...........................................................................................................48
5.15.8. Confidentiality of Trial Documents And Patient Records .......................................................48
5.16. Publication Policy .........................................................................................................................48
5.17. Bibliography..................................................................................................................................49
5.18. Abbreviations and Accronyms......................................................................................................50
2. SIGNATURES
Signature 
Meaning
Name
Title
Date
Signature
Author
Elke 
Sommerijns
Clinical 
Manager
22-Nov-2024 
14:16:45
sign-p14-i161471-
b20241122131645202
Reviewer
Sean Crowe
QA Manager
22-Nov-2024 
14:37:31
sign-p14-i161471-
b20241122133731358
Approver
Marta Walker
Director 
Regulatory
25-Nov-2024 
10:26:05
sign-p14-i161471-
b20241125092605314
3. TEMPLATE VERSION HISTORY (FILLED IN BY QA)
OP Document Number
Version
Change Description
Change Date
T-10118
1.0
Initial release
26-Jun-2023
4. DOCUMENT VERSION HISTORY
OP Document 
Number
Version
Change Description
Change 
Date
VER-DOC-
527
1.0
Initial release
30-Jun-
2023
VER-DOC-
527
2.0
Protocol Synopsis and Section 5.8: reworded IEC1 (removed 
future tense) 
01-Aug-
2023

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OP Document 
Number
Version
Change Description
Change 
Date
Section 5.4.3.2: Figure 4: replaced with an updated figure
Section 5.10.3.4:
 12-lead ECG to be obtained at the end of the procedure
 Fluoroscopy time will be measured for the entire procedure; 
fluoroscopy dose will be measured
Throughout document: administrative corrections were made 
(section numbering was corrected). 
Section 5.15.2: section on source documents was added. 
VER-DOC-
527
3.0
Section 5.4.2: 
Deleted size of catheter 
Picture of the VERAFEYE Imaging catheter removed
Section 5.4.3.2: clarified that Figure 3 is an example of the room 
setup during a procedure
Section 5.10.3.3: 
VERAFEYE imaging data will only be collected from the right 
atrium.
Clarified that standard of care imaging = standard of care 
echocardiography imaging (intracardiac echocardiography 
(ICE), transesophageal echocardiography (TEE) 
Section 5.10.3.4: VERAFEYE imaging time replaced with time 
VERAFEYE imaging catheter was in the body
Section 5.13.1: Reportable events were updated 
18-Dec-
2023
VER-DOC-
527
4.0
Protocol Synopsis: number of subjects updated to 40, Georgia 
removed as potential country
Table 1: VERAFEYE System components description 
restructured to improve clarity
Section 5.4: Device description updated to be aligned with IFU
Section 5.7: 
 Added that up to 4 operators per site will be allowed to perform 
22-Nov-
2024

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OP Document 
Number
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Change Description
Change 
Date
study procedures, unless written approval from LUMA Vision 
was obtained
 Added that enrolment in this study is competitive
 Added that subject procedures will follow a sequential pattern 
(one site after the other) 
 Number of subjects updated to 40 and rationale explained 
Section 5.9.1 and 5.9.2: Number of subjects updated to 40, 
Georgia removed as potential country
Section 5.10.3.1: Added that up to 4 operators per site will be 
allowed to perform study procedures, unless written approval 
from LUMA Vision was obtained.
5. PROTOCOL
 
              
 
Luma Visions feasibility study on the VERAFEYE system
LUMINIzE
 
Clinical Investigational Plan/Clinical Study Protocol
Protocol Number
P001

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Single Identification Number/CIV-ID
Not Applicable
ClinicalTrials.gov Number
NCT05931835
 
This protocol is a confidential document for the use of the investigators team and other persons 
involved in the study only. The information contained within this document shall not be communicated to 
a third party without prior written approval of LUMA Vision. The protocol will be kept confidential and 
maintained in a secure location.
 
 
5.1. CONTACT INFORMATION
Position
Details
Sponsor 
LUMA Vision Ltd.
Block C, Parkview House,
Beech Hill Office Campus,
Beech Hill Road,
Dublin 4, D04 K5D0
Ireland
Coordinating Principal 
Investigator 
Prof. Dr. Gabor Szeplaki
MD, PhD, FESC, FEHRA
Mater Private Network
Heart & Vascular Centre
72 Eccles Street
Dublin 7
D07 RD8P

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Ireland
Email: gabor.szeplaki@materprivate.ie
Clinical Manager
 
Elke Sommerijns
+32 479 76 71 56
Elke.sommerijns@lumavision.com
Clinical Research 
Engineer
 
Alisa Komleva
+44 7473 78 34 21
Alisa.komleva@lumavision.com
5.2. PROTOCOL SYNOPSIS
Study title:  LUMINIzE: Luma Visions feasibility study on the VERAFEYE system
Study Objective: The objective of the study is to collect data on the usability and integration of the 
VERAFEYE System in

standard of care catheter-based ablation treatments for Typical Atrial Flutter (AFL) or Atrial 
Fibrillation (AF)

standard of care left atrial appendage (LAA) closure procedures

standard of care atrial septal defect (ASD) closure procedures
Results from this study will be used to guide development and refinement the VERAFEYE System.
Indication for Use:  The VERAFEYE System is indicated for intracardiac and intraluminal ultrasound 
visualization of cardiac and great vessel anatomy and physiology as well as visualization of other 
devices in the heart and great vessels of patients.
Clinical Investigation Device: VERAFEYE System, comprising of

VIC - VERAFEYE Imaging Catheter

CIU - Catheter Interface Unit

SC  System Console
Control Device: NA
Study Design: The LUMINIzE study is a prospective, non-randomized, single-arm feasibility study.

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Planned Number of Subjects: Enrolment will be considered as complete when 40 subjects have 
completed the ablation, or LAA/ASD closure procedure with the VERAFEYE System as imaging system.
Planned Number of Sites/Countries: Up to 2 sites in Ireland may participate in this study.
Study Endpoints: This is a feasibility study and no formal endpoints or hypothesis testing are planned in 
the study. The study is not designed to collect data for product approval and as such does not have a 
safety or efficacy endpoint.
Inclusion Criteria:

IC1: Subject is 18 to 80 years of age at the time of consent

IC2: 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) closure procedure
      or

atrial septal defect (ASD) closure procedure
       *according to current international and local guidelines and currently approved indications    

IC3: Subject is able to understand and willing to provide written informed consent

IC4: Subject is able and willing to complete all study assessments
Exclusion Criteria:

EC1: 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

EC2: Any planned surgical or endovascular intervention within 30 days before or after the 
ablation, or LAA/ASD closure procedure.

EC3: 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)

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
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

EC4: Body mass index (BMI) > 40 kg/m2

EC5: Body weight < 50kg

EC6: 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)

EC7: Life expectancy less than 12 months

EC8: Subjects who are currently enrolled in another study
 Imaging Exclusion Criteria:

IEC1: Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of 
care imaging.
Subject Follow-Up: A study subjects participation will be considered complete when all protocol 
required visits have been completed. For subjects who underwent the ablation, or LAA/ASD closure 
procedure, subject participation in the study is concluded at 7 days follow-up.
Study Duration and Participant Duration:  Enrolment in the study is expected to be completed in 
approximately 6 months. The follow-up for each participant is expected to be approximately 7 days, 
therefore the total study duration is expected to last approximately 7 months.
Statistical Methods: There are no statistical methods to be employed in this feasibility study. Analysis 
of study data will use descriptive statistical methods.
 
 
Procedure/Assessment
 
Baseline Visit
 
Procedure Visit
 
Post-Procedure 
Visit
 
7- Day Follow-Up
(office visit/phone 
call)
 
≤ 60 days prior 
to Day 0
Day 0
Day 0- Day 2
 
Day 7 ± 2 days
 

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Procedure/Assessment
 
Baseline Visit
 
Procedure Visit
 
Post-Procedure 
Visit
 
7- Day Follow-Up
(office visit/phone 
call)
Informed Consent Form and 
Process
X
 
 
 
Eligibility Criteria
X
 
 
 
Demographics including age and 
gender
X
 
 
 
Medical history
X
 
 
 
Physical Assessment
X
X
X
 
Cardiac imaging*
X
(X)
(X)
Medication regimen
X
X
X
X
Procedural data collection
 
X
 
 
Investigational Data Collection
 
X
 
 
Device Performance
 
X
 
 
Protocol Deviations
X
X
X
X
Adverse Events
X
X
X
X
Device Deficiencies
 
X
 
 
*: per hospital standard of care
( ): optional, collect only if performed per hospitals standard of care
5.3. BACKGROUND
With an increasing number of interventional procedures performed for structural heart disease and 
cardiac arrhythmias each year, echocardiographic guidance is necessary for safe and efficient results(1, 

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2). Both transthoracic (TTE) and transesophageal echocardiography (TEE) are available echo options but 
have their limitations. Intracardiac echocardiography (ICE) provides advantages over TTE and TEE by 
providing imaging from within the heart, providing shorter image distances and higher resolution. 
Additionally, it is known that ICE has the benefit of avoiding general anesthesia, reducing procedure time 
and reducing x-ray exposure in comparison to other techniques. Studies have also reported that ICE 
may reduce periprocedural complications as compared with TEE. At the same time, the efficacy of 
procedures guided by ICE appear to be comparable to procedures guided by other imaging techniques. 
Importantly, echocardiography features as a key part of standard practice as recommended in all clinical 
practice guidelines referred to in this review; four of the guidelines name ICE specifically as an 
acceptable or standard imaging option(3-6). The growing body of evidence finding ICE to have 
comparable efficacy, and perhaps superior safety and added benefits relative to TEE, gives evidence 
that ICE is a critical part of the state of the art for intraprocedural imaging in Atrial Fibrillation (AF), Atrial 
Flutter (AFL), Left Atrial Appendage Closure (LAAC) and Atrial Septal Defect Closure (ASDC).         
Although transcatheter procedures for ablating tissues or closing cardiac defects are well established in 
standard practice, success rates and durability of those treatments have not reached satisfactory levels. 
AF after ablation, for example, commonly recurs in 25-50% of procedures or more(7-11). This leaves 
patients at higher risk for stroke and in need of additional procedures which incur additional risk. While 
clinical guidelines make recommendations to mitigate these risks, and studies are assessing procedural 
improvements and treatment modifications such as adding additional ablation lines or substrates to 
improve the acute and long-term outcomes, there remains a need for additional device advancements. 
Factors such as catheter-tissue contact(12) and precision of tag placement(13) in PVI have been shown to 
relate to durability of the ablation and ultimately to better long-term outcomes. Although contact-force 
catheters and other imaging techniques have improved the safety outcomes, there remains a need for 
additional improvement in those technologies that will enable better visibility of anatomy. Future device 
technologies are needed to provide improved imaging resolution and expanded 3-D imaging range and 
field of view.
Similarly, for procedures addressing structural heart defects, ICE provides important benefits, but also 
suffers from disadvantages that may hinder the achievement of ideal safety and performance outcomes. 
For example, the mono-planar nature of its images has been suggested to limit ICEs application to 
procedures such as the sizing of Left Atrial Appendage (LAA) occlusion devices(14) and also other 
structural heart interventions generally(15).Therefore, for the improvement of safety and performance 
outcomes in structural heart interventions, as with ablation procedures, it will be necessary to improve 
the resolution, far-field imaging and 3D capabilities of ICE.     
The design of the VERAFEYE System, developed by LUMA Vision, employs a catheter concept 
providing 360° imaging and verification all around the catheter. The system enables high-resolution real-
time anatomical imaging, while the catheter allows for dynamic navigation and requires minimal 
repositioning within the target anatomical structure. In combination with the dedicated processing in 
software, the VERAFEYE System can provide an advantage over commercially available ICE catheters 
by providing the operator with greater anatomical information.

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5.3.1. RATIONALE FOR THE CLINICAL STUDY
Numerous pre-clinical studies have demonstrated that the VERAFEYE System provides optimal 
visualization of anatomical structures that the Sponsor believes may lead to improved cardiac 
anatomical information and ultimately more effective treatment for patients undergoing electrophysiology 
and structural heart procedures. To further develop the VERAFEYE System, human data is required to 
assess the usability and integration of the VERAFEYE System in electrophysiology and structural heart 
workflows. Results from this study will be used to guide development and refinement the VERAFEYE 
System.
5.4. DEVICE DESCRIPTION
5.4.1. GENERAL
The VERAFEYE System (Figure 1) comprises of a disposable VERAFEYE Imaging Catheter (VIC) and 
the VERAFEYE Imaging System. The Imaging System consists of a System Console (SC) and a 
Catheter Interface Unit (CIU). The individual devices listed in Table 1 must be used together and it is not 
allowed to combine with non-investigational devices. 
Figure 1: The VERAFEYE System
The VERAFEYE Imaging System will be used according to the indications for use and the 
inclusion/exclusion criteria specified within this protocol. A copy of the device labeling and IFU will be 
provided in local language as required per national regulations.

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Table 1 provides an overview of the components of the VERAFEYE System, with their associated model 
numbers.
Table 1: VERAFEYE System
Individual Devices within the VERAFEYE System
Model Number
VERAFEYE Imaging Catheter
VF-VIC-001
VERAFEYE Imaging System
VF-VIS-001
System Console compromised of: 
System Console Computer
3D Tracking System
Pulse Phase Module
VF-SC-001
Catheter Interface Unit
VF-CIU-001
5.4.2. VERAFEYE IMAGING CATHETER
The VERAFEYE Imaging Catheter is a disposable, sterile, single-use component containing an 
ultrasound transducer at the tip. It is delivered by the VERAFEYE Imaging Catheter operator through 
femoral venous access to the patients heart. It has bidirectional steering at the distal end through a 
handle to allow the user to navigate the cardiac structures. The transducer is rotating to allow a 360° 
view around the tip axis. The catheter tip contains a radiopaque element. The proximal end provides a 
connector that is plugged into the VERAFEYE Imaging System Catheter Interface Unit.

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Figure 2: VERAFEYE Imaging Catheter
5.4.3. VERAFEYE IMAGING SYSTEM
5.4.3.1. System Console
A non-sterile component for multiple use installed and used in the operational room of a hospital. The 
System Console is placed on a dedicated cart next to the patient bed. Consists of the following 
proprietary and off-the-shelf components:

System Console Computer  the control and display unit of the VERAFEYE Imaging System 
which can be interacted with by the System Console operator via a keyboard and a computer 
mouse. It contains hardware to run the software of the VERAFEYE Imaging System (VeraApp). 
The software enables the hardware to control the Catheter Interface Unit, processes the data 
streams for visualization onto the display and provides the graphical user interface on the display 
to interact with the user. The System Console Computer operating hardware encompasses a 
central processing unit for running the operating system, graphics processing unit for processing 
the ultrasound data streams and displaying on the monitors. It also contains hardware for 
receiving Pulse Phase signals from the patient and hardware for tracking and location of the 
VERAFEYE Imaging Catheter tip through an electro-magnetic field.

Monitors components allowing for image display and manipulation to allow for image view and 
review for both VERAFEYE Imaging Catheter operator and System Console operator. The 
VERAFEYE Imaging System software on the Monitors is controlled by the users via an easy-to-

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use interface using multiple methods of input including a mouse, keyboard and/or a touch screen. 
Monitors interface with System Console Computer and displays the VERAFEYE Imaging System 
data acquisitions.

3D Tracking System  an electromagnetic tracking system to register the VERAFEYE Imaging 
Catheters position in the heart. The non-sterile, multiple use system is comprised of an 
3DTSensor Interface Unit that receives analogue tracking sensor signals from reference sensors 
on the patient's chest and back and from the VERAFEYE Imaging Catheter sensor inside the 
patients heart. The unit transmits a digital signal to a 3DT-System Control Unit that receives 
signals from and provides power to the 3DT field generator. The System Console operator 
connects the reference sensors and places the EM Field Generator close to the patient's chest to 
capture the sensor positions. The tracking signal will not be displayed to the VERAFEYE Imaging 
Catheter operator during the procedure but will be registered in the background. The System 
Console operator can tune the signal in the tracking's setup window in the GUI.

Pulse Phase Module  a module that receives and transmits heartbeat signals to the System 
Console Computer. The Pulse Phase signal will not be displayed to the VERAFEYE Imaging 
Catheter operator during the procedure but will be registered in the background. The System 
Console operator can tune the signal in a setup window in the GUI.
5.4.3.2. Catheter Interface Unit
A non-sterile component for multiple use intended to send and receive analog signals to/from the 
VERAFEYE Imaging Catheter. The sterile, single-use VERAFEYE Imaging Catheter is plugged into the 
non-sterile Catheter Interface Unit. The Catheter Interface Unit receives signals from the VERAFEYE 
Imaging Catheter, converts them into digital signals and transports them through optical fibers to the 
System Console Computer. Furthermore, the Catheter Interface Unit contains a motor drive for rotating 
the transducer in the VERAFEYE Imaging Catheter. The motor and the ultrasound conversion unit are 
controlled by the System Console Computer. The conversion unit rotates, the power, control and data 
signals are transmitted through rotating joints. The Catheter Interface Unit is placed on a dedicated cart 
next to the patient's bed and with proximity to the System Console cart.
Figure 3 provides an example of the room setup during a procedure.

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Figure 3: Room Setup During Procedure
5.4.4.  INDICATIONS FOR USE/CONTRAINDICATIONS
The VERAFEYE System is intended to be used for real-time, minimally-invasive guidance of 
endovascular and intracardiac procedures, e.g. such as cardiac ablation, structural heart procedures, or 
transseptal punctures. The system provides image information of cardiovascular anatomic features, 
physiological information of cardiovascular structures and features, and spatial relationships of other 
devices within the heart and great vessels. Please refer to the IFUs for an overview of contraindications.
5.5. STUDY OBJECTIVE
The objective of the study is to collect data on the usability and integration of the VERAFEYE System in
standard of care

catheter-based ablation treatments for Typical Atrial Flutter (AFL) or Atrial Fibrillation (AF)

left atrial appendage closure (LAAC) procedures

atrial septal defect (ASD) closure procedures
Results from this study will be used to guide development and refinement the VERAFEYE System.

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5.6. STUDY ENDPOINTS
This is a feasibility study and no formal endpoints or hypothesis testing are planned in the study. The 
study is not designed to collect data for product approval and as such does not have a safety or efficacy 
endpoint.
5.7. STUDY DESIGN
This is a prospective, non-randomized, single-arm feasibility study. This study is a pilot stage study 
according to ISO/FDIS 14155: 2020 (E) - Annex I. Results from this study will be used to guide 
development and refinement of the VERAFEYE System.
The study is designed to assess the usability and integration of the VERAFEYE System in standard of 
care, catheter-based ablation treatments for Typical Atrial Flutter (AFL) or Atrial Fibrillation (AF), 
standard of care left atrial appendage closure (LAAC) procedures and standard of care atrial septal 
defect (ASD) closure procedures. Results from this study will be used to guide development and 
refinement the VERAFEYE System.
Intended Users of the VERAFEYE System are interventional cardiologists and electrophysiologists who 
are trained in percutaneous and transseptal procedures and who have completed the VERAFEYE 
System training. The VERAFEYE System training is offered by the Sponsor. The VERAFEYE System 
should only be performed by these Intended Users.
A prospective study design will ensure that identical procedures are followed for data capture and 
review. 
Up to 4 operators per site will be allowed to perform study procedures, unless written approval from 
LUMA Vision was obtained.
A sample size of 40 subjects was chosen to allow for sufficient feasibility testing and data collection for 
the ablation,  LAA and ASD closure procedures. The sample size is not statistically based but is based 
on a reasonable number of data sets to assess the images collected with the VERAFEYE System.
In protocol rev 4.0, the sample size was extended from 20 subjects to 40 subjects, in order to collect 
more clinical data for further system development and to ensure the collection of information from 
different operators.
Enrolment in this study is competitive, there is no limit of enrolments per site.
Subject procedures will follow a sequential pattern (one site after the other) to allow LUMA Vision field 
support personnel to be present during the procedures and to ensure the availability and installation of 
necessary equipment.
Enrolment in the study is expected to be completed in approximately 6 months. The follow-up for each 
participant is expected to be approximately 7 days, therefore the total study duration is expected to last 
approximately 7 months.

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The Figure below shows the schematic of the study design.
Figure 4: Schematic of the LUMINIzE Study Design
5.8. SUBJECT SELECTION
Subjects will be recruited from the investigators general patient population. Subjects considered for 
participation in this study will be entitled to undergo a standard-of-care ablation, LAA or ASD closure 
procedure. It is the sites responsibility to verify the subjects eligibility for participation in the trial. A 
subject is considered as enrolled once the study-specific Informed Consent Form is signed.
An overview of the in-and exclusion criteria is listed in Table 2 below.
Table 2: In-and Exclusion Criteria for the LUMINIzE Study

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Inclusion Criteria
IC1: Subject is 18 to 80 years of age at the time of consent
IC2: 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) closure procedure
or
·        atrial septal defect (ASD) closure procedure
               *according to current international and local guidelines and currently approved indications
IC3: Subject is able to understand and willing to provide written informed consent
IC4: Subject is able and willing to complete all study assessments
Exclusion Criteria
EC1: 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
EC2: Any planned surgical or endovascular intervention within 30 days before or after the ablation, or 
LAA/ASD closure procedure.
EC3: Any of the following cardiac conditions:
·        New York Heart Association (NYHA) class IV

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·        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
EC4: Body mass index (BMI) > 40 kg/m2
EC5: Body weight < 50kg
EC6: 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)
EC7: Life expectancy less than 12 months
EC8: Subjects who are currently enrolled in another study
Imaging Exclusion Criteria
IEC1: Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care 
imaging.
5.9. SUBJECT ACCOUNTABILITY
5.9.1. POINT OF ENROLMENT
A subject is considered as enrolled when the study-specific Informed Consent Form has been obtained.
A study subjects participation will be considered complete when all protocol required visits have been 
completed. For subjects who underwent the ablation, LAA or ASD closure procedure, the last protocol 
required follow-up is at 7 days post procedure. Therefore, subjects who underwent the procedure will be 
followed from enrolment through the ablation/LAA/ASD closure procedure, hospital discharge, and 7-day 
follow up. There are no other additional study-related visits required for participating subjects except for 
those additionally scheduled per physicians decision.

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Study enrolment will be considered as complete when 40 procedure subjects have been enrolled (see 
section 'subject classification').
Enrolment in the study is expected to be completed in approximately 6 months. The follow-up for each 
participant is expected to be approximately 7 days, therefore the total study duration is expected to last 
approximately 7 months.
Up to 2 sites in Ireland may participate in the study. Enrolment in this study is competitive, there is no 
limit of enrolments per site.
5.9.2. SUBJECT CLASSIFICATION

Enrolled subject- Any participant who signs the informed consent form.

Screen Failure subject- Any participant who signs the consent form but is found to not meet 
eligibility criteria.

Intent subject- Any participant who signs the consent form, met the eligibility criteria but did not 
have the VERAFEYE Imaging Catheter inserted into the body.

Attempt subject- Any participant who signs the consent form, met the eligibility criteria, did have 
the VERAFEYE Imaging Catheter inserted into the body but did not undergo the 
ablation/LAA/ASD closure procedure per this study protocol.

Procedure subject - Any participant who undergoes the ablation/LAA/ASD closure procedure with 
the VERAFEYE System as imaging system per this study protocol.
These subjects are followed in accordance with the Follow-Up schedule and data will be included in all 
study analyses.

Withdrawn subject - A participant who chooses to or is withdrawn from the study.

Lost-to-follow up subject - A participant who cannot be reached anymore after 3 attempts.
Enrolment will be considered as complete when 20 procedure subjects have been enrolled.
The Figure below shows the subject classifications.

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Figure 5: Subject Classifications
5.9.3. END OF STUDY
Individual study subject participation will end when the last subject follow-up visit is completed; when the 
subject withdrew or was withdrawn from the study or when the subject is considered as lost-to-follow up.
The study will be considered as complete when the last subjects follow up visit occurs or when subjects 
are no longer being considered for participation. Routine management and standard practice of care will 
continue for the subjects who have completed the study.
5.9.4. WITHDRAWAL
In accordance with the legal requirements and ICH-GCP guidelines, a subject can leave the study at any 
time without having disadvantages. The subject may be withdrawn from the study at any time at the 
discretion of the investigator. The reason(s) for withdrawal shall be reported. Routine management and 
standard practice of care will continue for such a patient. Where a patient is withdrawn or excluded, the 

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patients number shall not be re‐assigned to another subject.  Data collected up to the point of subject 
withdrawal may be used but additional data may no longer be collected after the point at which a subject 
has been withdrawn from the study or withdraws consent.
5.9.5. LOST-TO-FOLLOW UP
Before a participant is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the participant (where possible, 3 telephone calls and, if necessary, a letter to the 
participants last known mailing address or local equivalent methods). These contact attempts should be 
documented in the participants medical record or study file. Should the participant continue to be 
unreachable, he or she will be considered as lost to follow-up.
5.10. STUDY ASSESSMENTS
5.10.1. INFORMED CONSENT
If a potential participant is found to be eligible for enrolment, the study consent form will be reviewed with 
the subject and the study methods and requirements will be explained. Subjects will be provided with 
sufficient information to make an informed decision about their participation in this study. Subjects will be 
given sufficient time to consider participation and ask questions if necessary.
No study-specific procedures should be conducted prior to consent. A copy of the signed consent form 
will be provided to the study participant and the original signed consent form will be maintained in the 
subjects files at the site. The consent form must be signed by the subject, and the Investigator-
designated research professional obtaining the consent.
All changes to the consent form shall require EC approval; a determination will be made by the sponsor 
regarding whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form.
The patients who have received the study patient information for consideration of participation in the 
study will be listed in a screening log, regardless of whether they are eligible to the study or whether they 
consented to participate or not. The screening log list will not include the patient identity information 
except for the first and the second name initials, and the date of providing the study written patient 
information to the patient.  
5.10.2. BASELINE VISIT
The data collection requirements for the baseline visit are outlined below and will be collected prior to the 
procedure.

Verification of eligibility criteria

Documentation of informed consent process, including ICF signature date (see section 13.1.1 
below)

Subject demographics, including age, gender and race

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
Medical history, including cardiac history and arrhythmia disorder history

Physical assessment (including height, weight, blood pressure, heart rate, 12-lead ECG))

Pre-procedural imaging per hospitals standard of care, if performed at baseline*

Medication Regimen

Adverse events, if applicable

Protocol deviations, if applicable
*Pre-procedural imaging data will be saved and stored to external media, as provided by the sponsor
5.10.3. PROCEDURE
5.10.3.1. General
The procedure visit must occur within 60 calendar days of the baseline visit.
The ablation, or LAA/ASD closure procedure must be performed by investigators trained in 
Electrophysiology or Interventional Cardiology, trained to the LUMINIzE study protocol and authorized by 
LUMA Vision to handle investigational devices. Up to 4 operators per site will be allowed to perform 
study procedures, unless written approval from LUMA Vision was obtained.
5.10.3.2. VERAFEYE System Preparation/LUMA Vision Support
The System Console will create a record for each view attempted. In order to accurately capture 
information
relevant to the study, the following steps need to be followed for each procedure:
1.
Start a new study. Input subject name, date of birth, gender and subject ID
2.
In Graphical User Interface (GUI) main screen, select appropriate 2D and 4D configs.
3.
In the Component screen, 

Home the motor (if the button is enabled).

Input the VERAFEYE Imaging Catheter serial number with the format.

Confirm the VERAFEYE Imaging Catheter has been flushed and confirm the connection.
4.
If tracking sensors are disconnected, 

Disable tracking from the tracking tab before inserting the sensor to the control unit.

Enable tracking again after connecting the sensor.
5.
Start imaging.
6.
Navigate to intended view (see section 12.6), manipulating 3D volume and 2D plane as required.
7.
Acquire clip and full data.
8.
Freeze if needed for measurements / change configurations and repeat acquisition.
9.
Navigate to the next intended view (see section 12.6).

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10. Before finishing a study, always freeze the imaging and wait until the motor stops. Then, select 
the finish option in the dropdown with the subject name. Close the study and the data will 
automatically save.
LUMA Vision will ensure (a) company representative(s) is/are present during each procedure to manage 
the System Console and to assist the physician with the VERAFEYE Imaging Catheter preparation.
5.10.3.3. Procedure Workflows
Pre-Procedural Imaging
Pre-procedural imaging will be performed per hospital standard of care to assess the anatomy and to 
exclude the presence of thrombus. If an intracardiac thrombus is visualized, the procedure will be 
aborted and the subject will be withdrawn from the study. Pre-procedural imaging may be collected at 
baseline or on the day of the procedure.
Intra-Procedural Imaging
VERAFEYE imaging data from the right atrium will be obtained during the ablation, or LAA/ASD 
closure  procedure. This procedure is to be performed using a commercially available ablation catheter 
or LAA/ASD closure device. The choice of the ablation catheter, or LAA/ASD closure device is at the 
operators discretion. This ablation, or LAA/ASD closure procedure will be performed according to 
standard of care. The ablation, or LAA/ASD closure procedure will not be guided by the data collected 
from the VERAFEYE System, the physician is to adhere to a standard workflow and rely on standard 
imaging and diagnostic tools, as applicable. In order to prevent artifact between the VERAFEYE System 
and the standard of care echocardiography imaging (intracardiac echocardiography (ICE) 
transesophageal echocardiography (TEE)), the VERAFEYE imaging has to be frozen during standard of 
care echocardiography imaging and vice versa.
No concomitant procedures are allowed to be performed at the time of the ablation, or LAA/ASD 
closure  procedure under this protocol. It is also not allowed to combine an ablation procedure with an 
LAA/ASD closure procedure or to combine an LAA closure procedure with an ASD closure procedure.
It is recommended that the following views with the VERAFEYE Imaging Catheter be obtained in order 
to visualize the major anatomical structures, as well as third party devices.
RA (typical AFL) Ablation

Home view

A variety of anatomical views from different VERAFEYE Imaging Catheter locations, at the 
discretion of the investigator

View to visualize mapping* and/or ablation catheter
*If used, per hospital standards of care

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LA (AF) Ablation

Home view

A variety of anatomical views from different VERAFEYE Imaging Catheter locations, at the 
discretion of the investigator

Transseptal puncture view

View to visualize mapping* and/or ablation catheters
*If used, per hospital standards of care
LAA Closure

Home view

A variety of anatomical views from different VERAFEYE Imaging Catheter locations, at the 
discretion of the investigator

Transseptal puncture view

View to visualize closure device delivery catheter
ASD Closure

Home view

A variety of anatomical views from different VERAFEYE Imaging Catheter locations, at the 
discretion of the investigator

View to visualize closure device delivery catheter
Indications for conversion to general anesthesia are at the discretion of the treating physicians and 
include, but are not limited to, hemodynamic instability, inability to maintain a protected airway during the 
procedure and patient discomfort. Routine clinical assessment for complications will be made during the 
case.
The VERAFEYE Imaging Catheter is to be removed after the removal of any third party catheters.
Post-Procedural Imaging
VERAFEYE imaging data will be collected after the last ablation has been performed/after deployment of 
the closure device. Prior to the completion of the procedure (after removing all the devices except the 
VIC), additional VERAFEYE imaging of the pericardial space maybe performed at the discretion of the 
physician.
5.10.3.4. Procedural Data Collection
The following data related to the procedure will be collected:

Date of procedure

Pre-procedural imaging per hospitals standard of care, if performed at procedure visit*

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
Intra-procedural imaging per hospitals standard of care, as applicable

Identification of all investigational study devices

Identification of non-study devices

Rhythm at the beginning of the procedure (by means of a 12-lead ECG)

Method of delivering sedation or anesthesia for the procedure

Method of access to left atrium: single or double transseptal

Performance of the study device

Procedural outcome details 

Ablation procedures: successful isolation of CTI (typical AFL) or PVs (AF)

LAA/ASD closure procedures: successful deployment of closure device
At the end of the procedure, the following information will be collected:

Total procedure time, defined as time elapsed from time first access sheath insertion into the 
subject until the last catheter removed

Total fluoroscopy time and dose

Total time VERAFEYE imaging catheter was in the body, defined as time elapsed from inserting 
the VIC into the subject until the time of VIC removal from the subject 

Rhythm at end of case (by means of a 12-lead ECG)

Physical assessment

Concomitant procedures, if applicable

Changes in Medication Regimen

Adverse Events if applicable

Device Deficiencies

Protocol Deviations, if applicable

The data collected through the System Console will be saved and stored to external media, as 
provided by the sponsor
*Standard of care imaging data will be saved and stored to external media, as provided by the sponsor
After the completion of the procedure, the images collected with the VERAFEYE System during the 
procedure may be reviewed with the physician and the physician will be asked to rate the performance 
of the system by means of a questionnaire.
5.10.4. POST-PROCEDURE VISIT
The Post-Procedure visit is applicable for attempt subjects and procedure subjects.
The post-procedure visit will occur per standard of care but not to exceed 2 days from the end of the 
study procedure. The data collection requirements of the post procedure visit are outlined below:

Date of visit

Physical assessment (incl. vital signs and 12-lead ECG)

Changes in Medications Regimen

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
Adverse Events, if applicable

Protocol Deviations, if applicable
5.10.5. 7-DAY FOLLOW-UP
The 7-day follow-up is applicable for attempt subjects and procedure subjects.
If the patient was discharged prior to the day 7 follow-up, a telephone contact will occur. If the patient is 
still hospitalized at the time of the day 7 follow-up, the 7 days follow-up will be performed as an in-
hospital visit.  The data collection at the day 7 follow-up includes:

Date of contact (visit/telephone call)

Changes in Medication Regimen

Adverse Events, if applicable

Protocol Deviations, if applicable
5.10.6. DATA COLLECTION SCHEDULE
The data collection schedule for the study is shown in Table 3. 
Table 3: Data Collection Schedule
Procedure/Assessment
Baseline Visit
Procedure Visit
Post-Procedure Visit
 
7- Days Follow-Up
(office/phone call)
 
 
≤ 60 days prior Day 
0
Day 0
Day 0- Day 2
 
Day 7
 
Informed Consent Form and 
Process
X
 
 
 
Eligibility Criteria
X
 
 
 
Demographics including age 
and gender
X
 
 
 

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Procedure/Assessment
Baseline Visit
Procedure Visit
Post-Procedure Visit
 
7- Days Follow-Up
(office/phone call)
 
Medical history
X
 
 
 
Physical Assessment
X
X
X
 
Cardiac imaging
X
(X)
 
(X)
Medication regimen
X
X
X
X
Procedural data collection
 
X
 
 
Investigational Data Collection  
X
 
 
Protocol Deviations
X
X
X
X
Adverse Events
X
X
X
X
Device Deficiencies
 
X
 
 
*: per hospital standard of care
( ): optional, collect only if performed per hospitals standard of care
5.11. POTENTIAL RISKS AND BENEFITS
5.11.1. RISKS ASSOCIATED WITH THE PROCEDURE
There are risks associated with the standard procedures that are part of the study such as exposure to 
radiation (e.g. because of the usage of fluoroscopy, or because of the standard of care imaging modality 
performed prior to/during the ablation or LAA/ASD closure procedures) or risks that are common to 
ablation or LAA/ASD closure procedures. These risks are not changed by the use of the VERAFEYE 
System.

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5.11.2. RISKS ASSOCIATED WITH THE STUDY DEVICE
The risks associated with use of the VERAFEYE System are not substantially or incrementally different 
from commercially available and widely used ICE systems for cardiac EP or LAA/ASD closure 
procedures. The below list of potential adverse effects associated with the use of this device and other 
devices in this field is widely known and understood when considering usage of ICE in EP or LAA/ASD 
closure procedures.
5.11.3. POTENTIAL ADVERSE EVENTS
Subjects participating in this study are subject to the same risks shared by all patients undergoing an 
ablation procedure for treatment of AFL or AF; or an LAA/ASD closure procedure. 
Based upon the current literature, the tables below includes an alphabetical list of the possible 
anticipated adverse events and possible adverse device effects associated with ablation catheters and 
closure devices. Occurrence of any of the listed events could lead to prolonged hospitalization for the 
subject. 
Table 4: Potential adverse events during catheter ablation procedures
Access site complications
Headache
Allergic reaction
Heart failure
Anemia
Hematoma
Arrhythmias
Hemothorax
Bleeding/Hemorrhage
Hemodynamic instability
Blurred vision
Hypertension/Hypotension
Cardiac perforation
Inadvertent injury to adjacent structures
Cardiac/pulmonary arrest
Infection
Catheter entrapment
Myocardial infarction
Cerebrovascular accident (CVA)
Nerve weakness/palsy/injury (i.e. phrenic/ vagus)
Chest discomfort/pain or pressure
Pericarditis
Complete heart block (transient/permanent)
Pneumothorax

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Complications of sedative 
agents/anesthesia/medications
Pseudoaneurysm
Coronary artery spasm
Pulmonary complications (i.e. edema, pulmonary 
hypertension, pleuritis, pneumonia)
Cough
Pulmonary vein stenosis
Death
Radiation injury/exposure
Diaphragmatic paralysis
Renal insufficiency/failure
Dizziness or lightheadedness
Respiratory Depression
Edema
Residual atrial septal defect (ASD)
Pericardial effusion/pleural effusion
Skin burns (i.e. radiation/defibrillator/ cardioverter)
Elevated cardiac enzymes
ST segment Elevation
Embolism (venous/arterial) (i.e.  air, gas, 
thrombo, pulmonary)
Sore Throat
Endocarditis
Tamponade
Esophageal injury
Thrombus/thrombosis
Fever
Transient ischemic attack (TIA)
Exacerbation of existing conditions
Valvular damage
Fatigue
Vasospasm
Fistula (arterial-venous, atrial-esophageal)
Visual disturbances
Gastroparesis
Vasovagal reactions
Table 5: Potential adverse events during catheter closure procedures
Air embolism
Hemoptysis

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Airway trauma
Hypotension
Allergic reaction to contrast media/medications 
or device
Hypoxia
Altered mental status
Improper wound healing
Anemia requiring transfusion
Inability to reposition, recapture, or retrieve the device
Anesthesia risks
Infection/pneuomina     
Angina
Interatrial septum thrombus
Anoxic encephalopathy
Intratracheal bleeding
Arrhythmias
Major bleeding requiring transfusion
Atrial septal defect
Misplacement of the device / improper seal of the 
appendage / movement of device from appendage 
wall
AV fistula
Myocardial erosion
Bruising, hematoma or seroma
Nausea
Cardiac perforation
Oral bleeding
Chest pain/discomfort
Pericardial effusion / tamponade
Confusion post procedure
Pericarditis
Congestive heart failure
Pleural effusion
Contrast related nephropathy
Prolonged bleeding from a laceration
Cranial bleed
Pseudoaneurysm
Death
Pulmonary edema
Decreased hemoglobin
Pulmonary embolism

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Deep vein thrombosis
Renal failure
Device embolism/migration
Respiratory insufficiency / failure
Device fracture
Surgical removal of the device
Device thrombosis
Systemic embolism
Edema
TEE complications (throat pain, bleeding, esophageal 
trauma)
Bleeding
Thrombocytopenia
Fever
Thrombosis
Groin pain
Transient ischemic attack (TIA)
Groin puncture bleed
Valvular damage
Hematuria
Vasovagal reactions
5.11.4. RISKS ASSOCIATED WITH STUDY PARTICIPATION
Subjects enrolled in the study will receive treatment with commercially-available devices and equipment 
per the sites standard-of-care. The investigational system will function independently from the 
commercially-available devices. Therefore, there is no risk that the investigational system will affect the 
functionality of the commercially-available devices.
Since all subjects enrolled in the study are required to undergo intracardiac echocardiography with the 
VERAFEYE System, the total procedure duration is likely to increase compared to a procedure without 
intracardiac echocardiography. Care will be taken to limit any potential increase in procedure time, and 
the total procedure time is expected to continue to be in line with standard of care intracardiac 
echocardiography cases. There is no increased risk for serious injury due to the potential increased 
procedure time. 
5.11.5. BENEFITS ASSOCIATED WITH STUDY PARTICIPATION
The VERAFEYE System is similar in technology and indication to existing commercially available ICE 
systems, such as UltraICE (Boston Scientific), AcuNav and Soundstar (Biosense Webster), ViewFlex 
(Abbott). ICE systems provide the operator with additional means of intra-operative guidance such as 
orientation within the heart, and evaluating the size of the lumens. While there may be no direct benefit 
from participating in this study, because the VERAFEYE System provides real-time imaging, 
complications may potentially be detected earlier on.

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The data collected in this clinical investigation will serve as critical input for VERAFEYE imaging 
technology improvement, as well as for the novel features development in future device releases. In this 
regard, the proposed clinical investigation is a pivotal step toward the development of next-generation 
intraoperative 4D-imaging devices, aimed to improve outcomes for future patients undergoing catheter 
ablation and structural heart procedures.
5.12. STATISTICAL DESIGN AND ANALYSIS
Given the nature of this feasibility study, analysis of study data will use descriptive statistical methods. 
The Sponsor shall use the imaging data for product development purposes only. Study data will be 
summarized and included in a clinical study report at the conclusion of the study enrolment.
5.13. SAFETY REPORTING
5.13.1. REPORTABLE EVENTS
The investigator is responsible for documenting and reporting any of the following events to the study 
Sponsor:

All Investigational Device Deficiencies

All Serious Adverse Events

Unanticipated Adverse Device Effects and Unanticipated Serious Adverse Device Effects

All Thromboembolic Events

All Device Related Adverse Events

All Procedure Related Adverse Events

New findings/updates in relation to already reported events
Definitions of reportable events are included in the Table below.
Table 6: Reportable Events Definitions
Term
Definition
Adverse Event
 
 
Any untoward medical occurrence, unintended disease or injury, or any untoward 
clinical signs (including an abnormal laboratory finding) in subjects, users or other 
persons, in the context of a clinical investigation, whether or not related to the 
investigational medical device and whether anticipated or unanticipated. 
NOTE 1: This includes events related to the investigational medical device or 
comparator.
NOTE 2: This definition includes events related to the procedures involved.

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Term
Definition
NOTE 3: For users or other persons, this definition is restricted to events related to 
the investigational medical device. 
Adverse Device 
Effect
Adverse event related to the use of an investigational medical device
NOTE 1: This includes any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, the 
installation, the operation, or any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.
NOTE 3: This includes comparator if the comparator is a medical device.
Serious Adverse 
Event
Adverse event that led to any of the following:
a.                death,
b.                serious deterioration in the health of the subject, users or other 
persons as defined by either:
1.      a life-threatening illness or injury, or
2.      a permanent impairment of a body structure or a body function, including 
chronic diseases, or 
3.      in-patient hospitalization or prolongation of existing hospitalization, or
4.      medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function
c. fetal distress, fetal death, or a congenital abnormality or birth defect including 
physical or mental impairment.
NOTE 1: Planned hospitalization for a pre-existing condition, or a procedure 
required by the clinical investigational plan, without a serious deterioration in 
health, is not considered a serious adverse event. 
Serious Adverse 
Device Effect 
(SADE)
Adverse device effect that has resulted in any of the consequences characteristic 
of a serious adverse event.

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Term
Definition
Unanticipated 
Adverse Device 
Effect
Any serious adverse effect on health or safety or any life-threatening problem or 
death caused by, or associated with, a device, if that effect, problem, or death was 
not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), 
or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects.  
Unanticipated 
Serious Adverse 
Device Effect
Serious adverse device effect which by its nature, incidence, severity, or outcome 
has not been identified in the current risk assessment.
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect which by 
its nature, incidence, severity or outcome has been identified in the risk 
assessment.
Serious Health 
Threat
 
Signal from any adverse event or device deficiency that indicates an imminent risk 
of death or a serious deterioration in the health in subjects, users or other persons, 
and that requires prompt remedial action
for other subjects, users or other persons.
NOTE 1: This would include events that are of significant and unexpected nature 
such that they become alarming as a potential serious health hazard or possibility 
of multiple deaths occurring at short intervals.
Device Deficiency
 
An inadequacy of a medical device related to its identity, quality, durability, 
reliability, usability, safety or performance. 
NOTE 1: Device deficiencies include malfunctions, use errors, and inadequacy in 
the information supplied by the manufacturer including labelling.
NOTE 2: This definition includes device deficiencies related to the investigational 
medical device [or the comparator].
5.13.2. REPORTING REQUIREMENTS
5.13.2.0.1. Investigator Reporting Requirements to Sponsor
All reportable events experienced by study participants must be reported if they occur after the point of 
enrolment as defined in the subject classification section. Pre-existing conditions should not be reported 
as adverse events unless they worsen in severity or increase in frequency.

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Adverse events and device deficiencies must always be reported to the Sponsor through the CRFs. 
Completed CRFs are to be sent to the following email address of the sponsor:
luminize@lumavision.com
Reporting timelines are included in Table 7 below.  
Table 7: Investigator Reporting Requirements
Event Classification
Communication Method
Communication Timeline pre-market 
studies
 
 
Complete AE CRF page 
with all available new and 
updated information.
 
·        Within 1 business day of first 
becoming aware of the event.
·        Terminating at the end of the study
Unanticipated Adverse 
Device Effect / 
Unanticipated Serious 
Adverse Device Effect
 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event, as 
requested by sponsor.
·        Upon request of sponsor.
Complete AE CRF page 
with all available new and 
updated information.
·        Within 3 calendar days of first 
becoming aware of the event or as per 
local/regional regulations.
·        Reporting required through the end 
of the study
Serious Adverse Event
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event.
·        Upon request of sponsor

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Event Classification
Communication Method
Communication Timeline pre-market 
studies
 
 
Complete AE CRF page 
with all available new and 
updated information.
·        Within 3 calendar days of first 
becoming aware of the event or as per 
local/regional regulations.
·        Reporting required through the end 
of the study
·        When documentation is available
Serious Adverse Device 
Effects
 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event.
·        At sponsor request.
Complete Device 
Deficiencies CRF with all 
available new and 
updated information.
·        Within 3 calendar days of first 
becoming aware of the event.
·        Reporting required through the end 
of the study
Device Deficiencies 
(including but not limited to 
failures, malfunctions, and 
product nonconformities)
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event.
·        Upon request of sponsor
Complete AE CRF page, 
which contains such 
information as date of AE, 
treatment of AE 
resolution, assessment of 
seriousness and 
relationship to the device.
Adverse Event including 
Adverse Device Effects
Provide all relevant 
source documentation 
(de-
·        In a timely manner after becoming 
aware of the information
·        Reporting required through end of 
study
·        Upon sponsor request

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Event Classification
Communication Method
Communication Timeline pre-market 
studies
 
 
identified/pseudonymized) 
for reported event, as 
requested by sponsor.
 
All events will be assessed by the investigator for relationship to study device and the study procedure.
Table 8: Relationship Events to Procedure/Device
Classification
Description
Not Related
Relationship to the device, comparator or procedures can be excluded when:
- the event has no temporal relationship with the use of the investigational device or the 
procedures related to the use of the investigational device;
- the serious event does not follow a known response pattern to the medical device (if 
the response pattern is previously known) and is biologically implausible;
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible  and reintroduction of its use (or increase 
of the level of activation/exposure), do not impact on the serious event;
- the event involves a body-site or an organ that cannot be affected by the device or 
procedure;
- the serious event can be attributed to another cause (e.g. an underlying
or concurrent illness/ clinical condition, an effect of another device, drug, treatment or 
other risk factors);
- the event does not depend on a false result given by the investigational device used 
for diagnosis, when applicable; 

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Classification
Description
In order to establish the non-relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the serious event.
Possibly 
Related
The relationship with the use of the investigational device or comparator, or the 
relationship with procedures is weak but cannot be ruled out completely. Alternative 
causes are also possible (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment). Cases where relatedness cannot 
be assessed or no information has been obtained should also be classified as possible.
Probably 
Related
The relationship with the use of the investigational device or comparator, or the 
relationship with procedures seems relevant and/or the event cannot be reasonably 
explained by another cause.
Causal 
Relationship
The serious event is associated with the investigational device or comparator or with 
procedures beyond reasonable doubt when:
- the event is a known side effect of the product category the device belongs to or of 
similar devices and procedures;
- the event has a temporal relationship with investigational device use/application or 
procedures;
- the event involves a body-site or organ that
-the investigational device or procedures are applied to;
-the investigational device or procedures have an effect on;
- the serious event follows a known response pattern to the medical device (if the 
response pattern is previously known);
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible);
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled out;
- harm to the subject is due to error in use;

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Classification
Description
- the event depends on a false result given by the investigational device used for 
diagnosis, when applicable;
In order to establish the relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the serious adverse event.
5.13.2.0.2. Sponsor Reporting Requirements
The sponsor is responsible for reporting adverse event information to all participating Principal 
Investigators, ECs and regulatory authorities, as applicable. All events will be assessed by the Sponsor 
for relationship to study device and study procedure.
5.13.3. DEATH REPORTING
A subject death during the study should be reported to LUMA Vision no later than 3 calendar days of site 
notification. A detailed narrative (death letter) that provides detailed information describing the 
circumstances surrounding the death and cause of death should be submitted to the sponsor. In 
addition, a death case report form needs to be submitted to the sponsor, including the following details:

Date and time of death

Primary organ cause of death

Timing of the death in relation to the procedure

Whether or not the death was witnessed/monitored

Whether the death was related to the procedure, or investigational device

Autopsy report, if applicable
5.14. REGULATORY AND ETHICAL ASPECTS
5.14.1. STUDY FINANCING
This study is financed by the Sponsor. The study site(s) shall enter into a clinical study agreement with 
the Sponsor that details the financing of the study as well as the rights and obligations of both the 
Sponsor and the site. The clinical study agreement must be executed before any participant is enrolled.
5.14.2. GENERAL DUTIES OF SPONSOR AND PRINCIPAL INVESTIGATOR
5.14.2.0.3. General Duties of Sponsor
The Sponsors general duties consist of submitting applications and information to appropriate regulatory 
authorities as required by local and national regulations, obtaining regulatory and EC approvals prior to 
allowing study start, selecting Investigators and ensuring proper clinical site monitoring.

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5.14.2.0.4. General Duties of Principal Investigator
It is the responsibility of the Principal Investigator to ensure that the study will be conducted according to 
the protocol, recognized ethical principles for medical research involving humans, principles of good 
clinical practice, (ICH-GCP), ISO 14155:2020 Clinical Investigation of medical devices for human 
subjects, principles of the Declaration of Helsinki, any conditions of approval imposed by the reviewing 
EC and by the local regulation, if applicable.  
The Principal Investigators will assure that all site personnel involved in the conduct of this study have 
completed ICH GCP Training as it pertains to this study. The protocol, informed consent form(s) and 
other related study materials will be submitted to the EC, and regulatory authority (as applicable) for 
review and approval. Approval of both the protocol and the consent form must be obtained before any 
participant is enrolled. Any additional requirements imposed by the EC or regulatory authority shall be 
implemented.
It is the responsibility of the Principal Investigator to ensure the following requirements are met before 
the start of the study:

sign the Clinical Study Agreement, and comply with the Investigator responsibilities as described 
in such Agreement.

sign the Investigator Brochure Signature Page and Protocol Signature page

provide his/her recent curriculum vitae and that of site staff involved in the study

insurance coverage for subjects in the study was obtained

EC approval was obtained
It is the responsibility of the Principal Investigator to

ensure that no deviations from this protocol occur, except if considered as needed to protect the 
life and physical well-being of a subject in an emergency. Any deviations that occurred during the 
study need to be documented, together with a rationale for the deviation.

ensure that source documents and essential study documents throughout the clinical study are 
maintained and retained per requirements.

ensure that the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports

record, report, and assess every adverse event as applicable per the protocol and observed 
device deficiency.

report to sponsor, per the protocol requirements, all reportable events

report to the EC and regulatory authorities any SAEs and device deficiencies that could have led 
to a SADE and potential UADE or USADE, as required by local/regional regulations

maintain the device accountability records and control of the devices

ensure that adequate facilities are available to perform the study

ensure that informed consent is obtained in accordance with applicable laws, this protocol and 
local EC requirements (see section 21.4)

allow the sponsor to perform monitoring and auditing activities.

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
regulatory authorities and ECs to perform auditing activities.
The Principal Investigator or his/her designee will take measures to prevent accidental or premature 
destruction of these documents.
5.14.2.0.4.1. Delegation of Responsibilities
The Principal Investigator may decide to delegate certain responsibilities to members of his/her site staff 
(Sub-Investigators, Clinical Research Coordinators and other site staff members, as applicable). These 
responsibilities shall then be appropriately documented prior to being performed. The Principal 
Investigator shall ensure his/her site staff is qualified and adequately trained prior to conducting any 
study-specific requirements. The Principal Investigator shall provide adequate supervision of those to 
whom tasks are delegated. Where there is a Sub- Investigator at a site, the Sub-Investigator cannot be 
delegated the primary supervisory responsibility for the site.
5.14.3. ROLE OF LUMA VISION REPRESENTATIVE(S)
LUMA Vision personnel can provide technical support to the investigator and other health care personnel 
(collectively HCP) as needed. Support may include HCP training, addressing HCP questions, or 
providing clarifications to HCPs concerning the operation of LUMA Visions equipment/devices.
At the request of the investigator and while under investigator supervision, LUMA Vision personnel may 
operate equipment during the procedure, and interact with the subject to accomplish requested activities.
Typical tasks may include the following:

Provide technical support or assist in the operation of the VERAFEYE System and other 
supporting equipment based on instructions provided by the HCP during the procedure.

Be present and have some direct contact with the patients at the procedure.

After the procedure, review how the study equipment performed, and transfer pseudonymized 
data to the Sponsors study database.

Assist and review the collection of information about the procedure and study documents for 
completeness and accuracy.

Complete the Technical Source Form during the procedure, in order to assist the HCP with data 
collection during the procedure.
LUMA Vision personnel will not do the following.

Practice medicine

Provide medical diagnosis or treatment to subjects

Discuss a subjects condition or treatment with a subject

Independently collect study data

Enter data in electronic data capture systems or on paper case report forms

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5.14.4. ETHICS COMMITTEE
The protocol, its modifications, and the patient consent forms will be reviewed and approved in writing by 
an Ethics Committee (EC) prior to initiation of the study. No changes can be made to the protocol or 
patient consent forms without Sponsor and EC approvals. No investigative procedures other than those 
defined in this protocol will be undertaken on the enrolled patients without the written agreement of the 
EC and Sponsor. The Principal Investigator will advise their EC of the progress of this clinical study 
according to EC reporting requirements. The EC must operate in accordance with the current national 
regulations. 
5.14.5. STUDY REGISTRATION
The study will be registered at the www.clinicaltrials.gov website. 
5.14.6. STUDY INSURANCE
The Sponsor shall maintain clinical study insurance to provide coverage for the reasonable and 
necessary costs associated with the diagnosis and treatment of a research injury, defined as: an illness 
or injury directly caused by the study product (drug/device) or study procedures required by the study 
protocol and would not have been expected from the standard treatment for a condition.
5.14.7. PATIENT CONFIDENTIALITY
Patient confidentiality will be maintained throughout the clinical study in a manner that ensures the 
information can always be tracked back to the source data. For this purpose, a unique patient 
identification code will be used that allows identification of all data reported for each patient. 
Data relating to the trial may be made available to third parties (e.g., in the case of an audit performed by 
a Regulatory Authority) provided the data are treated confidentially and that the patients privacy is 
guaranteed.
5.14.8. PROTOCOL DEVIATIONS
No deviations from the protocol are allowed, except to protect the rights, safety, and well-being of human 
subjects under emergency circumstances. In that event, the Investigator will notify Sponsor immediately 
in writing. The Investigator will also inform their EC of all deviations according to Institutional 
requirements. In the event of any deviation from the clinical protocol, a deviation CRF will be 
completed.  The occurrence of clinical investigation plan deviations will be monitored by the Sponsor on 
an ongoing basis.
5.14.9. PROTOCOL AMENDMENTS
Any amendment to the protocol will require review and approval by the EC, and regulatory authority (as 
applicable) before the changes are implemented to the study.

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5.14.10. EARLY TERMINATION
The Sponsor retains the right to terminate the study at any time after carefully weighing the benefits 
against any possible risks. In case of early termination of the study, the Sponsor will promptly inform the 
Principal Investigators, Ethics Committee and regulatory authorities, as applicable. The Sponsor shall 
provide the reason for early termination.
The following circumstances may justify early termination of a site:

The investigational site fails to comply with Good Clinical Practices (GCP) standards

The first subject fails to be recruited within a reasonable period after initiation of the 
investigational site

Recruitment of subsequent subjects is unreasonably slow.
The following circumstances may justify early termination of a study:

Occurrence of severe device-related complications in one or more subjects

Information that is expected to be gathered by this study has already been gained by other 
means

The development of the test product is discontinued by the Sponsor, or the study proves not to 
meet the expected goal

Instructions from the EC or regulatory authorities to suspend or terminate the study

Other important or unforeseen circumstances
5.15. STUDY DOCUMENTATION
5.15.1. DATA MANAGEMENT
All applicable case report forms per the protocol must be completed for every patient.   On completion, 
each CRF shall be signed and dated by the investigator ensuring the data accurately reflects the 
patients clinical results.  The sponsor will put a data management plan in place, describing the 
mechanisms for data collection and data cleaning.
5.15.2. SOURCE DOCUMENTS
Source document is the document where the data has been recorded first. Investigators are responsible 
for maintaining information of the patients medical records that contain the source data reported into
the CRFs. Source documentation includes but is not limited to those items noted in the Table below.
Table 9: Source Documentation Requirements

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Requirement
Disposition
Informed consent form and documentation of ICF 
consenting process
Retain at site
Documentation of:

Medical history

Physical examination

Demographics

Pregnancy, if applicable

Medication Regimen and Changes
Retain at site
12-lead ECGs
Retain at site
Signed Technical Source Form
Retain at site
VERAFEYE Imaging Data
Retain at site (saved to external media, as 
provided by the sponsor)
VERAFEYE Export Case Data
Submit to LUMA Vision
 
Standard of Care Imaging Data
Retain at site
Submit copy to LUMA Vision (saved to 
external media, as provided by the sponsor)
Printed Lab Procedure Report
Retain at Center
In the event of patient death (if available):

Death narrative

Relevant medical records

Death certificate

Autopsy report
Retain at site
Submit copy to LUMA Vision
 
5.15.3. TECHNICAL SOURCE FORMS
A Technical Source Form (TSF) is developed by LUMA Vision to capture protocol required data 
elements that are not duplicated in any other source documents. This form is to be used by the study 

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sites as a source document. A LUMA Vision representative may complete the TSF at the request of the 
Investigator performing the procedure. The TSF will be reviewed and signed for approval by the 
Investigator who performed the procedure at the end of each procedure.
5.15.4. INVESTIGATOR FILES/RETENTION OF DOCUMENTS
The investigator must maintain accurate records for full documentation of the study and study data 
verification. 
The Investigator's Study File will contain the signed protocol with all amendments, signed patient 
informed consent, CRFs, copies of the AE/SAE reports, EC and regulatory authority approvals and 
correspondence, correspondence with the Sponsor, staff curriculum vitae and financial/conflict 
disclosures for investigators physicians, Investigators Brochure, Instructions for Use and other 
appropriate documents. 
Patient Clinical Source Documents include all records to show eligibility to participate in and date of 
entry into the study, patient hospital/clinic records, physician's and nurse's notes from each visit. All AEs, 
their resolution and supporting documentation much also be maintained. The patients condition upon 
completion of the study or withdrawal must be included.
The investigator must keep these documents on file in compliance with the applicable regulatory 
requirements.
Should the investigator wish to assign the study records to another party or move them to another 
location, the Study Sponsor must be notified.
5.15.5. DEVICE ACCOUNTABILITY
All investigational devices of the VERAFEYE System shall be documented on a Device Accountability 
Log.
Upon receipt of the investigational devices, the site will ensure these devices are  stored in a locked 
cabinet and/or room, and access shall be strictly restricted to authorized users of the device, or to the 
site monitor. The site is responsible for keeping records of receipt, usage and return.
Records of receipt, use, and return of all investigational devices shall be maintained by the Investigator 
or his/her designee. Any investigational device damaged or considered unusable in shipment shall be 
documented in the study files and the Investigator shall notify the Sponsor.
Following accountability of the investigational devices and other hardware at the site, all used and 
unused devices will be returned to LUMA Vision. Used VERAFEYE Imaging Catheters shall be sanitized 
prior to return to the sponsor.  Any discrepancies noted between the device log and unused devices will 
be investigated, resolved, and documented prior to return of device(s).

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5.15.6. MONITORING
Contracted monitors, the Sponsor or their designee will perform site monitoring during the study to 
ensure compliance with the study protocol and applicable regulations, that data is collected in a timely, 
accurate and complete manner and that the Investigator continues to have appropriate staff and facilities 
to conduct the study safely and effectively. 
With appropriate notice, the Investigator will allow the monitor/s access to all relevant CRFs, study 
binders and patient records. The Investigator and a Clinical Research Coordinator will be available for 
monitoring visits. It is expected that the site will provide the monitors with a suitable working environment 
for review of Clinical Trial-related documents.
The monitor will assess compliance to the protocol and that the CRFs submitted by the Investigator with 
respect to timeliness, clarity and accuracy by reviewing source documents. The monitor will also assess 
that the site continues to have sufficient staff to conduct the study, training records, and completeness of 
site-specific binders.  
Patient confidentiality will be maintained in accordance with the local requirements.
The sponsor will put a monitoring plan in place, describing the monitoring activities to be performed for 
the study.
5.15.7. AUDITS AND INSPECTIONS
Source documents for this trial must be made available to personnel monitoring and auditing the study, 
and/or representatives of the Sponsor, EC, regulatory inspectors and to health authority inspectors after 
appropriate notification. The Case Report Forms must be made available for direct inspection by such 
parties and for comparison with the contents of the source documents.
5.15.8. CONFIDENTIALITY OF TRIAL DOCUMENTS AND PATIENT RECORDS
The Investigator must assure maintaining of the study participants anonymity at all occasions. Patients 
should be identified using a study identification code. The Investigator must keep a separate confidential 
patient enrolment log showing study numbers and patients identity codes/names.
5.16. PUBLICATION POLICY
The data and results from the Clinical Trial are the property of the Sponsor as governed by the Research 
Agreement.  LUMA Vision requires disclosure of its involvement as a sponsor or financial supporter in 
any publication or presentation relating to the LUMINIzE study or its results. LUMA Vision may submit 
study results for publication following the conclusion or termination of the study. LUMA Vision personnel 
may assist authors and investigators in publication preparation provided the first and senior authors are 
the primary drivers of decisions regarding publication content, review, approval, and submission. The 
directives of the International Committee of Medical Journal Editors will be respected when considering 
authorship (www.icmje.org). 

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Study results will be made available in accordance with the legal requirements and the recognized 
ethical principles. A Clinical Investigation Report will be made available to the Principal Investigator, EC 
and regulatory authorities, as applicable in accordance local requirements.  As applicable, an 
abbreviated Clinical Investigation Report will be made available on the www.clinicaltrials.gov website.
5.17. BIBLIOGRAPHY
1             Lung B, Vahanian A. Epidemiology of valvular heart disease in the adult. Nat Rev Cardiol. 
2011;8:16272.
2             DArcy JL, Prendergast BD, Chambers JB, Ray SG, Bridgewater B. Valvular heart disease: the 
next cardiac epidemic. Heart. 2011;97:913.
3             Saw J, Holmes DR, Cavalcante JL, et al. SCAI/HRS expert consensus statement on 
transcatheter left atrial appendage closure. Heart Rhythm. 2023;20(5):e1-e16.
4            Stout KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC Guideline for the Management of 
Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart 
Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(12):e81-e192.
5             Korsholm K, Berti S, Iriart X, et al. Expert Recommendations on Cardiac Computed 
Tomography for Planning Transcatheter Left Atrial Appendage Occlusion. JACC Cardiovasc Interv. 
2020;13(3):277-292.
6             Sperlongano S, Giordano M, Ciccarelli G, et al. Advances in Percutaneous Patent Foramen 
Ovale Closure: From the Procedure to the Echocardiographic Guidance. J Clin Med. 2022;11(14).
7            Kuo L, Frankel DS, Lin A, et al. PRECAF Randomized Controlled Trial. Circ Arrhythm 
Electrophysiol. 2021;14(1):e008993.
8             Matsubara TJ, Fujiu K, Asada K, et al. Direct left atrial ICE imaging guided ablation for atrial 
fibrillation without employing contrast medium. Int J Cardiol. 2016;203:733-739.
9             Kawakami T, Saito N, Yamamoto K, et al. Zero-fluoroscopy ablation for cardiac arrhythmias: A 
single-center experience in Japan. J Arrhythm. 2021;37(6):1488-1496.
10          Kirstein B, Morris A, Baher A, et al. Magnetic resonance imaging-guided cryoballoon ablation 
for left atrial substrate modification in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 
2020;31(7):1587-1594.
11          Reddy VY, Dukkipati SR, Neuzil P, et al. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 
1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021;7(5):614-627.
12          Sulkin MS, Laughner JI, Hilbert S, et al. Novel Measure of Local Impedance Predicts Catheter-
Tissue Contact and Lesion Formation. Circ Arrhythm Electrophysiol. 2018;11(4):e005831.

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13          Inoue K, Tanaka N, Ikada Y, et al. Characterizing clinical outcomes and factors associated with 
conduction gaps in VISITAG SURPOINT-guided catheter ablation for atrial fibrillation. J Arrhythm. 
2021;37(3):574-583.
14          Streb W, Mitrega K, Podolecki T, et al. Comparison of transesophageal and intracardiac 
echocardiography in guiding percutaneous left atrial appendage closure with an Amplatzer Amulet 
device. Postepy Kardiol Interwencyjnej. 2019;15(4):446-454.
15          Alkhouli M, Hijazi ZM, Holmes DR, Jr., Rihal CS, Wiegers SE. Intracardiac Echocardiography in 
Structural Heart Disease Interventions. JACC Cardiovasc Interv. 2018;11(21):2133-2147.
5.18. ABBREVIATIONS AND ACCRONYMS
AF
AFL
ASD
CRF
EC
EC (1-8)
EP
FIH
GUI
IC (1-4)
ICE
ICF
IEC (1)
LA
LAAC
LV
Atrial Fibrillation
Atrial Flutter
Atrial Septal Defect
Case Report Form
Ethics Committee
Exclusion Criterium
Electrophysiology
First In Human
Graphical Unser Interface
Inclusion Criterium
Intracardiac Echocardiography
Informed Consent Form
Imaging Exclusion Criterium
Left Atrium
Left Atrial Appendage Closure
Left Ventricle

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RA
RV
Right Atrium
Right Ventricle
 
Cross-project links