LSI (Lesion Index) Workflow Post-Market Observational Study
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express 
written consent of Abbott. 
87173 CIP Posting Cover Page Ver C 
Template 
Page 1 of 1 
 
NCT Number: NCT03906461 
LSI Workflow 
LSI (Lesion Index) Workflow Observational Study 
Study Document No: ABT-CIP-10276 
Version B 
Date: 04-MAR-2019 
 
 
Sponsor  
 
 
Abbott 
        
 
 
 
5050 Nathan Lane North 
 
 
 
 
Plymouth, MN 55442 
 
 
 
 
USA 
 
 
 

ABT-CIP-10276 Ver. B 
Study Name: CRD 970 LSI Workflow 
Clinical Investigation Plan 
 
 
 
Template: 86357 Rev. F 
 
Page 2 of 45 
SITE PRINCIPAL INVESTIGATOR 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: 
 
 
 

ABT-CIP-10276 Ver. B 
Study Name: CRD 970 LSI Workflow 
Clinical Investigation Plan 
 
 
 
Template: 86357 Rev. F 
 
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TABLE OF CONTENTS 
 
1.0 
INTRODUCTION .............................................................................................................................. 7 
1.1 
Background and Rationale ........................................................................................................... 7 
 
Background ........................................................................................................................... 7 
 
Rationale for Conducting this Clinical Investigation ............................................................... 8 
2.0 
CLINICAL INVESTIGATION OVERVIEW ........................................................................................ 8 
2.1 
Clinical Investigation Objective ..................................................................................................... 8 
 
Primary objective ................................................................................................................... 8 
 
Secondary objective .............................................................................................................. 8 
2.2 
Device(s) To Be Used in the Clinical Investigation ....................................................................... 9 
 
Name of the Device(s) Under Investigation ........................................................................... 9 
 
Indication for Use .................................................................................................................. 9 
 
Device Description and Intended Purpose .......................................................................... 10 
3.0 
CLINICAL INVESTIGATION DESIGN ............................................................................................ 12 
3.1 
Clinical Investigation Procedures and Follow-up Schedule ........................................................ 14 
3.2 
Suspension or Early Termination of the Clinical Investigation .................................................... 15 
4.0 
ENDPOINTS .................................................................................................................................. 16 
4.1 
Primary Endpoint and Rationale ................................................................................................. 16 
4.2 
Additional Evaluations ................................................................................................................ 16 
5.0 
SUBJECT SELECTION AND WITHDRAWAL ............................................................................... 17 
5.1 
Subject Population ...................................................................................................................... 17 
5.2 
Subject Screening and Informed Consent .................................................................................. 17 
 
Subject Screening ............................................................................................................... 17 
 
Informed Consent ................................................................................................................ 17 
5.3 
Eligibility Criteria ......................................................................................................................... 18 
 
General Eligibility Criteria .................................................................................................... 18 
 
Inclusion Criteria .................................................................................................................. 18 
5.3.2.1 
General Inclusion Criteria ............................................................................................. 18 
 
Exclusion Criteria................................................................................................................. 18 
5.3.3.1 
General Exclusion Criteria............................................................................................ 18 
5.4 
Subject Enrollment ..................................................................................................................... 19 
5.5 
Subject Withdrawal ..................................................................................................................... 19 
5.6 
Number of Subjects .................................................................................................................... 20 
5.7 
Total Expected Duration of the Clinical Investigation ................................................................. 20 
6.0 
TREATMENT AND EVALUATION OF ENDPOINTS ..................................................................... 20 

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Clinical Investigation Plan 
 
 
 
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6.1 
Baseline Clinical Assessments ................................................................................................... 20 
6.2 
Index Procedure ......................................................................................................................... 21 
 
Re-ablation Treatment Procedures ..................................................................................... 22 
6.3 
Post–procedure .......................................................................................................................... 22 
6.4 
Follow-up Assessments .............................................................................................................. 23 
 
Follow-up for All Subjects (Clinic Visit) ................................................................................ 23 
 
Patient Reported Outcome (PRO) Measures ...................................................................... 23 
 
Schedule of Events.............................................................................................................. 23 
7.0 
Adverse Events .............................................................................................................................. 26 
7.1 
Definition ..................................................................................................................................... 26 
 
Adverse Event ..................................................................................................................... 26 
 
Serious Adverse Event ........................................................................................................ 26 
7.2 
Device Relationship .................................................................................................................... 26 
7.3 
Serious Adverse Event Reporting ............................................................................................... 27 
 
Device Complaint Reporting ................................................................................................ 27 
8.0 
STATISTICAL CONSIDERATIONS ............................................................................................... 27 
8.1 
Analysis Populations .................................................................................................................. 27 
8.2 
Statistical Analyses ..................................................................................................................... 28 
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 ............................................................................................................ 30 
8.9 
Statistical Criteria for Termination ............................................................................................... 30 
8.10 
Success Criteria ......................................................................................................................... 30 
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 
 
Site Training ........................................................................................................................ 31 
10.4 
Monitoring ................................................................................................................................... 31 
10.5 
Deviations from CIP .................................................................................................................... 31 
10.6 
Quality Assurance Audit ............................................................................................................. 32 

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Clinical Investigation Plan 
 
 
 
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10.7 
Committees ................................................................................................................................ 32 
 
Publications Committee ....................................................................................................... 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 CONSIDERATION ......................................................................................................... 34 
12.1 
Institutional Review Board/Medical 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 
APPENDIX I: ABBREVIATIONS AND ACRONYMS ................................................................................. 37 
APPENDIX II: SITE CONTACT INFORMATION ...................................................................................... 38 
APPENDIX III: Informed Consent ............................................................................................................. 38 
APPENDIX IV: Clinical Data Summary ..................................................................................................... 39 
APPENDIX V: REVISION HISTORY ........................................................................................................ 40 
APPENDIX VI: CIP SUMMARY ................................................................................................................ 41 
APPENDIX VII: References ...................................................................................................................... 44 
 
 

ABT-CIP-10276 Ver. B 
Study Name: CRD 970 LSI Workflow 
Clinical Investigation Plan 
 
 
 
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COMPLIANCE STATEMENT:  
 
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan, the 
Declaration of Helsinki, applicable Good Clinical Practices and regulations (e.g., US 21 CFR Part 50, 21 
CFR Part 56, 21 CFR Part 812 and OUS ISO14155:2011) 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 Institutional Review Board (IRB)/Ethics Committee (EC) 
of the respective investigational site and by the applicable regulatory authorities (e.g., FDA, PMDA, MHRA, 
etc.). 
 
 
 
 
 

ABT-CIP-10276 Ver. B 
Study Name: CRD 970 LSI Workflow 
Clinical Investigation Plan 
 
 
 
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1.0 
INTRODUCTION 
This document is the clinical investigation plan (CIP) for the LSI Workflow Study. This clinical study is a 
prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage 
of the Lesion Index (LSI™) with the market-released TactiCath™ Contact Force Ablation Catheter, Sensor 
Enabled™ (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-world environment. 
This clinical study 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 
Atrial Fibrillation (AF) is an irregular and often rapid heart rhythm where the different chambers of the heart 
are not working together in a normal coordinated pattern, resulting in decreased blood flow. AF is a major 
cause of stroke, heart failure, sudden death, and cardiovascular morbidity. AF is also associated with high 
rates of hospitalization due to AF management, heart failure, myocardial infarction, and treatment 
associated complications.7-9 It has been estimated that 20.9 million men and 12.6 million women have AF 
worldwide and that one in four middle-aged adults in the US and Europe will develop AF in their lifetime.10-
13  
Treatment for AF includes thromboembolic risk management, heart rate control, and heart rhythm control, 
which includes cardioversion and catheter ablation. The 2016 ESC AF Guideline indicates that catheter 
ablation of AF is effective in restoring and maintaining sinus rhythm in patients with symptomatic 
paroxysmal, persistent, and probably long-standing persistent AF in general as a second-line treatment 
after 
failure 
of 
or 
intolerance 
to 
antiarrhythmic 
drug 
therapy.1 
The 
2017 
HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus on AF Ablation provided targeted contact force 
(CF) recommendations during ablation.2 Contact force sensing catheter system provide operators with 
information on how much force is being applied by the catheter tip on the cardiac wall – a key factor in 
effective lesion formation. 
The TactiCath™ Quartz and the TactiCath™ Sensor Enabled (SE) ablation catheters are ablation 
catheters with CF measuring capability. Measurement of CF between the catheter tip and the target tissue 
can help guide physicians during mapping and ablation procedures. The first recommendations for CF 
sensing during pulmonary vein isolation (PVI) procedures was provided for TactiCath Quartz. Data from 
several studies such as TOCCATA, EFFICAS I and EFFICAS II show that CF sensing is not only safe for 
use in PVI but also associated with lower rates of gap and atrial fibrillation (AF) recurrence.14-18 The Force 
Time Integral (FTI™) is a linear calculation that combines CF and radiofrequency (RF) ablation time. The 
EFFICAS I and II studies established a minimum FTI threshold of 400 gram-seconds (gs) that was 
associated with significantly higher PVI success rates at 3-months.14,16 The TOCCASTAR investigational 
device exemption (IDE) study provided evidence proving the safety and effectiveness of the TactiCath 
Quartz ablation catheter for the treatment of paroxysmal AF.19 The TactiCath SE ablation catheter is the 
latest TactiCath contact force sensing catheter from Abbott, which incorporates a magnetic sensor for 
tracking with the EnSite Precision Mapping System and utilizes a new handle and shaft to improve catheter 
handling. The TactiSense IDE study showed that TactiCath SE has a similar safety profile as TactiCath 
Quartz – 12-month effectiveness data is pending. The TactiCath Post Approval Study is underway and 
currently has 2 years of data for all subjects showing the TactiCath Quartz catheter is safe and effective. 

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The TactiCath Quartz Ablation Catheter Clinical Compendium (available from Abbott) provides a thorough 
review of clinical outcomes for AF Ablation with Contact Force and the Force Time Integral. Current 
recommendations are to target a CF of 20g (range 10-30g) with a minimum CF value of 10g and a minimum 
FTI value of 400gs for any ablation points.14,16 
The relationship between Power (P, Watts), Voltage (V, Volts), and Current (I, Amps) is expressed as P = 
I*V. Building on the concept of CF and FTI, the Lesion index (LSI™) is a proprietary index that combines 
CF, RF duration (S), and RF current into a single value: LSI = CF x S (RF Time) x I (Current). The LSI 
value expresses the gradual growth of lesion formation. All three sub-components are proportional to 
~൫1 −𝑒𝑒−𝑡𝑡/𝜏𝜏൯. Factors under an operator’s control during an ablation procedure include CF, duration of 
ablation, and the power (Watts) setting of the RF generator. LSI combines these variables into a single 
value that is displayed in the EnSite™ contact force module on the EnSite Velocity™ or EnSite Precision™ 
Cardiac Mapping Systems and can be used (outside of the US), along with FTI, as the AutoMark lesion 
color or size metric. Additional evaluations of data generated in the EFFICAS I, EFFICAS II, and 
TOCCASTAR studies, suggest that use of LSI provides a more uniform lesion delivery and that the addition 
of LSI to the CF recommendations may lead to a higher rate of durable PVI3,4, and long-term clinical 
success.5,6  
 Rationale for Conducting this Clinical Investigation 
To date, there have been no Abbott-sponsored prospective clinical studies focused on LSI. However, data 
from three previous studies was retrospectively analyzed. Two additional non-Abbott-sponsored studies 
have presented results via meeting abstracts. Results are summarized in Appendix V. These studies agree 
that LSI correlates with successful acute (intra-procedural) and longer-term PVI – which in turn is 
considered strongly correlated with freedom from AF recurrence. The purpose of this study is to 
systematically gather data on the use of LSI in real-world clinical settings with the new TactiCath SE 
catheter. 
2.0 
CLINICAL INVESTIGATION OVERVIEW 
2.1 
Clinical Investigation Objective 
 Primary objective  
The primary objective of this study is to characterize LSI achieved values for durable lesion formation using 
the TactiCath SE catheter in the different anatomical regions around the pulmonary veins (PVs) of the 
heart during RF ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF). 
 Secondary objective 
Secondary objectives of this study are as follows: 
• 
To characterize the use of EnSite Automap and AutoMark module software settings, including LSI 
threshold (OUS), contact force, time, power, flow, and AutoMark spacing using the TactiCath SE 
catheter for RF ablation for the treatment of drug-refractory PAF. 
• 
To characterize LSI achieved values for lesions that reconnected versus those that were durable, 
both in an acute procedural setting as well as in patients who undergo additional ablations during 
the 12-month follow-up period after an index RF ablation procedure for the treatment of drug-
refractory PAF. 

ABT-CIP-10276 Ver. B 
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Outside of the United States: 
The TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is indicated for use in cardiac 
electrophysiological mapping (stimulation and recording), and, when used in conjunction with a RF 
generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including 
atrial fibrillation. 
 Device Description and Intended Purpose 
Please refer to the relevant IFUs for additional information regarding all devices used in this clinical 
investigation. 
The TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) is designed to 
facilitate electrophysiological mapping of the heart chambers and to transmit radiofrequency (RF) current 
to the catheter tip electrode for intracardiac ablation purposes. For ablation, the catheter is used in 
conjunction with a RF generator, an irrigation pump, and a dispersive pad (indifferent patch electrode). 
TactiCath SE is compatible with introducers or sheaths with a minimum diameter of 8.5 F.  TactiCath SE 
is a sterile, single use catheter with a 7.5 F shaft and an 8 F distal section. It is constructed of thermoplastic 
elastomer material and noble metal electrodes.  
The catheter has novel force and magnetic sensors (Figure 1A). It has a fluid lumen connected to open 
conduits within a 6-hole tip electrode for saline irrigation during the ablation procedure. For both uni-
directional (Figure 1B) and bi-directional catheters (Figure 1C), the tip curvature is manipulated by the 
control mechanism located on the handle at the catheter's proximal end. To adjust the curve of the distal 
tip on the uni-directional catheter, the thumb control located on the handle may be pushed or pulled. To 
adjust the curve of the distal tip on the bi-directional catheter, the actuator may be used to deflect the 
catheter in either direction. The catheter interfaces with standard recording equipment and a compatible 
RF generator via the TactiSys Quartz Equipment using the optical connector and 19-pin electrical 
connector on the catheter. The catheters are available in eight distal curve shapes. 
 
 
 

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Clinical Investigation Plan 
 
 
 
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Figure 1. (A) Exposed View of TactiCath SE Tip. (B) Uni-Directional and (C) Bi-Directional TactiCath 
SE Catheter 
 
 

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Clinical Investigation Plan 
 
 
 
Template: 86357 Rev. F 
 
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3.0 
CLINICAL INVESTIGATION DESIGN 
This is a prospective, multicenter, post-market, single-arm, observational study designed to quantify and 
characterize the usage of LSI with the TactiCath SE catheter in a real-world environment. This study will 
enroll approximately 150 patients at approximately 10 sites. Since endpoint evaluations will be descriptive, 
there are no statistical power considerations for this sample size. 
Primary Endpoint 
The primary endpoint is a summary of LSI achieved values for RF lesion formation in different anatomical 
regions of the heart around the pulmonary veins (PVs, see Figure 2). The areas around the left and right 
pairs of PVs will be each divided into 5 zones, with 4 zones representing four circumferential quadrants 
and the fifth zone representing the region between the pair of veins.  
Figure 2. Numbered anatomical zones around the pulmonary veins (PVs). LSPV = Left Superior 
Pulmonary Vein; LIPV = Left Inferior Pulmonary Vein; RSPV = Right Superior Pulmonary Vein; RIPV = 
Right Inferior Pulmonary Vein. 
 
Additional evaluations 
• 
A summary of EnSite AutoMap and AutoMark module software settings, including LSI threshold (in 
OUS), contact force, time, power, flow, and AutoMark spacing 
• 
Acute electrical isolation of PVs, 20 minutes after last RF ablation in PV region 
• 
Device- or procedure-related SAEs within 7-days and 12-months of index procedure 
• 
Freedom from documented AF/AFL/AT recurrence at 12-months post-index ablation, excluding a 
90-day blanking period.  
o Freedom from AF/AFL/AT recurrence is defined as no documented episodes greater than 
30 seconds with a 24-Holter. 
• 
Proportion of patients with a repeat ablation up to 12-months post index procedure (excluding 90-
day blanking period) 
• 
Proportion of lesions generated during first-pass PVI that required touch-up* ablation 

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Clinical Investigation Plan 
 
 
 
Template: 86357 Rev. F 
 
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o *In this CIP, a “touch-up” ablation is defined as an ablation occurring during the same 
procedure that is performed to close an identified gap in the first-pass ablations 
• 
Proportion of pulmonary veins (PVs) requiring touch-up ablation 
• 
Proportion of patients who required at least one touch-up ablation during the index procedure 
• 
In patients who undergo any repeat RF ablation procedures up to 12-months post index procedure, 
characterization of LSI achieved values for lesions that resulted in electrically conducting gaps 
versus those that were durable 
• 
Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and 
any touch-up ablations  
• 
Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, 
and any touch-up ablations 
• 
Overall fluoroscopy time 
• 
Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-months post index ablation, 
compared to baseline scores 
• 
AAD use at 12-months 
• 
Health care utilization (including number of unscheduled hospital outpatient/ER visits and inpatient 
hospitalizations due to arrhythmias) collected throughout the 12-month follow-up period 

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Study visit windows: 
• 
Baseline Visit, after Informed Consent 
• 
Procedure Visit, preferably within 14 days but not more than 30 days of Informed Consent 
• 
3- to 6-Month* Follow-Up Visit, 90 to 183 ± 21 days after Procedure 
• 
12-Month Follow-Up Visit, 365 ± 21 days after Procedure 
• 
Repeat Ablation**, any time after Procedure during follow-up period, at physician’s discretion  
*A follow-up visit must occur between 3- and 6-months post-index procedure (with a 21-day window). For 
readability, this follow-up visit will be referred to as the “6-Month” follow-up visit. 
**Repeat ablations that occur within the 90-day blanking period will not be considered an effectiveness 
failure and will follow the repeat ablation procedure 
3.2 
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: 
• 
An oversight committee makes a recommendation to stop or terminate the clinical investigation 
(such as higher frequency of anticipated adverse device effects) 
• 
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 SAEs 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 IRB/EC (if applicable). All applicable clinical investigation documents shall be 
subject to the same retention policy as detailed in Section 11.5 of the CIP.  
 
A Principal Investigator, IRB/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. 
 

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4.0 
ENDPOINTS 
Outcomes were selected, when possible, following the recommendations published in “Harmonized 
Outcome Measures for Use in Atrial Fibrillation Patient Registries and Clinical Practice”24, which were 
endorsed by the Heart Rhythm Society Board of Trustees. 
All endpoints and additional evaluations will be descriptive, there will be no hypothesis testing, and there 
are no statistical power considerations. 
4.1 
Primary Endpoint and Rationale 
The primary endpoint is a summary of LSI values achieved for RF lesion formation in different anatomical 
regions of the heart around the pulmonary veins (PVs, see Figure 2).  
4.2 
Additional Evaluations 
• 
A summary of EnSite AutoMap and AutoMark module software settings, including LSI threshold 
settings (in OUS), contact force, time, power, flow settings, and AutoMark spacing 
• 
Acute electrical isolation of PVs, 20 minutes after last RF ablation in PV region 
• 
Device- or procedure-related SAEs within 7-days and 12-months of index procedure 
• 
Freedom from documented AF/AFL/AT recurrence at 12-months post-index ablation, excluding a 
90-day blanking period.  
o Freedom from AF/AFL/AT recurrence is defined as no documented episodes greater than 
30 seconds with a 24-Holter. 
• 
Proportion of patients with a repeat ablation up to 12-months post index procedure (excluding 90-
day blanking period) 
• 
Proportion of lesions generated during first-pass PVI that required touch-up ablation 
• 
Proportion of pulmonary veins (PVs) requiring touch-up ablation 
• 
Proportion of patients who required at least one touch-up ablation during the index procedure 
• 
In patients who undergo any repeat RF ablation procedures up to 12-months post index procedure, 
characterization of LSI achieved values for lesions that resulted in electrically conducting gaps 
versus those that were durable 
• 
Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and 
any touch-up ablations  
• 
Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, 
and any touch-up ablations 
• 
Overall fluoroscopy time 
• 
Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-months post index ablation, 
compared to baseline scores 
• 
AAD use at 12-months 
• 
Health care utilization (including number of unscheduled hospital outpatient/ER visits and inpatient 
hospitalizations due to arrhythmias) collected throughout the 12-month follow-up period 

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Study Name: CRD 970 LSI Workflow 
Clinical Investigation Plan 
 
 
 
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5.0 
SUBJECT SELECTION AND WITHDRAWAL  
5.1 
Subject Population 
This clinical investigation will enroll male and female subjects undergoing their first ablation procedure from 
the documented drug-refractory, paroxysmal atrial fibrillation (PAF) 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 
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). Once a duly dated and 
signed Informed Consent form is obtained, the clinical investigation-specific screening procedures may 
begin.  
 
Subjects must be screened for clinical investigation eligibility by a member of the site’s clinical investigation 
team previously trained to the CIP and will be entered into a site-specific screening log. 
 
In case the subject does not meet all inclusion criteria or meets any of the exclusion criteria, the subject is 
considered a screening point failure. The Principal Investigator or the delegated clinical investigation 
personnel will record the screening failure on a screening log as required. 
 
Patients meeting general inclusion criteria and no exclusion criteria will be asked to sign an Informed 
Consent form if they wish to participate in the clinical investigation.  
 
Subject data will be collected following informed consent into the clinical investigation. 
 Informed Consent 
The Investigator or his/her authorized designee (if applicable) will conduct the Informed Consent process, 
as required by applicable regulations and the center’s IRB/EC. This process will include a verbal discussion 
with the subject on all aspects of the clinical 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 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. The subject shall be provided with the Informed Consent form written in a language that is 
understandable to the subject and has been approved by the center’s IRB/EC. The subject shall have 
adequate time to review, ask questions, and consider participation. The Principal Investigator or his/her 
authorized designee will make efforts to ensure that the subject understands the information provided. If 
the subject agrees to participate, the Informed Consent form must be signed and dated by the subject and 
thereafter by the person obtaining the consent prior to any clinical investigation-specific procedures. The 
signed original will be filed in the subject’s medical record, and a copy will be provided to the subject. 

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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 IRB/EC according to the IRB’s/ 
EC’s reporting requirements. 
 
If, during the clinical investigation, new information becomes available that may 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 participation in the study by signing another informed consent. 
 
For US sites: 
In addition, an authorization for use and disclosure of the subject’s protected health information, in 
accordance with the Health Insurance Portability and Accountability Act (HIPAA), must be obtained from 
the subject.  
5.3 
Eligibility Criteria 
 General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interview with a 
candidate patient. 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 of 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. Subject must provide written informed consent prior to any clinical investigation related procedure. 
2. Subject is at least 18 years of age. 
3. Subject is willing and able to comply with the protocol-described evaluations and follow-up 
schedule. 
4. Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic 
paroxysmal AF using RF ablation. 
5. Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug. 
• 
For the purposes of this study, “intolerant” includes either: 
i. Subject attempted the drug at any dose and either the subject or their physician 
chose to discontinue for any reason 
ii. Subject was offered the drug and refused to take for any reason 
 
 
 Exclusion Criteria 
5.3.3.1 General Exclusion Criteria 
1. Previous ablation or surgery in the left atria. 

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2. Has an implantable cardiac defibrillator (ICD), pacemakers without defibrillation capacity are 
allowable). 
3. Participation in another clinical investigation that may confound the results of this study. 
4. Pregnant or nursing. 
5. 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. 
6. Life expectancy less than 12 months.  
5.4 
Subject Enrollment 
A patient is considered enrolled in the study after they have provided written informed consent, have been 
confirmed that they meet all the inclusion criteria and none of the exclusion criteria, and the mapping 
catheter has been inserted into their vasculature. 
If a subject that is enrolled into the study is later found to have met exclusion criteria or not all inclusion 
criteria, they will continue follow-up in the study and their data will be included in the analysis population. 
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’s follow-up is terminated according to Section 3.2 (Suspension or Early Termination of the 
Study) 
 
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 IRB/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. The subject’s status (deceased/alive) must be reported at the time of withdrawal. 
 
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 specified for 
the 12-month follow-up visit. 
 
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 

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• 
Cardiovascular disease history (most recent value prior to baseline visit) 
• 
Arrhythmia history including documentation of PAF diagnosis (as described in the inclusion 
criteria) 
• 
Complete physical exam (if the requested physical exam data are available from a standard of 
care visit prior to consent, they may be used if they were done within 30 days prior to consent)   
• 
Anti-arrhythmic drug (AAD) usage 
• 
Presence of a left atrial appendage occluder 
• 
Completion of the EQ-5D-5L and AFEQT questionnaires 
 
It 
is 
recommended 
to 
follow 
pre-ablation 
anticoagulation 
guidelines 
from 
the 
2017 
HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation for 
Atrial Fibrillation.2 
6.2 
Index Procedure 
The procedure will be performed according to the IFU of the EnSite Precision Cardiac Mapping System, 
the IFUs of the AutoMark and EnSite AutoMap modules, the IFU of the TactiCath SE catheter, and the 
respective IFUs of any other medical devices used during the 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 
must be delayed until the thrombus has been resolved, or the subject must be withdrawn from the 
investigation no later than 30 days after the first index procedure attempt. 
 
• 
A standard mapping procedure should be performed using a mapping catheter(s) of the operator’s 
choice, as long as it follows the respective IFU(s) and is compatible with the EnSite system and 
AutoMap module. 
• 
Ablation to achieve pulmonary vein isolation (PVI) must be conducted using the TactiCath SE 
catheter and the EnSite AutoMark module.  
o US only: Operators should choose their standard metrics for use with AutoMark. These 
settings will be collected. 
o OUS: Operators should use LSI as the color metric for AutoMark.  
• 
The start and finish procedure times and the RF time of the first-pass PVI should be noted. 
• 
PVI should be completed first. Then, subjects with documented atrial flutter, AT, or other SVT 
(spontaneous or induced) should undergo additional targeted ablation as clinically indicated 
following standard practice at the site. Additional ablations will be documented along with their 
additional procedure and RF ablation times. 
• 
PVI must be verified via entrance block with a multipolar catheter at or beyond 20 minutes from 
the last ablation lesion for each vein. Isolation of PVs must be documented. 
• 
Use of adenosine and/or isoproterenol is acceptable to assist in finding gaps. 
• 
Cardioversion after PVI is allowed to assist with checking for isolation. 
• 
If acute success of PVI is not achieved, a new map of the pulmonary vein region must be captured 
using the AutoMap module, if possible. The number and location of any reconnections or gaps 
should be noted. 
• 
Touch-up ablations to close identified gaps should be performed if possible, unless the operator 
decides that it would be better medically not to do so. AutoMark should be used, if possible, 
following the same guidelines as for the initial lesion set. 
• 
Re-mapping and touch-up ablation procedure and RF-ablation times should be noted. 
• 
Data on total RF ablation time, total fluoroscopy time, and total procedure time will also be 
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• 
The recorded procedure data from the EnSite system should be anonymized and backed up. 
 
Trained Sponsor personnel may provide technical expertise and technical guidance on the use of the 
EnSite system and the TactiCath SE catheter. While Sponsor representatives may perform these activities, 
the Principal Investigator remains responsible for ensuring all clinical investigation data is collected as 
required per the CIP. 
 
If for any reason the enrolled subject has the TactiCath SE inserted into their vasculature, but no ablation 
is performed, the subject will be followed for up to 30 days to assess safety, then exit the trial. 
 Re-ablation Treatment Procedures  
Subjects experiencing a recurrence of arrhythmia symptoms* may undergo additional ablations 
procedures at the discretion of their treating physician, following standard practice at the site. Re-ablations 
that occur during the 90-day “blanking” period post-index procedure will not be considered treatment 
failures in outcome analyses. Any re-ablation procedures must be conducted following the same device 
guidelines as the index procedure (i.e. EnSite Precision AutoMap and AutoMark, TactiCath SE, etc.). 
*Repeat procedures that only ablate CTI-dependent typical atrial flutter will be excluded from the 
re-ablation treatment procedures and requirements listed in this section but should be archived to 
the local EnSite system at the study site until the study is complete.  
In general, any re-ablation procedure should follow the standard practice of the site, with the following 
additions: 
• 
A standard mapping procedure that covers all areas ablated in a previous procedure will be 
performed using a mapping catheter(s) of the operator’s choice, as long as it follows the respective 
IFU(s) and is compatible with the EnSite system and AutoMap module. AutoMap settings will be 
collected. 
• 
The number and location of any reconnections or gaps will be noted by annotating the locations 
on the EnSite map and the CRF. 
• 
Ablations to close identified gaps should be performed if possible, unless the operator decides 
that it would be better medically not to do so. AutoMark should be used, if possible, following the 
same guidelines as for the initial procedure. 
• 
Any additional lesions deemed medically warranted, following standard practice at the site, can 
be created. 
• 
PVI must be verified via entrance block with a multipolar catheter at or beyond 20 minutes from 
the last ablation lesion for each vein. Additional “touch-up” ablations to complete the PVI should 
be performed if needed. Isolation of PVs must be documented. 
• 
Data on total RF ablation time, total fluoroscopy time, and total procedure time will be collected. 
Data will also be collected on the time (procedure and RF) required for the initial ablation set to 
isolate PVs (in this procedure), any additional ablations, and any “touch-up” ablations required due 
to incomplete PVI. 
• 
The recorded procedure data from the EnSite system should be anonymized and backed up. 
6.3 
Post–procedure  
It is recommended that sites follow the post ablation anticoagulation strategy recommendations from the 
2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical 
Ablation for Atrial Fibrillation2. 
 

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Antiarrhythmic drug usage, SAEs, and protocol deviations will be documented prior to hospital discharge. 
6.4 
Follow-up Assessments  
 Follow-up for All Subjects (Clinic Visit) 
In the clinic, subjects will undergo the following assessments described below at 6- and 12-months post-
ablation procedure.   
 
6-Month* (90 to 183 ± 21 days) and 12-Month (365 ± 21 days) Follow-up  
• 
24-hour Holter monitor (12-month follow-up only) 
• 
Document device- and procedure-related SAEs and protocol deviations 
• 
Document AAD usage 
• 
Complete EQ-5D-5L and AFEQT questionnaires 
• 
Healthcare utilization data, if needed 
 
*A follow-up visit must occur between 3- and 6-months post-index procedure (with a 21-day window). For 
readability, this follow-up visit will be referred to as the “6-Month” follow-up visit.  
 
Trained Sponsor personnel may provide technical expertise and technical guidance on the use of the 
Holter device. While Sponsor representatives may perform these activities, the Principal Investigator 
remains responsible for ensuring all clinical investigation data is collected as required per the CIP. 
 
 Patient Reported Outcome (PRO) Measures  
The Site Coordinator or designee will administer patient-reported outcome questionnaires. It is important 
the subject understands the meaning of all words and instructions in the questionnaires. The subject should 
be instructed to ask any questions about the questionnaires if further explanation is needed. Once the 
questionnaires are completed, the Site Coordinator or designee will review for completeness to verify that 
all questions have been answered according to the directions provided. 
 
The following PRO measures will be collected according to the CIP requirements. 
• 
EQ-5D-5L  
• 
AFEQT 
 
The EQ-5D-5L27 Questionnaire is a widely used validated questionnaire used to measure quality of life 
consisting of 6 questions. The subject is instructed to choose the option that best describes their health on 
the day of the assessment. The questionnaire takes approximately 5 minutes to complete.  
The AF Effect on Quality of life survey, or AFEQT28 questionnaire, is a reliable and responsive measure of 
quality of life, specifically for atrial fibrillation. It evaluates health related quality of life across three domains: 
symptoms, daily activities, and treatment concerns. It has an easy to use format with 20 questions on a 
seven-point Likert scale. It takes approximately 5 minutes to complete.  
 Schedule of Events 
The Informed Consent process can take place at or before the baseline visit. The schedule of activities 
specific to this clinical study are described in the preceding sections and are summarized in Table 2. 

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Repeat ablation activities would only occur if a repeat procedure was necessary, as determined by treating 
physician. (X) indicates ‘if applicable’. All study visits must occur in-person.  
 
 

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7.0 
Adverse Events 
To comply with worldwide standards and guidelines on clinical investigation adverse event reporting, the 
Sponsor has adopted uniform and worldwide applicable standard definitions and reporting timelines to be 
used and adhered to by the investigators.  
7.1 
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. 
 
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. 
 
Note 1: This definition includes events related to the medical device under investigation. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical devices 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 an investigational product or device under 
investigation caused or contributed to an SAE is to be determined by the Investigator and recorded on 

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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 
Serious 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. Device- and procedure-related SAE data will be collected throughout the time period 
defined above and will be reported to the Sponsor on a CRF. Additional information with regard to a 
previously-reported SAE should be updated within the appropriate CRF.  
 
SAE Reporting 
 
Clinical Site 
Reporting timelines 
All Sites 
Device- and procedure-related 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. 
 
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 IRB/EC according to the institution’s 
IRB/EC reporting requirements. 
 
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. 
 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 
alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or 
performance of a device after it is released for distribution. 
 
For Abbott products, the investigator must notify Abbott’s Product Performance Group (PPG) by submitting 
the information on the device via email to AF_ProductSurveillance@abbott.com or by phone +1-651-756-
5400 as soon as possible after becoming aware of the complaint. For non-Abbott products, the investigator 
must notify the manufacturer of the device per that manufacturer’s complaint reporting mechanisms or per 
the investigator’s user facility procedures. This information is not collected on a CRF for the study. 
8.0 
STATISTICAL CONSIDERATIONS 
The following section describes the statistical methods for the clinical investigation.  
 
8.1 
   Analysis Populations 
 
The primary analysis population for this study is the enrolled population. The enrollment criteria for this 
trial are as follows: 

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• 
Subject has provided written informed consent, and 
• 
Subject has confirmed that they meet all the inclusion criteria and none of the exclusion criteria, 
and  
• 
The mapping catheter has been inserted into the subject’s vasculature. 
 
8.2 
     Statistical Analyses  
 
The primary endpoint and additional evaluation analyses will be summarized descriptively based on 
available data or measurements in the analysis population. No formal hypothesis testing will be performed.  
 
In general, continuous (CONT) variables will be summarized with the numbers of observations, means 
with standard deviations, quartiles, minimums, maximums, and 95% confidence intervals for the means as 
per the table mockups.  
 
Categorical (CAT) variables will be summarized with subject counts and percentages/rates, and where 
specified in the table mockups, with exact 95% Clopper-Pearson confidence intervals.  
 
Survival (SURV) analysis will be conducted to analyze time-to-event variables.  Subjects without events 
will be censored at their last known event-free time point. Subjects withdrawn or otherwise lost-to-follow-
up during the follow-up period will be censored at their last known visit. Survival data will be presented 
using the Kaplan-Meier product limit method. 
 
The following list of analyses describes how the primary endpoint and additional evaluations will be 
analyzed: 
 
• 
Primary Endpoint: LSI values achieved for RF lesion formation in different anatomical regions of 
the heart around the pulmonary veins (CONT) 
• 
A summary of EnSite AutoMap and AutoMark module software settings, including LSI threshold (in 
OUS), contact force, time, power, flow, and AutoMark spacing (CONT) 
• 
Acute electrical isolation of PVs, 20 minutes after last RF ablation in PV region (CAT) 
• 
Device- or procedure-related SAEs within 7-days (CONT) and 12-months of index procedure 
(SURV) 
• 
Freedom from documented AF/AFL/AT recurrence at 12-months post-index ablation, excluding a 
90-day blanking period (SURV) 
• 
Freedom from AF/AFL/AT recurrence is defined as no documented episodes greater than 
30 seconds with a 24-Holter. (SURV) 
• 
Proportion of patients with a repeat ablation up to 12-months post index procedure (excluding 90-
day blanking period) (SURV) 
• 
Proportion of lesions generated during first-pass PVI that required touch-up ablation (CONT) 
• 
Proportion of pulmonary veins requiring touch-up ablation (CONT) 
• 
Proportion of patients who required at least one touch-up ablation during the index procedure 
(CONT) 
• 
In patients who undergo any repeat RF ablation procedures up to 12-months post index procedure, 
characterization of LSI achieved values for lesions that resulted in electrically conducting gaps 
versus those that were durable (CONT) 
• 
Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and 
any touch-up ablations (CONT) 

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8.8 
 Planned Interim Analysis 
 
No interim analyses are planned for this study.  
 
Since there are no formal hypotheses being tested, the Sponsor may analyze study procedure data after 
all procedures have been completed and 12-month outcome data after all subject have been followed up 
through 12-months post-procedure. 
 
8.9 
Statistical Criteria for Termination 
 
There are no statistical criteria for termination of this clinical investigation. 
 
8.10 Success Criteria 
 
Pass/Fail criteria do not apply to this study.   
 
8.11 
  Deviations from Statistical Plan 
 
Any major changes or less significant changes to the planned statistical analyses will be documented in 
the final report.   
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, IRB/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 IRB/EC or equivalent committee of 
the CIP amendment (administrative changes) or obtaining IRB’s/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.   
 

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Acknowledgement/approval by the IRB/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. 
10.3 Training 
 Site 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 IRB/EC or equivalent committee of all CIP deviations in 
accordance with their specific IRB/EC or equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or company 
representative will attempt to secure compliance by one or more of the following (and not limited to):  
• Visiting the investigator and/or delegate 
• Telephoning the investigator and/or delegate 
• Corresponding with the investigator and/or delegate 
 

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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.  
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 
 Publications Committee 
 
A Publication Committee may be established to oversee clinical investigations publications, including 
publication planning and authorship determinations, at the discretion of the Sponsor. 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, 
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the IRB/EC and clinical investigation monitor/Sponsor, adverse event reports, and information regarding 
subject discontinuation or completion of the clinical investigation. 
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. In order to comply with these regulatory 
requirements/GCP, the following information should be included in the subject record at a minimum and if 
applicable to the clinical 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) 
• 
Serious Adverse Events reported and their resolution including documentation of site awareness 
of SAEs and of investigator assessment of device relationship for SAEs. 
• 
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 and submitted 
to the Sponsor, preferably within 10 days.   
 
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 CONSIDERATION 
 
12.1 Institutional Review Board/Medical Ethics Committee Review and Approval 
Institutional Review Board (IRB)/ 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 IRB/EC and written 
approval obtained prior to implementation, according to each institution’s IRB/EC requirements.  
 
No changes will be made to the CIP or ICF or other written information provided to the patient without 
appropriate approvals, including IRB/EC, the Sponsor, and the regulatory agencies (if applicable).  
 
Until the clinical investigation is completed, the Investigator will advise his/her IRB/EC of the progress of 
this clinical investigation, per IRB/EC requirements. Written approval must be obtained from the IRB/EC 
yearly to continue the clinical investigation, or according to each institution’s IRB/EC requirements.  
 

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No investigative procedures other than those defined in this CIP will be undertaken on the enrolled subjects 
without the written agreement of the IRB/EC and the Sponsor. 
13.0 CLINICAL INVESTIGATION CONCLUSION 
The clinical investigation report will be submitted within one year of the end of the investigation (defined 
as 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 
 
The risks associated with the TactiCath SE catheter and other devices used in the clinical study can be 
found in the appropriate Instructions for Use. The clinical study does not require additional procedures or 
assessments beyond what could be considered standard of care. There are no additional risks introduced 
to subjects due to participation in this study. 
15.1 Anticipated Clinical Benefits 
The primary objective of this study is to characterize LSI achieved values for durable lesion formation using 
the TactiCath SE catheter in the different anatomical regions around the pulmonary veins (PVs) of the 
heart during RF ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF). 
The information collected in this clinical study will be added to the current knowledge and understanding 
of treatment options for patients with arrhythmias. Subjects participating in this clinical study are not 
expected to experience any additional benefit or harm compared to patients who are not participating in 
this clinical study as the clinical study will follow local standard practice. 

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15.2 Foreseeable Adverse Events and Anticipated Adverse Device Effects 
Risks associated with the specified devices and procedure, together with their likely incidence, are 
described in their respective IFUs.  There may be risks related to the device under investigation that are 
unknown at present.  Likewise, the exact frequency of the risk may be unknown. 
15.3 Risks Associated with Participation in this Clinical Investigation 
Risks to subjects enrolled in this clinical study include those risks currently associated with other 
commercially available electrophysiology diagnostic procedures and RF catheter ablation procedures. The 
risks of the procedure are related primarily to mechanical injury to the heart and vessels from catheter 
manipulation and thermal injury due to RF current delivery, including the risk of thromboembolism and 
myocardial perforation, especially for ablations in the left atrium.  
For those procedures where the physician applies sedation or anesthesia, the standard risks of anesthesia 
also exist and include allergic reactions, pneumonia, aspiration pneumonitis, atelectasis, prolonged 
sedation, other medical complications and in very rare cases, death. 
15.4 Steps Taken to Control or Mitigate Risks 
Every possible effort will be taken to minimize the risks, including: 
• 
Careful selection of experienced Investigators for the study  
• 
Training of Investigators and other applicable site personnel on the CIP 
• 
Conducting the clinical study in accordance with the CIP, all applicable laws and regulations and 
any conditions of approval imposed by the appropriate IRB/EC or applicable regulatory authorities 
where the clinical study is performed 
• 
Preparation of the all devices in accordance with device IFU, and conducting the ablation 
procedures in accordance with the IFU of corresponding devices 
 
In-depth recommendations, special precautions and instructions regarding patient selection and device 
handling are included in the IFU.  
 
It is also stated in the IFU that the devices can only be used by physicians who have received appropriate 
training on how to use the device. This statement is interpreted to mean that the physician users are 
expected to be aware of the known and foreseeable safety risks associated with the use of the devices 
including the surgical and/or non-surgical treatment of these conditions. 
 
Risks associated with the use of the device under investigation are minimized through device design, 
investigator selection and training, pre-specified patient eligibility requirements, and study monitoring to 
ensure adherence to the protocol. All adverse events and device deficiencies will be reported to the 
Sponsor and will be monitored internally for safety surveillance purposes. 
15.5 Risk to Benefit Rationale 
Catheter ablation is a recognized safe and effective treatment of cardiac arrhythmias. As this study follows 
the standard of care, it is not believed that any additional unanticipated risks will be introduced compared 
to current practice. 
 
 
 

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APPENDIX I: ABBREVIATIONS AND ACRONYMS 
AAD 
 
 
Anti-arrhythmic drug 
AE  
 
 
Adverse Event  
AF  
 
 
Atrial fibrillation  
AFL 
 
 
Atrial flutter 
AT  
 
 
Atrial tachycardia  
BMI 
 
 
Body Mass Index 
CIED   
 
Cardiac implanted electronic device  
CRF   
 
Case Report Form  
CTI  
 
 
Cavotriscuspid isthmus  
EC  
 
 
Ethics Committee  
ECG   
 
Electrocardiogram  
EDC   
 
Electronic Data Capture  
FTI 
 
 
Force time integral 
GCP   
 
Good Clinical Practice  
ICF  
 
 
Informed consent form  
ICH  
 
 
International Conference on Harmonization  
IFU 
 
 
Instructions for use 
LAA 
 
 
Left atrial appendage 
LIPV 
 
 
Left inferior pulmonary vein 
LSPV  
 
Left superior pulmonary vein 
LA 
 
 
Left atrium 
LSI 
 
 
Lesion Index 
LV  
 
 
Left ventricle  
NYHA   
 
New York Heart Association  
OUS 
 
 
Outside of the United States 
PAF 
 
 
Paroxysmal atrial fibrillation 
PV 
 
 
Pulmonary vein 
PVI  
 
 
Pulmonary vein isolation  
RF  
 
 
Radiofrequency  
RIPV  
 
Right inferior pulmonary vein 
RSPV  
 
Right superior pulmonary vein 
SAE   
 
Serious Adverse Event  
SD 
 
 
Standard deviation 
SJM 
 
 
Saint Jude Medical 
TEE   
 
Transesophageal echocardiography  
TIA  
 
 
Transient ischemic attack  
 
 

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APPENDIX II: SITE CONTACT INFORMATION 
Contact information for each participating clinical site is available under separate cover by contacting the 
Sponsor. 
 
 
APPENDIX III: INFORMED CONSENT 
A template informed consent form will be provided under a separate cover. 
 
 

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APPENDIX VI: CIP SUMMARY 
Clinical 
Investigation 
Name and 
Number 
LSI Workflow 
 
CRD 970 
Title 
LSI Workflow 
Objective(s) 
The primary objective of this study is to characterize LSI achieved values for 
durable lesion formation using the TactiCath SE catheter in the different 
anatomical regions around the pulmonary veins (PVs) of the heart during RF 
ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF). 
Secondary objectives of this study are as follows: 
• 
To characterize the use of EnSite Automap and AutoMark module 
software settings, including LSI threshold settings (in OUS), power, flow 
settings, and AutoMark spacing using the TactiCath SE catheter for RF 
ablation for the treatment of drug-refractory PAF. 
• 
To characterize LSI values for lesions that reconnected versus those that 
were durable, both in an acute procedural setting as well as in patients 
who undergo additional ablations during the 12-month follow-up period 
after an index RF ablation procedure for the treatment of drug-refractory 
PAF. 
Device Under 
Investigation 
EnSite Precision™ Cardiac Mapping System with the AutoMap, AutoMark, and 
Contact Force modules 
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ 
Number of 
Subjects Required 
for Inclusion in 
Clinical 
Investigation 
Approximately 150 patients at approximately 10 sites 
Clinical 
Investigation 
Design 
Prospective, multicenter, post-market, single-arm, observational study 
Primary 
Endpoint(s) 
The primary endpoint is a summary of LSI achieved values for RF lesion 
formation in different anatomical regions of the heart around the pulmonary 
veins 
Additional 
Evaluations  
• 
A summary of EnSite AutoMap and AutoMark module software settings, 
including LSI threshold settings (in OUS), contact force, time, power, flow 
settings, and AutoMark spacing 
• 
Acute electrical isolation of PVs, 20 minutes after last RF ablation in PV 
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• 
Device- or procedure-related SAEs within 7-days and 12-months of index 
procedure 
• 
Freedom from documented AF/AFL/AT recurrence at 12-months post-
index ablation, excluding a 90-day blanking period.  
o Freedom from AF/AFL/AT recurrence is defined as no 
documented episodes greater than 30 seconds with a 24-Holter. 
• 
Proportion of patients with a repeat ablation up to 12-months post index 
procedure (excluding 90-day blanking period) 
• 
Proportion of lesions generated during first-pass PVI that required touch-
up ablation 
• 
Proportion of pulmonary veins (PVs) requiring a touch-up ablation 
• 
Proportion of patients who required at least one touch-up ablation during 
the index procedure 
• 
In patients who undergo any repeat RF ablation procedures up to 12-
months post index procedure, characterization of LSI achieved values for 
lesions that resulted in electrically conducting gaps versus those that 
were durable 
• 
Overall procedure time and the subset of time elapsed for: first-pass PVI, 
any other ablations, and any touch-up ablations  
• 
Overall RF ablation time and the subset of RF ablation time for: first-pass 
PVI, any other ablations, and any touch-up ablations 
• 
Overall fluoroscopy time 
• 
AAD use at 12-months 
• 
Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-
months post index ablation, compared to baseline scores 
• 
Health care utilization (including number of unscheduled hospital 
outpatient/ER visits and inpatient hospitalizations due to arrhythmias) 
collected throughout the 12-month follow-up period 
Subject Follow-up 
• 
Baseline Visit, after Informed Consent 
• 
Procedure Visit, preferably within 14 days of Informed Consent 
• 
3- to 6-Month Follow-Up Visit, 90 to 183 ± 21 days after Procedure 
• 
12-Month Follow-Up Visit, 365 ± 21 days after Procedure 
• 
Repeat Ablation, any time after Procedure during follow-up period, at 
physician’s discretion 
Inclusion Criteria 
1. Subject must provide written informed consent prior to any clinical 
investigation related procedure. 
2. Subject is at least 18 years of age. 

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3. Subject is willing and able to comply with the CIP-described evaluations 
and follow-up schedule. 
4. Subject plans to undergo a pulmonary vein isolation (PVI) procedure due 
to symptomatic paroxysmal AF using RF ablation. 
5. Subject is refractory or intolerant to at least one class I or class III anti-
arrhythmic drug. 
a. For the purposes of this study, “intolerant” includes either: 
i. Subject attempted the drug at any dose and either the 
subject or their physician chose to discontinue for any 
reason 
ii. Subject was offered the drug and refused to take for any 
reason 
Exclusion Criteria 
1. Previous ablation or surgery in the left atria. 
2. Has an implantable cardiac defibrillator (ICD, pacemakers without 
defibrillation capacity are allowable). 
3. Participation in another clinical investigation that may confound the 
results of this study. 
4. Pregnant or nursing. 
5. 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. 
6. Life expectancy less than 12 months.  
 
 
 

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APPENDIX VII: REFERENCES 
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Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert 
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Soliman EZ, Safford MM, Muntner P, et al. Atrial fibrillation and the risk of myocardial infarction. 
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Dello Russo A, Fassini GM, Casella M, et al. Lesion index: a novel guide in the path of successful 
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Calkins H, Gliklich RE, Leavy MB, et al. Harmonized Outcome Measures for Use in Atrial Fibrillation 
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Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level 
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Spertus J, Dorian P, Bubien R, et al. Development and validation of the Atrial Fibrillation Effect on 
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