High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Cardiac Arrhythmia
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
 
87173 CIP Posting Cover Page Ver C 
Template 
Page 1 of 1 
 
NCT Number: NCT03882021 
WAVE-MAP AF 
High-Density Wave Mapping in Subjects with Atrial Fibrillation as a Predictor of Recurrence After a 
Single Ablation Procedure Using a PVI-Only Strategy 
Study Document No: ABT-CIP-10275 
Version A 
Date: 20-FEB-2019 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
5050 Nathan Lane North 
      
  
 
 
Plymouth, MN 55442 
        
 
 
 
USA 
 
 
 

ABT-CIP-10275 Ver. A 
Study Name: WAVE-MAP AF 
Clinical Investigation Plan 
 
 
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SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
The Principal Investigator at each participating site may be required to sign that he/she agrees to adhere 
to the CIP and all applicable regulatory requirements. If this is required per regulations, include the below 
signature page. 
 
 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Site Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

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Clinical Investigation Plan 
 
 
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TABLE OF CONTENTS 
 
 
 
 
1.0 
INTRODUCTION ........................................................................................................................... 7 
1.1 
Background and Rationale ......................................................................................................... 7 
2.0 
CLINICAL INVESTIGATION OVERVIEW ...................................................................................... 8 
2.1 
Clinical Investigation Objectives ................................................................................................. 8 
2.2 
Device(s) To Be Used in the Clinical Investigation ..................................................................... 9 
3.0 
CLINICAL INVESTIGATION DESIGN ......................................................................................... 10 
3.1 
Clinical Investigation Procedures and Follow-up Schedule ...................................................... 10 
3.2 
Measures Taken to Avoid and Minimize Bias ........................................................................... 11 
3.3 
Suspension or Early Termination of the Clinical Investigation .................................................. 12 
4.0 
ENDPOINTS ............................................................................................................................... 12 
4.1 
Primary Endpoint and Rationale .............................................................................................. 12 
4.2 
Additional Data ........................................................................................................................ 13 
5.0 
SUBJECT SELECTION AND WITHDRAWAL ............................................................................. 14 
5.1 
Subject Population ................................................................................................................... 14 
5.2 
Subject Screening and Informed Consent ................................................................................ 14 
5.3 
Eligibility Criteria ...................................................................................................................... 15 
5.4 
Subject Enrollment ................................................................................................................... 16 
5.5 
Subject Withdrawal .................................................................................................................. 16 
5.6 
Number of Subjects ................................................................................................................. 17 
5.7 
Total Expected Duration of the Clinical Investigation ............................................................... 18 
6.0 
TREATMENT AND EVALUATION OF ENDPOINTS ................................................................... 18 
6.1 
Baseline Procedures (within 14 days of index procedure) ........................................................ 18 
6.2 
Index Procedure ...................................................................................................................... 19 
6.3 
Post–Procedure and Early Follow Up ...................................................................................... 21 
6.4 
Follow-up Assessments ........................................................................................................... 21 
7.0 
ADVERSE EVENTS .................................................................................................................... 24 
7.1 
Definition .................................................................................................................................. 25 
7.2 
Device Relationship ................................................................................................................. 25 
7.3 
Adverse Event ......................................................................................................................... 25 
8.0 
STATISTICAL CONSIDERATIONS ............................................................................................. 27 
8.1 
Analysis Populations ................................................................................................................ 27 

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8.2 
Statistical Analyses .................................................................................................................. 27 
8.3 
Sample Size Calculation and Assumptions .............................................................................. 29 
8.4 
Timing of Analysis .................................................................................................................... 29 
8.5 
Subgroup Analysis ................................................................................................................... 29 
8.6 
Multiplicity ................................................................................................................................ 29 
8.7 
Procedures for Accounting for Missing Data ............................................................................ 29 
8.8 
Planned Interim Analysis ......................................................................................................... 29 
8.9 
Statistical Criteria for Termination ............................................................................................ 29 
8.10 
Success Criteria ....................................................................................................................... 29 
8.11 
Deviations from Statistical Plan ................................................................................................ 30 
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ............................................................... 30 
10.0 
QUALITY CONTROL AND QUALITY ASSURANCE ................................................................... 30 
10.1 
Selection of Clinical Sites and Investigators ............................................................................. 30 
10.2 
CIP Amendments ..................................................................................................................... 30 
10.3 
Training.................................................................................................................................... 31 
10.4 
Monitoring ................................................................................................................................ 31 
10.5 
Deviations from CIP ................................................................................................................. 31 
10.6 
Quality Assurance Audit ........................................................................................................... 32 
10.7 
Committees ............................................................................................................................. 32 
11.0 
DATA HANDLING AND RECORD KEEPING .............................................................................. 32 
11.1 
Protection of Personally Identifiable Information ...................................................................... 33 
11.2 
Data Management Plan ........................................................................................................... 33 
11.3 
Source Documentation ............................................................................................................ 33 
11.4 
Case Report Form Completion ................................................................................................ 34 
11.5 
Record Retention ..................................................................................................................... 34 
12.0 
ETHICAL CONSIDERATIONS .................................................................................................... 34 
12.1 
Ethics Committee Review and Approval .................................................................................. 34 
13.0 
CLINICAL INVESTIGATION CONCLUSION ............................................................................... 35 
14.0 
PUBLICATION POLICY .............................................................................................................. 35 
15.0 
RISK ANALYSIS ......................................................................................................................... 35 
15.1 
Anticipated Clinical Benefits ..................................................................................................... 35 
15.2 
Foreseeable Adverse Events and Anticipated Adverse Device Effects .................................... 36 
15.3 
Risks Associated with Participation in this Clinical Investigation .............................................. 36 
15.4 
Steps Taken to Control or Mitigate Risks ................................................................................. 36 
15.5 
Risk to Benefit Rationale .......................................................................................................... 36 

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APPENDIX I: ABBREVIATIONS AND ACRONYMS .............................................................................. 37 
APPENDIX II: DEFINITIONS ................................................................................................................. 38 
APPENDIX III: SITE CONTACT INFORMATION ................................................................................... 39 
APPENDIX IV: LITERATURE REVIEW ................................................................................................. 40 
APPENDIX V: INFORMED CONSENT FORM ....................................................................................... 48 
APPENDIX VI: MONITORING PLAN ..................................................................................................... 49 
APPENDIX VII: CASE REPORT FORMS .............................................................................................. 50 
APPENDIX VIII: GRID ELECTRODE CONFIGURATIONS .................................................................... 51 
APPENDIX IX: REVISION HISTORY ..................................................................................................... 55 
APPENDIX X: CIP SUMMARY .............................................................................................................. 56 
16.0 
REFERENCES ............................................................................................................................ 58 
 
 

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COMPLIANCE STATEMENT:  
 
This clinical investigation 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 
investigation will be approved by the appropriate Ethics Committee (EC) of the respective clinical site 
and as specified by local regulations. 
 
 

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1.0 
INTRODUCTION 
This document is a clinical investigation plan (CIP) for the WAVE-MAP AF clinical investigation.  This 
clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid 
Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 
12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach 
without further substrate modification. This clinical investigation will be conducted as a post-market study 
and is intended to support marketing claims for the Advisor™ HD Grid Mapping Catheter, Sensor 
Enabled™ (GRID). 
 
This clinical investigation is sponsored by Abbott. 
 
This clinical investigation 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 
 Background 
It has been estimated that 20.9 million men and 12.6 million women have Atrial Fibrillation (AF) 
worldwide.12 AF has a prevalence of approximately 3% in adults aged 20 years or older.3,4 Additionally, 
one in four middle-aged adults in the US and Europe will develop AF in their lifetime.5,6 In Australia, 5% 
of people aged 55 years or older have AF, and this number is projected to rise to 6% by 20347.  These 
estimates suggest that AF is a condition that impacts a significant number of people with implications for 
their healthcare systems.   
 
AF remains a major cause of stroke, heart failure, sudden death, and cardiovascular morbidity.  In a 
meta-analysis of contemporary, well-controlled, randomized clinical trials in AF, the average annual 
stroke rate is 1.5% with an annualized death rate of 3% in anticoagulated AF patients.8 A minority of 
these deaths are related to stroke, while sudden cardiac death and death from progressive heart failure 
are more frequent, emphasizing the need for interventions beyond anticoagulation.9,10 AF is also 
associated with high rates of hospitalization, commonly for AF management, but often hospitalization is 
also due to heart failure, myocardial infarction, and treatment associated complications.11,12,13  
Additionally, patients with AF have significantly poorer quality of life than healthy controls, experiencing a 
variety of symptoms including lethargy, palpitations, dyspnea, chest pain, sleeping difficulties, and mental 
distress.14,15,16,17  
 
AF is generally divided into three different types based on the frequency of the AF:  paroxysmal, 
persistent, and long-standing persistent. Paroxysmal AF (PAF) is defined as AF that terminates 
spontaneously or with intervention within 7 days of onset.  Persistent AF (PsAF) is defined as continuous 
AF that is sustained beyond 7 days.  Long-standing persistent AF (LSAF) is defined as continuous AF of 
greater than 12 months duration.   
 
Per Calkins, et al in the 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on 
Catheter and Surgical Ablation of Atrial Fibrillation (2017 Consensus)18, catheter ablation is a treatment 
option for all three types. Pulmonary vein isolation (PVI) is a recommended approach by the consensus 
paper for all de novo AF ablation procedures.  PVI alone does not cure all AF, and other techniques have 
been studied to supplement PVI ablation and improve outcomes.  Substrate modification beyond 

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A-TCSE-DD 
A-TCSE-FF 
A-TCSE-JJ 
A-TCSE-DF 
A-TCSE-FJ 
TactiSys™ Quartz Equipment 
PN-004 400 
SJM 
Cool Point™ Pump v24 or greater 
85784 (OUS) 
SJM 
Ampere™ RF Generator v1.04 or greater 
 
H700489 (OUS) 
SJM 
 
Additional commercially available tools may be used in this clinical study per physician’s discretion and 
per device IFUs unless specifically prohibited in this CIP.  
  Indication for Use 
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. 
 
All devices will be used according to their approved labelling in this study. 
 
Please refer to the IFUs for additional information regarding the devices used in this clinical investigation. 
3.0 
CLINICAL INVESTIGATION DESIGN 
This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid 
Mapping Catheter, Sensor Enabled™.  This study is aimed at determining correlations between pre-
ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation.  
 
   
 
Endpoints will be analyzed when all subjects have completed their 12-month follow up visits. 
 
3.1 
Clinical Investigation Procedures and Follow-up Schedule 
Subjects will be followed until they complete their 12-month visit.   Clinical Investigation visits will occur at 
Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months.  The flow 
chart below summarizes the visits and study procedures. 
 

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• 
To minimize selection bias, investigators are required to screen consecutive patients with planned 
de novo AF ablation procedures and record them on a screening log. 
• 
Strict inclusion/exclusion criteria are included in this CIP. 
• 
A standardized mapping and ablation protocol has been defined. 
• 
Individuals taking measurements from EnSite maps will not have access to the outcome data of 
the associated subject. 
3.3 
Suspension or Early Termination of the Clinical Investigation 
While no formal statistical rule for early termination of the clinical investigation for insufficient 
effectiveness of the device under investigation is defined, the Sponsor reserves the right to discontinue 
the clinical investigation at any stage or reduce the follow-up period with suitable written notice to the 
investigator. Possible reason(s) may include, but are not limited to: 
• 
A new unreasonable risk to the participating subjects has been identified such as an 
unanticipated increase in complaint rates related to the study. 
• 
Further product development is cancelled. 
 
Should the clinical investigation 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. The investigator shall return all clinical investigation materials to the Sponsor and provide 
a written statement to the EC (if applicable). All applicable clinical investigation documents shall be 
subject to the same retention policy as detailed in Section 11.0.  
 
A Principal Investigator, EC or regulatory authority may suspend or prematurely terminate participation in 
the clinical investigation at the investigational site(s) 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 investigation at an individual site in the 
interest of safety, the Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Principal Investigator or authorized designee will 
promptly inform the enrolled subjects at his/her site, if appropriate, and return patients to their standard 
medical treatment. 
4.0 
ENDPOINTS 
4.1 
Primary Endpoint and Rationale 
The primary outcome is one-year success, defined as freedom from AF/AFL/AT after removal from 
antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months 
following a single ablation procedure. 
 
Occurrence of isthmus-dependent atrial flutter, if confirmed during electrophysiology testing, should not 
be considered a failure for this outcome. 
 
This endpoint is based on the recommendations from the 2017 HRS consensus paper.18 

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4.2 
Additional Data 
Additional data to be collected will include the following: 
• 
Acute procedural success, defined as electrical isolation of all pulmonary veins. 
• 
Success post blanking period through 12 months using different definitions, including: 
o Freedom from symptomatic AF/AFL/AT after removal from AAD therapy 
o Single procedure clinical success defined as freedom from symptomatic AF/AFL/AT 
without a new or increased dose of class I or III AAD 
• 
 
• 
Data from EnSite maps using both HD Wave and Standard mapping modes2 in both sinus rhythm 
and AF including but not limited to: 
o Left atrial area using different boundaries (e.g. with and without LAA, etc.) 
o Low voltage area and proportion of left atria with low voltage using different cutoffs for 
voltage 
• 
Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies 
• 
LA volume and diameter 
• 
Adverse events including any device-, procedure-, or death-related events 
• 
Other baseline characteristics including but not limited to: 
o Time with AF 
o Type of AF 
o Sex 
o BMI 
o General medical history 
o Cardiovascular history 
o Arrhythmia history 
o NYHA classification 
o LVEF 
o Presence of pacemaker 
• 
Procedural characteristics, including but not limited to: 
o Power, temperature, and contact force 
o Procedure time 
o Mapping time 
o Cardioversions (if applicable) 
 
2 Difference in each measurement between the different mapping modes will be compared. 

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o Anesthesia 
o Fluoroscopy time 
5.0 
SUBJECT SELECTION AND WITHDRAWAL  
5.1 
Subject Population 
This clinical investigation will enroll male and female subjects from the general atrial fibrillation 
population. Subjects must meet all eligibility criteria and provide written informed consent prior to 
conducting any investigation-specific procedures not considered standard of care.  
5.2 
Subject Screening and Informed Consent 
 Subject Screening 
Subjects must be screened for clinical investigation eligibility by a member of the site’s clinical 
investigation team previously trained to the CIP and delegated to do so. All screened patients will be 
entered on a site-specific screening log.   
 
In case the 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 reason for the screen failure on the screening log. 
 
To minimize bias throughout the enrollment period for this study, consecutive de novo AF patients with 
planned ablation must be screened3, offered the study if they meet criteria, and added to a screening log. 
 
Potential patients presenting at the clinical sites will be fully informed about the clinical investigation, 
following the established Informed Consent process (described in Section 5.2.2). Patients meeting all 
inclusion criteria and no exclusion criteria will be asked to sign an Informed Consent form if they wish to 
participate in the clinical investigation.  
Once a duly dated and signed Informed Consent form is obtained, the clinical investigation-specific 
procedures may begin.  
 
 Informed Consent 
The Patient Informed Consent form must receive approval from the Sponsor and EC/IRB prior to 
beginning clinical investigation enrollment.   
The Investigator or his/her authorized designee (if applicable) will conduct the Informed Consent 
process, as required by applicable regulations and the center’s EC. This process will include a verbal 
discussion with the subject on all aspects of the clinical investigation that are relevant to the subject’s 
decision to participate, such as details of clinical investigation procedures, anticipated benefits, and 
potential risks of clinical investigation participation. Subjects must be informed about their right to 
withdraw from the clinical investigation at any time and for any reason without sanction, penalty or loss of 
 
3 This does not necessarily mean that the patient must be approached if their medical records indicate that they 
would not qualify.   

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benefits to which the subject is otherwise entitled. Withdrawal from the clinical investigation 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. Financial incentives will not be given to the 
subject. Subjects may be compensated for time and travel directly related to the participation in the 
clinical investigation. 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 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 clinical investigation-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. 
 
Failure to obtain informed consent from a subject prior to clinical investigation enrollment should be 
reported to Sponsor within 5 working days and to the reviewing center’s EC according to the EC’s 
reporting requirements. 
 
If, during the clinical investigation, new information becomes available that can significantly affect a 
subject's future health and medical care, the Principal Investigator or his/her authorized designee (if 
applicable) will provide this information to the subject. If relevant, the subject will be asked to confirm 
their continuing informed consent in writing. 
5.2.2.1 Special Circumstances for Informed Consent  
Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals 
without legal authority, are excluded from the study population. Individuals under the age of 18 or age of 
legal consent are excluded from the study population. Individuals unable to read or write are excluded 
from the study population. Pregnant or breastfeeding women are excluded from the study population. 
5.3 
Eligibility Criteria 
 General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interviews with 
candidate patients. If some of the clinical and laboratory tests are not included in site standard tests, they 
must be done but after written informed consent is obtained. Patients must meet ALL the inclusion 
criteria to be considered for the clinical investigation. If ANY of the exclusion criteria are met, the patient 
is excluded from the clinical investigation and cannot be enrolled. 
 Inclusion Criteria 
5.3.2.1 General Inclusion Criteria 
 
1. Documented atrial fibrillation with planned endocardial ablation procedure 
2. Age 18 years or older 

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3. Able and willing to provide written informed consent prior to any clinical investigation related 
procedure 
4. Able and willing to complete all required study procedures through 12 months 
 
 Exclusion Criteria 
5.3.3.1 General Exclusion Criteria 
 
1. Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in 
duration 
2. Previous ablation or surgery in the left atria 
3. Implanted left atrial appendage occluder 
4. Implanted mitral or tricuspid valve replacement 
5. Implanted cardiac defibrillator (ICD) 
6. Participation in another clinical investigation that may confound the results of this study 
7. Pregnant or nursing  
8. 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 investigation or to comply with follow-up requirements, or impact the scientific soundness 
of the clinical investigation results. 
9. Life expectancy less than 12 months 
5.4 
Subject Enrollment 
A patient is considered enrolled in the clinical investigation from the moment the patient provides written 
informed consent, has been confirmed to meet all inclusion criteria and none of the exclusion criteria and 
has had the mapping catheter inserted into the subject’s vasculature. 
5.5 
Subject Withdrawal 
Each enrolled subject shall remain in the clinical investigation until completion of the required follow-up 
period; however, a subject’s participation in any clinical investigation is voluntary and the subject has the 
right to withdraw at any time without penalty or loss of benefit. Conceivable reasons for discontinuation 
may include, but not be limited to, the following: 
• 
Subject death 
• 
Subject voluntary withdrawal  
• 
Subject lost-to follow-up as described below  
• 
Subject has a thrombus and is withdrawn per Section 6.2 
• 
Index ablation procedure is aborted prior to collection of at least one of the required maps. 
• 
Operator is not able to achieve pulmonary vein isolation. 
• 
Subject becomes a screen failure after consent 

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The Sponsor must be notified of the reason(s) for subject discontinuation. The site will provide this 
information to the Sponsor. Investigators must also report this to their respective EC as defined by their 
institution’s procedure(s).  
 
No additional follow–up will be required or data recorded from subjects once withdrawn from the clinical 
investigation. 
 
However, if a subject withdraws from the investigation due to problems related to the safety or 
performance of the device under investigation, the investigator shall ask for the subject's permission to 
follow his/her status/condition outside of the clinical investigation. 
 
In case of subject withdrawal of consent, the site should make attempts to schedule the subject for a final 
clinical investigation visit. At this final follow-up visit, the subject will undergo the assessments required at 
the 12-month follow up visit. 
 
If subjects are enrolled into the clinical investigation and are later found to have met exclusion criteria or 
not all inclusion criteria after the ablation procedure, these subjects will continue follow-up in the clinical 
investigation and may be included in the analysis population.  A protocol deviation must be completed on 
the applicable CRF.  Such subjects identified prior to the index procedure should be identified as screen 
failures and a protocol deviation is not necessary. 
 
Lost-to-Follow-up 
 
If the subject misses two consecutive scheduled follow-up time points and the attempts at contacting the 
subject detailed below are unsuccessful, then the subject is considered lost-to-follow-up. Site personnel 
shall make all reasonable efforts to locate and communicate with the subject (and document these efforts 
in the source documents), including the following, at each contact time point: 
• 
A minimum of two telephone calls on different days over the specified follow-up windows to 
contact the subject should be recorded in the source documentation, including date, time and 
initials of site personnel trying to make contact. 
• 
If these attempts are unsuccessful, a letter (certified if applicable) should be sent to the subject. 
• 
If a subject misses one or more non-consecutive follow-up contact time points, it will be 
considered a missed visit. The subject may then return for subsequent visits. If the subject misses 
two consecutive time points and the above-mentioned attempts at communicating with the 
subject are unsuccessful, the subject can be considered lost-to-follow-up.  
 
Note: Telephone contact with General Practitioner, non-clinical investigation cardiologist or relative 
without the presence of the subject or indirect documentation obtained via discharge letters will not be 
considered as subject contact. 
5.6 
Number of Subjects  
.  Individual study 
centers will be allowed to enroll 20% (~60 subjects) of the maximum total trial enrollment without 
additional approval.  Centers may have their maximum enrollment number increased with prior Sponsor 

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If the subject is identified as pregnant prior to the ablation procedure, they will be identified as a screen 
failure and the screening log will be updated. 
6.2 
Index Procedure 
The subject should be prepped for an electrophysiology study per the site’s standard of care.  If there is a 
thrombus noted the procedure can be delayed up to 90 days post consent until the thrombus has been 
resolved and the investigator has assessed it to be safe to proceed. In this case, data recorded from the 
baseline visit will be revisited to note any changes (e.g. updated medical history and medications).  If the 
investigator determines after 90 days the thrombus has not resolved, the subject should be identified as 
a screen failure and the screening log will be updated. 
 Mapping Protocol 
Prior to any ablation, perform the following steps with the GRID as the only mapping catheter using an 
HD Wave configuration. HD Wave configuration is defined as any configuration only collecting from 
electrodes with two orthogonal bi-poles. It is recommended to use the configuration from Figure 2.  See 
Appendix VIII for further details. 
 
 
Figure 2 Recommended HD Wave Configuration 

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• 
Start recording (F4) an EnSite Segment – label ‘LA geometry’. 
• 
Build LA geometry with GRID. 
• 
End Geometry (F4) collection EnSite recording segment. 
 
• 
Their first geometry may be a OneMap in sinus rhythm6 (SR) 
• 
Then record that segment label “SR OneMap’ 
 
• 
Collect Cardiac Triggered SR Map.  
• 
This is done via Cardiac Triggered AutoMap 
 
• 
Keep GRID in position for a recommended 5 cardiac cycles (2 minimum) 
 
Upon completion, attempt to induce AF7, and continue. 
• 
Start a new map in Non- Cardiac Triggered mode (i.e. mapping in AF) 
• 
Set Map Settings of Interior Projection/Exterior Projection to 6/6 mm. 
• 
Set Map Settings of Interpolation to 6 mm. 
 
{Consider OneMap to do the geometry collection and mapping} 
 
• 
Set up Map to collect with GRID. 
• 
Use the CFE Mean map as guidance for map point collection 
• 
CFE Mean: Suggested settings of Sensitivity 0.05 mV (above noise floor). Refractory 80 ms. 
Width 10 ms.  
• 
Set up CFE Mean map: Suggested CFE Mean Color High of 250 ms and Color Low of 80 ms.  
• 
Set up CFE Mean map with Segment Length of 8 seconds.  
 
• 
Start recording (F4) an EnSite Segment – label ‘LA AF Map’. 
• 
Set Auto Map Criteria as follows. Stable Distance to 5mm. Distance to 3mm.  
 
• 
Manually acquire first Auto Map point and then the Auto Map criteria will collect points based on 
its criteria.  
 
The catheter operator should aim, subject to their own discretion, to color the entire LA 
geometry using the above Auto Map settings. 
 
 
6 If sinus rhythm cannot be achieved, this map can be captured in another regular rhythm. 
7 If subject is in AF initially, the AF map can be collected first, then collect the SR map after cardioversion. 

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• 
At each anatomical location, catheter operator aims to hold GRID in place for 8 seconds.  
• 
End recording (F4) of Map collection segment. 
 
After the procedure, the complete deidentified EnSite case should be submitted to Abbott per their 
instructions.  This data will be analyzed independently of the investigator for purposes of avoiding bias 
and ensuring consistent measurements across all sites. 
 
If the procedure is aborted for any reason prior to the collection of at least one voltage map, the subject 
should be withdrawn from the study.  If the operator is not able to achieve pulmonary vein isolation, the 
subject should be withdrawn from the study once any ongoing serious adverse events have resolved or 
30 days, whichever comes first. 
 Treatment Strategy for Ablation 
Selected sites use a PVI-only strategy as standard of care for all de novo ablation of AF.  After 
completing the mapping protocol, ablate the pulmonary vein antrum to isolate the veins using a wide 
area circumferential ablation (WACA) technique8 with the TactiCath™ Contact Force Ablation Catheter, 
Sensor Enabled™ (TactiCath SE).  If isthmus dependent flutter is identified and confirmed by 
electrophysiological testing (e.g. entrainment maneuvers), ablation of the cavo tricuspid isthmus is 
recommended in the right atrium.  No deviations from standard of care9 should be performed unless 
medically necessary.  The AutoMark™ feature should be turned on for automated lesion-level data 
capture based on user-defined settings.  Event Markers should be used to note physician comments 
about changes in rhythm10. 
PVI should be confirmed bidirectionally using the GRID and confirmed after a recommended 20-minute 
wait time to ensure isolation is achieved.  In addition, use of isoproterenol or adenosine are allowed per 
the investigator’s discretion to confirm block. 
If arrhythmias remain after pulmonary vein isolation, it is recommended to treat with cardioversion and/or 
medication unless there is a medical necessity to perform additional ablation. 
6.3 
Post–Procedure and Early Follow Up 
Sites should follow standard of care for use of AAD during the blanking period to address symptoms 
during healing.  It is recommended to exclude Amiodarone due to its long half-life, since the effects of 
amiodarone could continue past the blanking period impacting recurrence rates. 
 
All other aspects of care should follow the site’s standard practice from discharge through the end of the 
3-month blanking period. 
6.4 
Follow-up Assessments  
The following sections describe the follow-up visits and procedures.  All windows are stated with respect 
to the index procedure unless otherwise noted.  It is recommended to follow the HRS Consensus 
guidelines for follow-up screening depending on type of AF (e.g. paroxysmal vs. persistent).  A 12-lead 
 
8 This may include ablation to address the carina within the WACA circle per the investigator’s discretion. 
9 Site’s standard of care is PVI-only, so no other substrate modification should be performed. 
10 For example, “AF resolved to sinus rhythm during ablation of lesion #23”. 

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ECG is recommended any time the subject returns to the clinic from 3- to 12-months post index 
procedure. 
 3-Month Follow Up (77 to 105 Days Post Index Procedure) 
The blanking period ends on the day of the 3-month follow up visit.  It is recommended the subject not be 
taking any class I or III AAD after the 3-month visit unless there is recurrence of AF.  At the 3-month visit, 
the following procedures will be completed: 
 
• 
Check for symptoms of recurrence 
• 
Perform 12-lead ECG 
• 
Document Adverse Events and Protocol Deviations 
• 
Document AAD usage 
• 
Document any recurrences including any details of repeat electrophysiology studies 
• 
Instruct the subject to contact the site if they experience any symptoms of recurrence. If 
there are any symptoms noted after the 3-month visits through the 12-month visit, check 
for recurrence using 12-lead ECG or other form of monitoring per site’s standard practice.  
 
It is also recommended to provide the subject with an event monitor for recording at regular intervals 
(e.g. monthly) or for symptomatic events through the 12-month visit. 
 
After the 3-month visit through the end of the study, any signs or symptoms of recurrence should be 
recorded, and the subject should have either a 12-lead ECG or other form of ECG monitoring per the 
site’s standard practice to determine if recurrence has occurred. 
 6-Month (169 to 197 Days) Follow Up Phone Visit 
Within two weeks of the 6-month time point post index procedure, the subject will be contacted via 
telephone (or seen in-clinic if standard of care) for the following assessments   
• 
Check for symptoms of recurrence 
• 
Document Adverse Events and Protocol Deviations 
• 
Document AAD usage 
• 
If there are symptoms of recurrence present, the subject should have either a 12-lead 
ECG or other form of ECG monitoring to determine if recurrence has occurred. 
• 
Document any recurrences including details of any repeat electrophysiology studies 
 
For persistent AF subjects, it is also recommended that a 24-hour holter be performed at the 6-month 
time point. 
 12-Month Follow Up Visit (335 to 395 Days Post Index Procedure) 
The 12-Month visit will include the following procedures: 
• 
Check for symptoms of recurrence 
• 
Perform 12-lead ECG 

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• 
Record Adverse Events and Protocol Deviations.  Make sure to record the status of each 
ongoing event at the time of study exit. 
• 
Document AAD usage 
• 
Complete 24-hour continuous ECG monitoring11, and record results on the applicable 
CRF 
• 
Document any recurrences including any details of repeat electrophysiology studies 
 
 
 
 
11 This does not have to be done on the day of the visit.  It can be done any time during the 12-month visit window. 

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7.1 
Definition 
 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 under investigation. 
 
This definition includes events related to the medical device(s) under investigation and the 
mapping/ablation procedures involved.  For users or other persons, this definition is restricted to events 
related to the medical devices under investigation. 
 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. 
 
7.2 
Device Relationship 
Determination of whether there is a reasonable possibility that a device under investigation 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). 
7.3 
Adverse Event  
 Adverse Event Reporting 
Safety surveillance and reporting starts as soon as the patient is enrolled in the clinical investigation. 
Safety surveillance and reporting will continue until the last follow-up visit has been performed, the 
subject is deceased, the subject concludes participation in the clinical investigation or the subject 
withdraws from the clinical investigation. Adverse event data, including deaths, will be collected 

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throughout the time period defined above and will be reported to the Sponsor on a CRF. Additional 
information with regard to an adverse event should be updated within the appropriate CRF.  
 
Unchanged, chronic, non-worsening, or pre-existing conditions are not AEs and should not be reported.  
 
An offline form will be made available to allow the investigator to report SAEs in the event the entry 
cannot be made in the EDC. This does not replace the EDC reporting system. All information must still 
be entered in the EDC system as soon as feasible. 
 
Non-cardiac related abnormal laboratory values will not be considered AEs unless:  
1. the investigator determined that the value is clinically significant,  
2. the abnormal lab value required intervention, or  
3. the abnormal lab value required subject withdrawal from the clinical investigation. 
 
For the purposes of this clinical investigation, the following events will be reported: 
• 
Adverse events that are considered to be related to any of the study devices or the 
mapping/ablation procedure by the investigator 
• 
Serious adverse events resulting in death 
 
Recurrence of AF, AFL, or AT are not considered reportable adverse events unless they occur in a 
severity, frequency, or other manner that is significantly worse than the subject’s baseline condition.  
These are considered lack of effectiveness and will be reported as a recurrence on the appropriate case 
report form. 
 
The investigator should report all SAEs to the Sponsor as soon as possible but no later than outlined 
below. 
 
SAE Reporting 
The investigator should report applicable SAEs to the Sponsor as soon as possible but no later than 
outlined below.  
 
Clinical Site 
Reporting timelines 
All Sites 
SAEs must be reported to the Sponsor no later than 3 calendar days from the 
day the site personnel became aware of the event or as per the investigative 
site’s local requirements, if the requirement is more stringent than those outlined 
above. 
 
The date the site staff became aware the event met the criteria of an SAE must be recorded in the 
source document.  The Investigator will further report the SAE to the local EC according to the 
institution’s EC reporting requirements. 
 
 Device Complaint Reporting 
The investigator is responsible for reporting all complaints to the manufacturer of a device that meets the 
definition of a complaint. A complaint is defined as any written, electronic or oral communication that 

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8.11 Deviations from Statistical Plan 
Any changes to the planned statistical analyses will be documented in the final report.   
 
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
The investigator/institution will permit direct access to source data/documents for the purpose of 
performing clinical investigation-related monitoring, audits, EC review and regulatory inspections. 
 
Subjects providing informed consent are agreeing to allow clinical investigation monitors or regulatory 
authorities including foreign countries to review, in confidence, any records identifying the subjects in this 
clinical investigation. This information may be shared with regulatory agencies; however, Sponsor 
undertakes not to otherwise release the subject's personal and private information. 
10.0 QUALITY CONTROL AND QUALITY ASSURANCE 
10.1 Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the clinical 
investigation. Sites will be selected based upon review of a recent site assessment, if applicable, and the 
qualifications of the investigators who will participate in the clinical investigation. 
10.2 CIP Amendments  
Approved CIP amendments will be provided to the Investigators by the Sponsor prior to implementing the 
amendment. The Principal Investigator is responsible for notifying the EC or equivalent committee of the 
CIP amendment (administrative changes) or obtaining EC’s approval of the CIP amendment (changes in 
subject care or safety), according to the instructions provided by the Sponsor with the CIP amendment.   
 
Acknowledgement/approval by the EC of the CIP amendment must be documented in writing prior to 
implementation of the CIP amendment. Copies of this documentation must also be provided to the 
Sponsor. 
 
 
 

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10.3 Training 
All Investigators and clinical investigation personnel are required to attend Sponsor training sessions, 
which may be conducted at an Investigator's meeting, a site initiation visit, or other appropriate training 
sessions. Over-the-phone or self-training may take place as required. Training of Investigators and 
clinical investigation personnel will include, but is not limited to, the CIP requirements, electronic case 
report form completion and clinical investigation personnel responsibilities. All Investigators and clinical 
investigation personnel that are trained must sign a training log (or an equivalent) upon completion of the 
training. Prior to signing the training log, Investigators and clinical investigation personnel must not 
perform any CIP-related activities that are not considered standard of care at the site.  
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 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 EC or equivalent committee of all CIP deviations in 
accordance with their specific 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 
investigation 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 investigation.  
 

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10.6 Quality Assurance Audit 
A Sponsor representative or designee may request access to all clinical investigation records, including 
source documentation, for inspection during a Quality Assurance audit.  
 
In the event that an investigator is contacted by a Regulatory Agency in relation to this clinical 
investigation, 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 investigation (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 
A Publication Committee may be established to oversee clinical investigations publications, including 
publication planning and authorship determinations. Publication Committee membership may include 
Principal Investigators, a representative of the Sponsor and a statistician. The Publication Committee will 
determine policy and strategies regarding individual presentations and/or publications arising from 
clinical investigation generated data. The committee will also review all external requests for accessing 
clinical investigation-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. 
11.0 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 investigation.  
 
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 investigation, 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.  
 
For the duration of the clinical investigation, the Investigator will maintain complete and accurate 
documentation including, but not limited to, medical records, clinical investigation progress records, 
laboratory reports, CRFs, signed ICFs, device accountability records (if applicable), correspondence with 
the EC and clinical investigation monitor/Sponsor, adverse event reports, and information regarding 
subject discontinuation or completion of the clinical investigation. 
 

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11.1 Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
clinical investigation.  
 
The Sponsor implements technical and physical access controls to ensure that Personal Information 
is accessible only to and processed only on a ‘need to know’ basis, including periodic review of 
access rights, and revocation of access when an individual’s employment is terminated or the 
individual transitions to a role that does not require access to Personal Information, and appropriate 
restrictions on physical access to premises, facilities, equipment, and records containing Personal 
Information. 
 
The Sponsor requires the investigational sites to transfer into Sponsor’s data management systems 
only pseudonymous Personal Information (key-coded) necessary to conduct the Clinical 
Investigation, such as the patient’s medical condition, treatment, dates of treatment, etc. The 
Sponsor discloses as part of the clinical investigation informed consent process that some Sponsor 
representatives still may see Personal Information at the participating sites for technical support of 
the participating physicians on the device implant or procedures, monitoring and quality control 
purposes. Confidentiality of Personal Information will be observed by all parties involved at all times 
throughout the clinical investigation. The privacy of each subject and confidentiality of his/her information 
will be preserved in reports and when publishing any data. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including any 
Personal Information) against unauthorized access and/or interference by third parties, intrusion, 
theft, destruction, loss or alteration. Clinical Investigation data are encrypted in transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable 
Law and industry best practices. 
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 investigation. 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. 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 investigation: 
• 
Medical history/physical condition of the subject before involvement in the clinical investigation 
sufficient to verify CIP entry criteria 
• 
Dated and signed notes on the day of entry into the clinical investigation referencing the Sponsor, 
CIP number, subject ID number and a statement that informed consent was obtained 

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• 
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).  
• 
Notes regarding CIP-required and prescription medications taken during the clinical investigation 
(including start and stop dates) 
• 
Subject’s condition upon completion of or withdrawal from the clinical investigation 
• 
Any other data required to substantiate data entered into the CRF 
• 
Patient reported outcome measures may be completed using CRF worksheets. These serve as 
the source documentation. 
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 investigation.   
 
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. 
11.5 Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the clinical 
investigation 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 investigation 
records. 
12.0 ETHICAL CONSIDERATIONS 
 
12.1 Ethics Committee Review and Approval 
Ethics Committee (EC) approval for the CIP and ICF/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 investigation. The approval letter must be received prior to the start of this clinical 
investigation 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 EC and written 
approval obtained prior to implementation, according to each institution’s EC requirements.  
 

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No changes will be made to the CIP or ICF or other written information provided to the patient without 
appropriate approvals, including EC, the Sponsor, and the regulatory agencies (if applicable).  
 
Until the clinical investigation is completed, the Investigator will advise his/her EC of the progress of this 
clinical investigation, per EC requirements. Written approval must be obtained from the EC yearly to 
continue the clinical investigation, or according to each institution’s 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 EC and the Sponsor. 
13.0 CLINICAL INVESTIGATION CONCLUSION 
The clinical investigation report will be completed within one year of the last visit of the last subject.  
 
 
The clinical investigation 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 investigation closure.  
14.0 PUBLICATION POLICY 
The data and results from the clinical investigation 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 investigation. The 
Investigators will not use this clinical investigation-related data without the written consent of the Sponsor 
for any purpose other than for clinical investigation 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 reviewed and approved by the Sponsor in a timely manner to enable Sponsor 
review in compliance with the Sponsor’s publication policy set forth in the Clinical Trial Agreement. 
 
The Sponsor will be responsible for determining whether to register the clinical investigation 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 investigation 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 investigation. 
15.0 RISK ANALYSIS 
 
15.1 Anticipated Clinical Benefits 
Subjects participating in this clinical study are not expected to experience any additional benefit 
compared to patients who are not participating in this clinical study that also undergo cardiac ablation, as 
the clinical study will follow local standard practice. Medical science may benefit from your participation 
which may lead to benefits for future patients with AF. The information gathered in this clinical study will 
add to the understanding of treatment options for other patients with AF. 

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15.2 Foreseeable Adverse Events and Anticipated Adverse Device Effects 
The most commonly known risks for any ablation procedure are listed below:  
• Bleeding or infection at the site where your catheter was inserted 
• Damage to your blood vessels where the catheter may have scraped as it traveled to your 
heart 
• Puncture of your heart 
• Damage or swelling to the sack which surrounds your heart, making it difficult for the heart 
to beat strongly 
• Damage to your heart valves 
• Damage to your heart's electrical system, which could worsen your arrhythmia and could 
require a pacemaker to correct 
• Blood clots in the legs or lungs (venous thromboembolism); 
• Stroke or heart attack 
• Narrowing of the veins that carry blood between your lungs and heart (pulmonary vein 
stenosis) 
• Damage to your kidneys from dye used during the procedure 
• Low blood pressure 
15.3 Risks Associated with Participation in this Clinical Investigation 
The required elements of this CIP are considered standard of care, except for additional diagnostic 
mapping.  This mapping procedure is anticipated to last 0 to 30 minutes longer than the site’s standard of 
care.  No additional exposure to radiation, additional ablation, or changes to treatment approach are 
required by the mapping protocol.  Considering electrophysiology studies typically last several hours, this 
risk is considered to be minor. 
15.4 Steps Taken to Control or Mitigate Risks 
In-depth recommendations, special precautions and instructions regarding the use of each 
device can be found in the applicable instructions for use.  
15.5 Risk to Benefit Rationale 
Use of GRID to facilitate electro anatomical 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.  
 
 
 
 

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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
Abbreviation/Acronym 
Definition 
AAD  
Antiarrhythmic Drug 
ACT  
Active Clotting Time 
AE  
Adverse Event 
AF or AFib 
Atrial Fibrillation 
AFL  
Atrial Flutter 
AT  
Atrial Tachycardia 
AV  
Atrio-Ventricular 
CEC  
Clinical Events Committee 
CF  
Contact Force 
CFAE  
Complex Fractionated Atrial Electrograms 
CIP  
Clinical Investigation Plan or Protocol 
CT  
Computed Tomography 
CTI  
Cavo Tricuspid Isthmus 
DMP  
Data Management Plan 
DVT  
Deep Vein Thrombosis 
EC  
Ethics Committee 
ECG  
Electrocardiogram 
eCRF  
electronic Case Report Form 
EDC  
Electronic Data Capture 
FTI  
Force Time Integral 
ICD  
Implantable Cardiac Defibrillator 
ICF  
Informed Consent Form 
IFU  
Instructions for Use 
IRB  
Institutional Review Board 
LSI  
Lesion Index 
MI  
Myocardial Infarction 
MRI  
Magnetic Resonance Imaging 
NYHA  
New York Heart Association 
PAF  
Paroxysmal Atrial Fibrillation 
PCI  
Percutaneous Coronary Intervention 
POD  
Post-Operative Day 
PsAF  
Persistent Atrial Fibrillation 
PV  
Pulmonary Vein 
PVI  
Pulmonary Vein Isolation 
RF  
Radiofrequency 
SAE  
Serious Adverse Event 
 

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APPENDIX II: DEFINITIONS 
Term 
Definition 
Documentation of 
Paroxysmal AF for Inclusion 
AF lasting up to 7 days that is documented by (1) physician’s note 
within 12 months of consent indicating recurrent self-terminating AF 
AND (2) one electrocardiographically documented AF episode  
Documentation of Persistent 
AF for Inclusion 
AF sustained beyond 7 days and less than 1-year that is documented 
by (1) a physician's note within 12 months of consent AND (2) a 24-
hour Holter within 90-days prior to the procedure, showing continuous 
AF, OR (3) two electrocardiograms (from any form of rhythm 
monitoring) showing continuous AF, with electrocardiograms taken at 
least 7 days apart 
Early Persistent AF 
Early persistent AF is defined as AF that is sustained beyond 7 days 
but is less than 3 months in duration. 
Non-Early Persistent AF 
Persistent AF sustained beyond 3 months but is less than 12 months in 
duration. 
 
 
 

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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: LITERATURE REVIEW 
The following literature was reviewed for the development of this CIP and summarizes the topic of low-voltage zones in the left atria, and 
their association with one-year success. 
 
Clinical Investigation 
Objective 
Study Arms 
Patient population 
Endpoints 
Results 
Lin, et al19 
High-resolution mapping 
of pulmonary vein 
potentials improved the 
successful pulmonary 
vein isolation using small 
electrodes and inter-
electrode spacing 
catheter 
Determine if 
smaller 
electrodes with 
a closer inter-
electrode 
spacing may 
improve the 
mapping 
resolution and 
outcome 
Substrate mapping 
of the left atrium 
and residual 
pulmonary vein 
(PV) potentials 
during sinus rhythm 
was sequentially 
performed using a 
Navistar 
Thermocool (3.5-
mm) and PentaRay 
(1-mm) in 33 
patients (Group 1) 
that underwent 
repeat atrial 
fibrillation (AF) 
procedures. PV 
gap identification 
and 
electrophysiological 
characteristics 
were compared. 
Arrhythmia 
freedomwas 
compared with a 
propensity matched 
(1:2) control group 
(66 patients, Group 
Paroxysmal and 
Persistent AF 
Arrhythmia 
freedom at one 
year 
In the Group 1 
patients, the total area 
of residual PV 
potentials measured 
using the 1-mm 
catheter was larger 
than that measured by 
the 3.5-mm catheter. 
Overall 1.97 ± 0.59 (1–
3) and 1.49 ± 0.62 (1–
3) PVs were identified 
by the 1-mm electrode 
and 3.5 mm catheters, 
respectively (P = 0.02). 
The gaps not identified 
by the 3.5 mm catheter 
had a smaller width 
and lower voltage. 
Radiofrequency 
catheter ablation in the 
areas with residual PV 
potentials identified by 
the 1-mm catheter 
resulted in complete 
electrical isolation of 
the PVs. Arrhythmia 
freedom at one year of 
follow-up was achieved 

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Results 
2) undergoing 
repeat AF 
procedures guided 
by wide inter-
electrode spacing 
catheter. 
in 26 of 33 (78.8%) 
patients in Group 1, 
which was significantly 
higher than the 
matched control group 
(33/66 [50%], P < 
0.05). 
Yagishita, et al20 
Identification and 
electrophysiological 
characterization of early 
left atrial structural 
remodeling as a predictor 
for atrial fibrillation 
recurrence after 
pulmonary vein isolation 
Determine 
optimal bipolar 
voltage cutoff 
for identifying 
mildly affected 
low-voltage 
area 
PVI only ablation 
Control without AF 
and structural heart 
disease 
Patients with PAF, 
PsAF, or LSAF 
undergoing a PVI-only 
ablation 
Recurrence of 
AF 
During the median 2.4 
years, patients with 
mild low-voltage area 
(<1.1mV) had higher 
recurrence rates 
(p<0.001) and 
presence of mild low-
voltage area was an 
independent predictor 
for recurrence in 
multivariate analysis 
(hazard ratio 3.944) 
Yagishita, et al21 
Long-Term Outcome of 
Left Atrial Voltage-
Guided Substrate 
Ablation During Atrial 
Fibrillation: A Novel 
Adjunctive Ablation 
Strategy 
Determine 
long-term 
outcomes after 
low-voltage 
area (LVA) 
ablation with 
PVI for AF 
Presence of LVA 
No LVA (non-LVA 
group) 
Both groups had 
PVI.  Only LVA 
group had 
additional substrate 
modification. 
Patients with PAF, 
PsAF, or LSAF  
Recurrence of 
AF 
After the index 
procedure, 72% of total 
population was free of 
AF after 12M.  There 
was no difference in 
the recurrence (log-
rank P-0.746), and 
complications (0% vs 
7%, P=0.125) between 
the groups.  Neither 
LVA nor Non-LVA was 
an independent 
predictor for the 
recurrence in a 
multivariate analysis. 

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Yagishita, et al22 
Correlation of Left Atrial 
Voltage Distribution 
Between Sinus Rhythm 
and Atrial Fibrillation: 
Identifying Structural 
Remodeling by 3-D 
Electroanatomic Mapping 
Irrespective of the 
Rhythm 
Compare point 
by point electro 
anatomical 
voltage 
mapping 
(EAVM) 
obtained during 
AF and SR in 
the same 
patient 
presenting for 
AF ablation 
Single arm 
consecutive 
patients compared 
to 6 controls 
 
The CARTO3-RMT 
and Stereotaxis 
systems were used 
for EAVM during 
AF and SR. The 
geometry fill 
threshold was set 
at 15 for a uniform, 
high-resolution 
EAVM. 
27 consecutive 
patients presenting for 
RF ablation for 
symptomatic AAD 
refractory PAF, PsAF, 
or LSAF. 
 
Excluded re-ablation 
LA and PV Antra 
voltage 
compared in 
both SR and AF 
There was a significant 
linear bipolar voltage 
correlation between 
SR and AF(r = 0.707, 
P < 0.001, Y = 1.515X 
+ 0.786). 
LA bipolar voltage in 
PAF patients was 
higher than non-PAF in 
SR (2.24 ± 1.51 vs. 
1.56 ± 1.53 mV) and in 
AF (0.81 ± 0.60 vs. 
0.58 ± 0.62 mV, both 
for P < 0.001). 
The pulmonary vein 
antra voltage was 
significantly lower than 
other LA regions in 
PAF (1.28 ± 0.79 vs. 
2.54 ± 1.50 mV, P < 
0.001) and Non-PAF 
patients (1.13 ± 1.04 
vs. 1.86 ± 1.72 mV, P 
< 0.001), while no 
voltage differences 
was found in the 
control group (P = 
0.998). 
Kircher, et al23 
Individually tailored vs. 
standardized substrate 
modification during 
radiofrequency catheter 
Compare 
efficacy and 
safety of PVI 
plus voltage-
guided ablation 
vs. PVI with or 
Control:  PVI with 
linear ablation 
(persistent) or 
without linear 
ablation 
(paroxysmal) 
124 persistent or 
paroxysmal AF  
No previous ablation 
allowed 
Freedom from 
arrhythmia 
(>30sec) via 7-
day holter at 
12M 
After a mean follow-up 
of 12 ± 3 months, 
significantly more 
patients in the LVA 
ablation group were 
free from atrial 

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ablation for atrial 
fibrillation: a randomized 
study 
without linear 
ablation 
depending on 
the type of AF. 
Treatment:  PVI 
plus ablation of 
low-voltage areas  
arrhythmia recurrence 
>30 s off 
antiarrhythmic drugs 
(AADs) after a single 
procedure (primary 
endpoint) compared 
with control group 
patients [40/59 (68%) 
vs. 25/59 (42%), log-
rank P = 0.003]. 
Arrhythmia-free 
survival on or off AADs 
was found in 33/59 
control group patients 
(56%) and in 41/59 
LVA ablation group 
patients (70%) 
(adjusted log-rank P = 
0.10). During the 7 day 
Holter monitoring 
period at 12 months, 
significantly more 
patients in the LVA 
ablation group were 
free from arrhythmia 
recurrence on or off 
AADs [45/50 (90%) vs. 
33/46 (72%), P = 0.04].  
Jadidi, et al24 
Ablation of Persistent 
Atrial Fibrillation 
Targeting Low-Voltage 
Areas With Selective 
Determine if 
PVI plus 
ablation of 
selective atrial 
low-voltage 
sites may be 
Group 1: PVI plus 
ablation of low-
voltage areas 
Group 2:  Matched 
control of 66 
85 consecutive 
persistent AF patients  
Single procedure 
arrhythmia 
freedom 
Single-procedural 
freedom at 13 months 
median follow-up was 
59/85 (69%) in group 1 
compared to 31/66 

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Activation 
Characteristics. 
more 
successful than 
PVI only 
patients with PVI 
only 
(47%) in group 2 
(p<0.001) 
Schreiber, et al25 
Catheter ablation of atrial 
fibrillation with box 
isolation of fibrotic areas: 
Lessons on fibrosis 
distribution and extent, 
clinical characteristics, 
and their impact on long-
term outcome 
Report 
outcomes using 
box isolation of 
fibrotic areas 
(BIFA) in 
patients with 
fibrotic atrial 
cardiomyopathy 
(FACM) 
Retrospective 
analysis compared 
PVI + BIFA (n=92) 
to non-fibrosis 
reference group 
with PVI only 
(n=49) 
92 de novo persistent 
and paroxysmal 
patients with PVI + 
BIFA based on 
detection of significant 
fibrotic areas defined 
as <0.5mV 
Arrhythmia free 
For BIFA ablation, 
single and multiple 
procedure arrhythmia-
free survival was 
68.8% and 82.8% with 
1.2 procedures/patient 
and a follow-up time of 
16.3 ± 8.2 months after 
the index procedure. 
FACMI+II pts showed 
a significantly better 
outcome compared to 
FACM III+IV pts (single 
procedure: 81.0 vs. 
40.9%, P < 0.001, 
multiple procedure 
92.8 vs. 61.4%, P < 
0.001). 
Non-fibrosis reference 
group had 
single/multiple 
procedure success 
rates of 84.4% and 
93.7% respectively 
with 1.1 procedures.   
Yamaguci, et al.26 
Long-term results of 
pulmonary vein antrum 
isolation in patients with 
atrial fibrillation: an 
To examine the 
impact of left 
atrial (LA) low-
voltage zones 
(LVZs) on atrial 
fibrillation (AF) 
Single arm with 
PVAI only 
76 paroxysmal and 
persistent AF 
Low voltage zones 
were identified in 32% 
of cases 
AF recurrence 
through 24M 
During 24+7 months of 
follow-up, 15 patients 
(63%) with LVZs and 
10 (19%) without had 
AF recurrences off 
antiarrhythmic drugs 

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Clinical Investigation 
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Endpoints 
Results 
analysis in regards to 
substrates and 
pulmonary vein 
reconnections. 
recurrence after 
pulmonary vein 
antrum isolation 
(PVAI) without 
LA substrate 
modification. 
(log-rank P , 0.001). A 
multivariate logistic 
regression analysis 
revealed that LVZ 
areas [odds ratio (OR): 
1.12 per 1 cm2, 95% 
confidence interval 
(CI): 1.04–1.23, P < 
0.001] and ATP-
induced reconnection 
(OR: 2.08, 95% CI: 
1.01–4.91, P < 0.046) 
were significant 
predictors of 
recurrence. 
In those with LVZs, the 
LVZ area was strongly 
correlated with the LA 
body volume (r = 0.81, 
P < 0.001) and a 
unique predictor of 
recurrence (OR: 1.17 
per 1 cm2, 95% CI: 
1.01–1.55, P = 0.031), 
while in those without 
an LVZ,ATP induced 
PV reconnection was a 
unique predictor (OR: 
3.24, 95% CI: 1.15–
15.39, P = 0.025). 

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Table 3 Summary of Relevant Review Articles 
Article 
Subject 
Summary 
Calkins, et al. 18 
2017 
HRS/EHRA/ECAS/APHRS/SOLAECE 
expert consensus statement on 
catheter and surgical ablation of atrial 
fibrillation: Executive summary. 
Calkins et al. Heart Rhythm. 2017; 14: 
e275-e444.  
The main objective of 
the document is to 
improve patients care 
by providing a 
foundation of 
knowledge for those 
involved with catheter 
ablation of atrial 
fibrillation.  A second 
major objective is to 
provide 
recommendations for 
designing clinical trials 
of AF ablation. 
The purpose of the 2017 Consensus Statement is to provide a state-of-
the-art review of the field of catheter and surgical ablation of AF and to 
report the findings of a writing group convened by five international 
societies.  Reflecting both the worldwide importance of AF, as well as 
the worldwide performance of AF ablation, this document is the result of 
a partnership between the Heart Rhythm Society (HRS), European 
Heart Rhythm Association (EHRA), European Cardiac Arrhythmia 
Society (ECAS), the Asia Pacific Heart Rhythm Society (APHRS), and 
the Latin American Society of Cardiac Stimulation and 
Electrophysiology (SOLAECE).  The consensus statement provides 
guidance on clinical definitions of AF, a discussion of 
electrophysiological features of AF, and the role of catheter ablation to 
treat PsAF along with safety and effectiveness reporting guidelines. 
Rolf et al.27 
Electro Anatomical Mapping of Atrial 
Fibrillation: Review of the Current 
Techniques and Advances. J A Fib. 
2014; 7.  
The objective of this 
review was to outline 
contemporary and 
upcoming electro 
anatomical key 
technologies focusing 
on new mapping tools 
and strategies in the 
context of AF catheter 
ablation.  
This review discussed how electro anatomical mapping technologies 
have facilitated mapping processes and enabled complex AF ablation 
strategies Electro anatomical mapping technologies and the benefits of 
use in AF ablation are discussed. There is focused review of specific 
mapping strategies including activation mapping, entrainment mapping, 
mapping of complex fractionated electrograms, multipolar mapping, 
mapping of high dominant frequencies, focal and rotor mapping and 
modulation, voltage mapping and substrate imaging, and ripple 
mapping. 
Saini et al.28 
Scar homogenization in Atrial 
Fibrillation Ablation: Evolution and 
Practice. J A Fib. 2017; 10.  
The objective of this 
review was to discuss 
the evidence behind 
the use of scar 
homogenization in AF 
This review discussed the association between fibrosis and atrial 
fibrillation along with methods for defining atrial scar. A thorough review 
of clinical trials that have targeted atrial substrate for AF ablation is 
included that identifies evidence in support of, and against, a substrate 
guided approach to AF ablation. The review concludes with highlighting 

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Article 
Subject 
Summary 
ablation, its evolution 
and scope in 
delivering optimal 
outcomes.  
the pitfalls of a substrate guided approach to AF ablation including 
variation in scar maps, discussion of an appropriate endpoint for 
substrate modification, and if scar is truly static substrate that 
encompasses all abnormal atrial substrate. 
Nery, et al29 
Characterization of Low-Voltage Areas in 
Patients With Atrial Fibrillation: Insights 
From High-Density Intracardiac Mapping  
Characterization of 
low-voltage left atrial 
substrate in AF 
This review determined the optimal catheter ablation strategy for 
persistent atrial fibrillation remains unknown. Current data highlight the 
need for a better understanding of the substrate and mechanisms of 
arrhythmia maintenance in the persistent AF population. Catheter 
ablation based on low-voltage (scar) substrate has recently emerged as 
a promising strategy for ablation of atrial fibrillation. Further research is 
needed to assess the role of voltage-based ablation for persistent AF. 
 
 
 
 
 

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APPENDIX V: INFORMED CONSENT FORM 
A template informed consent form will be provided under separate cover. 
 
 
 

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APPENDIX VI: MONITORING PLAN 
A copy of the Monitoring Plan can be obtained upon request from the Sponsor for the clinical 
investigation. 
 
 

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APPENDIX VII: CASE REPORT FORMS 
A copy of sample Case Report Forms can be obtained upon request from the Sponsor for the clinical 
investigation. 

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APPENDIX VIII: GRID ELECTRODE CONFIGURATIONS 
HD Wave Electrode Configuration 
For the purposes of this clinical study, HD Wave electrode configuration will be considered any 
configuration that only utilizes mapping data collected at electrodes with orthogonal bi-poles. Orthogonal 
bi-poles are defined as a pair of perpendicular bi-poles originating from a single electrode with one bi-
pole configured across two separate splines and one bi-pole configured along the spline. Automap 
settings will be set to select the ‘best duplicate’ at each electrode with orthogonal bi-poles. 
 
An example of GRID with HD Wave configuration is depicted in Figure 3. This HD Wave configuration 
utilizes bi-poles both along each spline of the catheter (A, B, C, and D) and across GRID catheter splines 
(A-B, B-C, and C-D) as depicted by the dark arrows. Bipolar electrogram voltages along the splines are 
configured as in the along-the-spline configuration described below; using electrode pairs 1-2, 2-3, and 
3-4 on each spline. Bipolar electrogram voltages across the splines are recorded using electrode pairs of 
the same number/position on adjacent splines (A1-B1, B1-C1, C1-D1, A2-B2, B2-C2, C3-D3, A3-B3, B3-
C3, C3-D3). Automap settings will be set to select the ‘best duplicate’ at each electrode shown in yellow.  
 
An alternate example of GRID with HD Wave configuration is depicted in Figure 4. Bipolar electrograms 
are configured as depicted by the dark arrows. Bipolar electrogram voltages along the splines are 
configured using the following electrode pairs and directionality: A1-A2, A2-A3, A4-A3, B1-B2, B2-B3, 
B3-B4, C2-C1, C3-C2, C4-C3, D1-D2, D3-D2, D4-D3. Bipolar electrogram voltages across the splines 
are configured using the following electrode pairs and directionality: A1-B1, B1-C1, D1-C1, A2-B2, B2-
C2, C2-D2, B3-A3, C3-B3, D3-C3, A4-B4, C4-B4, D4-C4. Automap settings will be set to select the ‘best 
duplicate’ at each electrode shown in yellow. 
  
  

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Figure 3. Example of GRID HD Wave Electrode Configuration 
 

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Figure 4. Example of alternative GRID HD Wave electrode configuration 
 
 
Along-the-Spline Configuration 
This configuration utilizes bi-poles, or electrogram pairs, along each of the GRID catheter splines 
(labeled A, B, C, and D). On each spline, electrodes are numbered 1 through 4, with 1 being the most 
distal electrode. Bipolar electrogram voltages are recorded using electrode pairs 1-2, 2-3, and 3-4. An 
additional bi-pole is recorded using the shaft electrodes (S1-S2). 

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Figure 5. Along-the-spline GRID Electrode Configuration 
 
 
Other Configurations 
For the purposes of this clinical study, any electrode configuration that does not meet the definition of HD 
Wave or along-the-spline configuration (i.e. use of all bipoles employing a combination of electrodes with 
orthogonal bipoles and electrodes with only along the spline configurations) will be classified as ‘other’.  
 
 
 

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3. Able and willing to provide written informed consent prior to any clinical 
investigation related procedure 
4. Able and willing to complete all required study procedures through 12 
months 
Exclusion Criteria 
1. Long-standing persistent atrial fibrillation defined as continuous AF greater 
than 12 months in duration 
2. Previous ablation or surgery in the left atria 
3. Implanted left atrial appendage occluder 
4. Implanted mitral or tricuspid valve replacement 
5. Implanted cardiac defibrillator (ICD) 
6. Participation in another clinical investigation that may confound the results 
of this study 
7. Pregnant or nursing  
8. 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 investigation or to comply with 
follow-up requirements, or impact the scientific soundness of the clinical 
investigation results. 
9. Life expectancy less than 12 months 
 
 
 

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ABT-CIP-10275 Ver. A 
Study Name: WAVE-MAP AF 
Clinical Investigation Plan 
 
 
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