The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry
Conditions: Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect, Patent Foramen Ovale, Mitral Valve Disease, Tricuspid Valve Disease, Aortic Valve Disease
Sponsor: Philips Clinical & Medical Affairs Global

 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
1  
Status: 
Final 
User Tool Version Date 
30May2019 
 
ICE-Guided Cardiac Interventional Percutaneous Procedures 
 
Project: “The Philips ICE Registry” 
 
Protocol ID:  IGT_IGD_ICE Registry Study_2019_10745 
 
Version 2.0 
 
Date: 24 APR 2021 
 
Registry Sponsor: 
Philips Image Guided Therapy Devices 
3721 Valley Center Drive, Suite 500 
San Diego, CA 92130 
 
 
 

 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
2  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Version History 
Version 
No.  
Amendment 
No.  
Version 
Date 
Summary of Changes  
Rationale 
1.0 
NA 
21OCT 
2019 
NA 
NA 
2.0 
1 
24APR 
2021 
• 
New template 
conversion 
• 
Updated primary and 
secondary analyses 
• 
Increase in no. of 
patients and sites 
• 
General formatting, 
grammatical updates 
Align with Philips process 
updates 
Streamlining data points for 
analyses 
 
 

 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
3  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Sponsor Sign-Off 
 
Authorized Philips Signer(s): 
Rashmi Ram, Associate Director, Clinical Development, 
(Author) 
Carrie Hill, Manager, Clinical Operations 
Kevin Najarian, Global Director of Biostatistics and Data 
Management  
 
 
 
 
 
 
 
Rashmi Ram, PhD 
 
Date 
Associate Director, Clinical Development (Author) 
 
 
 
Carrie Hill 
 
Date 
Manager, Clinical Operations 
 
 
 
 
 
Kevin Najarian, MS 
 
Date 
Global Director of Biostatistics and Data Management 
 
 
 
 
 
 

 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
4  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Abbreviations 
Abbreviation 
Definition 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
ANOVA 
Analysis of Variance 
CFR 
Code of Federal Regulation 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DDE 
Direct Data Entry 
DICOM 
 Digital Imaging and Communications in Medicine 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GCP 
Good Clinical Practice 
ICE 
Intracardiac echocardiography 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
PACS 
Picture Archiving and Communication System 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis Software 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
 

 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
5  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Table of Contents 
Abbreviations ................................................................................................................................ 4 
Statement of Compliance .............................................................................................................. 7 
1. 
PROTOCOL SUMMARY .................................................................................................... 8 
2. 
INTRODUCTION .............................................................................................................. 10 
2.1. 
Device Description ............................................................................................................ 10 
 
Background....................................................................................................................... 10 
 
Registry Rationale ............................................................................................................ 14 
 
Risk/Benefit Assessment .................................................................................................. 14 
 
REGISTRY DESIGN ......................................................................................................... 14 
 
General Description .......................................................................................................... 14 
 
Performance and Safety Analyses ................................................................................... 15 
 
Measures to Minimize Bias ............................................................................................... 16 
4. 
REGISTRY POPULATION ............................................................................................... 17 
 
Inclusion Criteria ............................................................................................................... 17 
 
Exclusion Criteria .............................................................................................................. 17 
 
Number of Subjects .......................................................................................................... 17 
 
Enrollment......................................................................................................................... 17 
 
Screen Failures................................................................................................................. 18 
 
Registry Exit Definition ...................................................................................................... 18 
 
Subject Discontinuation/Withdrawal from the Study ......................................................... 18 
 
Lost to Follow-Up .............................................................................................................. 18 
 
Registry Duration .............................................................................................................. 18 
5. 
DEVICE ACCOUNTABILITY ............................................................................................ 18 
6. 
REGISTRY PROCEDURES & EVALUATIONS ............................................................... 19 
 
Schema ............................................................................................................................ 19 
 
Schedule of Activities (SOA) ............................................................................................. 19 
 
Screening (up to 30 days prior to index procedure) .......................................................... 21 
 
Index Procedure ............................................................................................................... 22 
 
Post-procedure ................................................................................................................. 23 
 
Usability Assessments during Index Procedure ............................................................... 23 

 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
6  
Status: 
Final 
User Tool Version Date 
30May2019 
 
7. 
SAFETY EVENTS: DEFINITIONS AND REPORTING ..................................................... 24 
 
Definition ........................................................................................................................... 24 
 
Device Malfunction or Use Errors ..................................................................................... 25 
 
Reporting Requirements ................................................................................................... 25 
 
Severity of Event............................................................................................................... 26 
 
Relationship to Study Device ............................................................................................ 26 
 
Expectedness ................................................................................................................... 26 
 
Time Period and Frequency for Event Assessment and Follow-Up ................................. 27 
8. 
DATA ANALYSIS AND STATISTICAL CONSIDERATION .............................................. 27 
 
Sample Size Determination .............................................................................................. 27 
 
Populations for Analyses .................................................................................................. 27 
 
Statistical Analyses ........................................................................................................... 27 
9. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............. 28 
 
Regulatory, Ethical, and Study Oversight Considerations ................................................ 28 
 
Informed Consent Process, Procedures, and Documentation .......................................... 28 
 
Registry Discontinuation and Closure ............................................................................... 29 
 
Confidentiality and Privacy ............................................................................................... 29 
 
Safety Oversight ............................................................................................................... 30 
 
Clinical Monitoring ............................................................................................................ 30 
 
Quality Assurance and Quality Control ............................................................................. 31 
 
Data Collection and Management Responsibilities .......................................................... 32 
 
Data Handling and Record Keeping ................................................................................. 33 
 Study Records Retention .................................................................................................. 33 
 Protocol Deviations ........................................................................................................... 34 
 Publication and Data Sharing Policy ................................................................................. 34 
 Conflict of Interest Policy .................................................................................................. 35 
10. 
REFERENCES ................................................................................................................. 35 
11. 
INVESTIGATOR’S STATEMENT ..................................................................................... 38 
 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
7  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Statement of Compliance 
The trial will be carried out in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP), the principles of the Declaration of Helsinki, the applicable parts of ISO 
14155:2011 and the following: United States (US) Code of Federal Regulations (CFR) applicable to 
clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56 21 CFR Part 11). 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the 
protocol and the consent form must be obtained before any subject is enrolled. Any amendment to 
the protocol will require review and approval by the IRB before the changes are implemented to the 
study. In addition, all changes to the consent form will be IRB-approved; a determination will be 
made regarding whether a new consent needs to be obtained from subjects who provided consent, 
using a previously approved consent form.  
 
 
 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
8  
Status: 
Final 
User Tool Version Date 
30May2019 
 
1. PROTOCOL SUMMARY 
Study Title & ID 
The Philips ICE Registry 
Protocol ID:  IGT_IGD_ICE Registry Study_2019_10745 
Project Name 
“Philips ICE Registry” 
Study Description 
The purpose of this observational registry is to report real-world 
safety and performance of VeriSight for ultrasound guided ICE 
imaging in percutaneous cardiac intervention procedures when 
used in standard clinical practice. 
Study Design 
Prospective, multicenter, observational, single-arm registry 
Primary Analyses 
 
Technical success – defined as successful delivery of VeriSight 
to the target intracardiac position and sustained device operation 
during the procedure 
 
Imaging success – Adequate image quality as determined by 
the investigator.    
 
Clinical success – Adequacy of VeriSight imaging for 
visualization of major cardiac structures, and guiding procedural 
intervention, and ability to detect/ assess intra-procedural 
complications. 
 
Safety – Device-related adverse events periprocedural through 
discharge or ≤48 hours post-procedure, whichever is earlier. 
Secondary Analyses 
1. Procedural characterization when using VeriSight 
2. Device characterization when using VeriSight 
3. Physician survey regarding the Philips ICE system 
4. Staff survey regarding the Philips ICE system  
 
 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
9  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Patient Population 
Inclusion Criteria 
• 
≥18 years of age and willing to provide written, signed and 
dated, informed consent. 
• 
Scheduled for a procedure that is within the scope of clinical 
indications for VeriSight, per Instructions for Use (IFU) 
Exclusion Criteria 
• 
Contraindicated for ICE catheter placement or patient 
considerations that make placement of VeriSight not 
technically feasible 
• 
If alternate access (as needed instead of femoral) is not 
viable.  
• 
Known contraindicated conditions include sepsis, major 
coagulation abnormalities, presence of any intracardiac 
thrombus, presence of class IV angina or heart failure, deep 
vein thrombosis, or significant peripheral vascular disease. 
Planned Enrollment 
Up to 200 patients scheduled to undergo cardiac interventional 
percutaneous procedures for which ICE is indicated. Interim 
analysis is planned after the 100th patient before further continuity 
of enrollment in the registry. 
Registry Sites 
Up to 10 sites in the United States with a maximum enrollment of 
no more than 30% patients at each participating site 
Registry Exit 
Either at discharge or ≤48 hours post-procedure, whichever is 
earlier 
Registry Duration 
Duration of the registry is estimated to be approximately 24 – 36 
months. 
Statistical Methodology 
No hypothesis testing is planned. All subjects enrolled in the 
study will be accounted for in the study report. Descriptive 
statistics and 95% confidence intervals will be calculated for 
variables. 
 
 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
10  
Status: 
Final 
User Tool Version Date 
30May2019 
 
2. INTRODUCTION  
2.1. Device Description 
Philips Image Guided Therapy Devices has recently developed and received FDA approval an 
intracardiac echocardiography (ICE) catheter (VeriSight/ VeriSight Pro, henceforth defined as 
VeriSight in this protocol) that has 2D and/or 3D imaging capabilities. These catheters are for use 
with Philips EPIQ series of ultrasound system. The indication for use for VeriSight is intended for 
intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as 
well as visualization of other devices in the heart. The catheter is intended for imaging guidance 
only, not treatment delivery, during cardiac interventional percutaneous procedures. A detailed 
description of VeriSight can be found in the products’ IFU. 
The current benchmark for image guidance in percutaneous cardiac intervention procedure is 
transesophageal echocardiography. The major advantage of ICE over TEE is its unique imaging 
from within the heart, providing shorter image distances to target anatomy or device, and higher 
resolution. In addition, ICE can be used under conscious sedation thus avoiding the need of 
esophageal intubation and eliminating the risk for esophageal trauma. Further, ICE can also reduce 
fluoroscopy exposure to both the patient and the operator. 
 Background  
ICE has been around for more than 20 years and its use has significantly increased with the advent 
of invasive electrophysiology (EP) and percutaneous structural heart disease (SHD) interventions. 
ICE is an advanced imaging modality that has become an integral part of a variety of percutaneous 
interventional and EP procedures, potentially improving outcomes and reducing risks1-3.  
Recent reports demonstrate that ICE utility as a primary guidance or as a supplement to 
transesophageal echocardiography (TEE) in various SHD and EP interventions such as left atrial 
appendage (LAA) closure, interatrial shunt closure, left and right heart transcatheter valve 
intervention, ventricular septal defect (VSD) and patent ductus arteriosus (PDA) closure4. There are 
several ultrasound imaging tools/techniques to guide cardiac interventions. Transthoracic 
echocardiography (TTE) was initially described to guide percutaneous interventions in 1984 by 
Kronzon et al. and offers a unique way to provide real time imaging4,5. However, TTE is limited by 
shadow artifact from anterior structures, lower quality images from increased distances between the 
probe and heart, and image distortion from bone and lung tissue. The TTE probe over the chest 
wall also does not offer continuous procedural guidance and may disrupt the workflow during 
interventional procedures. TTE use during an intervention can be also problematic due to the need 
for a separate operator (a sonographer) to acquire and manipulate the images. TEE unlike TTE 
offers superior image resolution for left heart structures, and may allow visualization of the entire 
picture, including catheter tips, wires, and devices6. Drawbacks of TEE include the requirement for 
esophageal intubation and potential complications such as gastrointestinal tract injury, aspiration, 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
11  
Status: 
Final 
User Tool Version Date 
30May2019 
 
and anesthetics side effects7. Additionally, anterior structures may be difficult to visualize on TEE 
secondary to far-field exposure and shadowing from adjacent structures. The probe may also 
obscure the interventionalists’ field of view on fluoroscopy8. 
The use of ICE avoids most of those limitations. As such, ICE has become a widely used ultrasound 
based imaging tool in the interventional laboratory. Imaging with ICE has evolved from cross-
sectional imaging using a rotating transducer, to sector-based imaging using a phased-array 
transducer9. Phased array ICE has many advantages over rotational ICE including a greater 
frequency range, greater depth of field, steerability, and the possibility of acquiring Doppler and 
color flow imaging. Phased-array catheters can be easily advanced and positioned through short 
sheaths and do not require long guide sheaths. The major advantage of ICE over TEE is its unique 
imaging from within the heart, providing shorter image distances to target anatomy or device, and 
higher resolution. In addition, ICE can be used under conscious sedation thus avoiding the need of 
esophageal intubation and eliminating the risk for esophageal trauma. Further, ICE can reduce 
fluoroscopy exposure to both the patient and the operator10.  
Evidence of Prior Clinical Data with ICE Technology 
The performance and safety of the ICE imaging modality has been well established in different 
percutaneous interventions. Below we provide several examples of the outcomes of the utility of 
ICE technology in a variety of SHD and EP procedures. 
Structural Heart diseases interventions 
During transseptal catheterization, ICE helps provide direct visualization of the interatrial septum 
and is invaluable tool to guide a safe transseptal puncture. ICE delineates the anatomy of intra- and 
extracardiac structures not identified with fluoroscopy and simplifies correct positioning of the 
transseptal dilator, puncture of the fossa ovalis, and cannulation of the left atrium in a timely and 
uncomplicated fashion11. In another study, the use of AcuNav ICE catheter during left heart 
radiofrequency ablation and transcatheter closure procedures successfully guided transseptal 
catheterization, provided imaging of normal or aberrant anatomy of the right/left atrial (interatrial 
septum, fossa ovalis, appendages, 4 pulmonary vein ostia) and right/left ventricular (valves and 
papillary muscles) structures. AcuNav was crucial in providing early identification of procedure 
complications, including pericardial effusion (n = 2, detected before systematic hemodynamic 
deterioration) and thrombus formation on sheaths deployed in the right atrium (n = 9) and left atrium 
(n = 2, early elimination with management of the sheath)12.  
Atrial Septal Defect Closure 
Several studies have reported the feasibility and safety of ICE for guiding transcatheter closure of 
Atrial Septal Defect (ASD)3. There was close agreement between ICE and TEE in their assessment 
of device position and the adequacy of septal capture before device release (98%) and in identifying 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
12  
Status: 
Final 
User Tool Version Date 
30May2019 
 
the presence of significant residual shunts. ICE detected all potentially adverse events, including 
four malpositions, and guided appropriate remedial action13,14. 
Left Atrial Appendage (LAA) Imaging and Closure Procedures 
ICE provides adequate visualization of the LAA and can be used as an alternative to TEE in guiding 
LAA occlusion (LAAO) procedures15-17. Matsuo et al. investigated a total of 27 patients with AF 
receiving Watchman left atrial appendage closure under ICE guidance at a single center. All patients 
were successfully implanted. There were no major procedural complications. The overall procedure-
related complication rate was 14.8% primarily attributed to access site hematoma16.  
Baseline clinical and procedural characteristics, and in-hospital outcomes were compared between 
patients in whom a Watchman was implanted with ICE vs. TEE guidance. Device implantation 
success rate was 100% in both groups. There were no device embolization, significant peri-device 
leak, tamponade, stroke, and access site bleeding reported in any patient. Total hospital stay for 
stand-alone LAAO was comparable between groups (2 days [2-2] vs. 2 days [2-3.3], P = 0.17, in 
ICE vs. TEE, respectively)17.  
The impact of ICE to guide LAAO has been established15-18. Reported high technical success rates 
range between 96.7% and 100.0%, irrespective of RA or LA ICE probe position. Korsholm et al. 
studied the efficacy and safety of ICE and TEE from the left atrium for procedural guidance of 
transcatheter LAAO. Technical success was achieved in 99% of both the TEE and ICE group. 
Procedural success was 94.5% in ICE-guided group. Major peri-procedural complications occurred 
in 4.7% of the TEE group and 1.8% of the ICE group. In addition, contrast use and procedural time 
were reduced with ICE19. 
Mitral Valve Procedures 
ICE guidance for percutaneous catheter-based Mitral Valve (MV) repair techniques have been 
described. Saji et al. used ICE adjunctively with TEE for guiding percutaneous MV repair with the 
MitraClip system (Abbott Vascular) in patients with failed prior surgical rings. In this study, the ICE 
catheter was introduced transarterially into the LV and anteflexed to obtain a short-axis view of the 
valve. The authors state that ICE was helpful to assess the insertion of the posterior leaflet into the 
MitraClip’s arms, particularly in this group of patients, in which TEE imaging of the MV may be 
shadowed by the surgical ring20. During the MV Valvuloplasty procedure, ICE is used to rule out 
LAA thrombus, guide the transseptal catheterization, confirm optimal balloon position, monitor 
balloon inflation, and assess the valve before and after valvuloplasty21, 22. 
Transcatheter Aortic Valve Replacement (TAVR) 
ICE-guided TAVR may represent an important alternative to TEE for TAVR imaging guidance and 
possibly allow for less-intensive sedation or anesthesia23. Other advantages of ICE include 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
13  
Status: 
Final 
User Tool Version Date 
30May2019 
 
uninterrupted monitoring, no fluoroscopic interference, and precise Doppler-based assessment of 
pulmonary artery pressures24. 
Electrophysiology procedures 
The EP procedure involves study and treatment of rhythm disorders of the heart. There are several 
therapeutic and surgical methods to treat many of the rhythm disturbances of the heart such as 
surgical implantation of pacemakers and implantable cardioverter–defibrillator.  
ICE can be used in AF ablation procedures to guide transseptal puncture. ICE imaging can also be 
used in the following  procedural steps, including (1) characterization of pulmonary vein anatomy 
(number of veins, diameter, anatomic variants), (2) transseptal catheterization, (3) catheter 
positioning and contact monitoring, (4) assessment of lesion formation, (5) prevention and early 
detection of procedural complications such as pericardial effusion or thrombus formation, (6) 
assessment of pulmonary veins physiology/flow before and after ablation, and (7) location of the 
esophagus in relationship to the pulmonary vein ostium25, 26. ICE is useful to assist ablation of the 
cavotricuspid isthmus (CTI) in patients with typical atrial flutter. In a randomized trial that included 
102 patients with typical flutter, ICE-guided ablation of the CTI significantly shortened the procedure 
time radiation exposure, and time spent for ablation in comparison with fluoroscopy-only 
procedures. About 13% of the patients from the fluoroscopy-only group crossed over to ICE 
guidance because of failure to achieve CTI block and were all treated successfully27. 
ICE has an invaluable role in the mapping and ablation of ventricular arrhythmias. It provides real-
time visualization of the ablation catheter in relation to a particular anatomic structure, allowing for 
continuous assessment of catheter–tissue contact. This is key for effective energy delivery to the 
targeted structure of interest, possibly increasing effectiveness and limiting collateral damage. 
Lesion formation is typically visualized in ventricular tissue as the development of increased 
echogenicity during ablation28. Saksena et al. studied the role of ViewFlex ICE catheter in 
comparison to TEE in imaging of left atrium and interatrial septal during atrial fibrillation. ICE and 
TEE showed concordance for LAA, IAS and SEC imaging but not for LA and LAA thrombus 
detection where ICE imaging was less sensitive compared to TEE for LAA thrombus identification.  
There were no adverse events or complications reported for ICE or TEE29.  
Transvenous Lead Extraction 
Sadek et al. reported the utility of ICE during transvenous lead extraction. ICE imaging provides 
continuous monitoring for procedural complications. It allows for identification of lead binding sites 
within the heart or the SVC, which are predictive of a more complex procedure and the need for 
advanced extraction tools. In addition, ICE can detect the presence of lead-related echo densities, 
suggestive of thrombi or vegetations. Interestingly, these echo densities were found in 72% of 
patients, mostly in the absence of bacteremia30. 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
14  
Status: 
Final 
User Tool Version Date 
30May2019 
 
 Registry Rationale  
Until recently, ICE has been limited to only two-dimensional (2D) imaging planes. Enabling real-time 
three-dimensional (3D) imaging with the Philips VeriSight combines the advantages of ICE with 
imaging capabilities that so far have only been available for TEE, and it has the potential to improve 
procedural guidance; quickly and easily locate guidewires, catheters, and devices; and provide 
greater anatomic information during percutaneous interventions. This novel real time 2D/3D ICE 
system has received US Food and Drug Administration clearance for commercial use and 
distribution.  The purpose of this observational multi-center registry is to evaluate real-world safety 
and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac 
intervention procedures when used in standard clinical practice. The intended patient population are 
patients undergoing percutaneous cardiac intervention procedures for which VeriSight is indicated. 
The evidence from this post-market registry will be used for publications and to support regulatory 
filings outside of the US market.  
 Risk/Benefit Assessment   
This will be an open-label all-comers registry. The design of the protocol is observational and there 
are no interventions as part of the registry. All interventions such as procedures occurring during 
this protocol are the standard clinical practice and their use will be directed by the investigator as 
part of the standard care. The Philips VeriSight ICE catheter has received 510(k) clearance from 
FDA allowing U.S. commercial sale. Investigators enrolling patients into the registry, will be imaged 
with the VeriSight catheter. Use of the product in this registry will be on label per the IFU and 
standard clinical practice. Patients will not be placed at additional clinical risk by participating in this 
registry. Although there are no added risks due to standard of care, the benefit at large will involve 
a better understanding of the safety profile for the ICE catheter tech within the respective 
intervention. Any complications associated with the VeriSight catheter and those related to the 
cardiac intervention procedures will be collected and reported.  
 REGISTRY DESIGN  
 General Description 
This is a prospective, multi-center, observational, single-arm registry intended to gather real-world 
data to report VeriSight ICE catheter performance and safety. It will be conducted in the United 
States under the approval of one or more recognized institutional review boards and in compliance 
with GCP guidelines defined in ISO:14155;2011, the Declaration of Helsinki, and all applicable 
federal and local laws and regulations. Only on label uses of the VeriSight ICE catheter will be 
allowed. No specific claims are being validated during this registry, though data analyzed from this 
protocol are intended to inform of future claims regarding the performance and safety of the 
VeriSight catheter.  

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
15  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac 
interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-
procedure. The registry has a planned duration of approximately 24-36 months with interim analysis 
planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not 
intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are 
intended to be pooled for analysis.  It is possible that sub-analyses may be conducted to 
demonstrate VeriSight guidance for target intervention types in structural heart and 
electrophysiology procedures. 
 Performance and Safety Analyses 
The overall purpose of this observational multi-center registry is to report real-world performance 
and safety of VeriSight ultrasound guided ICE imaging in percutaneous cardiac intervention 
procedures when used in standard clinical practice. 
Primary Analyses 
The primary analyses will include the following: 
a) Technical success – defined by successful delivery of VeriSight to the target 
intracardiac position and sustained device operation during the procedure 
Successful device delivery is defined as ability of the VeriSight catheter to reach the target 
intracardiac anatomical position. Sustained operation of VeriSight is absence of technical 
complications or procedural delays/ disruption. 
b) Imaging success – Adequate image quality as determined by the investigator using a 
Likert scale assessment.  
c) Clinical success - Adequacy of VeriSight imaging for visualization of major cardiac 
structures, and guiding procedural intervention, and ability to detect/ assess intra-
procedural complications. 
Clinical success will be measured by ability of VeriSight to adequately guide procedural 
intervention using the following parameters:  
i. 
number of great vessels imaged, number of chambers imaged, including angle of 
views, axis, and modality  
ii. 
assessment of key cardiac structures and sizing relevant anatomy  
iii. 
verification of delivery and/or placement of interventional device (e.g. trans septal 
puncture devices, closure devices (LAAO, PFO, ASD, VSD), valves (e.g for TAVR), 
clip devices (e.g. mitral clip), annuloplasty devices (e.g. Cardioband), ablation 
devices (e.g cryoballoon, RF ablation catheter), leads (leads extraction), etc.),  
iv. 
assessment of procedural related complication (e.g. cardiac tamponade, pericardial 
effusion, thrombus) will be documented for each patient based on the procedure 
type. 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
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Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
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Status: 
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d) Safety - Device related adverse events periprocedural through discharge or 48 hours 
post-procedure, whichever is earlier. 
 
Secondary Analyses  
Secondary analyses will include the following:  
a) Procedural characterization when using VeriSight measured by 
i. 
type of procedure utilizing ICE imaging  
ii. 
total procedural room time (door-in to door-out, mins), total procedure time (skin 
to skin, mins) 
iii. 
total fluoroscopy time (mins) 
iv. 
total contrast volume used (cc), fluoroscopic dosage (mGy) 
v. 
ability to image from the right side of the heart for a left sided intervention  
vi. 
TEE usage rate and avoidance of TEE procedure 
vii. 
Other imaging modality used during the procedure 
viii. 
Change in management from use of VeriSight – need for high risk patient and/or 
procedure management 
ix. 
Duration and type of anesthesia 
x. 
Freedom from general anesthesia  
b) Device characterization when using VeriSight based on a scoring scale for the physical 
attributes of the VeriSight catheter 
c) Physician survey regarding the Philips ICE using a five-point ordinal Likert-type rating 
scale  
d) Staff survey regarding the Philips ICE using a five-point ordinal Likert-type rating scale  
 Measures to Minimize Bias 
The following measures will be taken to minimize and/or avoid bias in this registry: 
a) A multi-center observational registry design is used to help ensure a representative sample 
of physicians performing the procedure and to provide a reasonable enrollment period. 
b) Sites will have the ability to represent all-comers in various percutaneous cardiac 
intervention procedures. 
c) Subjects will be screened to confirm study eligibility with defined inclusion/exclusion criteria 
prior to inclusion. Sites are required to maintain a log of all subjects screened and enrolled 
for the study. 
d) Data collection requirements and study procedures will be standardized across all sites. All 
sites will follow the same version of the protocol and eCRFs.  
e) Collection and archiving of image data will be managed adequately to reduce the impact of 
data loss and error in analysis. 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
17  
Status: 
Final 
User Tool Version Date 
30May2019 
 
f) Standardized protocol training will be developed and distributed to all participating sites to 
ensure data of uniform quality are obtained from all subjects 
g) Regular monitoring will be conducted to verify source data and adherence to the protocol. 
4. REGISTRY POPULATION 
 Inclusion Criteria 
1. 18 years of age and willing to provide written, dated and signed, informed consent  
2. Scheduled for a procedure that is within the scope of clinical indication for VeriSight per 
Instructions for Use (IFU) 
 Exclusion Criteria 
Patients who have ANY of the following exclusion criteria are NOT eligible for participation on 
the registry.  
1. Contraindicated for ICE catheter placement or patient considerations that make placement 
of VeriSight not technically feasible 
2. If alternate access (as needed instead of femoral) is not viable 
3. Known contraindicated conditions include sepsis, major coagulation abnormalities, 
presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep 
vein thrombosis, or significant peripheral vascular disease. 
 Number of Subjects 
Enrollment of up to 200 all-comers is planned with distribution across multiple case types such as 
structural heart disease interventions and electrophysiology procedures. Based on a sample of 100 
patients, minimum representation of anticipated enrollment for each procedure type based on 
investigator survey is the following: minimum of 30 cases for electrophysiology, minimum of 30 
cases for left atrial appendage occlusion, minimum of 20 cases for valve intervention, and 5 for 
ASD/PFO. Each participating registry site will be allowed a maximum enrollment of no more than 
30% patients from the total planned enrollment. 
 Enrollment 
Subjects who sign the informed consent form and are indicated for treatment procedure per 
VeriSight commercial labeling will be considered for the registry. A subject is considered enrolled in 
the registry when VeriSight has been placed in their vasculature and the device is switched “ON”. 
Participation is complete at discharge or ≤48 hours post-procedure from the registry site, whichever 
occurs first.  

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
18  
Status: 
Final 
User Tool Version Date 
30May2019 
 
 Screen Failures 
Only consented subjects who are considered enrolled in the registry will be followed. Those who 
provide consent, but then are determined to be ineligible at the time of enrollment will be considered 
screen failures. 
 Registry Exit Definition 
A subject is considered to have completed and exited the registry if he or she has completed all 
phases of the study including the last visit or the last scheduled procedure shown in the Schedule 
of Activities (SoA), Section 6.2. 
 Subject Discontinuation/Withdrawal from the Study 
Study participation is voluntary. The subject may refuse to consent or may withdraw from the study 
at any time without penalty or loss of benefits of quality of care to which he/she is otherwise entitled. 
All information regarding the subject’s withdrawal must be recorded in the subject’s medical record. 
In addition, the appropriate case report forms must be completed for the Subject and clear 
documentation of the subject’s withdrawal must be provided to the Sponsor. 
 Lost to Follow-Up 
Follow-up in this registry is limited to discharge or ≤48 hours post-procedure, whichever is earlier. 
All follow-up data is expected to be collected and lost to follow-up is not anticipated in this registry.  
 Registry Duration 
The expected duration of the registry is estimated to be approximately 24 – 36 months. 
5. DEVICE ACCOUNTABILITY 
The Philips VeriSight catheter is a commercially approved device that will be used within their 
approved indication. The intended indication is for intracardiac and intra-luminal visualization of 
cardiac and great vessel anatomy and physiology as well as visualization of other devices in the 
heart. A complete description of the VeriSight catheter can be found in the product’s IFU. 
The Philips VeriSight catheter will be purchased by each site and will not require product packing 
and shipment information to be tracked. The EPIC console will be loaned to site with the latest 
software for use with the VeriSight ICE catheter. 
 
 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
19  
Status: 
Final 
User Tool Version Date 
30May2019 
 
6. REGISTRY PROCEDURES & EVALUATIONS 
Subjects enrolled in this registry will have at least one visit and may have up to three visits, 
depending on the scheduling of their procedure at each clinical site. Individual visits and their 
specific procedures will consist of the events described below. 
 Schema 
Patients scheduled to undergo percutaneous cardiac intervention procedures in which VeriSight will 
be used for imaging and are willing to participate in the registry may be enrolled. Subjects will be 
enrolled at up to 10 clinical sites in the United States. Patients who are indicated for the use of 
VeriSight per the commercial IFU will be screened for registry participation at the screening/baseline 
visit, and enrolled subjects will be evaluated on the day of the procedure and again within discharge 
or ≤48 hours post-procedure (whichever is first), as per site’s standard of care. Figure 1 provides an 
overview of the registry procedures at each visit. 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Study flow diagram  
 Schedule of Activities (SOA) 
Table 1 provides an overview of registry procedures per visit. 
 
 
Enrollment 
 
Demographics 
 
Medical History 
 
Physical 
Index Procedure 
Post Procedure 
 
Catheter delivery 
 
De-identified image visualization 
and grading by investigator 
 
Ability to complete procedure 
 
Procedural workflow and details 
 
Device malfunction/ deficiency 
 
Device related adverse events 
Device related adverse 
events at discharge or 
≤48hrs post-procedure 
Usability assessment 
 
Catheter attributes evaluation 
 
Physician and staff 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
20  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Table 1. Overview of registry procedure 
 
Procedures 
 
Screening* 
 
Index procedure 
Post-Procedure 
(at discharge or 48hrs) 
Assessment of eligibility 
X 
 
 
Informed consent 
X 
 
 
Record demographics 
X 
 
 
Medical History and Physical (H&P) 
X 
 
 
Record any baseline diagnostic 
imaging  
 
X 
 
ICE imaging with VeriSight 
 
X 
 
Image grading 
 
X 
 
Procedural workflow and details 
 
X 
 
Adverse device effects related to 
VeriSight  
 
X 
X 
Registry exit 
 
 
X 
Usability assessment 
Aggregate input 
 
Physical attributes of catheter 
After 1st patient 
enrolled 
After 10th patient 
enrolled 
After last patient enrolled 
Physician and staff survey 
After 1st patient 
enrolled 
After 10th patient 
enrolled 
After last patient enrolled 
*up to 30 days prior to index 
Below are the brief study procedure steps. 
• 
Subjects are evaluated for eligibility based on the inclusion and exclusion criteria 
• 
Record demographics of subjects: age, gender, height, weight, ethnicity/race (if applicable) 
• 
Record relevant medical and surgical histories 
• 
The subjects will be imaged using the VeriSight device according to the routine workflows 
• 
Relevant imaging for each procedural steps will be recorded.  
• 
The Investigator will grade the imaging recorded 
• 
The corresponding clinical information and information about the use of device and system, 
including device deficiencies and safety-related adverse device effects related to VeriSight, 
will be recorded by the Investigator in the CRF 
• 
The registry examinations including all collected de-identified images will be transferred to 
Philips 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
21  
Status: 
Final 
User Tool Version Date 
30May2019 
 
• 
After the completion of the procedure, subject are dismissed from the registry after 
monitoring for post-procedure adverse device effects either at discharge or ≤48 hrs post-
procedure, whichever is sooner. 
 Screening (up to 30 days prior to index procedure) 
This visit consists of screening and enrollment activities and may also include any pre-procedural 
planning in accordance with standard practice and local institution protocol. Subjects will be 
recruited from a pool of regular patient population that are eligible for percutaneous cardiac 
intervention procedure. This visit will consist of the following procedures.  
Assessment of Eligibility 
The Investigator will assess the subject’s eligibility for this study per the inclusion and exclusion 
criteria listed in Section 4.0 and will document the outcome of the eligibility assessment. If the subject 
qualifies, he or she will then undergo the registry-related imaging examinations described below. 
The investigator shall screen the patient and deem them suitable for conducting the procedure under 
conscious sedation. 
Informed Consent 
Study participation is voluntary. The potential subject if deemed eligible for the study based on the 
known information in the medical records, will be informed about the study and asked to participate. 
He/she will be given the most current IRB-approved Informed Consent Form (ICF) to read.  Ample 
time will be provided for review and an opportunity to ask questions about the study.  If the subject 
agrees to participate, they will sign the ICF and be given a copy of the signed document for their 
records.  All components of the consent process will be documented in source documents.  A 
detailed description of the consent process is provided in Section 9.2.  
Medical History and Demographics 
Standard subject demographics (e.g. age, gender, race, ethnicity, height, weight), relevant medical 
and surgical histories will be recorded. The assessments will be performed following the institutions’ 
standard protocols and the results recorded on the appropriate subject case report forms. Any 
pertinent diagnostic imaging as it relates to the index procedure (e.g. CT, MRI, TTE) if performed per 
standard institutional protocol will be documented. 
New information about the study 
As the subject will exit registry at discharge, or ≤48 hrs post-procedure, whichever is earlier, it is 
unlikely that any new information will influence a subject’s decision to participate. However, as 
ultrasound technology is constantly evolving it may be necessary from time to time to update the ICF 
so the subject may be informed of any new information. This will be done in conjunction with IRB 
approval, as appropriate. 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
22  
Status: 
Final 
User Tool Version Date 
30May2019 
 
 Index Procedure 
Subjects enrolled in the registry will undergo imaging using the VeriSight catheter at the time of the 
index procedure. This visit will consist of the following procedures. 
The indication for ICE imaging and the types of procedures that utilized VeriSight will be 
documented. Patient management and treatment decisions are at the discretion of the care team 
per routine standard clinical practice. The model of VeriSight and the venous access approach are 
to be per the investigator’s discretion. Confirmation of the delivery of the VeriSight catheter to reach 
the target intracardiac anatomical position including the number of attempts depending on the 
procedure type will be recorded. The sustained operation of the catheter will be monitored 
throughout the case and recorded as part of the device technical complications including device 
malfunction/ deficiency and any additional procedural delays/ disruption when using VeriSight for 
various procedures. 
Clinical data on the imaging views obtained during the procedure will be obtained.  The angle of the 
views (0, 45, 90, 135 sweep) including axis, and the use of xPlane, iRotate, 2D or 3D, TrueVue, 
MultiVue modalities are left to the investigator’s discretion. The anatomical landmarks for image 
quality assessment depend on the procedure type. Image acquisitions of cardiac structures with 
VeriSight shall be recorded depending on the procedure type.  
The sequence of imaging for each procedure type are according to physician workflow preference. 
The method and access to the left atrium including transseptal puncture depending on the procedure 
type are to be per the investigator’s discretion. For each procedure labeled screenshots and 
respective measurements will be documented for key procedural steps. The number of great 
vessels and chambers imaged will be documented. Sizing relevant anatomy for intervention or 
device placement and visualization, guidance and verification for delivery and/or placement of 
interventional device will also be noted in the case report form. Imaging with VeriSight for 
visualization and evaluation of intra-procedural complications and hemodynamic monitoring will be 
captured. Images obtained from different procedure types will be reviewed by the participating 
investigators at regular intervals as part of ongoing development of standard of care workflow with 
VeriSight ICE imaging.  
The image quality will be scored by the investigator using a four point ordinal Likert-type rating 
scale with the following response options: excellent, good, acceptable, unacceptable, and 
unusable. The image quality evaluation is an overall assessment of the quality of images of each 
anatomical position/ utilization for the procedure types.  
During the procedure, the total length of the procedure (wheels in/out time, and skin to skin time), 
fluoroscopy time, total contrast volume, and fluoroscopic dosage will be documented. The ability 
to image from the right side of the heart for a left sided intervention for certain procedure types will 
be noted in the case report form. Change in management (if any) including both patient and 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
23  
Status: 
Final 
User Tool Version Date 
30May2019 
 
procedural aspects as a result of information provided by imaging with VeriSight will be 
documented. 
Any additional standard of care procedural imaging used in addition to VeriSight, or as conversion, 
including TTE, TEE, fluro, etc. or avoidance of TEE procedure will be collected and pertinent 
images maintained in the sponsor’s image library. Labeled screenshots of side by side VeriSight 
and TEE images when utilized in the same procedure may be documented for educational 
purposes. The duration and type of anesthesia will be documented. Freedom from general 
anesthesia will be captured. Indications for conversion to general anesthesia if using conscious 
sedation related to patient discomfort, hemodynamic instability, inability to maintain a protected 
airway, or inadequate cardiac imaging with VeriSight are at the discretion of the investigators.  
Note: The total amount of contrast administered to a subject shall be limited per the labelling 
recommendations of the contrast agent and at the discretion of the investigator. 
Safety Evaluation 
Device related peri-procedural complication and outcomes attributed to VeriSight will be recorded. 
Adverse device effects related to the VeriSight catheter during the procedure will be documented 
appropriately in the case report form. The subcategories are defined per ISO14155:2011, as 
described in Section 7.0. 
 Post-procedure 
Patients will be followed up until discharge or until ≤48 hours post procedure whichever is earlier. 
Adverse device effects related with the use of the VeriSight device will be captured in the case 
report form during this visit as defined in Section 7.0. 
 Usability Assessments during Index Procedure 
Physical attributes of Catheter evaluation method 
The evaluation of the physical attributes of the catheter such as catheter handling characteristics, 
EPIQ system navigation, and imaging modality will be assessed at specific enrollment stages at 
each participating site: after first patient enrolled, 10th patient enrolled, and last patient enrolled. 
Evaluation of response will be captured via a scoring scale (poor, average, good, excellent) based 
on experience acquired with VeriSight in this registry.  
The participating investigator will evaluate the same physical characteristics of the catheter, 
ultrasound system navigation, and imaging modality based on their own clinical experiences of 
imaging that would have been generally used during the procedure. This rating score is defined as 
inferior, better, superior and will be gathered at first enrollment, 10th enrollment, and last enrollment 
at each participating site.  
 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
24  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Physician and staff survey 
Physician and staff evaluations regarding Philips ICE will be collected at first enrollment, 10th 
enrollment, and last enrollment at each participating site. The survey will consist of a series of claim 
statements (“stimuli”), each of which will be presented alongside a five-point ordinal Likert-type 
rating scale that will be evaluated by the participating investigator using the knowledge and 
experience acquired during the registry, and additionally individual clinical experience working with 
other ICE products or imaging modalities (e.g., TEE).  
7. SAFETY EVENTS: DEFINITIONS AND REPORTING 
 Definition  
Adverse Event (AE) - any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects during registry participation, which 
does not necessarily have a causal relationship with the VeriSight device or procedures.  
 
Serious Adverse Events (SAE) - defined as an AE that: 
• 
Led to Death 
• 
Are Life-threatening 
• 
Led to Hospitalization (in-patient or prolonged) 
• 
Resulted in Disability or Permanent Damage 
• 
Led to Fetal Distress, Fetal Death or Congenital Anomaly/Birth Defect 
• 
Required Intervention to Prevent Permanent Impairment or Damage 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the 
clinical investigational plan, without serious deterioration in health, is not considered an SAE.  
Adverse Device Event (ADE) - an AE related to the use of a medical device. This definition includes 
AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, 
installation, or operation, or any malfunction of the VeriSight catheter. This definition also includes 
any event resulting from use error or from intentional misuse of the medical device. 
Serious Adverse Device Effect (SADE) - adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event 
Unanticipated Serious Adverse Device Effect (USADE) - serious adverse device effect which by its 
nature, incidence, severity or outcome has not been identified in the current version of the risk 
analysis report 
Note: anticipated serious adverse device effects (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report  

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
25  
Status: 
Final 
User Tool Version Date 
30May2019 
 
Device Deficiency - inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance such as malfunctions, misuse or use errors and inadequate labeling 
 Device Malfunction or Use Errors 
Device malfunctions or use errors will be recorded and evaluated for possible untoward effects on 
the subject. For the purposes of this study, a device malfunction is defined as a failure of the device 
to perform its intended function when used in accordance with the Instructions for Use (IFU). If a 
VerSight device malfunction results in an adverse experience for the subject, this adverse 
experience should be considered an adverse device effect and recorded on the appropriate CRF. 
A device malfunction by itself should not be reported as ADE unless it leads to the new medical 
condition or worsening of pre-existing condition. If a VeriSight device malfunction occurs in this 
registry, the site should follow standard commercial procedures. 
 Reporting Requirements 
Philips VeriSight catheter used in this registry for imaging during percutaneous cardiac 
interventional procedures is cleared for commercial use by the FDA. Therefore, the use described 
in this protocol constitutes a standard clinical practice use. Information related to contraindications, 
adverse effects, warnings and precautions are included in the device instructions for use.  
Reporting for this registry will be limited to peri-procedural (at discharge or ≤ 48H) ADEs, SADEs 
and USADEs (per the above definition) occurring while performing the index procedure with the 
guidance of Philips VeriSight. VeriSight may be used in the detection/monitoring of adverse events 
related to the procedure (i.e., post cardiac procedure thrombus recognition) during the procedure. 
Adverse device effects related to the device should also be reported to the Study Medical Monitor 
(see below). All adverse device effects must be reported to Philips IGTD as soon as possible after 
first awareness of the event; every attempt must be made to report such events to Philips IGTD 
within 24 hours of first awareness of the event.   
Study Medical Monitor contact information for adverse device effects reporting: 
Peter Angelopoulos, M.D 
Medical Monitor  
Philips Image Guided Therapy Devices 
Mobile: +1 (516) 967-6261 
Email: peter.angelopoulos@philips.com   
The Investigator is responsible for reporting the adverse device event to the approving IRB as 
dictated by the guidelines defined by the IRB and, if applicable, regulatory authorities. The 
investigator is required to submit to the sponsor and to the reviewing IRB, a report of any 
unanticipated adverse device effects occurring during an investigation as soon as possible, but in 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
26  
Status: 
Final 
User Tool Version Date 
30May2019 
 
no event later than 10 working days after the investigator first learns of the effect. Additionally, the 
Investigator will report to regulatory authorities as required by national regulations. 
Contact information for complaint reporting is: IGTD.CustomerInquiry@philips.com. The sites 
should follow standard commercial procedures for reporting device complaints. Device deficiencies 
are NOT to be reported as ADEs. However, if there is an ADE that results from a device deficiency, 
that specific event would be recorded on the appropriate case report form. 
 Severity of Event 
The following guidelines will be used to assess event severity: 
• 
Mild – Events require minimal or no treatment and do not interfere with the subjects daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a subject’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.) 
 Relationship to Study Device 
Relationship to registry device administration will be determined as follows: 
• 
Possible Relationship: An AE that follows a reasonable temporal sequence with use of the 
VeriSight device and follows a known response pattern to the study treatment but could have 
been produced by the subject’s clinical state or by other therapies. 
• 
Probable Relationship: An AE that follows a reasonable temporal sequence with use of the 
VeriSight device; follows a known response pattern to the study treatment; and cannot be 
reasonably explained by the known characteristics of the subject’s clinical state or by other 
therapies. 
• 
Definite Relationship: An AE that follows a plausible temporal sequence with use of the 
VeriSight device and follows a known response pattern to the study treatment. The reaction 
cannot be reasonably explained by the known characteristics of the subject’s clinical state 
or other modes of therapy administered to the subject. 
• 
Unknown/Impossible to Determine: Given the information available, sequence and timing of 
events, it is unknown or impossible to determine the relationship of the AE with the VeriSight 
device. 
 Expectedness  
The Principal Investigator will be responsible for determining whether an adverse device event is 
expected or unexpected.  An ADE will be considered unexpected if the nature, severity, or frequency 
of the event is not consistent with the risk information previously described for the device in this 
registry. Please refer to the instructions for use for a listing of adverse effects. 

 
 
Clinical Registry Protocol  
IGT_IGD_ICE Registry Study_2019_10745 
 
Document 
ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
27  
Status: 
Final 
User Tool Version Date 
30May2019 
 
 Time Period and Frequency for Event Assessment and Follow-Up 
Only ADEs will be collected starting from the time the subject is enrolled until the time of discharge 
which is less than or equal to 48 hours post procedure. Events will be followed until resolution if 
possible.  
Events will be reported via the electronic case report form and submitted to the Sponsor.  
Information to be collected includes event description, time of onset, clinician’s assessment of 
severity, relationship to study device (assessed only by those with the training and authority to make 
a diagnosis), and time of resolution/stabilization of the event.  
 
Any medical condition that is present at the time that the subject is screened will be considered as 
baseline and not reported as an AE. However, if the study subject’s condition deteriorates at any 
time during the study due to the use of the study device, it will be recorded as an ADE.  
8. DATA ANALYSIS AND STATISTICAL CONSIDERATION 
 Sample Size Determination  
The sample size of up to 200 subjects was selected based on a goal for the registry to be able to 
obtain performance and safety associated with use of the VeriSight catheter. This study is 
observational.  Outcomes remain in the exploratory phase, and therefore hypotheses will not be 
created.  Instead, the study will serve to monitor, measure, and evaluate outcomes as a basis for 
future research.  This sample size will provide the opportunity to make proper statistical inference 
for hypothesis generation. Due to the various procedure types available for use with VeriSight, up 
to 200 subjects could be enrolled in order to analyze the secondary endpoints by case type.  
 Populations for Analyses  
All subjects age 18 and older that are scheduled for and will undergo a planned cardiac 
interventional percutaneous procedure in which the guidance of ICE is indicated, eligible and willing 
to sign an informed consent without meeting any of the exclusion criteria set and meeting all the 
inclusion criteria set forth in the protocol will be included in the population for analyses. Those who 
sign consent but do not undergo a cardiac procedure utilizing the Philips ICE catheter will be 
excluded from the analyses (screen failures). 
 Statistical Analyses  
No formal statistical hypothesis test is planned and the primary and secondary endpoints will be 
presented as descriptive statistics only. An interim analysis will be conducted following 100th patient 
enrollment to monitor, measure, and review performance and safety measures prior to 
determination of further enrollment in the registry. 

 
 
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Statistical analyses will be done on the real-world, all-comer population and presented as descriptive 
statistics and 95% confidence intervals. Subject data from all clinical sites are intended to be pooled 
for analysis to broaden demographic representation. However, it is possible that sub-analyses may 
be conducted in a population stratified by procedure characteristics and baseline characteristics. 
9. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 Regulatory, Ethical, and Study Oversight Considerations 
This registry will be conducted in accordance with the relevant parts of the Code of Federal 
Regulations (21 CFR 11, 50, 56), ISO 14155:2011, the ICH-E6 Guidelines for GCP, the Declaration 
of Helsinki (2013). Additional state and local regulations will be followed when applicable.   
 
Investigators and sites are required to have the protocol, informed consent forms, and any other 
materials related to this study plan approved by the IRB. Any additional requirements imposed by 
the IRB shall be followed. Any amendments to the protocol must be reviewed and approved by the 
study Sponsor, and subsequently, by the designated IRB, according to the approval committee’s 
requirements. Prior to enrollment, the Sponsor or designee will review the written approvals for 
completeness, including the required elements of the consent form, and the Sponsor will provide 
protocol and study administration training. The continued eligibility for participation by an 
investigator and the institution requires maintenance of all approvals (e.g. annual reviews, 
amendment reviews).   
 
Each subject will provide written, informed consent as outlined in Section 9.2 prior to any study 
activities taking place. 
  Informed Consent Process, Procedures, and Documentation 
In obtaining and documenting informed consent, the investigator must comply with applicable 
regulatory requirements (e.g., 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56) and should adhere 
to ICH GCP. Prior to the beginning of the registry, the investigator should have the IRB’s written 
approval for the protocol and the written informed consent form(s), ICF and any other written 
information to be provided to the subjects. The consent form describes in detail the study, 
procedures, and risks. If new information becomes available during the course of the study that is 
relevant to the safety or well-being of the subjects, the consent form may be updated and presented 
to the subjects for review and consideration of continued participation. Consent forms will be 
provided to subjects in their native language and will be translated from the IRB approved version.  
Study participation is voluntary. Potential subjects, and/or their legal representatives if subject is 
unable to consent on their own behalf, are given the most current IRB-approved consent form to 
read.  They shall be provided ample time for review and an opportunity to ask questions about the 
study.  If they agree to participate, they shall sign the consent form and be given a copy of the signed 
document for their records, along with any additional subject information.  Each of these 

 
 
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actions/steps shall be documented.  Only after Informed Consent has been obtained, may the 
remaining study procedures begin. 
Patients scheduled for percutaneous cardiac intervention procedure and not contraindicated for ICE 
use will be asked to provide consent to use their data. Patients who agree to study participation 
must sign an IRB-approved ICF. Subjects will be informed that their participation in this study is 
voluntary and they may refuse to participate or discontinue from the study at any time. Subjects may 
withdraw from the study at their own request or at the request of their legally acceptable 
representative. The sponsor must be informed in each withdrawal case. The reason for withdrawal 
must be recorded in the eCRF and in the patient medical record. 
 Registry Discontinuation and Closure 
When a registry is prematurely terminated, refer to Section 4.7, for handling of enrolled study 
subjects. 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the Sponsor to the study Principal Investigators.  If the study is prematurely terminated 
or suspended, the Principal Investigator (PI) will promptly inform study subjects, the Institutional 
Review Board (IRB), and will provide the reason(s) for the termination or suspension.   
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the Sponsor, IRB and/or Food and Drug Administration (FDA).) 
 Confidentiality and Privacy  
This registry protocol, its associated methodologies, study devices, study-generated data, and the 
data management system contain confidential and proprietary information. Subject confidentiality 
will be maintained according to the Health Insurance Portability and Accountability Act of 1996 
(HIPAA). Release of such information outside the scope of planned study operation is prohibited.  
All federal and local laws regarding protection of patient confidentiality will be followed, as well as 
any additional site-specific requirements that may be required. Personal Health Information (PHI) 
will be acquired during the consenting process of the subject and from the medical records. All data 

 
 
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will be de-identified at each site before being entered into EDC. Individual subjects and their 
research data will be identified by a unique study identification number. The protocol, 
documentation, data, and all other information generated will be held in strict confidence to the 
extent allowed by law, including PHI. At the end of the study, all study databases will be de-identified 
and archived by the Sponsor. 
 
The study monitor, Sponsor and other authorized representatives of the sponsor, representatives 
of the Institutional Review Board (IRB), or regulatory agencies may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical records 
(office, clinic, or hospital) for the subjects in this study. The clinical study site will permit access to 
such records. 
 
The study subject’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for 
as long a period as dictated by the reviewing IRB, Institutional policies, or Sponsor requirements. 
 
 Safety Oversight 
Due to the nature of this observational real world registry, a safety oversight/data safety 
monitoring committee is not planned for this post-market registry. 
 Clinical Monitoring 
This study will be monitored using a risk-based monitoring approach, consistent with the FDA 
guidance Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (2013) and 
Philips clinical study monitoring procedures.  Registry monitoring is the responsibility of the Sponsor. 
The Sponsor or designee will monitor the study throughout its duration. Monitoring will ensure that 
documents used to originally record subject data (source documents) are maintained, and to verify 
that transcribed data are accurately reflected on the study electronic Case Report Forms (eCRFs).  
Monitoring visits will be scheduled based on the enrollment rate at each site, duration of the registry, 
compliance, and any known or suspected inconsistency in data that requires investigation. 
Monitoring visits may be conducted onsite and/or remotely (e.g., virtual visit), as necessary. 
The sponsor may terminate investigator and site participation in the registry if there is evidence of 
an investigator’s failure to maintain adequate clinical standards or evidence of an Investigator or 
staff’s failure to comply with the protocol. Notification of suspension or termination will occur no later 
than 5 working days after the Sponsor makes the determination. In the event of registry suspension 
or termination, the Sponsor will send a report outlining the circumstances to the reviewing IRB and 
the appropriate regulatory agencies, and to all participating investigators. 

 
 
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The registry may also be suspended or discontinued early if there is an observation of serious 
adverse events presenting an unreasonable risk to the registry subjects or inadequate subject 
enrollment. 
The sponsor may delegate some of the above monitoring activities to appropriately qualified contract 
personnel.  
 Quality Assurance and Quality Control  
Each site, both clinical and laboratory, should have SOPs for quality management that describe:   
• 
How data will be evaluated for compliance with the protocol, ethical standards, regulatory 
compliance, and accuracy in relation to source documents.  
• 
The documents to be reviewed (e.g., CRFs, clinic notes, product accountability records, 
specimen tracking logs, questionnaires, audio or video recordings), who is responsible, and 
the frequency for reviews.   
• 
Who will be responsible for addressing QA issues (e.g., correcting procedures that are not 
in compliance with protocol) and QC issues (e.g., correcting errors in data entry).  
• 
Staff training methods and how such training will be tracked. 
• 
If applicable, calibration exercises conducted prior to and during the study to train examiners 
and maintain acceptable intra- and inter-examiner agreement. 
Regular monitoring and an independent audit, if conducted, must be performed according to ICH 
GCP.  See also Section 9.6. 
 
Each clinical site will perform internal quality management of study conduct, data collection, 
documentation and completion.  An individualized quality management plan will be developed to 
describe a site’s quality management. 
 
Quality control (QC) procedures will be implemented beginning with the data entry system and data 
QC checks that will be run on the database will be generated. Any missing data or data anomalies 
will be communicated to the site(s) for clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical 
trial is conducted and data are generated and biological specimens are collected, documented 
(recorded), and reported in compliance with the protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP), and applicable regulatory requirements (e.g., 
Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)).  
 
The investigational site will provide direct access to all trial related source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and 
regulatory authorities. 

 
 
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 Data Collection and Management Responsibilities  
This registry will use an electronic data capture system, DataTrak EDC that is a 21 CFR Part 11-
compliant data capture system provided by the Sponsor. The data system includes password 
protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source 
documents. Limited access will be granted to only those working directly on the study and with study 
subjects. It is expected that electronic case report forms be completed no later than 5 working days 
from the time of data collection and submitted to the Sponsor for review.  This includes the eCRF 
along with imaging obtained as part of the study. Data queries should be resolved within a timely 
manner but no later than 30 days of being issued.  
 
Access to the EDC system will be protected by login identification and password.  The Sponsor will 
train delegated Site personnel on procedures for data entry into the web-based system. Following 
training, delegated staff will be provided ID codes and passwords unique to each team member’s 
delegated study role.  They will be trained on Philips guidelines for maintenance of electronic ID 
codes and passwords.  A staff member’s ID code/password will never be shared or used by another 
staff member, in any circumstance.  If prior training has already been delivered for other Philips-
sponsored studies of similar design, this training may be reinforced via teleconference prior to study 
commencement as appropriate. 
 
Source data are all information, original records of clinical findings, observations, or other activities 
in a clinical trial necessary for the reconstruction and evaluation of the registry.  Electronic source 
data are data initially recorded in electronic form. Hardcopies of the study visit worksheets will be 
provided for use as source document worksheets for recording data for each subject enrolled in the 
registry.  Data recorded in the electronic case report form (eCRF) derived from source documents 
should be consistent with the data recorded on the source documents. It is acceptable to use 
worksheets that mirror the eCRFs as source documents. Physician surveys and imaging collection 
worksheets will be provided to the site to capture data that may not otherwise be found in typical 
source documents.   
 
It is not acceptable for the CRF to be the only record of a subject’s inclusion in the study.  Registry 
participation should be captured in a subject’s medical record.  This is to ensure that anyone who 
would access the subject’s medical record has adequate knowledge that the subject is participating 
in the registry. 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents should be completed in a neat, legible 
manner to ensure accurate interpretation of data.   

 
 
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Version: 
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 Data Handling and Record Keeping  
This study will be performed using an electronic data capture (EDC) system with password 
protection. The investigator and study site staff will receive training and support on the use of the 
EDC system and will be granted specific user privileges. All eCRF data are to be completed by the 
investigator, study coordinator, or other designated site personnel. The investigator will perform a 
final review and sign-off at designated times (e.g. registry exit). 
 
Images acquired by the EPIQ console will be downloaded and anonymized to a removable drive or 
can be downloaded from PACS after anonymization, prior to transfer of images to DataTrak 
following appropriate privacy protections. All images will be saved in Digital Imaging and 
Communication in Medicine (DICOM) format and transferred to a DICOM server. For any 
representative images, loops and/or 3D volumes that are collected as part of the scan, subject 
names and identifiers will be removed. The site may provide to the Sponsor any additional de-
identified baseline, procedural images that are performed as part of the index procedure (TEE, TTE, 
CT, MRI, fluro etc.). De-identified images, loops, and/or 3D volumes may be used for 
internal/external training, marketing brochures, and promotions.  
 
Completeness of data entry will be monitored against the medical record by a monitor during the 
onsite and/or remote data reviews against the information in the subject’s medical records.  The 
clinical database will be a closed system, allowing for tracking all the data elements and any 
changes made.  
Sponsor will provide the investigational site with supplies for setting up the study files.  Essential 
documents are listed below: 
• 
Signed Protocol and amendments; 
• 
Signed Investigator Agreement; 
• 
IRB Committee approval letters, consent forms and correspondence; 
• 
Investigator and Sponsor Reports; 
• 
Relevant correspondence between the Investigator and Sponsor; 
• 
Signed Informed Consent Forms (site files only); 
• 
Notification to Sponsor and IRB of Serious Adverse Events; 
• 
Administrative Tracking Logs (Monitoring Visits, Training Logs, etc.). 
 Study Records Retention  
Study documents should be retained for a minimum of 2 years after the conclusion of the study (all 
patients at all sites have concluded participation and the Sponsor has indicated the registry is 
completed/closed out) or longer if institution requirements dictate. . No records will be destroyed 
without the written consent of the sponsor. It is the responsibility of the sponsor to inform the 
investigator when these documents no longer need to be retained. 

 
 
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 Protocol Deviations  
A protocol deviation is defined as an event where the clinical Investigator or site personnel deviate 
from the registry protocol or study procedures.  It is the Investigator’s responsibility to ensure that 
there are no deviations from the protocol without prior notification and approval of the Sponsor or 
Sponsor’s designee and in full compliance with all established procedures and conditions of the 
reviewing IRB.   
 
The Investigator may deviate from the protocol without prior written approval from the Sponsor or 
Sponsor’s designee in cases of medical emergencies, when the deviation is necessary to eliminate 
an apparent immediate hazard to the subject.  In that event, the Investigator will notify the Sponsor 
or Sponsor’s designee immediately by phone or electronic communication, notify the reviewing IRB, 
and confirm notification to the Sponsor or designee in writing.  Prior deviation approval is generally 
not expected in situations where unforeseen circumstances are beyond the Investigator’s control, for 
example, the subject was not available for a scheduled follow-up office visit.  These events, although 
outside the Investigator’s control, are still required to be reported on the appropriate protocol 
deviation form in order to ensure that all deviations from the standard subject population are 
adequately documented and reported.  The Investigator will inform the Sponsor or Sponsor’s 
designee of all deviations, and the reviewing IRB of all protocol deviations as per the IRB 
requirements for this study.  The Investigator shall document all protocol deviations on the electronic 
case report form and submit to the Sponsor for review.  
 
The occurrence of protocol deviations will be monitored by the Sponsor or Sponsor’s designee for 
evaluation of Investigator compliance to the Protocol, Good Clinical Practices, and regulatory 
requirements.   
 Publication and Data Sharing Policy 
The results of this registry may be submitted for publication to clinical or medical journals or to 
congresses or conferences for podium presentations.  The rights for publication of results from this 
registry remain with Philips.  The Investigator must request permission from Philips prior to initiating 
any publication and received in writing.  Review and approval of any data, abstract or manuscript is 
required.  Philips reserves the right to delay publication to review the presentation of study 
methodology, data collection, data analysis, interpretation of data, proprietary information or 
patented technology.  A request for delay and the reason(s) shall be communicated by Philips to 
the Investigator in writing.   
The study will be registered on ClinicalTrials.gov and the NCT number will be noted in the Sponsor 
study files. The registry results will be used for publications and therefore will be posted on the 
website. 

 
 
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 Conflict of Interest Policy 
The independence of this registry from any actual or perceived influence, such as by the medical 
device industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in 
the design, conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. 
Furthermore, persons who have a perceived conflict of interest will be required to have such conflicts 
managed in a way that is appropriate to their participation in the design and conduct of this trial.  
The   Institute or Center (IC) may have established policies and procedures for all study group 
members to disclose all conflicts of interest and may have established a mechanism for the 
management of all reported dualities of interest. Each investigator participating in the research will 
be asked to complete a financial disclosure form, submit a copy to the Sponsor, and notify the 
Sponsor when there is a change in such disclosures during the course of the study and one year 
following investigator discontinuation of participation. Investigators should continue to follow their 
institutional policies regarding the reporting of conflicts of interest in addition to any Sponsor 
requirements. 
10. REFERENCES  
 
1. Marrouche NF, Martin DO, Wazni O, et al. Phased-array intracardiac echocardiography monitoring 
during pulmonary vein isolation in patients with atrial fibrillation: impact on outcome and complications. 
Circulation. 2003;107(21):2710-2716. 
2. Boccalandro F, Baptista E, Muench A, et al. Comparison of intracardiac echocardiography versus 
transesophageal echocardiography guidance for percutaneous transcatheter closure of atrial septal 
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3. Bartel T, Konorza T, Arjumand J, et al. Intracardiac echocardiography is superior to conventional 
monitoring for guiding device closure of interatrial communications. Circulation. 2003;107(6):795-797. 
4. Basman C, Parmar YJ, Kronzon I. Intracardiac Echocardiography for Structural Heart and 
Electrophysiological Interventions. Curr Cardiol Rep. 2017;19(10):102. 
5. Kronzon I, Glassman E, Cohen M, et al. Use of Two-Dimensional Echocardiography During Transseptal 
Cardiac Catheterization. J Am Coll Cardiol. 1984;4(2):425-428. 
6. Faletra FF, Pedrazzini G, Pasotti E, et al. 3D TEE during catheter-based interventions. JACC 
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7. Mathur SK, Singh P. Transoesophageal echocardiography related complications. Indian J Anaesth. 
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8. Kliger C, Cruz-Gonzalez I, et al. The present and future of intracardiac echocardiography for guiding 
structural heart disease interventions. Rev Esp Cardiol (Engl Ed). 2012;65(9):791-794. 
9. B.P. Knight. Use of intracardiac echocardiography during ablation for atrial fibrillation. F Sylvestry, SE 
Wiegers (Eds), Intracardiac Echocardiogr Martin-Dunitz, London, UK. 2005:105-120. 

 
 
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Philips ICE Registry   
Version: 
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User Tool ID:  
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Status: 
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User Tool Version Date 
30May2019 
 
10. Enriquez A, Saenz LC, Rosso R, et al. Use of Intracardiac Echocardiography in Interventional 
Cardiology: Working With the Anatomy Rather Than Fighting It. Circulation. 2018;137(21):2278-2294. 
11. Daoud EG, Kalbfleisch SJ Hummel JD. Intracardiac echocardiography to guide transseptal left heart 
catheterization for radiofrequency catheter ablation. J Cardiovasc Electrophysiol. 1999;10(3):358-363. 
12. Ren JF, Marchlinski FE, Callans DJ, et al. Clinical use of AcuNav diagnostic ultrasound catheter 
imaging during left heart radiofrequency ablation and transcatheter closure procedures. J Am Soc 
Echocardiogr. 2002;15(10):1301-1308. 
13. Mullen MJ, Dias BF, Walker F, et al. Intracardiac echocardiography guided device closure of atrial 
septal defects. J Am Coll Cardiol. 2003;41(2):285-292. 
14. Hijazi Z, Wang Z, Cao Q, et al. Transcatheter closure of atrial septal defects and patent foramen ovale 
under intracardiac echocardiographic guidance: feasibility and comparison with transesophageal 
echocardiography. Catheter Cardiovasc Interv. 2001;52(2):194-199. 
15. Ho IC, Neuzil P, Mraz T, et al. Use of intracardiac echocardiography to guide implantation of a left atrial 
appendage occlusion device (PLAATO). Hear Rhythm. 2007;4(5):567-571. 
16. Matsuo Y, Neuzil P, Petru J, et al. Left Atrial Appendage Closure Under Intracardiac Echocardiographic 
Guidance: Feasibility and Comparison With Transesophageal Echocardiography. J Am Hear Assoc. 
2016;5(10). 
17. Frangieh AH, Alibegovic J, Templin C, et al. Intracardiac versus transesophageal echocardiography for 
left atrial appendage occlusion with watchman. Catheter Cardiovasc Interv. 2017;90(2):331-338. 
18. Masson JB, Kouz R, Riahi M, et al. Transcatheter Left Atrial Appendage Closure Using Intracardiac 
Echocardiographic Guidance From the Left Atrium. Can J Cardiol. 2015;31(12):e7-1497. 
19. Korsholm K, Jensen JM, Nielsen-Kudsk JE. Intracardiac Echocardiography From the Left Atrium for 
Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion. JACC Cardiovasc Interv. 
2017;10(21):2198-2206. 
20. Saji M, Rossi AM, Ailawadi G, et al. Adjunctive intracardiac echocardiography imaging from the left 
ventricle to guide percutaneous mitral valve repair with the MitraClip in patients with failed prior surgical 
rings. Catheter Cardiovasc Interv. 2016;87(2):75-82. 
21. Salem MI, Makaryus AN, Kort S, et al. Intracardiac echocardiography using the AcuNav ultrasound 
catheter during percutaneous balloon mitral valvuloplasty. J Am Soc Echocardiogr. 2002;15(12):1533-
1537. 
22. Green NE, Hansgen AR Carroll JD. Initial clinical experience with intracardiac echocardiography in 
guiding balloon mitral valvuloplasty: technique, safety, utility, and limitations. Catheter Cardiovasc 
Interv. 2004;63(3):385-394. 
23. Kadakia MB, Silvestry FE, Herrmann HC. Intracardiac echocardiography-guided transcatheter aortic 
valve replacement. Catheter Cardiovasc Interv. 2015;85(3):497-501. 
24. Bartel T, Edris A, Velik-Salchner C, et al. Intracardiac echocardiography for guidance of transcatheter 
aortic valve implantation under monitored sedation: a solution to a dilemma? Eur Hear J Cardiovasc 

 
 
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Imaging. 2016;17(1):1-8. 
25. Schmidt M, Daccarett M, Marschang H, et al. Intracardiac echocardiography improves procedural 
efficiency during cryoballoon ablation for atrial fibrillation: a pilot study. J Cardiovasc Electrophysiol. 
2010;21(11):1202-1207. 
26. Nölker G, Heintze J, Gutleben KJ, et al. Cryoballoon pulmonary vein isolation supported by intracardiac 
echocardiography: integration of a nonfluoroscopic imaging technique in atrial fibrillation ablation. J 
Cardiovasc Electrophysiol. 2010;21(12):1325-1330. 
27. Bencsik G, Pap R, Makai A, et al. Randomized trial of intracardiac echocardiography during 
cavotricuspid isthmus ablation. J Cardiovasc Electrophysiol. 2012;23(9):996-1000. 
28. Callans DJ, Ren JF, Narula N, et al. Effects of linear, irrigated-tip radiofrequency ablation in porcine 
healed anterior infarction. J Cardiovasc Electrophysiol. 2001;12(9):1037-1042. 
29. Saksena S, Sra J, Jordaens L, Kusumoto F, et al. A prospective comparison of cardiac imaging using 
intracardiac echocardiography with transesophageal echocardiography in patients with atrial fibrillation: 
the intracardiac echocardiography guided cardioversion helps interventional procedures study. Circ 
Arrhythm Electrophysio. 2010;3(6):571-577. 
30. Sadek MM, Cooper JM, Frankel DS, et al. Utility of intracardiac echocardiography during transvenous 
lead extraction. Hear Rhythm. 2017;14(12):1779- 1785. 
 
 

 
 
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ID: 
IGT_IGD_ICE Registry 
Study_2019_10745 
Document title: 
Classification: 
Confidential 
Modified: 
24 APR 2021 
Philips ICE Registry   
Version: 
2.0 
User Tool ID:  
16.2.6UserTool0004 
Page: 
38  
Status: 
Final 
User Tool Version Date 
30May2019 
 
11. INVESTIGATOR’S STATEMENT 
I agree to conduct the trial as outlined in this registry protocol in accordance with the Sponsor’s guidelines, 
Good Clinical Practices, the Declaration of Helskinki, and other applicable FDA regulations, and conditions of 
approval imposed by the reviewing IRB.  The Sponsor’s guidelines include, but are not limited to: 
• 
Provide Philips with current curriculum vitae including a statement regarding relevant experience. 
• 
Provide accurate financial disclosure information to allow Philips to make an accurate disclosure 
statement as required under 21 CFR, Part 54 for the course of the investigation and for up to one 
year after its completion  
• 
Provide supervision of all testing of the device involving human subjects.   
• 
If applicable, provide Philips with information regarding past investigations or other research that was 
terminated, including an explanation of the circumstances that led to the termination.   
• 
Permission to allow Philips and/or regulatory agencies to inspect study facilities and pertinent records 
at reasonable times and in a reasonable manner that ensures subject confidentiality.  If this study is 
to be inspected by a regulatory agency, Philips is to be notified as soon as possible. 
• 
Submission of the proposed clinical investigation including the protocol and the consent form to an 
IRB for approval and the acquisition of written approval for each subject ensuring that the 
requirements for obtaining informed consent are obtained prior to the use of any test articles. 
• 
Submission of any proposed change in or significant deviation from the protocol to the IRB using a 
signed formal amendment document prepared by the Sponsor.  Any proposed changes or deviations 
from the protocol require that the informed consent also reflects such changes or deviations and that 
the revised informed consent be approved by an IRB. 
• 
Documentation and explanation of individual protocol deviations and violations are captured with 
explanations as indicated. 
• 
Submission of reports of Adverse Events to the Sponsor and IRB as outlined in the protocol. 
• 
Submission of timely progress reports to the IRB/EC and Sponsor at appropriate intervals on a 
schedule determined by the IRB or Sponsor, as indicated. 
• 
Record keeping:  the Investigator shall maintain adequate and accurate records designed to record 
completion of all study procedures, related observations and other key data (such as safety, 
compliance and product accountability) pertinent to the investigation on each subject enrolled.  The 
investigator must maintain these records for a period as specified by Philips following completion of 
the study report. 
I agree that all information provided to me by the Sponsor including pre-clinical data, protocols, electronic 
databases, CRFs, and verbal and written information shall be kept strictly confidential and confined to the 
clinical personnel involved in conduct of the trial.  It is recognized that this information may be related in 
confidence to the IRB.  I also understand that reports or information about the trial or its progress shall not be 
provided to anyone not involved in the trial other than the Sponsor or other legally constituted authority. 
 
 
 
 
 
_______________________________________________________________  
___________________ 
Principal Investigator’s Signature 
 
 
 
 
Date 
 
 
______________________________________________________________ 
Principal Investigator’s Printed Name