Advisor High Density (HD) Grid Mapping Catheter Observational Study
Conditions: Persistent Atrial Fibrillation, Ventricular Tachycardia
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
 
87173 CIP Posting Cover Page Ver C 
Template 
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NCT Number: NCT03733392 
Advisor HD Grid 
Advisor™ HD Grid Observational Study 
Study Document No: ABT-CIP-10257 
Version B 
Date: 25-SEP-2018 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
5050 Nathan Lane North 
      
  
 
 
Plymouth, MN 55442 
        
 
 
 
USA 
 
 
 

ABT-CIP-10257 Ver. B 
Study Name: Advisor HD Grid Observational Study 
Clinical Investigation Plan 
 
 
Template: 86357 Rev. E 
 
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SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
 
 
I have read and agree to adhere to the clinical study plan and all regulatory requirements applicable in 
conducting this clinical study. 
 
 
Site Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

ABT-CIP-10257 Ver. B 
Study Name: Advisor HD Grid Observational Study 
Clinical Investigation Plan 
 
 
Template: 86357 Rev. E 
 
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TABLE OF CONTENTS 
 
1 
INTRODUCTION .............................................................................................................................. 8 
1.1 
Background and Rationale ......................................................................................................... 8 
1.1.1 
Background ........................................................................................................................ 8 
1.1.2 
Rationale for Conducting this Clinical Study ........................................................................ 9 
2 
CLINICAL STUDY OVERVIEW ......................................................................................................... 9 
2.1 
Clinical Study Objective ............................................................................................................. 9 
2.1.1 
Outcomes Objective: ........................................................................................................ 10 
2.1.2 
Utility Objective: ................................................................................................................ 10 
2.2 
Device(s) To Be Used in the Clinical Study .............................................................................. 10 
2.2.1 
Names of Devices Used in the Study ................................................................................ 10 
2.2.2 
Intended Indication for Use ............................................................................................... 11 
2.2.3 
Description of the Devices Used in this Study ................................................................... 11 
3 
CLINICAL STUDY DESIGN ............................................................................................................ 11 
3.1 
Clinical Study Procedures and Follow-up Schedule ................................................................. 11 
3.2 
Measures Taken to Avoid and Minimize Bias ........................................................................... 13 
3.3 
Suspension or Early Termination of the Clinical Study ............................................................. 13 
4 
ENDPOINTS ................................................................................................................................... 13 
4.1 
Descriptive Endpoint(s) ............................................................................................................ 13 
4.1.1 
Outcomes Objective ......................................................................................................... 13 
4.1.2 
Utility Objective ................................................................................................................. 14 
4.1.3 
Additional descriptive endpoints ........................................................................................ 15 
5 
SUBJECT SELECTION AND WITHDRAWAL ................................................................................. 15 
5.1 
Subject Population ................................................................................................................... 15 
5.2 
Subject Screening and Informed Consent ................................................................................ 16 
5.2.1 
Subject Screening ............................................................................................................. 16 
5.2.2 
Informed Consent ............................................................................................................. 16 
5.2.3 
Vulnerable Populations ..................................................................................................... 17 
5.3 
Eligibility Criteria ...................................................................................................................... 17 
5.3.1 
General Eligibility Criteria .................................................................................................. 17 
5.3.2 
Inclusion Criteria ............................................................................................................... 17 
5.3.3 
Exclusion Criteria .............................................................................................................. 17 
5.4 
Subject Enrollment ................................................................................................................... 18 
5.5 
Subject Withdrawal .................................................................................................................. 18 
5.5.1 
Lost-to-Follow-up .............................................................................................................. 19 

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5.6 
Total Expected Duration of the Clinical Study .......................................................................... 19 
5.7 
Expected Duration of Each Subject’s Participation ................................................................... 19 
5.8 
Number of Subjects ................................................................................................................. 19 
6 
TREATMENT AND EVALUATION OF ENDPOINTS ....................................................................... 20 
6.1 
Baseline Visit ........................................................................................................................... 20 
6.1.1 
Baseline/Pre-procedure Clinical Assessments .................................................................. 20 
6.2 
Procedure Visit ........................................................................................................................ 21 
6.2.1 
Pre-procedure thrombus assessment ............................................................................... 21 
6.2.2 
Electroanatomical mapping ............................................................................................... 22 
6.2.3 
Indication-specific Procedural Recommendations ............................................................. 22 
6.2.3.1 
Persistent AF: ............................................................................................................ 22 
6.2.3.2 
VT: ............................................................................................................................. 23 
6.3 
Pre-discharge Visit (In-hospital) ............................................................................................... 23 
6.4 
Follow-up Visits ........................................................................................................................ 23 
6.4.1 
6-month (180 days ± 90 days) and 12-month (360± 90 days) Visits .................................. 23 
6.4.2 
Unscheduled Visits ........................................................................................................... 24 
6.4.3 
Healthcare Utilization Documentation ............................................................................... 24 
6.4.4 
Patient Reported Outcome Measures – Quality of Life Questionnaires ............................. 24 
6.4.5 
Schedule of Events ........................................................................................................... 25 
6.5 
Core Laboratory ....................................................................................................................... 25 
7 
ADVERSE EVENTS ....................................................................................................................... 26 
7.1 
Definitions ................................................................................................................................ 26 
7.1.1 
Adverse Event .................................................................................................................. 26 
7.1.2 
Serious Adverse Event ..................................................................................................... 26 
7.2 
Device Relationship ................................................................................................................. 27 
7.2.1 
Adverse Device Effect (ADE) ............................................................................................ 27 
7.2.2 
Serious Adverse Device Effect (SADE) ............................................................................. 27 
7.3 
Safety Reporting ...................................................................................................................... 27 
7.3.1 
Adverse Event Reporting .................................................................................................. 27 
7.3.2 
SAE Reporting .................................................................................................................. 27 
7.3.3 
Complaints ........................................................................................................................ 28 
8 
STATISTICAL CONSIDERATIONS ................................................................................................ 28 
8.1 
Analysis Populations ................................................................................................................ 28 
8.2 
Statistical Analyses .................................................................................................................. 29 
8.2.1 
Descriptive endpoints........................................................................................................ 29 
8.2.2 
Analysis Methodology ....................................................................................................... 29 

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8.3 
Sample Size Calculation and Assumptions .............................................................................. 29 
8.4 
Timing of Analysis .................................................................................................................... 29 
8.5 
Subgroup Analysis ................................................................................................................... 29 
8.6 
Multiplicity ................................................................................................................................ 30 
8.7 
Procedures for Accounting for Missing Data ............................................................................ 30 
8.8 
Planned Interim Analysis ......................................................................................................... 30 
8.9 
Statistical Criteria for Termination ............................................................................................ 30 
8.10 
Success Criteria ....................................................................................................................... 30 
8.11 
Deviations from Statistical Plan ................................................................................................ 30 
8.12 
Analysis of Baseline Data ........................................................................................................ 30 
8.13 
Analysis of Quality of Life ......................................................................................................... 30 
8.14 
Poolability Assessment ............................................................................................................ 30 
9 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ................................................................... 31 
10 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................... 31 
10.1 
Selection of Clinical Sites and Investigators ............................................................................. 31 
10.2 
CIP Amendments ..................................................................................................................... 31 
10.3 
Training.................................................................................................................................... 31 
10.3.1 
Site Training ..................................................................................................................... 31 
10.3.2 
Training Required for the Use of the Device ..................................................................... 32 
10.4 
Monitoring ................................................................................................................................ 32 
10.5 
Deviations from CIP ................................................................................................................. 32 
10.6 
Quality Assurance Audit ........................................................................................................... 32 
10.7 
Committees ............................................................................................................................. 33 
10.7.1 
Publications Committee .................................................................................................... 33 
11 
DATA HANDLING AND RECORD KEEPING .............................................................................. 33 
11.1 
Protection of Personally Identifiable Information ...................................................................... 33 
11.2 
Data Management Plan ........................................................................................................... 34 
11.3 
Source Documentation ............................................................................................................ 34 
11.4 
Case Report Form Completion ................................................................................................ 34 
11.5 
Record Retention ..................................................................................................................... 35 
12 
ETHICAL CONSIDERATION....................................................................................................... 35 
12.1 
Institutional Review Board/Medical Ethics Committee Review and Approval ........................... 35 
13 
CLINICAL Study CONCLUSION ................................................................................................. 35 
14 
PUBLICATION POLICY .............................................................................................................. 35 
15 
RISK ANALYSIS ......................................................................................................................... 36 
15.1 
Foreseeable Adverse Events and Anticipated Adverse Device Effects .................................... 36 

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15.1.1 
Risks Associated with Participation in this Clinical Study .................................................. 36 
15.1.2 
Steps Taken to Control or Mitigate Risks .......................................................................... 36 
15.2 
Possible Interactions with Concomitant Treatments ................................................................. 37 
15.3 
Anticipated Benefits ................................................................................................................. 37 
15.4 
Risk to Benefit Rationale .......................................................................................................... 37 
16 
References .................................................................................................................................. 37 
APPENDIX I: ABBREVIATIONS AND ACRONYMS .............................................................................. 39 
APPENDIX II: CASE REPORT FORMS ................................................................................................. 40 
APPENDIX III: SITE CONTACT INFORMATION ................................................................................... 41 
APPENDIX IV: INFORMED CONSENT FORM ...................................................................................... 42 
APPENDIX V: HD GRID ELECTRODE CONFIGURATIONS ................................................................. 43 
APPENDIX VI: REVISION HISTORY ..................................................................................................... 49 
APPENDIX VII: CIP SUMMARY ............................................................................................................ 50 
 
TABLE OF TABLES 
 
Table 1. Clinical Study Devices .............................................................................................................. 10 
Table 2. Clinical Study Specific Tests/Activities and Procedures ............................................................ 25 
 
 
TABLE OF FIGURES 
Figure 1. Clinical Study Flow Chart ........................................................................................................ 12 
Figure 2. Example of HD Grid HD Wave Electrode Configuration .......................................................... 44 
Figure 3. Example of Alternative HD Grid HD Wave Electrode Configuration ......................................... 45 
Figure 4. Along-the-spline HD Grid Electrode Configuration .................................................................. 46 
Figure 5. All Bipole HD Grid Electrode configuration .............................................................................. 47 
 
 

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COMPLIANCE STATEMENT:  
 
This clinical study will be conducted in accordance with this Clinical Investigation Plan, the Declaration of 
Helsinki, ISO 14155:2011 standards and the appropriate local legislation(s). The most stringent 
requirements, guidelines or regulations must always be followed. The conduct of the clinical study will be 
approved by the appropriate Ethics Committee (EC) of the respective clinical site and as specified by 
local regulations. 
 

ABT-CIP-10257 Ver. B 
Study Name: Advisor HD Grid Observational Study 
Clinical Investigation Plan 
 
 
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1 
INTRODUCTION 
This document is the clinical investigation plan (CIP) for the Advisor HD Grid Observational Study. This 
clinical study is a prospective, multi-center, observational study intended to quantify and characterize the 
outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the 
market-released Advisor™ HD Grid Mapping Cather, Sensor Enabled™ in subjects with persistent atrial 
fibrillation (PersAF) or ventricular tachycardia (VT) in the real-world environment. This clinical study is 
sponsored by Abbott.  
 
This clinical study will be conducted in accordance with this CIP. All investigators involved in the conduct 
of the clinical investigation will be qualified by education, training, or experience to perform their tasks 
and this training will be documented appropriately. 
1.1 Background and Rationale 
1.1.1 Background 
Atrial Fibrillation (AF) is a supraventricular arrhythmia characterized by rapid and irregular activation in 
the atria, and, when maintained greater than seven days, is known as Persistent AF (PersAF).1 Patients 
with PersAF have an increased risk of stroke and are likely to develop life-threatening problems such as 
tachycardia-induced cardiomyopathy and congestive heart failure which can increase mortality. 
Restoration and maintenance of sinus rhythm in these patients may confer mortality benefit.1, 2  
 
Sustained monomorphic VT is a cardiac arrhythmia emanating from the ventricles at a rate greater than 
100 bpm that is sustained longer than 30s or requires intervention due to hemodynamic instability.3 
Sustained VT is associated with increased mortality risk including risk of sudden cardiac death. Patients 
are often implanted with an implantable cardiac defibrillator (ICD) for treatment when episodes occur, 
although treatment with an ICD is not curative and is associated with increased mortality and decreased 
quality of life. Treatment to avoid recurrent symptoms is therefore both desirable and may improve 
survival in patients.4  
 
Catheter ablation is an established treatment option for PersAF and VT, although corresponding success 
rates in long-term sinus rhythm maintenance remain modest and could benefit from further research. 
Ablation strategies target the pathogenic mechanisms that initiate and perpetuate abnormal electrical 
activity within the heart including abnormal substrate. However, identifying and eliminating the 
pathogenic mechanisms is not straightforward, especially with complex arrhythmias such as PersAF and 
VT in which the distribution of potential arrhythmogenic drivers is heterogeneous across the patient 
population and there remains a lack of consensus on approach to identifying and ablating mechanistic 
drivers. 
 
PersAF is electrophysiologically characterized by fast and regular atrial activities, complex fractionated 
atrial electrograms, direction of wave front propagation, and low peak-to-peak voltage. Potential drivers 
of PersAF beyond pulmonary vein triggers may include areas of fibrosis, focal automaticity, or foci, areas 
of rapidly rotating reentrant circuits, or rotors, asynchronous activation of myocyte bundles identified by 
complex fractionated electrograms, overactive ganglionated plexi, and dissociation and interaction 
between epicardial and endocardial layers.1, 5, 6 The role of such mechanisms continues to be debated 
along with their implication on therapeutic strategy, especially since ablation techniques aim to eliminate 
AF triggers or modify arrhythmogenic substrate.  Similarly, the majority of patients with sustained 
monomorphic VT requiring therapy have some type of structural heart disease, and VT associated with 

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Clinical Investigation Plan 
 
 
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structural heart disease is characterized by scar tissue and slow conduction zones which form a critical 
isthmus.4 Multiple techniques are used to both locate such pathologic substrate including identification of 
local abnormal ventricular activities (LAVA), late potentials, fractionated electrogram signals, and 
wavefront mapping, and to guide ablation strategies including targeting all LAVA or late potentials, scar 
homogenization, and dechanneling.7  
 
Recent advancements in high-density three-dimensional catheter mapping strategies enable the 
evaluation of such electrophysiologic characteristics that are used as surrogates for identifying the 
mechanisms responsible for PersAF and VT.6, 7 Identification of electrophysiological characteristics 
depends on the ability of mapping catheter electrodes and electrode pair electrograms to detect voltage 
characteristics. However, unipolar and/or bipolar EGM amplitudes may be influenced by the direction of 
the wavefront, catheter orientation, electrode size, interelectrode spacing, proximity to tissue and 
contamination by far-field signals.7 Accurate electrogram depiction of underlying substrate is limited by 
adequate bipole orientation which can be challenging to achieve with traditional linear mapping 
catheters, noncompliant catheters unable to make adequate tissue contact, and high density mapping 
catheters with inconsistent electrode spacing. The Advisor™ HD Grid, Sensor Enabled™ (HD Grid) 
diagnostic mapping catheter with equispaced multipolar grid electrodes provides known bipole spacing in 
orthogonal directions, thereby providing the ability to discriminate voltage differences in two directions for 
enhanced directionality and amplitude detection. This is done by using the HD Wave electrode 
configuration with AutoMap best duplicate enabled during electroanatomical map creation (Appendix V). 
It is hypothesized that the use of HD Wave mapping will allow high-resolution substrate identification, but 
the impact of this mapping catheter and configuration on the subsequent ablation strategy used by 
physicians remains unknown.  
 
1.1.2 Rationale for Conducting this Clinical Study 
The HD Grid catheter is a recently launched multielectrode catheter with electrodes evenly distributed in 
a grid to allow for orthogonal bipole orientations that may overcome current multielectrode catheter 
limitations. Not much is known about how HD Grid is used clinically in the real world, with published 
literature including only two case reports.8, 9 It is hypothesized that electroanatomical mapping with the 
HD Grid catheter and HD Wave mapping will provide high-density and high-resolution mapping for 
improved insight to the extent of structural disease and assist in the determination of the “critical” 
atrial/ventricular targets to guide catheter ablation strategy. This can allow physicians to avoid both 
unnecessary overtreatment that could result in increased risk of complication, procedure duration, and 
fluoroscopy exposure, and undertreatment with increased likelihood of recurrence in patients that present 
with complex arrhythmias.  
 
Therefore, investigation of the new-to-market HD Grid mapping catheter will be useful in elucidating how 
the high-density, multielectrode catheter and HD Wave mapping configuration are used to identify 
arrhythmogenic heterogeneous substrate in complex PersAF and VT substrate, guide ablation strategy, 
and achieve favorable procedural characteristics, while overcoming current limitations to traditional 
multielectrode catheters. 
2 
CLINICAL STUDY OVERVIEW 
2.1 Clinical Study Objective 
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, 
and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor 

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Additional commercially available tools may be used in this clinical study, per physician’s discretion and 
per device IFUs.  
2.2.2 Intended Indication for Use 
Indications for use may be found in the appropriate device IFU. Indications for the use of HD Grid and 
EnSite Precision are described below.  
 
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode 
electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only.  This 
catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.  
 
The EnSite Precision™ Cardiac Mapping System is a catheter navigation and mapping system capable 
of displaying the three-dimensional (3D) position of conventional and sensor enabled electrophysiology 
catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D 
isopotential maps of the cardiac chamber. The contoured surfaces of these three-dimensional maps are 
based on the anatomy of the patient’s own cardiac chamber. 
 
The EnSite Precision™ Cardiac Mapping System (including AutoMap) is a suggested diagnostic tool in 
patients for whom electrophysiology studies have been indicated.  
 
The EnSite Precision™ system interfaces to either MediGuide™ Guided Medical Positioning System or 
the EnSite Precision™ Module to combine and display magnetic processed patient positioning and 
orientation mapping information. When used with an EnSite Precision™ Surface Electrode Kit, the 
EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional 
electrophysiology (EP) catheters in the heart. 
2.2.3 Description of the Devices Used in this Study 
Please refer to the IFU for additional information regarding the devices used in this clinical study. 
3 
CLINICAL STUDY DESIGN 
This is a prospective, non-randomized, multicenter observational study to quantify and characterize the 
outcomes of RF ablation after, and the utility of electroanatomical mapping with HD Grid and the EnSite 
Precision with HD Wave in subjects with PersAF or VT in real-world clinical settings. A total of 500 
subjects will be enrolled at up to 30 investigational sites worldwide.  
 Subjects will be followed for up to 12-months after 
their initial ablation procedure. The outcome and utility descriptive endpoints will be evaluated when all 
subjects have completed their long-term follow-up visits (12-months for PersAF and 6-months for VT). 
Additional descriptive endpoints will be evaluated when all subjects have completed their 12-month 
follow-up visits. 
 
  
3.1 Clinical Study Procedures and Follow-up Schedule 
Subjects will be consented for the trial prior to any data collection. Once eligibility is confirmed and a 
subject is consented, baseline information will be collected and the subject will undergo the RF ablation 
procedure per physician discretion using electroanatomical mapping with the HD Grid mapping catheter. 
Subjects will be followed for 12-months post procedure. Follow-up assessments will occur either in 
person at a clinic or via phone contact after the procedure. The study visits will occur at baseline, 

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3.2 Measures Taken to Avoid and Minimize Bias 
Multiple measures will be taken to avoid bias in this clinical study. First, the Advisor HD Grid 
Observational Study is prospective, such that the outcome of the study is unknown at time of enrollment, 
and all subjects must meet pre-defined eligibility criteria thereby minimizing selection bias. Next, 
guidance will be provided to sites regarding data collection for questionnaires and post-procedure follow-
up visits and/or phone calls, and case report forms for data collection will be provided to all sites thereby 
minimizing inter-observer variability.  Evaluation of arrhythmia recurrence via Holter monitoring will be 
performed by an independent core laboratory. Adverse events will be internally assessed by the Sponsor 
independent of assessment by the physician as reported by the site.  Additionally, protocols are in place 
to minimize subjects lost to follow-up and collection of missing data to minimize the impact or bias 
caused by missing data. 
3.3 Suspension or Early Termination of the Clinical Study 
No formal statistical rule for early termination of the clinical study is defined.  
 
The Sponsor reserves the right to discontinue the clinical study at any stage or reduce the follow-up 
period or sample size with suitable written notice to the investigator.  
 
Should the clinical study be discontinued by the Sponsor, subjects will be followed per routine hospital 
practice with device-related AEs reported to the Sponsor as per vigilance/commercial reporting 
requirements. 
 
Should this occur, the investigator shall provide a written statement as to why the premature termination 
has taken place to the IRB/EC (if applicable). All applicable clinical study documents shall be subject to 
the same retention policy as detailed in Section 11 of the CIP.  
 
A Principal Investigator, IRB/EC, or regulatory authority may suspend or prematurely terminate 
participation in the clinical study at the investigational sites for which they are responsible. The 
investigators will follow the requirements specified in the Clinical Trial Agreement.  
 
If the Sponsor suspends or prematurely terminates the clinical study at an individual site in the interest of 
safety, the Sponsor will inform all other Principal Investigators. 
4 
ENDPOINTS 
The objectives of this study will be addressed through multiple descriptive endpoints and will be reported 
using summary statistics. All descriptive endpoints will be evaluated independently for the PersAF and 
VT subjects. 
4.1 Descriptive Endpoint(s)  
4.1.1 Outcomes Objective 
The first objective is to quantify and characterize the acute- and long-term success rate of RF ablation 
after electroanatomical mapping with HD Grid and EnSite Precision with HD Wave in subjects with 
PersAF or VT. 
 

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To quantify and characterize the acute- and long-term success rate of RF ablation after 
electroanatomical mapping with HD Grid, the following will be summarized: 
• 
Rate of acute success defined as the proportion of subjects who receive HD Grid mapping and 
RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to 
SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation 
(cardioversion allowed prior to inducibility attempt).  
 
• 
Rate of long-term success defined as the proportion of subjects who receive HD Grid mapping 
and RF energy delivery with the following pre-defined procedural endpoints: 
Persistent AF (utilizing a 90-day blanking period following index ablation): 
o freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as 
documented by 48-hr Holter at 12-month follow-up) and new or increased dose of 
class I/III antiarrhythmic drug (AAD). 
o freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as 
documented by 48-hr Holter at 12-month follow-up) on or off class I/III AAD. 
VT (utilizing a 14-day blanking period following index procedure): 
o freedom from recurrence of sustained monomorphic VT and new or increased dose of 
class I/III AAD at 6-month follow-up 
o freedom from recurrence of sustained monomorphic VT on or off class I/III AAD at 6-
month follow-up. 
 
Where recurrence of sustained monomorphic VT is defined as: 
 
Sustained monomorphic VT greater than 30s or requiring appropriate ICD 
pacing or shocks for patient with ICDs  
 
Sustained monomorphic VT greater than 30s recorded in follow-up visits or 
requiring intervention due to hemodynamic instability for patients without ICDs 
 
4.1.2 Utility Objective 
The second objective is to quantify and characterize the use of HD Grid and EnSite Precision with HD 
Wave in the electroanatomical mapping of PersAF or VT in real-world clinical settings. 
 
Use of HD Grid and EnSite Precision with HD Wave will be quantified and characterized through the 
summary of the following: 
• 
Overall procedure time: defined as time from initial catheter insertion to final catheter removal.  
• 
Radiofrequency (RF) time: defined as duration of time RF energy is delivered 
• 
Fluoroscopy time: defined as total time subject is exposed to fluoroscopy 
• 
Mapping time associated with mapping arrhythmia: defined as the total cumulative mapping 
time and mapping time for the creation of each map (including any new or retrospective map 
created with Manual, AutoMap, and TurboMap mapping) 
• 
Number of mapping points collected: defined as total number of mapping points collected for 
the creation of each map 
• 
Number of mapping points used: defined as the total number of mapping points used in each 
map 
• 
Number of used mapping points per minute: defined as the total number of mapping points 
used divided by the relative mapping time 
• 
Substrate characteristics identified: for each type of arrhythmogenic substrate this will be 
defined as the frequency of substrate type identified in cases that attempted to identify the 
specific substrate 

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• 
Ablation strategy(s) used: defined by both the type of map used to define ablation strategy 
and the frequency each ablation strategy/target was used by physicians 
• 
Role of HD Wave map relative to along-the-spline map in ablation strategy decision: as 
assessed by physician survey comparing maps generated with HD Wave electrode 
configuration to along-the-spline electrode configurations. 
• 
Maneuverability of HD Grid catheter: defined as the ability to maneuver the HD Grid to each 
specified anatomic location if attempted, the ability to contact cardiac tissue, and the 
incidence of induced ectopic beats during maneuvering 
• 
HD Grid electrogram quality relative to ablation catheter electrograms: defined as the 
proportion of electrograms collected with HD Grid that have better quality/less noise than 
electrograms collected with the ablation catheter at the same cardiac location as assessed by 
physician survey 
 
4.1.3 Additional descriptive endpoints 
Additional descriptive endpoints include: 
• 
Change in quality of life (QOL) at 6 and 12 months after receiving HD Grid mapping and RF 
ablation relative to baseline: defined as change in quality of life assessed in validated QOL 
surveys (EQ-5D and AFEQT for subjects with PersAF, EQ-5D and HADS for subjects with VT) 
• 
Rate of periprocedural and immediate post procedural (48hrs) procedure- or device- related 
adverse events in all subjects in whom the HD Grid is inserted (regardless of RF energy delivery).  
• 
Rate of procedure- or device-related adverse events and cardiovascular serious adverse events 
in all subjects in whom the HD Grid is inserted (regardless of RF energy delivery) through 30 
days post study procedure. 
• 
Proportion of VT subjects who receive HD Grid mapping and RF energy delivery free from 
recurrence of sustained monomorphic VT and new or increased dose of class I/III AAD, and free 
from recurrence of sustained monomorphic VT on or off class I/III AADs at 12-month follow-up 
outside the blanking period. 
• 
Rate of repeat ablations after study procedure during 12-month follow up defined as proportion of 
subjects without an additional ablation procedure to treat indicated cardiac arrhythmia (outside 
blanking period, if applicable). 
• 
For subjects treated for PersAF: 
o Proportion with atypical atrial flutter (AFL) identified during procedure 
 
Of those receiving HD Grid mapping and RF ablation for AFL: Utility of HD Grid 
specific to the identification and treatment of atypical AFL (as defined in section 
4.1.2), including role of HD wave relative to along-the-spline maps in identifying 
ablation target(s), and time of RF application to terminate atypical AFL 
5 
SUBJECT SELECTION AND WITHDRAWAL  
5.1 Subject Population 
This clinical study will enroll male and female subjects over the age of 18 years who are indicated for 
cardiac RF ablation with electroanatomical mapping for the treatment of PersAF or substrate-based VT. 
Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any 
study-specific procedures not considered standard of care.  
 

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5.2 Subject Screening and Informed Consent 
5.2.1 Subject Screening 
Members of the site’s clinical study team (physician and/or research coordinator, or other delegated and 
qualified personnel) previously trained to this CIP must screen potential patients for clinical study 
eligibility based on the inclusion and exclusion criteria (section 5.3) and document the screening effort 
onto a site-specific Screening Log.   
 
In case a potential patient does not meet all inclusion criteria or meets any of the exclusion criteria, the 
patient is considered a screening failure. The Principal Investigator or the delegated clinical investigation 
personnel will record the screening failure in the hospital records and on the screening log as required. 
 
Patients who meet all inclusion criteria and none of the exclusion criteria are eligible to participate in this 
clinical study. Eligible patients presenting at clinical sites will be fully informed about the clinical study 
and asked to sign an Informed Consent form if they wish to participate in the clinical study. These 
patients will also be entered into the screening log.  
The following assessments may need to be performed after obtaining consent and prior to the procedure, 
as part of the screening process: 
• 
Pregnancy test 
• 
Intracardiac thrombus assessment 
 
Subject data will be collected for the clinical study after obtaining signed Informed Consent. 
5.2.2 Informed Consent 
A template informed consent form will be provided to each site by the Sponsor under separate cover for 
use in this clinical study.  Site-specific language will be added to the template and approved by research 
personnel, the Sponsor, and governing IRB/EC prior for use in the trial. 
The Investigator or his/her authorized designee will conduct the Informed Consent process, as required 
by applicable regulations and the center’s IRB/EC. This process will include a verbal discussion with the 
subject on all aspects of the clinical study that are relevant to the subject’s decision to participate, such 
as details of clinical study procedures, anticipated benefits, and potential risks of clinical study 
participation. Subjects must be informed about their right to withdraw from the clinical study at any time 
and for any reason without sanction, penalty or loss of benefits to which the subject is otherwise entitled. 
Withdrawal from the clinical study will not jeopardize their future medical care or relationship with the 
investigator.  
 
During the discussion, the Principal Investigator or his/her authorized designee will avoid any improper 
influence on the subject and will respect subject’s legal rights. The subject shall be provided with the 
Informed Consent form written in a language that is understandable to the subject and has been 
approved by the center’s IRB/EC. The subject shall have adequate time to review, ask questions and 
consider participation. The Principal Investigator or his/her authorized designee will make efforts to 
ensure that the subject understands the information provided. If the subject agrees to participate, the 
Informed Consent form must be signed and dated by the subject and thereafter by the person obtaining 
the consent prior to any study-specific procedures. The signed original will be filed in the subject’s 
hospital or research charts, and a copy will be provided to the subject. 
 

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Failure to obtain informed consent from a subject prior to clinical study enrollment should be reported to 
the Sponsor within 5 working days and to the reviewing center’s IRB/EC according to the IRB’s/ EC’s 
reporting requirements. 
 
If, during the clinical study, new information becomes available that can significantly affect a subject's 
future health and medical care, the Principal Investigator or his/her authorized designee will provide this 
information to the subject. If relevant, the subject will be asked to confirm their continuing informed 
consent in writing. 
 
5.2.3 Vulnerable Populations 
 
Vulnerable patients are defined as patients whose willingness to volunteer in a clinical study could be 
unduly influenced by the expectation, whether justified or not, of benefits associated with participation or 
of retaliatory response from senior members of a hierarchy in case of refusal to participate.  Examples of 
populations which may contain vulnerable patients include: Individuals with lack of or loss of autonomy 
due to immaturity or through mental disability, persons in nursing homes, children, impoverished 
persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, 
and those incapable of giving informed consent. Other vulnerable patients include, for example, 
members of a group with a hierarchical structure such as university students, subordinate hospital and 
laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in 
detention.  Enrollment of vulnerable patients in this clinical study is not allowed (exclusion criterion 13).   
5.3 Eligibility Criteria 
5.3.1 General Eligibility Criteria 
Assessment for general eligibility criteria is based on review of medical records, interview with a 
candidate patient, and determination by the investigator. If some of the clinical and laboratory tests 
required to assess eligibility are not performed as part of the sites standard of care, they must be done 
after written informed consent is obtained. Patients must meet ALL inclusion criteria to be considered for 
the clinical study. If ANY of the exclusion criteria are met, the patient is excluded from the clinical study. 
5.3.2 Inclusion Criteria 
1. Subject must provide written informed consent for study participation and willing and able to 
comply with the protocol described evaluations and follow up schedule 
2. Over 18 years of age 
3. Indicated for cardiac electroanatomical mapping and RF ablation procedure to treat PersAF or VT 
4. Subject is diagnosed with either PersAF OR VT as defined by: 
a. Persistent AF: 
i. Documented symptomatic persistent AF defined as continuous atrial fibrillation that 
is sustained beyond 7 days but less than 12 months  
b. VT: 
i. Sustained monomorphic ventricular tachycardia with record of VT event within last 
6 months and history of prior myocardial infarction 
5.3.3 Exclusion Criteria 
1. Life expectancy less than 12 months 

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2. Women who are pregnant or nursing 
3. Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure  
4. Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index 
ablation procedure 
5. Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure 
6. Documented cerebroembolic event within the past 12 months (365 days) 
7. History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to 
require valve replacement or repair within 12 months 
8. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 
9. Current acute illness or active systemic infection or sepsis 
10. Currently enrolled in another clinical study that could confound the results of this study 
11. Any cause for contraindication to ablation procedure or systemic anticoagulation 
12. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological 
conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the 
clinical study or to comply with follow-up requirements, or impact the scientific soundness of the 
clinical study results. 
13. Vulnerable patient or individuals whose willingness to volunteer in a study, in the judgement of 
investigator or public authorities, could be unduly influenced by lack of or loss of autonomy  
14. Indication-specific exclusion criteria including: 
a. PersAF: 
i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, 
or reversible or non-cardiac cause. 
ii. LAD > 55 mm (parasternal long axis view) 
iii. LVEF < 40% 
iv. Uncontrolled heart failure or NYHA function class III or IV 
v. Presence of implanted ICD/CRT-D. 
b. VT: 
i. VT/VF thought to be from channelopathies  
ii. Active ischemia or other reversible cause of VT  
iii. Incessant VT at time of procedure 
iv. Implanted with a ventricular assist device (VAD) (e.g. TandemHeart) 
v. Chronic NYHA Class IV heart failure  
vi. Ejection fraction < 15%  
 
Incessant VT is defined as continuous sustained VT that promptly recurs despite repeated intervention 
for termination over ≥3 hours. 
5.4 Subject Enrollment 
A subject is considered enrolled in the clinical study from the moment the patient provides written 
informed consent, has been confirmed to meet all inclusion criteria and none of the exclusion criteria, 
and the HD Grid catheter is inserted. 
5.5 Subject Withdrawal 
Each enrolled subject shall remain in the clinical study until completion of the required follow-up period; 
however, a subject’s participation in any clinical study is voluntary and the subject has the right to 
withdraw at any time without penalty or loss of benefit. Subjects will be requested to specify the reason 

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6.2 Procedure Visit  
The procedure should be performed according to the IFU of the HD Grid mapping catheter, EnSite 
Precision™ Cardiac Mapping System, and any other medical devices used during the procedure. 
Physicians performing electroanatomical mapping and ablations must be qualified operators and trained 
on the study.  Each physician who ablates during a particular case needs to be documented on the 
Procedure CRF.   
 
The following information will be collected during the Procedure Visit: 
 
• 
Antiarrhythmic medications- any current class I/III AAD and dose 
• 
Anticoagulant medications 
• 
Subject cardiac rhythm when they enter the EP lab 
• 
Subject cardiac rhythm during mapping  
• 
Mapping and ablation tools used during the procedure 
• 
Procedural characteristics (set up and timing) 
• 
Fluoroscopy time 
• 
Mapping time (total time to collect mapping data and time for each map created/ retrospectively 
generated) 
• 
Mapping points collected and used for each map created/ retrospectively generated 
• 
Mapping location(s) 
• 
Electrode configuration used for clinical electroanatomical mapping 
• 
Map type(s) (i.e. Voltage, LAT, CFE, etc.) 
• 
AutoMap settings used (if applicable) 
• 
Arrhythmogenic substrate identified 
• 
Field Scaling use 
• 
Standard and HD Wave map comparisons  
• 
Ablation strategy 
• 
AutoMark settings used (if applicable) 
• 
Cardioversions performed during procedure 
• 
Attempt(s) at induction of arrhythmia as applicable before and after RF delivery 
• 
Subject rhythm after completion of procedure 
 
The entire case (procedure) must be recorded and stored on a study-specific USB (password-protected), 
provided by the Sponsor, and returned within a reasonable timeline to the Sponsor.  
 
Protocol deviations (refer to Section 10.5 for details) that were observed during the procedure, which 
include any device used off-label during the procedure, will also be recorded at this time. 
6.2.1 Pre-procedure thrombus assessment 
Thrombus assessment is required before procedure and will be performed per investigator’s standard of 
care. If a thrombus is discovered, the procedure should be postponed and the subject placed on 
anticoagulation until the thrombus is resolved and confirmed by imaging. The subject will not need to be 
re-consented for the study after the thrombus resolves, provided that the subject continues to meet all 
eligibility criteria and will undergo an RF ablation procedure unless otherwise indicated by the governing 
IRB/EC. Baseline visit information should be verified and updated as necessary.  

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6.2.2 Electroanatomical mapping 
The HD Grid Mapping catheter must be used with EnSite Precision to generate a baseline 
electroanatomical map prior to ablation procedure. Complete contact with the cardiac wall should be 
achieved before collecting data.  Mapping will be done per investigator discretion and is recommended to 
use an HD Wave electrode configuration for catheter set-up (see Appendix V).  Additional maps may be 
created or retrospectively generated using TurboMap per physician standard practice for diagnostic 
purposes.  
 
For comparison of HD wave and along-the-spline electrode configuration maps, any HD Wave 
configuration map used during the case should also be generated using the along-the-spline electrode 
configurations, preferably using TurboMap with the same geometry as baseline map (see Appendix V for 
details on configuration and transitions between map types). This may be done during the diagnostic 
procedure as part of standard of care procedure flow for relevant comparisons prior to ablation strategy 
determination. If not performed during the procedure, this should be performed after completion of the 
ablation procedure for comparison of maps resulting from different electrode configurations. Similarly, 
any along-the-spline electrode configuration map used during the procedure should have a comparable 
HD Wave configuration map generated for comparison.  
 
For the purposes of this protocol, creating a map or mapping, is considered to be the process of 
collecting electroanatomical data points within heart via movement or positioning of the mapping catheter 
within the heart.  
 
A retrospective map will be defined as the generation of a map that does not require collection of any 
new or additional electroanatomical data points but instead reuses already collected mapping data with 
new point collection or acquisition settings or electrode configurations selected (via TurboMap) or manual 
alteration of a copied open map. 
 
Information related to each map generated, and comparison of any HD wave and respective along-the-
spline maps will be reported on the appropriate CRF.  
6.2.3 Indication-specific Procedural Recommendations 
6.2.3.1 Persistent AF:  
Create a baseline geometry and map (at a minimum, collect baseline map, other maps may be collected 
or retrospectively generated per standard of care) of entire left atrium using HD Grid with HD Wave 
electrode configuration. Create or retrospectively generate any additional electroanatomical maps (may 
include generation of maps with along-the-spline configuration, preferably using TurboMap with same 
geometry; see Appendix V). Use the baseline HD Wave map and/or additional maps as clinically 
necessary, to identify ablation target(s), and use ablation catheter per IFU to perform ablation per 
standard of care. Assess acute procedural success. Collect additional maps and perform additional 
ablation as clinically necessary. Ablation to treat other arrhythmias that occur during the procedure are 
allowed per physician discretion and standard of care. 
 
If the subject presents in atypical AFL at any time during the procedure or as a result of induction, 
diagnostic mapping and RF ablation will be allowed. If this occurs, HD Grid with HD Wave electrode 
configuration should be used to create diagnostic maps per standard of care. Create or retrospectively 
generate any additional electroanatomical maps (may include generation of maps with along-the-spline 
configuration, preferably using TurboMap with same geometry; see Appendix V). Use the HD Wave map 
and/or additional maps as clinically necessary, to identify ablation target(s), and use ablation catheter per 

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IFU to perform ablation per standard of care. Information related to diagnostic mapping and ablation of 
the atypical AFL will be collected.  
6.2.3.2 VT: 
Create a baseline geometry and map (at a minimum, collect baseline voltage map, other maps may be 
collected per standard of care) of the ventricle(s) using HD Grid with HD Wave electrode configuration. 
Create or retrospectively generate any additional electroanatomical maps (may include generation of 
maps with along-the-spline configuration, preferably using TurboMap with same geometry; see Appendix 
V). Use the voltage HD Wave map, and/or other maps as clinically necessary to identify ablation 
target(s). Use ablation catheter per IFU to perform ablation per standard of care. Attempt to re-induce 
any VT ablated if possible. Assess acute procedural success. Create post-ablation voltage map or collect 
additional maps and perform additional ablation if clinically necessary.   
6.3 Pre-discharge Visit (In-hospital) 
Prior to discharge after the study procedure, a Pre-discharge visit will be completed. The following 
information will be collected from each subject at the Discharge Visit: 
• 
12-lead ECG 
• 
Collect ICD session records and interrogation reports if applicable 
• 
Arrhythmia recurrence 
o For the purposes of this clinical study recurrence of arrhythmia is deemed to have 
occurred only when the arrhythmia is documented on ICD, ECG, or other monitoring 
device used per standard of care. Atrial arrhythmias 30 seconds or longer will be 
collected. Ventricular arrhythmias treated by an ICD, or lasting 30 seconds or longer will 
be collected 
• 
Antiarrhythmic medications- any current class I/III AAD and dose 
• 
Adverse events if applicable 
• 
Protocol deviations if applicable 
6.4 Follow-up Visits 
 
Follow-up visits are scheduled at 6 months and 12 months post procedure. The scheduled visit windows 
are calculated from the index procedure.  
6.4.1 6-month (180 days ± 90 days) and 12-month (360± 90 days) Visits 
The 6-month follow-up visit may be competed in-clinic or via phone call per investigational site standard 
of care. The 12-month follow-up visit must be completed in-clinic. The following information will be 
collected at each visit:  
• 
Arrhythmia recurrence 
• 
Antiarrhythmic medication- including any current class I/III AAD and dose 
• 
Completion of the EQ-5D/AFEQT (for subjects treated for PersAF) or EQ-5D/HADS (for subjects 
treated for VT)  
• 
Collect ICD session records and interrogation reports if applicable 
• 
Holter monitoring at 12-month visit (for patients treated for PersAF) 
o *Subjects treated for PersAF will be issued a Holter monitor at the 12-month visit and 
instructed to obtain a 48-hour recording. A core laboratory will review each recording and 
report findings to the Sponsor. 

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• 
Other monitoring device source documentation of arrhythmia if applicable 
• 
Adverse events if applicable 
• 
Document any cardiovascular healthcare utilization performed since the last scheduled study visit 
as defined in Section 6.4.3 if applicable 
• 
Protocol deviations if applicable 
NOTE: The Sponsor may request access to other patient data during the required protocol follow up 
visits or throughout the follow up period, which may include, but is not limited to, data from implanted 
device(s). 
Record the required information on the appropriate CRF(s). Documentation of arrhythmia (e.g. ECG 
printouts, Holter printouts, session records) where applicable, should be retrieved and submitted 
electronically through EDC to the Sponsor.  
Sponsor representatives can be involved in providing support during the follow-up procedures. 
6.4.2 Unscheduled Visits 
If a subject is seen by any physician for possible arrhythmia recurrence and/or arrhythmia associated 
symptoms outside of a regularly scheduled study visit and/or had an urgent care or emergency room visit 
regarding possible arrhythmia, these visits need to be documented as “Unscheduled Visits”.  Minimally, 
the following information should be documented for an unscheduled visit.   
• 
12-lead ECG, if performed during the visit 
• 
ICD session records and interrogation reports if applicable 
• 
Other monitoring device source documentation of arrhythmia if applicable 
• 
Antiarrhythmic medication- including any current class I/III AAD and dose 
• 
Occurrence of any repeat ablation 
• 
Document adverse events and cardiovascular healthcare utilization if applicable   
• 
Protocol deviations if applicable  
6.4.3 Healthcare Utilization Documentation 
Healthcare utilization for cardiac-related hospitalizations (inpatient or outpatient), emergency room visits, 
and/or urgent care visits will be documented in this clinical study. Subjects will be interviewed at each 
scheduled visit to determine if they had any cardiac-related hospitalizations (inpatient or outpatient), 
emergency room visits, and/or urgent care visits since their last scheduled visit.  Source documentation 
for these visits should be obtained and a Healthcare Utilization form completed.   
6.4.4 Patient Reported Outcome Measures – Quality of Life Questionnaires 
The coordinator or designee will administer patient-reported outcome questionnaires. It is important the 
subject understands the meaning of all words and instructions in the questionnaires. The subject should 
be instructed to ask any questions about the questionnaires if further explanation is needed. Once the 
questionnaires are completed, the coordinator or designee will review for completeness to verify that all 
questions have been answered according to the directions provided. 
 
The following patient-reported outcome measures will be collected for the respective patient populations: 
• 
Persistent AF: 
o EuroQol Five Dimensions Questionnaire (EQ-5D) 
o AF Effect on Quality of Life Survey (AFEQT) 
• 
VT: 

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The core lab will provide independent review of this data by appropriately trained personnel using 
standardized procedures to interpret Holter monitor tracings for adjudication of atrial arrhythmias.  
Findings will be communicated to the investigator and to Abbott.  The core lab’s adjudication findings will 
be used for analysis. 
7 
ADVERSE EVENTS 
To comply with worldwide standards and guidelines on clinical investigation adverse event reporting, the 
Sponsor has adopted uniform and worldwide applicable standard definitions and reporting timelines to be 
used and adhered to by the investigators.  
 
7.1 Definitions 
7.1.1 Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the medical device used in this study. 
 
Note 1: This definition includes events related to the medical device(s) used in this study. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical devices used 
in this study. 
7.1.2 Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
 
a) Led to a death, 
b) Led to a serious deterioration in health of the subject, that either resulted in  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient hospitalization or prolongation of existing hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or injury or permanent 
impairment to a body structure or a body function. 
5. chronic disease  
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: A planned hospitalization for pre-existing condition, or a procedure required by the CIP, without a 
serious deterioration in health, is not considered to be an SAE. 
 

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7.2 Device Relationship 
Determination of whether there is a reasonable possibility that a device used in this study caused or 
contributed to an AE is to be determined by the Investigator and recorded on the appropriate CRF 
form. Determination should be based on assessment of temporal relationships, evidence of alternative 
etiology, medical/biologic plausibility, and patient condition (pre-existing condition). 
 
7.2.1 Adverse Device Effect (ADE) 
The following definition will be used to categorize non-serious procedure or device-related AEs: 
 
• 
An adverse event related to the use of a device used in this study. 
• 
This definition includes adverse events resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation, or operation, or any malfunction of the medical 
device used in this study. 
• 
This definition includes any event resulting from the use error or from intentional misuse of the 
medical device used in this study. 
 
7.2.2 Serious Adverse Device Effect (SADE) 
The following definition will be used to categorize serious procedure or device-related AEs: 
 
• 
Adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event. 
• 
This definition includes events related to the medical device used in this study. 
7.3 Safety Reporting 
7.3.1 Adverse Event Reporting 
Safety surveillance and reporting starts for each subject as soon as the subject is enrolled in the clinical 
study and will continue until the subject’s 12-month follow-up visit has been performed, the subject is 
deceased, the subject concludes participation in the clinical study, or the subject withdraws from the 
clinical study. All device effects regardless of severity (ADEs and SADEs) and cardiovascular SAE data, 
will be collected throughout the time period defined above and will be reported to the Sponsor on the 
Adverse Event CRF. Additional information with regard to an adverse event and death should be 
updated within the appropriate CRF.  
 
Recurrence of AF, AFL, or AT in subjects treated for PersAF or recurrence of VT in subjects treated for 
VT are not considered reportable adverse events unless they occur in severity, frequency, or other 
manner that is significantly worse than the subject’s baseline condition. Recurrence of arrhythmia will be 
reported as part the descriptive endpoints and will be reported on the Follow-Up Visit CRF.  
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be reported.  
 
7.3.2 SAE Reporting 
The investigator should report all cardiovascular SAEs to the Sponsor as soon as possible but no later 
than outlined below.  
 

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8.6 Multiplicity 
No hypothesis testing will be performed; therefore, no adjustments will be made for multiplicity in the 
endpoint analyses.  
8.7 Procedures for Accounting for Missing Data 
Every effort will be made to collect all required data. All data available for the endpoints specified among 
the analysis population will be used. Missing data will not be imputed. Kaplan-Meier analysis will censor 
subjects withdrawn or otherwise lost-to-follow-up at last known visit. 
8.8 Planned Interim Analysis 
An interim analysis of acute descriptive endpoints related to the use of HD Grid and the Precision system 
with HD Wave will be performed when 250 subjects have been enrolled and completed the procedure 
visit and related data collection. 
8.9 Statistical Criteria for Termination 
There are no statistical criteria for termination of this clinical study. 
8.10 Success Criteria 
Pass/Fail criteria do not apply to this study.   
8.11 Deviations from Statistical Plan 
Any major changes or less significant changes to the planned statistical analyses will be documented in 
the final report.   
8.12 Analysis of Baseline Data 
Tables will be created to define the study population at baseline. Tables will include demographics, 
physical examination, cardiac history, arrhythmia history, 12-lead ECG, antiarrhythmic/anticoagulant 
medication use, and QOL data. 
8.13 Analysis of Quality of Life 
The EQ-5D/AFEQT questionnaires will be analyzed for subjects treated for Persistent AF, and the EQ-
5D/HADS questionnaires will be analyzed for subjects treated for VT.  Data will be assessed at baseline 
and then at 6 and 12 months. Data will be compared at each assessment interval to the baseline score.   
 
8.14 Poolability Assessment 
An analysis will be conducted to determine if there is a site bias on descriptive endpoint analyses 
including acute-and long-term outcomes, procedure time, RF time, fluoroscopy time, and mapping time.  
Sites enrolling small (one through five) and moderate (six through 15) numbers of subjects will be pooled 

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10.3.2 Training Required for the Use of the Device 
 
All investigators involved in the conduct of this clinical study will be qualified by education, training, or 
experience to perform their tasks and this training will be documented appropriately.  Each physician 
participating in the study procedure must have experience using HD Grid and EnSite Precision for 
PersAF and/or VT treatment prior to participation in the study.  
10.4 Monitoring 
 
It is the responsibility of the Sponsor to ensure the clinical study is conducted, recorded and reported 
according to the approved CIP, subsequent amendment(s), applicable regulations and guidance 
documents. 
 
Centralized monitoring will occur through routine internal data review. This monitoring is designed to 
identify missing and inconsistent data, data outliers, and potential CIP deviations that may be indicative 
of site non-compliance. On-site monitoring may occur at the discretion of the Sponsor. 
 
10.5 Deviations from CIP 
The Investigator should not deviate from the CIP for any reason except in cases of medical emergencies 
when the deviation is necessary to protect the rights, safety and well-being of the subject or eliminate an 
apparent immediate hazard to the subject. In that event, the Investigator will notify the Sponsor 
immediately by phone or in writing.  
 
No waivers for CIP deviations will be granted by the Sponsor.  All deviations must be reported to the 
Sponsor using the Deviation CRF. The occurrence of CIP deviations will be monitored by the Sponsor for 
evaluation of investigator compliance to the CIP and regulatory requirements and dealt with according to 
written procedures. Investigators will inform their IRB/EC or equivalent committee of all CIP deviations in 
accordance with their specific IRB/EC or equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or 
company representative will attempt to secure compliance by one or more of the following (and not 
limited to):  
• Visiting the investigator and/or delegate 
• Telephoning the investigator and/or delegate 
• Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the CIP or any other conditions of the clinical 
study may result in further escalation in accordance with the Sponsor’s written procedures, including 
securing compliance or, at its sole discretion, Sponsor may terminate the investigator's participation in 
the clinical study.  
10.6 Quality Assurance Audit 
A Sponsor representative or designee may request access to all clinical study records, including source 
documentation, for inspection during a Quality Assurance audit.  
 

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In the event that an investigator is contacted by a Regulatory Agency in relation to this clinical study, the 
Investigator will notify Sponsor immediately. The Investigator and Research Coordinator must be 
available to respond to reasonable requests and audit queries made during the audit process. The 
Investigator must provide Sponsor with copies of all correspondence that may affect the review of the 
current clinical study (e.g., Form FDA 483, Inspectional Observations, Warning Letters, Inspection 
Reports, etc.). Sponsor may provide any needed assistance in responding to regulatory audits. 
10.7 Committees 
10.7.1 Publications Committee 
 
A Publication Committee may be established to oversee clinical study publications, including publication 
planning and authorship determinations in alignment with the study publication plan. Publication 
Committee membership may include investigational site Principal Investigators, a representative of the 
Sponsor, and a statistician. The Publication Committee may determine policy and strategies regarding 
individual presentations and/or publications arising from clinical study generated data. The committee 
may also review all external requests for accessing clinical study-related data and strategies aligning with 
the Sponsor’s presentation and publication team expectations. The committee will also follow the 
Sponsor’s applicable policies and Standard Operating Procedures. 
 
11 DATA HANDLING AND RECORD KEEPING  
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used in data 
collection for the duration of the clinical study.  
 
CRF data collection will be performed through a secure web portal and only authorized personnel will 
access the Electronic Data Capture (EDC) system using a unique username and password to enter, 
review or correct data. Passwords and electronic signatures will be strictly confidential.   
 
The data will be subjected to consistency and validation checks within the EDC system and 
supplemental review by the Sponsor.    
 
At the conclusion of the clinical study, completed CRF images with the date-and-time stamped electronic 
audit trail indicating the user, the data entered, and any reason for change (if applicable) will be provided 
to the investigational sites, if requested.  
 
For the duration of the clinical study, the Investigator will maintain complete and accurate documentation 
including, but not limited to, medical records, clinical study progress records, laboratory reports, CRFs, 
signed ICFs, device accountability records (if applicable), correspondence with the IRB/EC and clinical 
study monitor/Sponsor, adverse event reports, and information regarding subject discontinuation or 
completion of the clinical study. 
11.1 Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
clinical study. The privacy of each subject and confidentiality of his/her information will be preserved in 
reports and when publishing any data. Confidentiality of data will be observed by all parties involved at all 
times throughout the clinical study. All data will be secured against unauthorized access. 

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11.2 Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data cleaning, and 
issuing and resolving data discrepancies. If appropriate, the DMP may be updated throughout the 
duration of the clinical study. All revisions will be tracked and document controlled. 
11.3 Source Documentation 
 
Regulations and GCP require the Investigator to maintain information in the subject’s original medical 
records that corroborates data collected on the CRFs. In order to comply with these regulatory 
requirements/GCP, the following information should be included in the subject record at a minimum and 
if applicable to the clinical study: 
• 
Medical history/physical condition of the subject before involvement in the clinical study sufficient 
to verify CIP entry criteria 
• 
Dated and signed notes on the day of entry into the clinical study referencing the Sponsor, CIP 
number, subject ID number and a statement that informed consent was obtained 
• 
Dated and signed notes from each subject visit (for specific results of procedures and exams) 
• 
Adverse events reported and their resolution, including supporting documents, such as discharge 
summaries, catheterization laboratory reports, ECGs, and lab results including documentation of 
site awareness of SAEs and of investigator assessment of device relationship for SAEs. 
• 
CIP-required laboratory reports and 12-lead ECGs, reviewed and annotated for clinical 
significance of out of range results (if applicable). It is acceptable to have labs and/or ECGs 
reviewed and annotated in the electronic medical record system for site’s that have these 
capabilities.  For those sites that do not have such capability, the labs and ECGs should be 
printed and signed by the investigator. 
• 
Notes regarding CIP-required and prescription medications taken during the clinical study 
(including start and stop dates) 
• 
Subject’s condition upon completion of or withdrawal from the clinical study 
• 
Any other data required to substantiate data entered into the CRF 
 
11.4 Case Report Form Completion 
 
Primary data collection based on source-documented hospital and/or clinic chart reviews will be 
performed clearly and accurately by site personnel trained on the CIP and CRF completion. The 
investigator will ensure accuracy, completeness, legibility and timeliness of the data reported to the 
Sponsor on the CRFs and in all required reports. Data on CRFs will be collected for all subjects that are 
enrolled into the clinical study.   
 
Only authorized site personnel will be permitted to enter the CRF data through the EDC system deployed 
by the Sponsor. An electronic audit trail will be used to track any subsequent changes of the entered 
data. 

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11.5 Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the clinical study as 
per the applicable regulatory record retention requirements. The Investigator must obtain permission 
from Sponsor in writing before destroying or transferring control of any clinical study records. 
 
 
12 ETHICAL CONSIDERATION 
 
12.1 Institutional Review Board/Medical Ethics Committee Review and Approval 
Institutional Review Board (IRB)/ Ethics Committee (EC) approval for the CIP, ICF, and other written 
information provided to the patient will be obtained by the Principal Investigator at each investigational 
site prior to consenting and enrolling patients in this clinical study. The approval letter must be received 
prior to the start of this clinical study and a copy must be provided to the Sponsor.  
 
Any amendments to the CIP as well as associated ICF changes will be submitted to the IRB/EC and 
written approval obtained prior to implementation, according to each institution’s IRB/EC requirements.  
 
No changes will be made to the CIP or ICF or other written information provided to the patient without 
appropriate approvals, including IRB/EC, the Sponsor, and the regulatory agencies (if applicable).  
 
Until the clinical study is completed, the Investigator will advise his/her IRB/EC of the progress of this 
clinical study, per IRB/EC requirements. Written approval must be obtained from the IRB/EC yearly to 
continue the clinical study, or according to each institution’s IRB/EC requirements.  
 
No investigative procedures other than those defined in this CIP will be undertaken on the enrolled 
subjects without the written agreement of the IRB/EC and the Sponsor. 
13 CLINICAL STUDY CONCLUSION 
The clinical study will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to investigators or the Sponsor has provided formal 
documentation of clinical study closure. 
14 PUBLICATION POLICY 
The data and results from the clinical study are the sole property of the Sponsor. The Sponsor shall have 
the right to access and use all data and results generated during the clinical study. The Investigators will 
not use this clinical study-related data without the written consent of the Sponsor for any purpose other 
than for clinical study completion or for generation of publication materials, as referenced in the Clinical 
Trial Agreement. Single-center results are not allowed to be published or presented before the multi-
center results. Any proposals for publications or presentations by the investigators must be submitted to 
the Sponsor for review and approval in a timely manner to enable Sponsor review in compliance with the 
Sponsor’s publication policy set forth in the Clinical Trial Agreement. 
 

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Publications or presentations of clinical study methods or results will adhere to Sponsor’s publication 
policy, which is based on Good Publication Practices and International Committee of Medical Journal 
Editors (ICMJE) guidelines. A copy of the policy will be provided upon request of the investigator. 
Investigators will be notified via email about the dissemination of study data and opportunities for 
involvement as authors on publications/presentations.  
 
The Sponsor will be responsible for determining whether to register the clinical study on 
www.clinicaltrials.gov or any other clinical trials, in accordance with the International Committee of 
Medical Journal Editors guidelines, or any other applicable guidelines. In the event Sponsor determines 
that the clinical study should be registered, Sponsor shall be responsible for any such registration and 
results posting as required by the ClinicalTrials.gov website. Institution and/or Principal Investigator(s) 
shall not take any action to register the clinical study. 
15 RISK ANALYSIS 
 
The risks associated with HD Grid mapping system can be found in the appropriate Instructions for Use. 
The clinical study does not require additional procedures or assessments beyond what could be 
considered standard of care. There are no additional risks introduced to subjects due to participation in 
this study.  
15.1 Foreseeable Adverse Events and Anticipated Adverse Device Effects 
Refer to applicable IFU for list of Anticipated Adverse Device Effects. There may be risks related to the 
devices used in this study that are unknown at present.  Likewise, the exact frequency of the risk may be 
unknown. 
15.1.1 Risks Associated with Participation in this Clinical Study 
Risks to subjects enrolled in this clinical study include those risks currently associated with other 
commercially available electrophysiology diagnostic procedures and RF catheter ablation procedures. 
The risks of the procedure are related primarily to mechanical injury to the heart and vessels from 
catheter manipulation and thermal injury due to RF current delivery, including the risk of 
thromboembolism and myocardial perforation, especially for ablations in the left atrium.  
For those procedures where the physician applies sedation or anesthesia, the standard risks of 
anesthesia also exist and include allergic reactions, pneumonia, aspiration pneumonitis, atelectasis, 
prolonged sedation, other medical complications and in very rare cases, death.  
15.1.2 Steps Taken to Control or Mitigate Risks 
Every possible effort will be taken to minimize the risks, including: 
• 
Careful selection of experienced Investigators for the study  
• 
Training of Investigators and other applicable site personnel on the CIP 
• 
Conducting the clinical study in accordance with the CIP, all applicable laws and regulations and 
any conditions of approval imposed by the appropriate IRB/EC or applicable regulatory 
authorities where the clinical study is performed 
• 
Preparation of the all devices in accordance with device IFU, and conducting the ablation 
procedures in accordance with the IFU of corresponding devices 

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15.2 Possible Interactions with Concomitant Treatments 
There are no known interactions with concomitant treatments. 
 
15.3 Anticipated Benefits 
The aim of this study is to quantify and characterize the utility and outcomes of ablation after 
electroanatomical mapping with HD Grid and EnSite Precision with HD Wave in subjects with PersAF or 
VT in real-world clinical settings. 
The information collected in this clinical study will be added to the current knowledge and understanding 
of high-density electroanatomical mapping and treatment options for patients with arrhythmias. Subjects 
participating in this clinical study are not expected to experience any additional benefit or harm compared 
to patients who are not participating in this clinical study as the clinical study will follow local standard 
practice.  
15.4 Risk to Benefit Rationale 
Use of HD Grid mapping system to facilitate electroanatomical mapping in the heart is believed to not 
introduce any unanticipated risks compared to current practice. Catheter ablation is a recognized safe 
and effective treatment of cardiac arrhythmias.  
16 REFERENCES 
 
1. 
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, 
Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, 
d'Avila A, de Groot N, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, 
Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman 
WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, 
Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, 
Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, 
Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 hrs/ehra/ecas/aphrs/solaece expert 
consensus statement on catheter and surgical ablation of atrial fibrillation. Heart rhythm. 
2017;14:e275-e444 
2. 
Parkash R, Verma A, Tang AS. Persistent atrial fibrillation: Current approach and controversies. 
Current opinion in cardiology. 2010;25:1-7 
3. 
European Heart Rhythm A, Heart Rhythm S, Zipes DP, Camm AJ, Borggrefe M, Buxton AE, 
Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, 
Roden DM, Silka MJ, Tracy C, Smith SC, Jr., Jacobs AK, Adams CD, Antman EM, Anderson JL, 
Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, 
Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, 
Morais J, Osterspey A, Tamargo JL, Zamorano JL, American College of C, American Heart 
Association Task F, European Society of Cardiology Committee for Practice G. Acc/aha/esc 2006 
guidelines for management of patients with ventricular arrhythmias and the prevention of sudden 
cardiac death: A report of the american college of cardiology/american heart association task 
force and the european society of cardiology committee for practice guidelines (writing committee 
to develop guidelines for management of patients with ventricular arrhythmias and the prevention 
of sudden cardiac death). Journal of the American College of Cardiology. 2006;48:e247-346 
4. 
Pedersen CT, Kay GN, Kalman J, Borggrefe M, Della-Bella P, Dickfeld T, Dorian P, Huikuri H, 
Kim YH, Knight B, Marchlinski F, Ross D, Sacher F, Sapp J, Shivkumar K, Soejima K, Tada H, 
Alexander ME, Triedman JK, Yamada T, Kirchhof P, Lip GY, Kuck KH, Mont L, Haines D, Indik J, 

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Dimarco J, Exner D, Iesaka Y, Savelieva I. Ehra/hrs/aphrs expert consensus on ventricular 
arrhythmias. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of 
the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the 
European Society of Cardiology. 2014;16:1257-1283 
5. 
Saini A, Huizar JF, Tan A, Koneru JN, Ellenbogen KA, Kaszala K. Scar homogenization in atrial 
fibrillation ablation: Evolution and practice. Journal of atrial fibrillation. 2017;10:1645 
6. 
Rolf S, Hindricks G, Sommer P, Richter S, Arya A, Bollmann A, Kosiuk J, Koutalas E. 
Electroanatomical mapping of atrial fibrillation: Review of the current techniques and advances. 
Journal of atrial fibrillation. 2014;7:1140 
7. 
Aziz Z, Tung R. Novel mapping strategies for ventricular tachycardia ablation. Current treatment 
options in cardiovascular medicine. 2018;20:34 
8. 
Bellmann B, Luker J, Steven D, Sultan A. First epicardial mapping of the left ventricle using the 
advisor hd grid catheter. Journal of interventional cardiac electrophysiology : an international 
journal of arrhythmias and pacing. 2018 
9. 
Bellmann B, Plenge T, Sultan A, Steven D. First endocardial mapping of the left ventricle using 
the advisortm hd grid catheter in a patient with a mitral valve clip. European heart journal. 2018 
 
 

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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
Acronym/Abbreviation 
Description 
AAD 
Antiarrhythmic drug 
AE 
Adverse event 
AF 
Atrial fibrillation 
AFEQT 
Atrial Fibrillation Effect on QualiTy of Life  
AFL 
Atrial flutter 
AT 
Atrial tachycardia 
CEC 
Clinical Events Committee 
CIP 
Clinical investigation plan 
CRF 
Case report form 
CRT-D 
Cardiac resynchronization therapy defibrillator 
DMP 
Data Management Plan 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
EDC 
Electronic data capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICD 
Implantable cardioverter defibrillator  
ICF 
Informed Consent form 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
LAD 
Left atrial diameter 
LVEF 
Left ventricular ejection fraction 
MI 
Myocardial infarction 
NYHA 
New York Heart Association 
PCI 
Percutaneous coronary intervention 
PV 
Pulmonary vein 
PVI 
Pulmonary vein isolation 
QOL 
Quality of Life 
RF 
Radiofrequency 
SAE 
Serious adverse event 
SE 
Sensor enabled 
SOC 
Standard of Care 
TIA 
Transient ischemic attack 
UADE 
Unanticipated adverse device effect 
VT 
Ventricular tachycardia 
 
 

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APPENDIX II: CASE REPORT FORMS 
The Final CRFs will be kept under a separate cover and are available upon request. 
 

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APPENDIX III: SITE CONTACT INFORMATION 
Contact information for each participating clinical site is available under separate cover by 
contacting the Sponsor. 
 
 

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APPENDIX IV: INFORMED CONSENT FORM 
A template informed consent form will be provided under a separate cover and will be available 
upon request.