A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using Electrographic Flow (EGF™) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation in Real-world Setting.
Conditions: Atrial Fibrillation, Persistent, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases
Sponsor: Ablacon, Inc.

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AF-FLOW Registry 
A post market, global registry to evaluate the identification of Atrial Fibrillation 
sources using the Ablamap Electrographic FLOW (EGF) Mapping System to 
guide ablation therapy in patients with Atrial Fibrillation 
 
Sponsor: 
  
 
Ablacon, Inc. 
 
Business Address: 
4800 Wadsworth Blvd, Suite 310 
80033 Wheat Ridge, CO USA  
Protocol No: 
 
CP-003 
Date:   
 
 
May 3, 2022 
Product: 
 
 
Ablamap® Electrographic Flow Software 
Revision Number: 
REV A 
Sponsor Contact:   
Patty Hevey 
 
 
 
 
Ablacon, Inc. 
 
 
 
 
Patty.hevey@ablacon.com 
 
 
 
 
+1.650.222.3666 
 
Principal Investigator:   Kent Nilsson, MD, Piedmont Athens Hospital  
Atul Verma, MD, Southlake Regional Health Center 
 
 
 
 
 
Study Management: 
Ablacon, Inc. 
 
 
 
  
 
 
 
 
CONFIDENTIAL:  The contents of this document are proprietary and confidential. This protocol 
contains valuable engineering, clinical and commercial information which must not be disclosed to 
potential competitors. Duplication and distribution of this document requires prior approval from Sponsor. 
 
 

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  PROTOCOL SUMMARY 
Objective 
This post-market global registry will evaluate the ability of the 
Ablamap® Software to identify atrial fibrillation sources and guide 
ablation therapy in patients with atrial fibrillation 
Test Device 
Ablacon Electrographic Flow (EGF) algorithm technology 
(Ablamap® Software) 
Study Design 
Post-market, prospective, multi-center, global registry  
Planned Subject Sample 
Size 
Up to 100 subjects  
No. of Sites 
Subjects will be enrolled at up to ten (10) investigational sites in 
Europe and United States 
Primary Efficacy 
Endpoint 
Acute procedure success defined as the ability to successfully ablate 
AF sources identified by the Ablamap Software  
Secondary Efficacy 
Endpoints 
Freedom from documented episodes of AF recurrence following the 
blanking period (90 days post-ablation) through 12 months  
Inclusion Criteria 
 
1. Suitable candidate for intra-cardiac mapping and ablation of 
arrhythmias. 
2. Above eighteen (18) years of age or of legal age to give 
informed consent specific to state and national law.   
3. Subjects with a history of documented symptomatic atrial 
fibrillation. 
Exclusion Criteria 
1. Subjects who are not candidates for cardiac ablation 
procedures. 
2. Pregnant or nursing.  
3. Presence of 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 investigation or comply with 
follow-up requirements.   
 
Follow-Up Schedule 
Follow-up Visit 
Schedule 
Subject Visit Description 
Timeframe / Visit Window 
Ablation Procedure 
Day 0 
12 Month Follow-Up 
365 ± 45 days 
Unscheduled Visits 
As needed/necessary for AF recurrences 
 
 
 

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Table of Contents 
PROTOCOL SUMMARY ............................................................................................... 2 
1. 
INTRODUCTION................................................................................................. 5 
2.1 TEST DEVICE DESCRIPTION ................................................................................ 6 
2.2  JUSTIFICATION OF TRIAL DESIGN ...................................................................... 7 
2.3  INDICATIONS FOR USE ....................................................................................... 7 
2.4  INTENDED USE .................................................................................................. 7 
2.5  POTENTIAL RISKS AND BENEFITS ...................................................................... 7 
2.5.1 ANTICIPATED RISKS ASSOCIATED WITH THE ABLAMAP SOFTWARE ............. 7 
2.5.2 RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY ............. 7 
2.5.3 ANTICIPATED BENEFITS ............................................................................... 7 
3. 
STUDY PROTOCOL ........................................................................................... 8 
3.1 
OBJECTIVE ................................................................................................... 8 
3.2 
STUDY ENDPOINTS ....................................................................................... 8 
3.3 
STUDY DESIGN ............................................................................................ 8 
3.4 
ENROLLMENT/SCREEN FAILURES ................................................................ 8 
3.5 
SUBJECT FOLLOW-UP ................................................................................... 8 
3.6 
STATISTICAL ANALYSIS ............................................................................... 8 
4 
SUBJECT SELECTION ...................................................................................... 9 
4.1 
PATIENT SELECTION-CRITERIA FOR ELIGIBILITY ......................................... 9 
4.2 
STUDY INCLUSION CRITERIA ..................................................................... 10 
4.3 
STUDY EXCLUSION CRITERIA .................................................................... 10 
5 
DATA COLLECTION ....................................................................................... 10 
5.1 
INFORMED CONSENT .................................................................................. 10 
5.2 
BASELINE DATA ........................................................................................ 10 
5.3 
PRE-PROCEDURE REQUIREMENTS .............................................................. 11 
5.4 
GENERAL PROCEDURAL RECOMMENDATIONS ........................................... 11 
5.5 
EGF PROCEDURE ....................................................................................... 11 
5.6 
BLANKING PERIOD ..................................................................................... 14 
5.7 
FOLLOW-UP VISITS .................................................................................... 14 
5.7.1 12-MONTH FOLLOW-UP ............................................................................ 14 
5.8 
SCHEDULE OF EVENTS ............................................................................... 14 
5.9 
SUBJECTS LOST TO FOLLOW-UP ................................................................ 16 
5.10 
SUBJECT WITHDRAWALS AND DISCONTINUATIONS ................................... 16 
5.11 
EARLY TERMINATION OF CLINICAL INVESTIGATION .................................. 16 
5.12 
ADVERSE EVENT REPORTING..................................................................... 17 
5.13 
ASSESSMENT OF ADVERSE EVENT SEVERITY ............................................. 19 

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5.14 
RELATIONSHIP TO THE DEVICE: ................................................................. 20 
5.15 
ANTICIPATED ADVERSE EVENTS AND DEVICE EFFECTS ............................ 20 
5.16 
DEVICE DEFICIENCIES ................................................................................ 20 
6 
REGULATORY CONSIDERATIONS ............................................................ 20 
6.1 
INVESTIGATOR RESPONSIBILITIES .............................................................. 21 
6.2 
CONFIDENTIALITY AND DATA PROTECTION ............................................... 21 
6.3 
INSURANCE ................................................................................................ 21 
6.4 
PROTOCOL AMENDMENTS .......................................................................... 21 
6.5 
STUDY REPORTS ........................................................................................ 21 
6.6 
MONITORING ............................................................................................. 22 
7 
PUBLICATION POLICY .................................................................................. 22 
8 
ABBREVIATIONS AND DEFINITIONS ........................................................ 22 
8.1 
TABLE OF ABBREVIATIONS ........................................................................ 22 
REFERENCES ................................................................................................................ 24

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1.  INTRODUCTION 
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with increased 
mortality, morbidity and impaired quality of life. Catheter ablation has become the standard of 
care for symptomatic patients with drug-refractory AF and the cornerstone of ablation remains 
the electrical isolation of the pulmonary veins (pulmonary vein isolation = PVI).1 For patients 
with paroxysmal AF, long-term effectiveness of an approach based on PVI as the sole ablation 
strategy is reported to be 81.6% at 12 months, 73.8% at 24 months, and 68.1% at 36 months 
post-ablation.2 However, the success rate of PVI for patients with persistent AF is significantly 
lower with rates of freedom from AF at 12 months post-ablation ranging from 51 up to 60% 
regardless of the catheter ablation strategy, addition of antiarrhythmic drugs, use of cryoballoon 
v. RF ablation, or lesion set performed.3-6  This ceiling of efficacy in the persistent AF 
population may be attributable to the complex functional mechanisms of AF contributing to an 
individual patient’s disease state.   
Beyond the pulmonary vein triggers, the development and persistence of AF depends upon a 
localized source—a trigger or driver as well as susceptible substrate, such as re-entrant circuits 
and or regions of fibrotic atrial myocardium with abnormal conduction properties.1,7,8 After 
pulmonary vein isolation has been performed, accurate, enhanced mapping techniques that can 
localize extra-PV drivers/triggers is needed to further guide the next step in the ablation strategy.  
Efforts to hone in on AF mechanisms underlying persistent AF have multiplied and several 
different methods for identifying these localized sources have been put forth using global or 
panoramic mapping techniques.9-12  However, due to the chaotic nature of the intracardiac 
electrograms (EGMs) characteristic of AF, identifying active focal sources relevant to the initiation 
and maintenance of AF has remained challenging.  
Electrographic Flow (EGF) Mapping (Ablamap® Software, Ablacon, Wheat Ridge, CO) is an 
innovative technique to create full temporospatial visualizations of organized cardiac action 
potential flow within the chaotic conduction of AF that can discriminate between active sources 
of excitation and passive rotations, which do not generate action potentials; and can estimate the 
average activity of such a source during a time interval such as one minute.11 It has been shown 
that only those sources that are generating excitation and that are active more than a quarter of the 
time are significant predictors for AF recurrence after PVI.12 Using a 64-electrode basket mapping 
catheter, the software collects unipolar intracardiac EGMs.  These EGMS are then processed using 
a proprietary algorithm employing Green’s energy-optimizing formula to create a smooth 
landscape of voltage potentials for each sample point in time.  An optical flow mapping algorithm 
is then applied to assemble these snapshots into a continuous recording of the excitation waves’ 
behavior and propagation over time.  The software also displays the dominant patterns of the 
excitation wave propagation recordings as vector flow maps, whose consistency over time can be 
measured and statistically analyzed (Figure 1): 
 
 
 

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Figure 1: Methodology of EGF Mapping 
 
 
Ablacon has recently completed enrollment in the first randomized, controlled, clinical study to 
evaluate the Ablamap Software (FLOW-AF Study, NCT:  NCT04473963). A total of  85 subjects 
were enrolled across four European centers. All subjects are being followed through twelve 
months, and the results will be available in late 2022.  
The goal of this registry is to continue to evaluate the Electrographic Flow mapping software for 
identifying AF sources in patients to optimize ablation success in a real-world setting. 
2.1 Test Device Description 
The Ablamap Software is an electrophysiological mapping software application designed to 
analyze the flow of excitation in cardiac tissue. The software uses an optical flow algorithm to 
process recorded files of electrocardiogram (ECG) signals from multiple-electrode mapping 
catheters (e.g., basket catheters) by transforming the time domain waveform information from all 
electrodes into space domain information and calculating velocity vectors of the electrographic 
action potential flow (EGF) for each point in space.  
 
The output is a set of files that graphically depict flow directions (velocity vectors) and sources 
where the flow is generated. The software discriminates between sources that may be focal or 
rotational and passive rotations that are not sources; detects spatial and temporal stability of 
sources; and defines the activity of sources as the percentage of time a source is at its maximum 
stability.  
 
The Ablamap Software is stand-alone software installed on a standard, commercially available 
desktop or laptop computer. The software processes ECG data files that have been saved on a USB 
memory device, the computer, or a data server. The software does not control or interface with any 
medical device. There is no user or patient contact.  
 

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2.2  Justification of Trial Design 
The AF-FLOW Registry is a global post-market registry being conducted to collect clinical data 
to further characterize the performance of the Ablamap Software for its intended use. We also 
intend to continue to clinically validate the ability of the Ablamap Software to identify AF sources 
and guide ablation therapy in patients with atrial fibrillation.    
2.3  Indications for Use 
The Ablamap Software is used to analyze intra-cardiac electrogram (EGM) signals and display 
results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex 
cardiac arrhythmias. 
2.4  Intended Use 
The Ablamap Software is intended to be used during electrophysiology procedures on patients for 
whom an electrophysiology procedure has been prescribed and only by qualified medical 
professionals trained in electrophysiology. 
The Ablamap Software is CE-marked and FDA 510(k) cleared for use in the EU and United States.   
2.5  Potential Risks and Benefits 
2.5.1 Anticipated Risks associated with the Ablamap Software 
There are no patient or user safety issues or hazards identified for the Ablamap Software in the 
clinical data analyzed within a comprehensive literature review and the FLOW-AF Clinical 
Study. Internal data generated as part of the risk analysis of the Ablamap Software indicates 
there were no patient or user safety issues or hazards identified. 
The Ablamap Software Safety Classification per BS EN 62304:2006+A1:2015 is Safety Class 
A where the hazard probability is Improbable and the hazard severity is Negligible.   
Current market experience shows no evidence to suggest that the Ablamap Software poses any 
safety issues or any hazards and there are no safety issues or hazards that outweigh the benefits 
of the system. 
2.5.2 Risks Associated with Participation in the Clinical Study 
There is no foreseen increased risk to subjects for participating in the clinical study.  
 
2.5.3 Anticipated Benefits 
The benefit to the subjects enrolled in this study is the potential for improved judgement by the 
clinician due to the additional information provided by the Ablamap software.  Specifically, the 
software analyses will guide and support physicians to enable targeted ablation techniques that 
may improve acute and long-term clinical outcomes.     

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3. STUDY PROTOCOL 
3.1  Objective 
The objective of this global post-market registry is to obtain clinical data in order to further 
characterize the performance of the Ablamap System for its intended use. Specifically, we will 
evaluate the ability of the Ablamap Electrographic Flow (EGF) System to identify AF sources and 
guide ablation therapy in patients with atrial fibrillation.    
3.2 Study Endpoints 
• Primary Efficacy Endpoint: Acute procedure success defined as the ability to successfully 
ablate AF sources identified by the Ablamap Software. 
• Secondary Efficacy Endpoint: Freedom from documented episodes of AF recurrence 
following the blanking period (90 days post ablation) through 12 months. 
3.3 Study Design   
The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain 
clinical data in order to characterize the performance of the Ablamap Software for its intended use 
in a real-world setting.  Specifically, we will evaluate the ability of the Ablamap Software to 
identify AF sources and guide ablation therapy in patients with atrial fibrillation.  This registry 
will enroll up to 100 subjects.  Subjects that present with atrial fibrillation and meet 
inclusion/exclusion criteria will be eligible for enrollment.     
3.4 Enrollment/Screen Failures 
A subject is considered enrolled after signing the informed consent.  All enrolled subjects will then 
proceed to complete the screening and baseline tests.  
3.5 Subject Follow-up 
All subjects will be followed per protocol in relation to the date of the index ablation procedure.  
Follow up will be required at 12 months (±45 days) post index ablation procedure. If a subject 
presents at any time during the 12-month follow-up period with recurrence of AF, the subject will 
be eligible for an EGF-guided ablation procedure. The follow-up schedule will remain the same 
and will not be reset if the patient requires a recurrence procedure.     
   
Note:  If any recurrences occur between any study procedures, cardioversion is allowed as 
often as needed.  The number of cardioversions for each subject will be counted and reported.   
 
3.6 Statistical Analysis 
The primary efficacy endpoint of this registry is the successful elimination of significant sources 
of excitation. Target parameter is the activity of the leading source. According to the retrospective 
data analyzed previously, the critical threshold for significance of a source is an activity of 26%.  

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Significance of the leading source will be tested in each patient at multiple times, in every 
procedure performed, in both atria, before and after PVI or PV touch-up and before and after 
ablation. The effect of targeted ablation will be statistically analyzed by determining the rate of 
reduction of leading source activity below threshold upon ablation. If an ablation is not 
successfully reducing the activity or if the location of the leading source changes upon ablation, 
ablation will be repeated.  
The secondary endpoint of the study is freedom from documented episodes of AF recurrence 
following the blanking period (90 days post ablation) through 12 months. 
We will analyze the level of significance of this difference based on the patients with sources 
above threshold that were successfully ablated and remained AF free versus those patients where 
no sources or sources below threshold were seen but were not ablated.    
Descriptive summary statistics for continuous variables will include the number of subjects, mean, 
standard deviation or standard error, median, minimum, and maximum. Nominal categorical 
variables will be summarized using counts and percentages. Ordinal variables may be analyzed as 
if they were continuously scaled. Subject disposition, the number and percentage of subjects who 
complete and discontinue as well as reasons for early discontinuation will be presented. 
Demographic and baseline characteristics will be summarized descriptively.  
 
4 SUBJECT SELECTION 
4.1 Patient Selection-Criteria for Eligibility 
Subjects enrolled in the AF-FLOW Registry should be selected from the investigators’ general 
patient population with a history of atrial fibrillation that meet eligibility criteria. Patient selection 
may also be performed by review of the medical records of those subjects who have had prior AF 
treatment with ablation therapy.  Investigators are responsible for screening all potential subjects 
and selecting those who meet the eligibility criteria for the study.   
 
 

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4.2 Study Inclusion Criteria 
Subjects must meet ALL the following criteria: 
1. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias. 
2. Above eighteen (18) years of age or of legal age to give informed consent specific to state 
and national law.  
3. History of documented symptomatic atrial fibrillation. 
4.3 Study Exclusion Criteria 
Candidates will be excluded from the study if any of the following apply: 
1. Subjects who are not candidates for cardiac ablation procedures. 
2. Pregnant or nursing.  
3. Presence of 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 investigation or comply with follow-up requirements.   
5 DATA COLLECTION  
5.1 Informed Consent 
All subjects who meet all inclusion criteria and agree to participate in the AF-FLOW Registry will 
be asked to sign an Informed Consent Form after an explanation of the risks and potential benefits 
have been provided. Informed consent must be obtained from each subject prior to conducting any 
study related procedures including screening procedures that are not part of the standard of care at 
the institution.   
5.2 Baseline Data 
Subject source data will be collected per the relevant worksheets, medical reports, procedural 
reports, lab reports and any other original document in the study subject’s chart. In case of 
electronic source data, accessible without audit trail, printouts have to be produced, verified, and 
confirmed. Source data will be transferred to CRFs.  
 
After eligible subjects have signed an informed consent form and before the scheduled 
interventional procedure, subjects will undergo a baseline evaluation. This evaluation may be 
conducted in accordance with the hospital’s standard of care procedures.  
The evaluation will include but not limited to the following:  
• Medical History and Physical Exam: 
o Subject Demographics  
o Baseline Physical Assessment 
▪ Height and weight 
▪ Resting blood pressure 
▪ Resting heart rate 
o Medical History  

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▪ History and documentation of AF  
▪ NYHA score 
▪ CHA2DS2-VASc score  
▪ Cardiovascular or other medical history as it pertains to eligibility criteria 
▪ Smoking history 
o Medication History 
▪ Class I-IV AAD history, current doses and/or failure or intolerance 
▪ Other:  Anticoagulants and other cardiac medications 
• Baseline Imaging  
o Baseline imaging to rule out LA/LAA thrombus may be done at time of procedure 
or up to 48 hours prior to the start of any study procedure; however, if any 
evidence of left atrial thrombus is discovered, the ablation procedure will not be 
performed at that time. The subject may either be excluded from the study or 
maintained on oral anticoagulation for an additional period of time (at 
investigator’s discretion).  Repeat imaging to rule out thrombi will be required 
prior to study procedure.  
o A new echocardiogram (transthoracic or transesophageal) should be performed 
prior to ablation procedure if one has not been performed within six months of the 
enrollment procedure or if previous data is not available. 
5.3 Pre-Procedure Requirements 
Subjects should stop all AADs 48 hours prior to the procedure and be appropriately anticoagulated.  
Regular amiodarone use should be discontinued at least 1 month prior to the index ablation 
procedure and not restarted after the ablation procedure.  
5.4 General Procedural Recommendations 
The ablation procedures (including patient preparation, fluid, ACT, and access site management) 
should be performed per the institution’s standard EP lab protocol. All procedure logistical data, 
ablation parameters, procedural outcomes, and adverse events, will be recorded throughout the 
procedure. Prophylactic administration of intravenous diuretics during or after the procedure is 
allowed and will not be considered an adverse event.   
5.5 EGF Procedure 
The procedure should begin by verifying the effectiveness and durability of the prior PVI for redo 
subjects or a complete PVI for de novo subjects.  Adenosine or isoproterenol may be administered 
following the PVI to detect dormant reconnections.  If pharmacologic challenge is not used to 
detect dormant reconnections, a 20-minute wait following the last RF application for PVI should 
be performed. A commercially available, 64-electrode basket catheter will be introduced into both 
the right and left atria and unipolar electrograms from the basket catheter will be recorded for one 
minute each.  Recordings are then analyzed with the Ablamap Software. If no sources are seen, or 
only sources below threshold are detected, the basket should be repositioned until the physician is 
confident adequate endocardial anatomical coverage has been achieved. If sources above threshold 

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are seen, the patient proceeds to ablation. For those subjects that have no identifiable sources or 
sources below threshold, the investigator may choose to ablate those subjects per their standard 
ablation practices.   
Once the baseline (i.e., post PVI/PVI touch up) EGF maps are complete, the targeted AF source 
ablations will be determined according to the results of the EGF analysis using a pre-specified 
threshold. Ablations should be performed using standard, commercially available ablation 
catheters/systems. 3D-electroanatomical mapping of both atria will be performed using standard, 
commercially available mapping systems.  
High density bi-atrial voltage mapping using a commercially available multipolar diagnostic 
mapping catheter during the ablation procedure is required and will be collected for analysis.  
EGF mapping should be repeated in the RA and the LA until no further EGF sources above 
threshold are identified. If AF persists after completion of ablations, cardioversion should be 
performed. 
 
 

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Figure 2. Workflow for portion of procedure involving EGF-Guided ablation following 
pulmonary vein isolation 
 
 
 

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5.6 Blanking Period 
The blanking period is the 90-day period following the index ablation procedure.   During the 
blanking period, repeat ablation should not be performed; however, cardioversion may be done 
at the discretion of the investigator.  If the subject has a recurrence of AF during the 
blanking period and is placed on AADs, they should be discontinued from the AADs 90 
days post ablation. 
5.7 Follow-up Visits 
Investigators should follow their standard practices for following subjects post ablation.  The AF-
FLOW Registry will formally collect baseline demographics, medical history, ablation procedural 
data and 12-month follow-up visit data.   
If a subject returns at any time within the 12-month follow-up period with evidence of AF 
recurrence, the data will be collected on an Unscheduled Visit CRF.   
5.7.1 12-Month Follow-Up 
All subjects must be evaluated at twelve months (365 +/- 45 days) after the index ablation 
procedure.  
During this follow-up, the following will be performed: 
• Any previously unreported AF recurrences since the index ablation procedure (or 
cardioversion or repeat ablation procedure for previous AF recurrence). 
• Any medication changes (AADs, anticoagulants, and other cardiac medications) 
• Perform a 12-lead ECG  
• Complete the Study Completion CRF 
5.8 Schedule of Events 
The tests and measurements to be conducted at baseline, during the treatment procedure, and 
during follow-up visits are illustrated in the following chart: 
 
 

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Schedule of Events 
Schedule of 
Tests: 
Baseline 
Assessment 
Index Ablation 
Procedure 
Discharge 
12 Months 
(+/- 45  
days) 
Informed 
Consent 
X 
-- 
-- 
-- 
Eligibility 
Criteria 
X 
-- 
-- 
-- 
Pre-ablation 
Cardiac MRI* 
X 
-- 
-- 
-- 
High Density 
Voltage 
Map(s) 
-- 
X 
-- 
-- 
Medical 
History and 
Demographics 
X 
-- 
-- 
-- 
Baseline 
Physical Exam 
X 
-- 
-- 
-- 
Medication 
Assessment 
X 
X 
X 
X 
ECG 
X 
-- 
X 
X 
Adverse Events 
-- 
X 
X 
X 
Procedural 
Data 
-- 
X 
-- 
-- 
Protocol 
Deviations 
X 
X 
X 
X 
*If performed as part of the investigator’s standard of care. 

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5.9 Subjects Lost to Follow-Up 
The investigator will attempt to contact a subject at least three times prior to designating them as 
lost-to-follow-up subjects; two of these attempts should include attempting to contact subject via 
registered mail.  The investigator will document the date and type of attempted communication 
and will complete the Study Exit/Completion Form when a subject is confirmed lost to follow-
up.  
5.10 
Subject Withdrawals and Discontinuations 
Subjects have the right to withdraw from the clinical investigation at any time and for any reason 
without prejudice to their future medical care by the investigation team or investigation site. The 
investigator will ask for the reason for their withdrawal and will record all information regarding 
the subject discontinuation on the Study Exit/Completion Case Report Form.  
5.11 
Early Termination of Clinical Investigation 
Both the Sponsor and Investigator reserve the right to terminate the clinical investigation at any 
time.  
The Sponsor may suspend or prematurely terminate either a clinical investigation or the entire 
clinical investigation for significant and documented reasons. Such reasons are as follows: 
• If suspicion of an unacceptable risk to subjects arises during the clinical investigation, 
or when so instructed by the EC/IRB or regulatory authorities, the sponsor may suspend 
the clinical investigation while the risk is assessed. The sponsor may terminate the 
clinical investigation if an unacceptable risk is confirmed. 
• Monitoring or auditing identifies serious or repeated deviations on the part of an 
investigator. 
After review of the clinical safety data, the Sponsor and Investigator may agree to terminate the 
clinical investigation if necessary. If necessary, and after review and consultation with Principal 
Investigator, Sponsor will make a final determination on whether to terminate the study. 
A principal investigator, EC/IRB, or regulatory authority may suspend or prematurely terminate 
participation in the clinical study at the investigation sites for which they are responsible. 
If suspension or premature termination occurs, the terminating party shall justify its decision in 
writing and promptly inform the other parties with whom they are in direct communication.  The 
Principal Investigator and sponsor will keep each other informed of any communication received 
from either the EC/IRB or the regulatory authority. 
If, for any reason, the sponsor suspends or prematurely terminates the investigation at an individual 
investigation site, the sponsor shall inform the responsible regulatory authority as appropriate and 
ensure that the EC or IRB is notified, either by the principal investigator or by the sponsor. If the 
suspension or premature termination was in the interest of safety, the sponsor shall inform all other 
principal investigators. 

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If suspension or premature termination occurs: 
• The sponsor remains responsible for providing resources to fulfill the obligations from 
the protocol and existing agreements for following up the subjects enrolled in the 
clinical investigation, and 
• The Principal Investigator or his/her authorized designee will promptly inform the 
enrolled subjects at his/her investigation site, if appropriate. 
5.12 
Adverse Event Reporting 
An adverse event (AE) is any untoward medical occurrence in a subject. All adverse events are 
to be reported on the Adverse Event Case Report Form. All adverse events will be documented 
with the date of occurrence, relatedness to device or procedure, severity, action taken, resolution 
and any pertinent additional information.  
Adverse events will be reported and classified by the investigator from the medical diagnosis, 
using clinical signs, symptoms or abnormal laboratory values as needed.  The investigator will 
classify the adverse events based on the definitions as follows (ISO 14155:2011). 
Term 
Definition 
Adverse event (AE):   
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 test device. 
Adverse device effect (ADE): 
Adverse event related to the use of a test 
device. 
Serious adverse event (SAE): 
Is an adverse event that: 
a) led to a death, 
b) led to serious deterioration in the 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) an 
in-patient 
or 
prolonged 
hospitalization or, 
4) a medical or surgical intervention to 
prevent life-threatening illness or 
injury or permanent impairment to a 
body structure or a body function. 
 
NOTE: Planned hospitalization for a pre-
existing condition, or a procedure required 

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Term 
Definition 
by the clinical investigational plan, without 
serious deterioration in health, is not 
considered a serious adverse event. 
Serious adverse device effect (SADE): 
Adverse device effect that has resulted in any 
of the consequences characteristic of a serious 
adverse event. 
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: Device deficiencies include 
malfunctions, use errors, and inadequate 
labeling. 
Device Deficiency: 
A device deficiency is an inadequacy of a 
medical device with respect to its identity, 
quality, durability, reliability, safety or 
performance. 
Device Malfunction: 
Failure of an investigational medical device to 
perform in accordance with its intended 
purpose when used in accordance with the 
instructions for use or clinical investigational 
plan (CIP). 
Use Error: 
Act or omission of an act that results in a 
different medical device response than 
intended by the manufacturer or expected by 
the user. 
NOTE 1: User error includes slips, lapses, 
and mistakes. 
NOTE 2: An unexpected physiological 
response of the subject does not in itself 
constitute a use error. [ISO 14971:2012, 
definition 2.27] 
 
The Investigator will report to the sponsor, without unjustified delay, all serious adverse events 
and device deficiencies that could have led to a serious adverse device effect; this information shall 
be promptly followed by detailed written reports [ISO 14155:2011].  

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The Investigator will document all Serious Adverse Events (SAEs), including device deficiencies 
in the study participant’s patient file and report it to the Sponsor and/or CRO within 24-hours of 
knowledge of event.  Source data are preferentially immediately transferred to the Adverse Event 
CRF.  
Hospitalizations due to recurrent AF or prolonged hospitalization following procedure to adjust 
anticoagulation regimen or to administer diuretic medication are not considered AEs for this study.  
If a subject returns with a recurrence at any time during the study, the incident must be reported 
on an Unscheduled Visit CRF.   
When medical reports (lab results, examinations, etc.) associated with adverse events are submitted 
to the CRO or Sponsor, all personal subject information (name, address, etc.) MUST be removed 
or redacted.  The redacted materials must be identified only with the Site and Subject’s Study 
Numbers. 
The sponsor is responsible for classification and reporting of adverse events and ongoing safety 
evaluation of the clinical investigation in line with ISO 14155:2011 and regulatory requirements.  
The investigator will monitor all AEs until they are resolved, determined to be a chronic condition 
or the subject is lost to follow-up. The investigator will report all AEs regardless of whether they 
are anticipated or unanticipated and regardless of classification, seriousness, severity, outcome or 
causality.  
Upon notification of serious adverse events, Sponsor will initiate and complete a review and 
evaluation of the event within time frames that will maintain reporting compliance with applicable 
regulatory agencies.  
If insufficient information is available to reach a definitive diagnosis, Sponsor will contact the 
study monitor responsible for the site to request additional confirmatory information, if any. In the 
event of subject death, the Investigator will make reasonable effort to obtain a copy of the autopsy 
report and/or death summary. The investigator will determine the cause of death and its 
relationship to the investigational device. The Investigator will record results on the Adverse  
Event Form. The Investigator will include copies of an autopsy report, if available, and/or a death 
summary with this form. 
5.13 
Assessment of Adverse Event Severity 
Where the determination of AE severity rests on medical judgment, the determination of severity 
must be made with the appropriate involvement of a medically-qualified investigator. 
The severity of AEs will be graded using the following definitions: 
Mild 
Awareness of sign, symptom, or event, but easily tolerated 
Moderate 
Discomfort enough to cause interference with usual activity and may warrant 
intervention 
Serious 
Incapacitating with inability to do usual activities or significantly affects 
clinical status, and warrants intervention 

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5.14 
Relationship to the Device:  
Principal Investigators are required to assess whether there is a reasonable possibility that the test 
device caused or contributed to an AE. Sponsor defines three degrees of relatedness: not related, 
possible and related to the Test Device. The following definitions will be used to assess the 
relationship of the Adverse Effect. 
Not related 
no temporal association, or the cause of the event has been identified; or the 
device cannot be implicated 
Possibly 
related 
temporal association, but other etiologies are likely to be the cause; however, 
involvement of the device cannot be excluded 
Related 
temporal association; other etiologies are possible, but unlikely 
5.15 
Anticipated Adverse Events and Device Effects 
The anticipated adverse events and device effects that will occur during this investigation are not 
different than those risks related to standard catheter ablation procedures.  There will be no 
additional risks to the subjects as a result of using the Ablamap software.    
5.16 
Device Deficiencies  
All device deficiencies related to the identity, quality, durability, reliability, safety or performance 
of the test device shall be documented and reported to the Sponsor. For the purposes of this study 
protocol, the Ablamap software under evaluation will be considered the test device.  If a device 
used during the study procedure (basket catheter, diagnostic catheters, sheaths, etc.) malfunctions 
at any time, the study site should follow the procedures for returning the product for investigation 
to the manufacturer of the device.  In the unlikely event that the Ablamap software fails, a detailed 
description of the failure mechanism should be summarized on the Device Deficiency Case Report 
Form.   
6 REGULATORY CONSIDERATIONS 
This study will be conducted in conformity with the ethical principles stated in the latest version 
of the Declaration of Helsinki, the applicable guidelines for good clinical practices, MEDDEV 
2.7/4 (Guidelines on Clinical investigations: a guide for manufacturers and notified bodies) and 
2.7/3 (Clinical investigations: serious adverse event reporting), ISO 14155:2011 and FDA 21 CFR 
parts 50, 54, 56, 812, or the applicable local and international regulations, whichever provide the 
greater protection of the individual.  The clinical investigation plan and other relevant 
documentation shall be submitted to the appropriate Ethics Committee/IRB for review. The study 
will not start without the written approval of the Ethics Committee/IRB and, where needed, the 
Competent Authority approval and after the completion of any other local regulation requirement. 
Before commencement of the study, each Investigator must provide the Sponsor with written 
documentation of Ethics Committee/IRB approval of both the protocol and the informed consent 
form, which must comply with all requirements outlined by the Sponsor. This approval must refer 
to the informed consent form and the study by title and the protocol number as given by Sponsor.   
Any Investigator who is also a member of the Ethics Committee and/or IRB is not to participate 
in the protocol approval decision.  This non-participation must be noted in the approval letter. 

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6.1 Investigator Responsibilities 
The role of the Investigators is to implement the day-to-day conduct of this clinical investigation 
as well as to ensure data integrity and the rights, safety and well-being of the subjects involved in 
the clinical investigation in accordance with ISO 14155:2011 for the conduct of clinical 
investigations of medical devices. The Investigators shall be qualified by education, training and 
experience for the proper conduct of this clinical investigation. The investigative site will have the 
required number of eligible subjects, a qualified investigation team, and adequate facilities for the 
foreseen duration of this study. The Investigators will provide the sponsor copies of all 
communication with the EC/IRB, will perform safety reporting to both the sponsor and the EC/IRB 
according to EC/IRB requirements and to this clinical investigational plan and will promptly report 
to the EC/IRB any deviations that affect the right, safety, or well-being of the subject, or the 
scientific integrity of the clinical investigation, as required by local regulations.  The Investigators 
shall ensure compliance with the Informed Consent process and with the clinical investigational 
plan/protocol and will provide adequate medical care to the subjects during and after their 
participation in the clinical investigation. 
6.2 Confidentiality and Data Protection 
Health data will be recorded and forwarded to the sponsor of the study, and to participating Ethics 
Committees, IRBs, as applicable, for evaluation as required. Any information that is obtained in 
connection with this study that can be identified with the subjects will remain confidential.  data 
that may be published in scientific journals will not reveal the identity of the study participants.   
6.3 Insurance 
In order to cover possible damage to health, in relation to participation in this study, Sponsor has, 
as required by law, obtained appropriate insurance coverage. 
6.4 Protocol Amendments 
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Any modifications to the Clinical 
Protocol shall be agreed and signed by the investigator(s). The amendment should be submitted to 
their respective EC/IRB that originally approved the investigation. A summary explaining the 
changes, the rationale for changes and other documents will be provided in accordance with 
applicable requirements, to ECs/IRBs and regulatory authorities. Appropriate approvals of the 
revised protocol must be obtained prior to implementation. 
6.5 Study Reports  
The study will be considered complete for the purpose of reporting results regarding the primary 
endpoints after all subjects have completed the 12-month follow up visit. A final study closeout 
report will be created after the last 12-month follow-up visit is complete; all subjects are exited 
from the study; all data queries are resolved; and the investigator has signed off on the accuracy 
of the data. The PI will review and sign the document, and Sponsor will supply it to the governing 
Ethics Committee and to the respective regulatory authorities as applicable.  The Sponsor may do 

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an interim analysis on the study data at a pre-determined time outlined in the data management 
plan.   
6.6 Monitoring 
Monitoring will be performed during the study by individuals that are appropriately trained and 
qualified to assess continued compliance with the protocol and applicable regulations.  In addition, 
the monitor will verify that the study records are adequately maintained, that the data are reported 
in a satisfactory manner with respect to timeliness, adequacy, and accuracy, and that the 
Investigator continues to have sufficient staff and facilities to conduct the study safely and 
effectively.  The investigator/institution guarantees direct access to original source documents by 
the Sponsor personnel, their designees, and appropriate regulatory authorities. 
A protocol-specific Monitoring Plan will describe the frequency and extent of the monitoring, 
including source documentation verification required for the study.  Data will be reviewed for 
trends in changes in the site compliance, and appropriate corrective and preventive actions as well 
as corrective action plans, will be developed.  This review may trigger increased monitoring 
frequency and/or implementation of corrective action plans at the site. 
Monitors will be selected and assigned by Sponsor’s clinical management or personnel authorized 
to supervise the monitoring program. 
7 PUBLICATION POLICY 
The results of the study may be submitted for publication, upon the prior written consent of 
Sponsor. Investigator shall have the rights to publish papers related to the Study. 
If written permission from the Sponsor is provided, the PI may publish and/or present the results 
of the study conducted at their site, provided that, prior to any such publication or presentation, 
the site and/or the PI shall furnish the Sponsor one electronic copy of any materials intended for 
publication or presentation at least sixty (60) days prior to the submission of manuscripts.  The 
Sponsor shall then have sixty (60) days from the receipt of such materials to review and provide 
the site and/or the PI with written comments.  
8 ABBREVIATIONS AND DEFINITIONS 
8.1 Table of Abbreviations  
Abbreviation 
Definition  
AAD 
Antiarrhythmic drugs 
AE 
Adverse Event 
AF 
Atrial Fibrillation 
EC 
Ethics Committee 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
IFU 
Instructions for use 
IRB 
Investigational Review Board 

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ISO 
International Standard Organization 
IU 
International Unit 
LA 
Left Atrium 
LVEF 
Left Ventricular Ejection Fraction 
NYHA 
New York Heart Association 
RA 
Right Atrium 
RF 
Radiofrequency 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 

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