Medtronic Reveal LINQ Insertable Cardiac Monitor Registry
Conditions: Arrhythmias, Cardiac
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

 
Clinical Investigation Plan Title 
Reveal LINQ Registry  
ClinicalTrials.gov Identifier 
NCT02746471 
Sponsor 
Medtronic 
8200 Coral Sea St NE 
Mounds View, MN 55112 
Document Title 
Reveal LINQ Registry Clinical Investigation Plan 
Document Version (Date) 
2.0 (29-JAN-2016) 
 

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Reveal LINQ Registry CIP
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Reveal LINQ Registry
Clinical Investigation Plan
Version 2.0
29 JAN 2016
Regional Sponsors and Contacts 
United States
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View, MN U.S.A. 55112
1-800-328-2518
Europe, Middle East, Africa
Medtronic, Bakken Research Center B.V.
Endepolsdomein 5
6229 GW Maastricht
The Netherlands
+31-43-35-66-566
Japan
Medtronic Japan Co., Ltd.
Comodio Shiodome
2-14-1 Higashi-Shimbashi, Minato-ku
Tokyo, 105-0021
JAPAN
+81-3-6430-2011
China 
Medtronic (Shanghai) Management Co., Ltd. 
Block 11, No. 3000 Long Dong Avenue
Pudong
Shanghai 201203
China
+86-21-2032-5888

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TABLE OF CONTENTS
Sponsor Contact Information..........................................................................................................7
Oversight Committee.......................................................................................................................8
1.
Synopsis ..........................................................................................................................9
2. INTRODUCTION .......................................................................................................................12
2.1 Study purpose.................................................................................................................... 12
2.2 Study description................................................................................................................ 12
3.
Background and Justification .....................................................................................13
4.
System Description and Intended Use .....................................................................16
4.1
Reveal LINQ System .................................................................................................. 17
5.
Regulatory Compliance...............................................................................................18
6.
Methodology..................................................................................................................19
6.1 Primary Objectives............................................................................................................. 19
i.
Primary objective #1
19
ii.
Primary objective #2
19
6.3
Subject selection criteria............................................................................................. 20
viii.
Inclusion criteria
20
ix.
Exclusion criteria
20
6.4
Minimization of Bias.................................................................................................... 20
7.
Study Procedures.........................................................................................................21
7.1
Role of the sponsor representatives ........................................................................... 21
7.2
Investigator / Investigation site selection..................................................................... 21
7.3
Site activation ............................................................................................................. 21
7.4
Data collection............................................................................................................ 23
7.5
Patient Informed Consent process.............................................................................. 23
7.6
Enrollment .................................................................................................................. 26
7.7
Baseline...................................................................................................................... 26
7.8
Procedure................................................................................................................... 26
7.9
Subject Follow-up ....................................................................................................... 26
7.9.1
Follow-up Due to AF Ablation
27
7.9.2
Modes of Data Collection
27
7.9.3
Frequency of Follow-up
28
7.9.4
Arrhythmia Event and Action Taken Assessment (ongoing)
28
7.9.5
Follow-up Duration
29
7.10
System Modification.................................................................................................... 29

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7.11
Study Exit ................................................................................................................... 29
7.12
Subject Death............................................................................................................. 30
8.
Study Deviations...........................................................................................................31
9.
Adverse events and Device deficiencies..................................................................32
9.1
Adverse Event Assessment........................................................................................ 32
9.1.1
Adverse Events
32
9.1.2
Device Deficiencies
33
9.1.3
Processing Updates and Resolution
33
9.2
Adverse Event and Device Deficiency Definitions....................................................... 33
9.3
Adverse Events and Deficiency Classification............................................................. 35
9.4
Adverse Event and Device Deficiency Reporting Requirements................................. 36
10.
Risk Analysis.................................................................................................................39
10.1
Risk Minimization........................................................................................................ 39
10.2
Potential Benefits........................................................................................................ 39
11.
Planned study closure, early termination of study or study suspension..............40
11.1
Planned study closure ................................................................................................ 40
11.2
Early termination or suspension.................................................................................. 40
i.
Study-wide termination or suspension
40
ii.
Investigator/site termination or suspension
40
11.3
Procedures for termination or suspension................................................................... 41
iii.
Medtronic-initiated and regulatory authority-initiated
41
iv.
Investigator-initiated
41
v.
Ethics committee-initiated
41
12.
Statistical methods and data analysis.......................................................................43
12.1
Primary Objective #1 .................................................................................................. 43
i.
Analysis Methods
43
ii.
Determination of Subjects/Data for Analysis
43
iii.
Sample Size
43
12.2
Primary Objective #2 .................................................................................................. 44
i.
Analysis Methods
44
ii.
Determination of Subjects/Data for Analysis
44
iii.
Sample Size
44
12.3
.................................................................................................... 45
13.
Data and quality management...................................................................................47
14.
Warranty/Insurance information.................................................................................48
14.1
Warranty..................................................................................................................... 48
14.2
Insurance (Europe, Middle East, Africa)...................................................................... 48
14.3
Insurance (Japan)....................................................................................................... 48
14.4
Insurance (Greater China) .......................................................................................... 48
15.
Monitoring......................................................................................................................49
15.1
Monitoring Visits ......................................................................................................... 49
16.
Required records and reports ....................................................................................50

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16.1
Investigator records .................................................................................................... 50
16.2
Investigator reports..................................................................................................... 50
16.3
Sponsor records ......................................................................................................... 52
16.4
Sponsor reports.......................................................................................................... 52

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Listing of Tables
Table 1: Study Sponsor Contact Information.................................................................................. 7
Table 3: Oversight Committee Contact Information........................................................................ 8
Table 4: Reveal LINQ System Component Information................................................................ 17
Table 5: Summary of Data Collection........................................................................................... 23
Table 6: Adverse Event Definitions .............................................................................................. 33
Table 7: Adverse Event classification responsibilities................................................................... 36
Table 8: Adverse Event Reporting Requirements......................................................................... 37
Table 9 Sample Size Calculation for Estimating Acute InfectionRate........................................... 45
Table 10: Investigator Reports applicable for all geographies per Medtronic requirements .......... 51
Table 11: Investigator reports applicable to Japan per Ethical Guidelines on Medical Research 
involving Human Beings............................................................................................................... 51
Table 12: Sponsor Reports .......................................................................................................... 53

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Listing of Appendices
Appendix A:  Draft data collection elements (Case Report Forms)............................................... 54
Appendix B: Publication plan ....................................................................................................... 55
Appendix C: Informed consent templates and Data Review Files ................................................ 57
Appendix D: Participating Investigators and Institutions ............................................................... 58
Appendix E: Ethics Committee List .............................................................................................. 59
Appendix F: Additional information for Japanese centers............................................................. 60
Appendix G: Committees ............................................................................................................. 61
Appendix H: Labeling................................................................................................................... 62
Appendix I: Definitions ................................................................................................................. 63
Appendix J: Modifications to the clinical investigation plan........................................................... 66

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SPONSOR CONTACT INFORMATION
Medtronic contact information is provided below. This information is subject to change during the 
course of the clinical study. Periodic updates to study contact information will be sent to the sites
as needed.
Table 1: Study Sponsor Contact Information
Study sponsors and contacts 
Worldwide clinical study leader
Jen Diouf, Clinical Research Specialist
Europe, Central Asia / Middle East, Africa (ECA/MEA))
Silvia Giuli, Sr. Project and Clinical Research Specialist
Japan
Tomoyuki Tejima, Clinical Research Supervisor
China
Lauren Zhang, Clinical Research Manager
Monitoring Contact Information
Worldwide monitoring leader
Taryn Randall, Clinical Monitoring Manager

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OVERSIGHT COMMITTEE
An Oversight Committee will be utilized to provide oversight of study execution and evidence 
generation for the Reveal LINQ Registry. Additional members may be added at a later date. Any 
changes to the Oversight Committee membership will be provided under separate cover.
Table 2: Oversight Committee Contact Information
Committee Member 
Contact information
Suneet Mittal, MD
Coordinating Investigator
The Valley Hospital
1111 Amsterdam Ave Fl 3
New York, NY 10025 USA
Sean C. Beinart, MD, FACC
Washington Adventist Hospital 
15225 Shady Grove Rd Ste 201
Rockville, MD 20850-3278 USA
Andrea Natale, MD, FACC, FHRS, 
FESC
California Pacific Medical Center
1015 E 32nd St Ste 500 
Austin, TX 78705-2708 USA
Atul Verma, MD, FRCP(C)
York Clinical Cardiology
581 Davis Dr Ste 602B
Newmarket, ON L3Y 2P6 Canada
Hans-Christoph Diener, MD, PhD
University Hospital Essen
Hufelandstrasse 55
45122 Essen, Germany
Alpesh Amin, MD, MBA, FACP
The University of Texas (UT) Southwest
5939 Harry Hines Blvd Ste 603
Dallas, TX 75390 USA
Scott Kasner, MD, MSCE
Hospital of the University of Pennsylvania
3400 Spruce St.
Philadelphia, PA 19104-4283

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1. SYNOPSIS
Title
Reveal LINQ Registry
Purpose
The purpose of the Reveal LINQ Registry is to generate reliable long-term “real world” data of 
product performance, economic valuation, site-of-service procedural information, and will assist 
with identification of the Reveal LINQ™Insertable Cardiac Monitor (ICM) in the care pathway.
Design
The study is a prospective, non-randomized, observational, multi-center, post-market, global study. 
The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and 
estimate procedure-related acute infection rate. Approximately 2,300 subjects will be implanted 
with a Reveal LINQ ICM and be followed prospectively from insertion through 3 years.
Medical device
The Reveal LINQ Registry study will be conducted using the components of the Medtronic Reveal 
LINQ system, as described in the below.
Model Number 
Component (Manufacturer)
Investigational or Market-
released
LNQ11 or currently 
market released model
Reveal LINQ Insertable Cardiac Monitor 
Market- released
2090 or currently 
market released model
Medtronic Programmer
Market- released
960000 or currently 
market released model
Patient Assistant 
Market- released
24950 or currently 
market released model
MyCareLink® Patient Monitor 
Market- released
Objectives 
Primary Objectives:
•
Characterize clinical actions initiated by Reveal LINQ arrhythmia detection
•
Estimate procedure-related acute infection rate
Ancillary Objectives:
•
Characterize healthcare utilization
•
Characterize conditions diagnosed and clinical actions taken initiated by Reveal 
LINQ detection
•
Characterize procedure-related acute infections
•
Characterize onset and/or progression of diseases
•
Summarize reasons for post-insertion modifications to Reveal LINQ

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Subject population
The study is expected to be conducted at approximately 100 study sites globally with 
approximately 2,300 subjects contributing to total enrollment numbers. Participating geographies 
are expected to include, but are not limited to: the United States, Europe Middle East and Africa
(EMEA), China and Japan. Subjects will be followed for 3 years or until study closure which is 
expected to be in January of 2021.
Inclusion criteria

Subject or legally authorized representative provides written authorization and/or consent 
per institution and geographical requirements

Subject is intended to have a Reveal LINQ ICM inserted in the next 30 days

Subject consent prior to Reveal LINQ ICM insertion
Exclusion criteria

Subject who is, or is expected to be inaccessible for follow-up

Subject with exclusion criteria required by local law

Subject is enrolled in a concurrent study that may confound the results of this study. Co-
enrollment in any concurrent clinical study (including registries) requires approval of the 
study manager or designee.

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Clinical Procedures
Data Collection Item(s)
Enrollment/ 
Baseline
Procedure
Follow-Up
Consent Form or Data 
Release Form Completion
X
Inclusion/Exclusion 
Assessment
X
Subject Demographics, 
Medical History
X
Subject Arrhythmia/Symptom
Status
X
    Medications
X
X*
    Treatments
X
Procedure Information
X
Device Information
X
Device/Monitor Data
X
X
AF Follow-Up
X**
AF Procedure and AF Status
Reported upon occurrence
Adverse Events
Device Deficiencies
System Modification
Study Deviations
Subject Exit
Subject Death
*If applicable
**Only completed if the subject received an AF Ablation after Reveal LINQ ICM implant

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2. INTRODUCTION
2.1 Study purpose
Medtronic, Inc. is sponsoring the Reveal LINQ Registry, a prospective, non-randomized, 
observational, multi-center, post-market, global clinical study.
The purpose of the Reveal LINQ Registry is to generate reliable long-term “real world” data 
of product performance, economic valuation, site-of-service procedural information, and will 
assist with identification of the Reveal LINQ Insertable Cardiac Monitor (ICM) in the care 
pathway. The primary endpoint will characterize clinical actions initiated by Reveal LINQ 
arrhythmia detection and estimate procedure-related acute infection rate.
The registry data is intended to benefit and support interests of patients, hospitals, clinicians, 
regulatory bodies, payers, and industry. Observational data collection in large populations 
over time provides an effective means of assessing product performance, patient safety and 
other clinical outcomes. 
This post market registry is not required by any regulatory body. However, data collected in 
this registry may be submitted to a regulatory body for specific purposes when appropriate.
2.2 Study description
The study is expected to be conducted at approximately 100 study sites globally with 
approximately 2,300 subjects contributing to total enrollment numbers. Participating 
geographies are expected to include, but are not limited to: the United States, Europe Middle 
East and Africa (EMEA), China and Japan. Subjects will be followed for 3 years or until study 
closure which is expected to be in January of 2021.
To ensure a widespread distribution of data and minimize site bias in study results, the 
maximum number of subjects who may have a Reveal LINQ inserted at a single site is
recommended to be fifteen percent (15%) of total projected enrollment in a given geography 
based on enrollment allocations. Sites that enroll faster than others will be allowed to do so 
in order to maintain an adequate overall study enrollment rate, but may not exceed the 
maximum number of insertions per site.   
All subjects will be followed in-office in accordance with standard care practices of their 
respective care provider. Follow-up data collection is required at minimum every 6 months 
post-insertion and real time reporting is required for arrhythmia events and actions taken as a 
result of the Reveal LINQ ICM. This data may be collected via in-office subject clinic visit, 
remote monitor transmissions review, or chart review. Subjects are followed until subject
death or exit, the implanted device becomes inactive or explanted, the subject has been
followed for 3 years, or study closure which is expected to be in January of 2021.

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3. BACKGROUND AND JUSTIFICATION
The Reveal LINQ™ programmable device is a subcutaneously Insertable Cardiac Monitor (ICM) 
designed to simplify the diagnosis, monitoring, and management of cardiac arrhythmias.  The 
Reveal LINQ ICM is able to record cardiac arrhythmias including pause, bradycardia, and 
tachycardia episodes, specifically atrial fibrillation, asystole, bradycardia, fast VT and VT.  The 
Reveal LINQ ICM has the capability to identify the detection and termination of all detected 
episodes.  The identification and recording of these arrhythmias are essential in diagnosing and 
monitoring disease and its progression.  
The Reveal LINQ ICM system is equipped with a number of features that enable ease of use.  The 
size of the device has a volume of 1.2 cc which is 87% smaller than its predecessor Reveal XT.  
This small size facilitates a simple, minimally invasive insertion procedure using local anesthetic 
and not requiring the device to be internally fixated with sutures.  In the Reveal LINQ Usability 
study, 90% of implantations were rated as easy or very easy.1  These insertion procedures have a 
very high success rate on the first attempt with minimal complications.  In an analysis of a 
controlled clinical trial and a real-world registry, the Reveal LINQ infection rate was 1.3 and1.6%, 
respectively and procedure-related serious adverse events were 0.7 and1.6% of patients.2
The Reveal LINQ ICM system has wireless and continuous monitoring capabilities and is able to 
store up to 59 minutes of ECG recordings.  The data from these recordings is automatically 
transmitted daily via the patient’s MyCareLink home monitor to Medtronic’s CareLink network.  
The MyCareLink monitor performs the automatic transmission overnight when the patient is 
sleeping close to the monitor.  If the automatic daily transmission was incomplete or not received, 
the patient has the option of performing a manual transmission which only lasts approximately 10 
minutes.  Nearly 97% of patients using the MyCareLink monitor in the LINQ Usability study 
indicated the monitor was “very easy to use”.3  Clinicians have the option to set up CareAlerts 
which will notify a clinician via CareLink based on pre-defined thresholds that a received 
transmission indicates a patient activated or device-detected episode (Pause, brady, tachy), low 
batter, or electrical reset.  
The Reveal LINQ ICM has similar arrhythmia detection features compared to its predicate devices 
(Reveal DX®, Reveal XT®).  However, Reveal LINQ has enhanced AF detection capabilities using 
the Reveal LINQTM ICM P-SENSE algorithm.  The original AF detection algorithm looked at 
differences in the pattern of R-R interval.  The improved algorithm utilized in the Reveal LINQ ICM
works on R-R interval regularity along with P-wave enhancements which improves accuracy by
reduction in inappropriate AF detection potentially caused by noise, sinus tachycardia, etc..
Pürerfellner et al compared the original algorithm in the Reveal XT to the improved algorithm 
implemented in the Reveal LINQ ICM.4  This study reported an overall performance with similar 
                                                
1 Pürerfellner, Helmut, et al. "Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-
human experience." Heart Rhythm 12.6 (2015): 1113-1119.
2 MITTAL, SUNEET, et al. "Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two 
Prospective Trials." Pacing and Clinical Electrophysiology 38.12 (2015): 1464-1469.
3 Pürerfellner, Helmut, et al. "Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-
human experience." Heart Rhythm 12.6 (2015): 1113-1119.
4 Pürerfellner, Helmut, et al. "P-wave evidence as a method for improving algorithm to detect atrial 
fibrillation in insertable cardiac monitors." Heart Rhythm 11.9 (2014): 1575-1583.

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device sensitivity and included a reduction in total duration of false positives by 55%, a reduction 
in total number of false positives by 46%.  In addition, the study reported that episodes with ≥ 1 
hour in duration have 100% sensitivity and a 95% positive predictive value.  With the 
advancement in AF detection utilizing the P-SENSE algorithm in the Reveal LINQTM ICM device, 
detection of AF is more accurate allowing clinicians to better manage patients with all types of AF 
including that which is symptomatic or asymptomatic.
While indication for use varies across geographies, use of ICM devices has been effectively 
utilized to monitor various types of arrhythmias to provide data for various conditions.  One 
common use is in patients with suspected cardiac causes of syncope.  The actual diagnosis of 
syncope can be difficult requiring conventional testing (Holter + tilt table) and be resource 
intensive; however, using ICM with remote monitoring is superior to these methods (52% vs. 20%, 
p = 0.012).5  In addition, ICMs have proven to be helpful in guiding diagnosis recurrent syncope 
events.6
Another common use is using ICMs as part of a stroke primary prevention strategy (identification 
of AF to inform clinical decisions).  Worldwide 15 million people suffer a stroke resulting in 5 
million deaths and leaving 5 million others with permanent disabilities each year.7 The presence of 
AF is a risk factor for stroke increasing the risk of stroke by 5-fold.8 9 10  Furthermore, device-
detected AF burden has been associated with an increase ischemic stroke risk.11 12 13  Leveraging 
the Reveal LINQTM ICM to correctly identify the total AF duration of AF14 may be effectively used to 
manage patients at risk for stroke.
Similarly, ICMs have been proven to be beneficial in the management of patients with cryptogenic 
stroke.  Around 20% to 40% of strokes are cryptogenic in nature where the mechanism cannot be 
identified despite extensive evaluation.15  The ability to detect AF in cryptogenic stroke is important 
                                                
5 Krahn, A. D., et al. "Randomized assessment of syncope trial (RAST): Conventional investigations vs. 
Implanted loop recorder." Circulation. Vol. 102. No. 18. 530 WALNUT ST, PHILADELPHIA, PA 19106-3621 
USA: LIPPINCOTT WILLIAMS & WILKINS, 2000.
6 Edvardsson, Nils, et al. "Use of an implantable loop recorder to increase the diagnostic yield in 
unexplained syncope: results from the PICTURE registry."Europace 13.2 (2011): 262-269.
7 World Heart Federation. http://www.world-heart-federation.org/cardiovascular-health/stroke/
8 Wolf PA, Dawber TR, Thomas HE Jr, Kannel WB. Epidemiologic assessment of chronic atrial fibrillation 
and risk of stroke: The Framingham study. Neurology. 1978;28(10):973-977.
9 Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham 
Study. Stroke. 1991;22(8):983-988.
10 Wang TJ, Massaro JM, Levy D, Vasan RS, Wolf PA, D’Agostino RB, Larson MG, Kannel WB, Benjamin 
EJ. A risk score for predicting stroke or death in individuals with new-onset atrial fibrillation in the 
community: The Framingham Heart Study. JAMA. 2003;290(8):1049-1056.
11 Glotzer, Taya V., et al. "The Relationship between daily atrial tachyarrhythmia burden from implantable 
device diagnostics and stroke risk the trends study." Circulation: Arrhythmia and Electrophysiology 2.5 
(2009): 474-480.
12 Kaufman, Elizabeth S., et al. "Positive predictive value of device-detected atrial high-rate episodes at 
different rates and durations: an analysis from ASSERT." Heart Rhythm 9.8 (2012): 1241-1246.
13 Boriani, Giuseppe, et al. "Device-detected atrial fibrillation and risk for stroke: an analysis of> 10 000 
patients from the SOS AF project (Stroke preventiOn Strategies based on Atrial Fibrillation information from 
implanted devices)." European heart journal 35.8 (2014): 508-516.
14 Pürerfellner, Helmut, et al. "P-wave evidence as a method for improving algorithm to detect atrial 
fibrillation in insertable cardiac monitors." Heart Rhythm 11.9 (2014): 1575-1583.
15 Guercini F, Acciarresi M, Agnelli G, Paciaroni M. Cryptogenic stroke: time to determine aetiology. J 
Thromb Haemost. 2008;6(4):549-554.

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as AF detection may prompt a change from antiplatelet to anticoagulation medication16 17 18.  ICM’s
are superior at yielding an AF diagnosis when compared to standard monitoring in patients with a 
history of cryptogenic stroke and without a history of AT/AF.19
A third use of an ICM device is to monitor arrhythmias in patients with a history of AF and ablation.  
AF ablation efficacy at one year has been reported to be 66% to 89%.20 Arrhythmia monitoring of 
AF patients post-ablation has been shown to be of value in both symptomatic and asymptomatic 
patients to help guide long-term treatment decisions.21  Using Reveal LINQ ICM may be an 
optimal strategy for deciding whether to perform a second ablation or to implement drug therapy in 
patients with recurrences after their first ablation.
The evidence collected during the Reveal LINQ Registry trial will provide information necessary to 
inform current and future clinical practice for patients implanted with the Reveal LINQ ICM.  A 
better understanding of the incorporation of Reveal LINQ ICM in the current care pathway and 
understanding the clinical actions to treat patients with arrhythmias will be observed.    
                                                
16 Adams Jr HP, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with 
ischemic stroke: a guideline from the American Heart Association/ American Stroke Association Stroke 
Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the 
Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary 
Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational 
tool for neurologists. Circulation. 2007;115:e478-e534.
17 Sacco R. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack. 
A statement for healthcare professionals from the American Heart Association/American Stroke Association 
Council on Stroke. Stroke. 2006;37:577-617.
18 The European Stroke Organisation (ESO) Executive Committee, ESO Writing Committee. Guidelines for 
management of ischaemic stroke and transient ischaemic attack 2008. Cerebrovasc Dis. 2008;25:457-507.
19 Sanna, Tommaso, et al. "Cryptogenic stroke and underlying atrial fibrillation."New England Journal of 
Medicine 370.26 (2014): 2478-2486.
20 Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, 
DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, 
Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, 
Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, 
Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao 
HM, Wilber D; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 
2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: 
recommendations for patient selection, procedural techniques, patient management and follow-up, 
definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on 
Catheter and Surgical Ablation of Atrial Fibrillation. Heart Rhythm. 2012;9(4):632-696.
21 Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, 
DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, 
Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, 
Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, 
Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao 
HM, Wilber D; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 
2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: 
recommendations for patient selection, procedural techniques, patient management and follow-up, 
definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on 
Catheter and Surgical Ablation of Atrial Fibrillation. Heart Rhythm. 2012;9(4):632-696.

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4. SYSTEM DESCRIPTION AND INTENDED USE
The study will be conducted using the components of the Medtronic Reveal LINQ system
which are currently market-released in the participating geography, as described in Table 
3 below. The Reveal LINQ system is being used in accordance with the geography 
indications for the device. 
US Indications
The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and 
automatically-activated monitoring system that records subcutaneous ECG and is 
indicated in the following cases:

Patients with clinical syndromes or situations at increased risk of cardiac 
arrhythmias.

Patients who experience transient symptoms such as dizziness, palpitation, 
syncope, and chest pain that may suggest a cardiac arrhythmia.
OUS Indications (EMEA, China)
The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and 
automatically-activated monitoring system that records subcutaneous ECG and is
indicated in the following cases:

Patients with clinical syndromes or situations at increased risk of cardiac 
arrhythmias

Patients who experience transient symptoms that may suggest a cardiac 
arrhythmia

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Table 3: Reveal LINQ System Component Information
Model Number 
Component (Manufacturer)
Investigational or 
Market-released
LINQ11 or currently market released model
Reveal LINQ Insertable Cardiac  Monitor Market-released
2090 or currently market released model
Medtronic Programmer
Market-released
960000 or currently market released model
Patient Assistant
Market-released
24950 or currently market released model
MyCareLink Patient Monitor
Market-released
4.1
Reveal LINQ System
The Reveal LINQ system consists of 4 main components as illustrated in Table 3.
The Medtronic Reveal LINQ ICM is a programmable device that continuously monitors a 
patient’s ECG and other physiological parameters. The device records cardiac information in 
response to automatically detected arrhythmias and patient activation. 
The device is designed to record the occurrence of an arrhythmia in a patient automatically.
Arrhythmias may be classified as tachyarrhythmia, brady arrhythmia, pause, atrial 
tachyarrhythmia, or atrial fibrillation. In addition, while experiencing or immediately after a 
symptomatic event, the patient can activate the device to record their cardiac rhythm.
Reveal LINQ ICM: is a small, leadless device that is inserted under the skin, in the chest. 
Two electrodes on the body of the device monitor the patient’s subcutaneous ECG 
continuously. The device memory can store up to 27 min of ECG recordings from 
automatically detected arrhythmias and up to 30 min of ECG recordings from patient-
activated episodes. The system provides 3 options for segmenting the patient-activated 
episode storage: up to four 7.5 min recordings, up to three 10 min recordings, or up to two 
15 min recordings. Arrhythmia detection parameters are set to pending automatically, based 
on patient information entered on the programmer during pre-insertion device setup: the 
patient’s Date of Birth and the clinician’s Reason for Monitoring the patient. Arrhythmia 
detection parameters can also be programmed manually by the clinician.
Medtronic Programmer: is used to set up the device to detect arrhythmias. It also allows 
the user to view, save, or print the information stored by the device. 
Patient Assistant: is a hand-held, battery-operated telemetry device that enables the 
patient to activate the recording of cardiac information in the Reveal LINQ ICM while 
experiencing or immediately after a symptomatic event. The clinician uses the recorded 
information to determine if the symptoms were associated with a cardiac event. 
MyCareLink Patient Monitor: is used by patients to gather information automatically from 
their inserted device and communicate the information to their physician. The inserted 
device communicates wirelessly with this monitor which then transmits the information over 
a cellular telephone connection to the Medtronic CareLink Network. This daily wireless audit 
transmission is scheduled by the clinic and is usually set for a time when the patient is 
asleep. At other times, if requested to do so by their physician or clinic, the patient can use 
their monitor to perform a manual device interrogation to gather information from their 
inserted device and communicate it to their physician. Patient interaction with their monitor 
includes the initial setup procedure, performing physician-requested data gathering, and 
responding to physician-specified notifications on the monitor screen. Refer to the literature 
that is included with the MyCareLink Patient Monitor for connection and usage information.
Additional information related to the Reveal LINQ ICM, including indications, 
contraindications, warnings and precautions can be found in the respective clinician manual.

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5. REGULATORY COMPLIANCE
This study will be conducted in compliance with international ethical and scientific quality 
standards, known as good clinical practice (GCP). GCP includes review and approval by an 
independent Ethics Committee (i.e., Ethics Board/Institutional Review Board (IRB)/Medical Ethics 
Committee (MEC)/Research Ethics Board (REB)) before initiating a study, continuing review of an 
ongoing study by an Ethics Committee, and obtaining and documenting the freely given informed 
consent of a subject before initiating the study.
The registry is designed to reflect the GCP and other international clinical requirements outlined 
below. These include the protection of the rights, safety and well-being of human subjects, controls 
to ensure the scientific conduct and credibility of the study and the definition of responsibilities of 
the sponsor and investigators. 
The study will be conducted according to federal, national and local laws, regulations, standards, 
and requirements of the countries/geographies where the study is being conducted and this clinical 
investigation plan (CIP), and the Clinical Trial Agreement (CTA) at each site. The study will also be 
conducted in accordance with the Declaration of Helsinki (most current version) outside of the 
United States. The principles of the Declaration of Helsinki have been implemented through the 
patient informed consent (IC) process, the subject data release process, Ethics Committee
approval or a written statement by the Ethics Board Chairperson stating approval is not required, 
study training, clinical trial registration, risk benefit assessment and publication policy.
In addition:

In the US, the study will be conducted in compliance with 21 CFR Parts 11 (Electronic 
Records; Electronic Signatures), 50 (Protection of Human Subjects), and 56 (Institutional 
Review Boards (IRBs)).

In EMEA, local laws and regulations will be followed

In Japan, Ethical Guidelines for Medical and Health Research Involving Human Subjects 
will be followed.
For additional countries added at a later time, local laws and regulations will be followed.
Geography-specific requirements will be documented under a separate cover.
The study will be publicly registered in accordance with the 2007 Food and Drug Administration 
Amendments Act (FDAAA) and Declaration of Helsinki on http://clinicaltrials.gov (PL 110-85, 
Section 810(a)). The study will be also registered in national databases of participating 
geographies as required.
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study center: 

Medtronic 

Principal Investigators (where required by local law)

Geography-specific regulatory authorities (if regulatory approval is required) 

An independent Ethics Committee.
Similarly, approval of subsequent revisions to the CIP is required at each study center from the 
above mentioned groups prior to implementation of the revised CIP at that center.
For any subject recruitment materials, documented approval of each site’s Ethics Committee must 
have been received prior to use in the study, if applicable.

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6. METHODOLOGY
Study objectives
The Reveal LINQ Registry will characterize clinical actions and procedure related data in subjects
implanted with Medtronic Reveal LINQ ICM.
The study is observational in nature. Sample size calculations for the study objectives provide 
information on the reliability of the estimates. At the same time, data analysis may be carried out 
throughout the study without having all enrolled subjects completing study required follow-ups.
6.1 Primary Objectives
i.
Primary objective #1
Characterize clinical actions initiated by Reveal LINQ arrhythmia detection feature. 
ii.
Primary objective #2
Estimate procedure-related acute infection rate (up to 30 days post insertion procedure).
6.2 

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6.3
Subject selection criteria
Patients will be screened to ensure they meet all of the inclusion and none of the exclusion criteria
prior to study enrollment. Ethics Committee approval of the Reveal LINQ Registry Clinical 
Investigation Plan and Informed Consent Form (ICF) or Data Release Form (DRF) must be 
obtained prior to enrolling patients in the study. 
Subjects are considered enrolled in the study upon signing the ICF or DRF. Enrollment of the 
subject must occur before insertion of the Reveal LINQ ICM.
viii.
Inclusion criteria

Subject or legally authorized representative provides written authorization and/or 
consent per institution and geographical requirements

Subject is intended to have a Reveal LINQ ICM inserted in the next 30 days

Subject consent prior to Reveal LINQ ICM insertion
ix.
Exclusion criteria

Subject who is, or is expected to be inaccessible for follow-up

Subject with exclusion criteria required by local law

Subject is enrolled in a concurrent study that may confound the results of this 
study. Co-enrollment in any concurrent clinical study (including registries) requires 
approval of the study manager or designee.
6.4
Minimization of Bias
The following methods have been incorporated to minimize potential bias:

Subjects will be confirmed eligible for enrollment with defined
Inclusion/Exclusion criteria.

Demographics and medical history will be collected at baseline in order to later
assess possible characteristics that may influence endpoints.

To ensure a widespread distribution of data from study sites, no more than 15%
of total expected insertions may come from a single site in a given geography 
based on enrollment allocations.

All study site and Medtronic personnel will be trained using standardized training
materials.

Regular monitoring visits will be conducted to verify source data and adherence to 
the Clinical Investigation Plan

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7. STUDY PROCEDURES
Prior to performing study related procedures, all sites must have Ethics Board/IRB/MEC approval
or a written statement by the Principal Investigator/Ethics Board Chairperson stating approval is 
not required and associated regulatory authority approval if applicable (e.g., Competent Authority 
approval) as well as documentation from Medtronic of site readiness.
7.1
Role of the sponsor representatives
Sponsor representatives may provide support as required for the study under supervision of the 
Principal Investigator, including:

Provide study training relevant and pertinent to the involvement of personnel conducting 
study activities and investigator responsibilities

Technical support during the insertion procedure and follow-up under the supervision of 
a study investigator as part of standard of care, but no data entry, shall be performed by 
Medtronic personnel or their representatives at sites
7.2
Investigator / Investigation site selection
Sites participating in the study are located globally. At a minimum, the following criteria will be met 
before sites are selected for participation:
The principal investigator shall:

Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation

Be experienced in the diagnoses and treatment of patients receiving Reveal LINQ ICM

Disclose potential conflicts of interest that interfere with the conduct of the clinical 
investigation or interpretation of results
The principal investigator shall be able to demonstrate that the proposed investigational site:

Has the required number of eligible subjects needed within the recruitment period

Has one or more qualified investigators, a qualified investigational site team and adequate 
facilities for the foreseen duration of the clinical study
Center personnel training will be completed prior to participation in this clinical study.
7.3
Site activation
During the activation process (prior to subject enrollment), Medtronic will train site personnel on
the CIP, relevant standards and regulations, if needed, informed consent process, and on data 
collection and reporting tools. If new members join the study center team, they will receive training 
on the applicable clinical study requirements relevant to their role before contributing to the clinical 
study.
Prior to enrolling any patients into the study, sites must fulfill all local law and regulatory 
requirements. The term Ethics Board will be used to define Institutional Review Board (IRB), 
Medical Ethics Committee (MEC), Research Ethics Board (REB), or Human Research Ethics 
committee (HREC). Participation readiness includes, but is not limited to:

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
Documented Ethics Board and sponsor approval of the current version of the CIP and
Patient Informed Consent or Data Release Form (if required) and voting list, as required by 
local law

A legally executed Clinical Trial Agreement (CTA)

Insurance certificates (as required per geography)

Applicable Regulatory Approval (as required per geography)

Documentation of study training, including training on the CIP, informed consent process 
and data collection tools depending on the responsibilities

Documentation of delegated tasks

Curriculum Vitae (CV) of investigators and key members of the investigation site team (as 
required by law)
Additional requirements imposed by the Ethics Committee and regulatory authority shall be 
followed, if appropriate. 
All participating site staff must be trained on the current version of the CIP and must be delegated 
by the principal investigator to perform study related activities.
Upon site readiness, the site will be provided with the Investigator Site File for filing of the study 
documentation, and database access will be granted for the investigator and each authorized 
designee. Medtronic will provide each study site with documentation of study site/investigator 
readiness; this letter must be received prior to subject enrollment.

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7.4
Data collection
Data collection requirements are summarized in Table 4 below.
Table 4: Summary of Data Collection 
Data Collection Item(s)
Enrollment/ 
Baseline
Procedure
Follow-Up
Consent Form or Data 
Release Form Completion
X
Inclusion/Exclusion 
Assessment
X
Subject Demographics, 
Medical History
X
Subject Arrhythmia/Symptom 
Status
X
     Medications
X
X*
     Treatments
X
Procedure Information
X
Device Information
X
Device/Monitor Data
X
X
AF Follow-Up
X**
AF Procedure and AF Status
Reported upon occurrence
Adverse Events
Device Deficiencies
System Modification
Study Deviations
Subject Exit
Subject Death
*If applicable
**Only completed if the subject received an AF Ablation after Reveal LINQ ICM implant
7.5
Patient Informed Consent process
Patient Informed Consent is defined as legally effective, documented confirmation of a 
patient’s (or their legally authorized representative or guardian) voluntary agreement to 
participate in a particular clinical study after information has been given to the patient on all
aspects of the clinical study that are relevant to the subject’s decision to participate in the 
clinical study. The Patient Informed Consent Form (PIC) or Data Release Form (DRF) is 
signed only after all relevant information regarding participation has been provided to the 
patient.
Patient Informed Consent will be obtained in accordance with local law and regulations. The 
PIC or DRF and in the US only an Authorization for Access to and use of Health Information 

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(HIPAA) must be approved by the sponsor and the site’s Ethics Board unless an Ethics 
Board waiver for consent is obtained. 
In addition, the documents referenced must be maintained in such a way as to assure 
control for the document (i.e. version and/or date) such that the version(s) approved by the 
Ethics Board are clear with a documented change history for all revisions.
The process for obtaining informed consent shall:

Ensure that the principal investigator or an authorized designee conducts the PIC process.

Include all aspects of the clinical study that are relevant to the patient’s decision to 
participate throughout the clinical study.

Avoid any coercion of, or undue improper influence on or inducement of patients to 
participate

Not waive or appear to waive patient’s legal rights

Ensure the PIC and Authorization to Use and Disclose Personal Health
Information/Research Authorization/HIPAA/other privacy language as required by law are 
given to the subject (or their legally authorized representative or guardian) in a non-
technical language the patient is able to read and understand.

Provide documents to the patients in a language s/he is able to read and understand

Provide ample time for the patient to read and understand the patient informed consent 
form and to consider participation. All questions about the clinical study should be 
answered to the satisfaction of the patient. 

Include a personally dated signature of the patient or legal representative acknowledging 
that their participation in the clinical study is voluntary

Include a personally dated signature by the responsible clinician (if required by local law). 

Include any other locally required signatories, such as witnesses, as indicated by country-
specific legislations.

In addition to the requirement of obtaining written informed consent, 

Ensure the subject (or their legally authorized representative or guardian) are notified of 
any significant new findings about the study that become available during the course of the 
study which are pertinent to the safety and well-being of the subject, as this could impact a 
subject’s willingness to participate in the study.
In the event that the patient cannot read or write, a witnessed (impartial third party) PIC or 
DRF and authorization/data protection will be allowed (as determined by local law), provided 
detailed documentation of the process is recorded in the patient’s case history and the 
witness signs and dates the appropriate PIC or DRF and the authorization. 
The PIC shall be obtained through a supervised oral process. An independent witness must 
be present throughout the process. The PIC and any other information must be read aloud 
and explained to the prospective subject or his/her legally authorized representative. The 
witness signs and personally dates the PIC attesting that the information was accurately 
explained and that informed consent was freely given. The subject should “make his mark” 
(sign or otherwise physically mark the document so as to indicate consent) on the PIC as 
well. The PIC should document the method used for communication with the prospective 
subject and the specific means by which the prospective subject communicated agreement 

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to participate in the study. The original of the signed and dated PIC must be filed in the 
hospital/clinical chart or with the subject’s study documents.
The PIC and Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language as required by law must be available for monitoring and 
auditing. 
Any designated Medtronic personnel who support the procedure must be able to review the 
subject’s signed and dated PIC and verify its completeness prior to proceeding with the 
procedure. In the event the designated Medtronic personnel identify PIC as being incomplete, 
the procedure will not be allowed to occur until the consent of the subject can be adequately 
and appropriately obtained.
Unless waived by the Ethics Board (geography specific) the signed PIC or DRF and the 
authorization (US only) must be filed at the center. A copy of the signed and dated PIC must 
be provided to the patient. The original signed PIC or DRF and the authorization (US only) or 
other privacy language where required by law must be retained and made available for 
review by site monitors, auditors, or inspectors. All important new information should be 
provided in written form to new and existing subjects throughout the study. If relevant, all 
affected subjects must be asked to confirm their continuing informed consent in writing.
The consent process should be documented at each site with a progress note in the patient’s 
case history.
Prior to initiation of any study-specific procedures, patient informed consent must be 
obtained from the subject (or their legally authorized representative). If the PIC is obtained 
the same day the subject begins participating in study-related procedures, it must be 
documented in the subject’s case history that consent was obtained prior to participation in 
any study-related procedures.
DRF and PIC templates will not be automatically updated with a protocol amendment 
unless the protocol changes impact the elements of the PIC or DRF. Medtronic must 
approve any adaptation of the templates prior to use in consenting patients. For all sites 
requiring a Patient Informed Consent the Ethics Board and Medtronic must approve the 
final PIC prior to use in consenting prospective patients.

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7.6
Enrollment
Enrollment of a patient is complete once consent (DRF or PIC) and an Authorization 
(geography specific) have been obtained. Additionally, the signature date will be collected at 
consent on the DRF or PIC. The subject must consent prior to insertion and be intended to 
have a Reveal LINQ ICM inserted within the next 30 days. 
A subject ID log must be maintained and the hospital patient file must be marked to indicate 
that subject’s enrollment in the clinical study (if required by local law/regulations).
7.7
Baseline
The baseline visit can be a standalone visit or can be performed on the same day as 
enrollment, but the visit must be prior to the insertion procedure. 
The following information is required to be collected at the baseline visit:

Inclusion/Exclusion Assessment

Subject Demographics, Medical History

Medications
7.8
Procedure
The insertion procedure will be performed in accordance with the standard insertion practice 
and in accordance with the Medtronic Reveal LINQ insertion instructions which are located 
within the respective clinician manual. The following information is required to be collected 
during the procedure visit:

Procedure information (physician, location of procedure, duration, procedure 
technique, etc.)

Device information (model, serial numbers, etc.)

Device/Monitor Data
o
Submit device data via CareLink transmission, or transfer from a 
programmer printout to the eCRF

Adverse Events assessment
7.9
Subject Follow-up
All subjects are followed in-office in accordance with the standard care practices of their 
respective care provider. However, in addition to the scheduled follow up visits, real time 
reporting is required for arrhythmia events and actions taken. Follow-up data collection is 
required at minimum every 6 months (+/- 3 months) post-insertion as shown in Figure 1.
The following information will be collected within the follow-up windows shown in Figure 1:
•
Subject Arrhythmia/Symptom Status
•
Treatments
•
Assess subject status and/or review subjects medical records for 
occurrence of any of the following treatments and indicate whether they 
were triggered by the Reveal LINQ ICM data review or any other reason:
•
AF ablation
•
Cardioversion (electrical and/or pharmacological)
•
Implant of cardiac rhythm system

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•
Medication changed/administered
•
Revascularization (PCI and/or CABG)
•
Or other cardiac treatment
•
Device/Monitor Data
•
New Diagnoses as a result of Reveal LINQ ICM data
•
Actions taken as a result of monitor data review
•
Submit complete device data via device transmission (i.e., CareLink), or 
transfer from a printout to the eCRF
•
Medications (if the subject received an AF Ablation since Reveal LINQ ICM implant)
•
Imaging testing results
•
Medtronic requests that the site send any copies of these test results 
completed as part of standard of care by the time the subject is exited 
from the study
•
Adverse Events Assessment
7.9.1
Follow-up Due to AF Ablation
Subject follow-up may also include:

Ablation Procedure 
•
Collected for each ablation procedure that occurs post Reveal LINQ ICM 
insertion
•
Payer information
•
Heart Rhythm Status
•
Procedure Information
•
Ablation Strategy
•
Device Information
•
Imaging/Navigation
•
Procedure Results
•
Discharge
•
Adverse Event Assessment

AF follow-up
•
If an AF ablation(s) occurred after Reveal LINQ ICM insertion, AF follow-up 
information is collected at all follow-up visits
•
Recurrent atrial arrhythmias
•
AF ablation related adverse event assessment and description

AF Status
•
If an AF ablation(s) occurred after Reveal LINQ ICM insertion, AF status is 
collected at follow-up visits in which the subject experienced recurrent atrial 
fibrillation since the previous follow-up
•
AF Status details
•
Cardiac Medications History
7.9.2
Modes of Data Collection
The study employs multiple methods of data collection to ensure the most robust and
reliable registry dataset is available. Modes of collection may include such methods as:

In-office subject clinic visit

Remote monitor transmissions (e.g., CareLink)  review with no subsequent in-office 
assessment

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
Chart review for reportable events
7.9.3
Frequency of Follow-up
Follow-up data collection as described in section 7.9.2 is required at minimum every 6 
months (+/- 3 months) post-insertion as shown in Figure 1. These follow-up windows 
ensure regular subject status assessments are completed. Data may be collected more 
than once within each designated follow-up window.
Figure 1 Minimum* Required Reveal LINQ Registry Follow-up Schedule
Implant
0         3          6          9         12        15        18        21        24       27        30        33        36     39
* In addition to the scheduled follow up visits, real time reporting is required for Arrhythmia 
Events and Actions Taken. Data may be collected more than once within each designated 
follow-up window.
7.9.4
Arrhythmia Event and Action Taken Assessment (ongoing)
Data may be collected more than once within each designated follow-up window as real 
time reporting is required for Arrhythmia Events and Actions Taken. 

Arrhythmia Event
o Regardless if action is taken, any time a new arrhythmia is recorded on the device a 
follow-up form is required

Action Taken
o If an action is taken as a result of an arrhythmia, a follow-up form is required. 
Actions include:

Medication change

Treatment

AF ablation

Cardioversion (electrical and/or pharmacological)

Implant of cardiac rhythm system

Medication changed/administered

Revascularization (PCI and/or CABG)

Or other cardiac treatment

Diagnostic work up

CT/MRI/PET Scan, X-Ray/Fluoroscopy, Cardiac Catheterization, 
Biopsy, Echocardiogram, Exercise Stress Test, Venous Ultrasound, 
Month

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Radionuclide ventricular cardiography/MUGA, Tilt test, 
electrongencephalography (EEG), Electromyography (EMG), 
Laboratory test, Doppler of carotids/intracerebral arteries and other 
7.9.5
Follow-up Duration
Subjects are followed until:

Death or exit,

Implanted device becomes inactive or explanted (with no related adverse events 
pending further treatment) , or

Subject has been followed for a minimum of 3 years (i.e. 1096 days)
7.10 System Modification
A system modification will be reported if the Reveal LINQ ICM requires modification (e.g. 
explant, repositioning, replacement, etc.). In the event of a system modification, the follow-
up schedule for the subject will remain unchanged. At a minimum the following types of data
are collected for a system modification procedure:

General relevant modification information (reason for modification, actions taken )

Device information (model, serial numbers, etc.)

Events assessment
A procedure report should be obtained to ensure all available modification information 
including any reportable adverse events are submitted.
In the event of a system modification, the follow-up schedule for the subject will remain 
unchanged unless the modification results in the subject no longer being study eligible in 
which case the subject must be exited from the study. Sites should make every effort to 
return all explanted devices. 
It is recommended that all products be returned when possible for analysis. Procedures
for returning products vary by geographic location. Please contact your local Medtronic
field representative for more information or to obtain prepaid postage mailer kit.
7.11 Study Exit
A study exit e-CRF is required for all subjects except in the case of death.  Prior to exiting a 
subject from the study, it is recommended to follow the subject until all ongoing system 
and/or procedure related AEs are resolved or unresolved with no further actions planned.  
Upon exiting from the study, no further study data will be collected or study visits will occur 
for the subject.  All data available through the time of the subject’s exit will be used for 
analysis. 
Subjects may be exited from the study under the following circumstances:
Study Closure
Lost to follow-up

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No eligible product was implanted
Inclusion/Exclusion criteria not met
Subject chooses to withdraw (e.g. consent withdrawal)
Physician deems withdrawal necessary (e.g. medically justified, failure of subject
to maintain adequate study compliance)
Reveal LINQ system is inactive 
Subject has been followed for 3 years
The following information is required to be collected at study exit on the study exit e-CRF:
Date of exit
Reason for exit
In the case that the subject is deemed to be lost to follow-up, details of a minimum of two 
attempts and the method of attempt (e.g., one letter and one phone record or two letters) to 
contact the subject must be documented. In addition, follow the regulations set forth by the 
governing Ethics Committee. 
7.12 Subject Death
All deaths must be reported to Medtronic as soon as possible after the clinician/site
coordinator first learns of the death.
Death Classification
Cause of death will be reported along with the clinician’s assessment of product relatedness
(See Appendix G for definitions)
Death Data Collection
For all subject deaths deemed to be product related, sufficient supporting documentation 
will be required in order to properly adjudicate and classify the subject’s death. Provide as 
much of the following information as possible:

Death certificate (if allowed by state/local law)

Death summary/hospital records (if allowed by state/local law)

Autopsy report (if allowed by state/local law)

Device Data if applicable and available
Further supporting evidence that is not originally provided by the site may be requested by
Medtronic to aid in the adjudication of the death.

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8. STUDY DEVIATIONS
A study deviation is defined as an event within a study that did not occur according to the Clinical 
Investigation Plan or the Clinical Trial Agreement.
Prior approval by Medtronic is expected in situations where the investigator anticipates, 
contemplates, or makes a conscious decision to deviate. Prior approval is not required when a 
deviation is necessary to protect the safety, rights or well-being of a subject in an emergency or in 
unforeseen situations beyond the investigator’s control (e.g. subject failure to attend scheduled 
follow-up visits, inadvertent loss of data due to computer malfunction, inability to perform required 
procedures due to subject illness).
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going 
forward. This may also apply for other unforeseen situations (e.g. the subject permanently refuses 
to complete a study required procedure and the data will not contribute to the primary end point 
analysis). However, prior approval from Medtronic is required for such situations. 
All study deviations must be reported on the Study Deviation e-CRF regardless of whether 
medically justifiable, pre-approved by Medtronic, an inadvertent occurrence, or taken to protect 
the subject in an emergency. The deviation description must be recorded with an explanation for 
the deviation. In the occurrence of a corrupted device interrogation file, Medtronic may request a 
deviation to document that a readable interrogation file is unavailable.
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the 
life or physical well-being of a subject in an emergency, the deviation must be reported to the 
Ethics Committee per local requirement and Medtronic as soon as possible. Reporting of all other 
study deviations should comply with Ethics Committee policies and/or local laws and must be 
reported to Medtronic as soon as possible upon the site becoming aware of the deviation. 
Reporting of deviations must comply with Ethics Committee policies, local laws, and/or regulatory 
agency requirements.  
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the Clinical Investigation Plan, conduct 
additional training, terminate the investigation). Repetitive or serious investigator compliance 
issues may result in initiation of a corrective action plan with the investigator and site, and in some 
cases, necessitate suspending enrollment until the problem is resolved or ultimately terminating 
the investigator's participation in the study. Medtronic will provide site-specific reports to 
investigators summarizing information on deviations that occurred at the investigational site on a 
periodic basis.

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9. ADVERSE EVENTS AND DEVICE DEFICIENCIES
Reporting and analysis of safety data are mandated by regulatory authorities worldwide. 
Medtronic has established procedures in conformity with worldwide regulatory requirements to 
ensure appropriate reporting of safety information. This study is conducted in accordance with 
these procedures and regulations.
Since the safety reporting requirements and classification systems vary for each regulatory 
agency, requirements from all geographies are taken into account for the collection and reporting 
of safety information.
The Reveal LINQ ICM is approved with demonstrated evidence of safety and effectiveness for 
their intended use. It is not the purpose of the study to demonstrate product safety and 
effectiveness for the purpose of obtaining product approval nor to obtain approvals for expanded 
indications of use, new material or design change for medical device already on the market.
For the Reveal LINQ registry, all AEs occurring after consent that are potentially system related 
or procedure related will be collected, as well as:

Stroke

Transient ischemic attack (TIA)

Bleeding events, and

Ablation-related events

Espophageal injury, phrenic nerve injury, PV stenosis/occlusion, silent microembolismsm,
late hematoma, pseudoaneurysm, AV fistula, dry cough, hemoptysis, other
In all geographies, Unavoidable AEs, listed in Table 5 need not to be reported if resolved within 
the timeframe specified.
9.1
Adverse Event Assessment
9.1.1
Adverse Events
AE definitions are provided in Table 5. AEs that are potentially system related or procedure 
related as well as stroke, TIA, bleeding events, and ablation-related events will be collected and 
reported to Medtronic during the study, starting from the time the subject completes consent. 
Reporting of these events to Medtronic will occur on the AE eCRF.
Each AE must be recorded on a separate AE eCRF and include a description of the event, the 
diagnosis, the date of event onset, the date the site became aware of the event, the relatedness 
and seriousness of the event, diagnostic tests and procedures performed, actions taken as a 
result of the event, and the outcome of the event. Documented pre-existing conditions are not 
considered AEs unless the nature or severity of the condition has worsened. Additionally, 
detected arrhythmias (including AF) for which no intervention is made are not reportable as AEs.
In all geographies, Unavoidable AEs, listed in Table 5 need not to be reported if resolved within 
the timeframe specified.
For AEs that require immediate reporting (see Table 7), initial reporting may be done by phone, or 
on the CRF completing as much information as possible. The AE CRF must be completed as 
soon as possible. 
In case the investigator requires information from the sponsor in an emergency situation, the 
investigator can contact the study sponsor (Table 1).
An assessment for Device Related, Procedure-Related Events as well as stroke, TIA, bleeding 
events, and ablation-related events will be conducted at each subject follow-up.  Submit any 

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additional supporting evidence which could assist in the assessment and review of reported
events e.g. device transmissions and/or device uploads. 
9.1.2
Device Deficiencies
Device deficiency information will be collected throughout the study and reported to Medtronic. 
Device deficiencies that did not lead to an Adverse Event should be reported as a device 
deficiency only.
9.1.3
Processing Updates and Resolution
For any changes in status of a previously reported AE (i.e. change in actions taken, change in 
outcome, change in relatedness), an update to the original AE must be completed. All reported 
AEs must be followed until the AE has been resolved, is unresolved with no further actions 
planned, the subject exits the study or until study closure, whichever occurs first. 
In the event that a subject is exited from the study prior to study closure, all efforts should be 
made to continue following the subject until all unresolved procedure or system related AEs, as 
classified by the investigator, are resolved or they are unresolved with no further actions planned. 
At the time of study exit, all AEs with an outcome of “Unresolved, further actions or treatment 
planned” must be reviewed and an update to the original AE must be reported. At a minimum, if 
there are no changes to the description, relatedness, test and procedures or actions taken, the 
outcome must be updated to reflect “Unresolved at time of study closure.”
9.2
Adverse Event and Device Deficiency Definitions
All reportable AEs and device deficiencies will be reviewed by a Medtronic representative. AEs 
will be classified according to the definitions provided. 
Where the definition indicates “device”, it refers to any device used in the study. Refer to 
Appendix I for event definitions. Every effort has been made to align study definitions with the 
ISO 14155:2011 standard but since the study is not within the scope of ISO, minor modifications 
have been made to better align with the purpose of the study. Specifically, the reference to the 
term “investigational” has been removed from the definitions with all other content unchanged.
Table 5: Adverse Event Definitions
General
Adverse Event 
(AE)
(ISO 14155-
2011, 3.2)
Any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other person, whether 
or not related to the medical device
Note 1: This definition includes events related to the medical device or the comparator
Note 2:  This definition includes events related to the procedure involved
Note 3:  For users or other persons, this definition is restricted to the medical device.

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Adverse Device 
Effect (ADE)
(ISO 
14155:2011, 3.1)
Adverse event related to the use of a medical device.
Note 1: This definition includes any adverse event resulting from insufficient
or
inadequate instructions for use or the deployment, implantation, 
installation, or operation, or any malfunction of the medical device.
Note 2: This definition includes any event resulting from user error or from intentional
misuse of the medical device
Device 
Deficiency (DD)
(ISO 
14155:2011, 
3.15)
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance. 
NOTE: Device deficiencies include malfunctions, use errors and inadequate labeling 
Relatedness
Procedure 
Related
An adverse event that occurs that is directly related to the implantation or modification of 
the Reveal LINQ system.
System Related
An adverse event that results from the presence or performance (intended or otherwise) of 
any component of the system (including: Reveal LINQ ICM, Programmer, Patient 
Assistant, and MyCareLink Patient Monitor).
Seriousness
Serious Adverse 
Event (SAE)
(ISO 1455-2011, 
3.37)
An Adverse Event that:
a) led to a death,
b) led to a serious deterioration in the health of the subject, that either resulted in
1.
a life-threatening illness or injury
2.
a permanent impairment of a body structure or a body function
3.
in-patient hospitalization or prolongation of existing hospitalization
4.
medical or surgical intervention to prevent permanent impairment to body 
structure or a body function
c) led to foetal distress, foetal death or a congenital abnormality or birth defect.
Note: Planned hospitalization for a pre-existing condition without serious deterioration in
health is not considered a serious event
Serious Adverse 
Device Effect 
(SADE)
(ISO14155-
2011, 3.36)
Adverse device effect that has resulted in any of the consequences characteristic of a 
serious adverse event
Unanticipated 
Serious Adverse 
Device Effect
(USADE) 
(ISO14155:2011, 
3.42)
Serious adverse device effect which by its nature, incidence, severity or outcome has not 
been identified in the current version of the risk analysis report.
Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report.

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Other
Unavoidable 
Adverse Event
An Adverse Event inherent to a surgical procedure that is expected to occur in all 
subjects for a projected duration according to the Investigator’s opinion, including, but not 
limited to:
Event Description
Time (hrs) from end of 
Procedure
Anesthesia related nausea / vomiting
24 hrs
Low-grade fever (<100oF or < 37.8oC)
48 hrs
Pocket site / incisional pain
72 hrs
Mild to moderate bruising / ecchymosis
168 hrs (7 days)
Sleep problems (insomnia)
72 hrs
Back pain related to laying on the table
72 hrs
Shoulder pain / discomfort / stiffness / related to shoulder
immobilization during procedure
72 hrs
Infection
Infection will be defined as deep incision site or superficial infection. 
Deep incision site are classified as pain, redness, or drainage at incision site requiring the 
device to be removed or IV antibiotics administered.
Superficial infections are defined as redness beyond procedure expectation and oral 
antibiotics administered.
For both deep incision and superficial infections, a physician directed intervention must 
occur for the event to be defined as an infection.
9.3
Adverse Events and Deficiency Classification
All reportable AEs and device deficiencies will be reviewed by a Medtronic representative. AEs will be 
classified according to the definitions provided.
The site will report the clinician’s assessment of the event relative to relatedness (e.g. device or procedure) 
and seriousness. Upon receipt of AEs at Medtronic, a Medtronic representative will review the AE /device 
deficiency for completeness and accuracy and when necessary will request clarification and/or additional 
information from the Investigator. Medtronic will utilize MedDRA, the Medical Dictionary for Regulatory 
Activities, to assign a MedDRA term for each AE based on the information provided by the investigator. 
Regulatory reporting of all safety events, which may include SAEs and device deficiencies that could have 
led to an SADE, will be completed according to local regulatory requirements.
AEs and Deaths will be classified according to the standard definitions as outlined below: 

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Table 6: Adverse Event classification responsibilities
What is classified? Who classifies? Classification Parameters
Relatedness
Investigator
System-related (including: Reveal LINQ ICM, 
Programmer, Patient Assistant, and MyCareLink Patient 
Monitor), Procedure-related 
Sponsor
System-related (including: Reveal LINQ ICM, 
Programmer, Patient Assistant, and MyCareLink Patient 
Monitor), Procedure-related
Severity
Investigator
SAE, SADE  
Sponsor
SAE, SADE, USADE, Complication or Observation (for all 
system or procedure related AEs), Life Threatening 
Diagnosis
Investigator
Based on presenting signs and symptoms and other 
supporting data
Sponsor
MedDRA term assigned based on the data provided by 
Investigator
Death Classification Investigator
Sudden Cardiac, Non-sudden Cardiac, Non-Cardiac, 
Unknown
9.4
Adverse Event and Device Deficiency Reporting Requirements
Regulatory reporting of AEs/DDs will be completed according to local regulatory requirements. Refer to 
Table 7: Adverse Event Reporting Requirements for a list of required investigator reporting requirements 
and timeframes, and of required Medtronic reporting requirements and timeframes. Each geography has 
the responsibility to follow current local reporting requirements.
The investigator is required to report SAEs and SADEs/USADEs to Medtronic immediately, and to the 
Ethics Committee per local requirements. Medtronic is also required to report these events to the local 
regulatory authority based on their requirements. It is the responsibility of the investigator to abide by any 
additional AE/DD reporting requirements stipulated by the Ethics Committee responsible for oversight of 
the study.
For AEs/DDs that require immediate reporting, initial reporting may be done by contacting the study 
sponsor per the sponsor contact information provided in this document. 
The reporting of product complaints is not part of the clinical study and should be done in addition to the 
Adverse Event reporting requirements. It is the responsibility of the investigator to report all product 
complaint(s) associated with a medical device distributed by Medtronic, regardless whether they are 
related to intended use, misuse or abuse of the product. Reporting must be done immediately and via the 
regular channels for market released products.

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Table 7: Adverse Event Reporting Requirements
Serious Adverse Events (SAEs)
Investigator submit to:
Medtronic
EMEA: Immediately after the investigator first learns of the event or of new information in
relation with an already reported event. (ISO 14155 and local law)
All other geographies: Report to the sponsor, without unjustified delay, all serious adverse
events.
Ethics 
Committee All geographies: Submit per local Ethics Committee requirement.
Regulatory 
authorities All geographies: As per local reporting requirement.
Sponsor submit to:
Regulatory 
authorities All geographies: Submit to regulatory authority per local reporting requirement.
Ethics 
Committee All geographies: Submit to Ethics Committee per local reporting requirement.
Serious Adverse Device Effects (SADEs) including Unanticipated Serious Adverse Device 
Effects(USADEs)
Investigator submit to:
Medtronic
EMEA: Immediately after the investigator first learns of the event or of new information in
relation with an already reported event. (ISO 14155 and local law)
All other geographies: Submit in a timely manner after the investigator first learns of the
event.
Regulatory 
authorities All geographies: As per local reporting requirement.
Ethics 
Committee All geographies: Submit per local Ethics Committee requirement.
Sponsor submit to:
Regulatory 
authorities All geographies: Submit to regulatory authority per local reporting requirement.
Ethics 
Committee All geographies: Submit to Ethics Committee per local reporting requirement.
Adverse Device Effects
Investigator submit to:
Medtronic
EMEA: Immediately after the investigator first learns of the effect. (ISO 14155 and local law)
All other geographies: Submit in a timely manner after the investigator first learns of the
effect.
Regulatory 
authorities All geographies: As per local reporting requirement.
Ethics 
Committee All geographies: Reporting timeframe as per local Ethics Committee requirement.
Sponsor submit to:
Regulatory 
authorities All geographies: Submit to regulatory authority per local reporting requirement.

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Ethics 
Committee All geographies: Submit to Ethics Committee per local reporting requirement.
All other reportable Adverse Events 
Investigator submit to:
Medtronic All geographies: Submit in a timely manner after the investigator first learns of the event.
Regulatory
Authorities All geographies: Submit to regulatory authority per local reporting requirement.
Ethics 
Committee All geographies: Submit to Ethics Committee per local reporting requirement.
Sponsor submit to:
Regulatory 
authorities All other geographies: Submit to regulatory authority per local reporting requirement.
Device Deficiencies
Investigator submit to:
Medtronic All geographies: Submit in a timely manner after the investigator first learns of the event.
Regulatory 
Authorities All geographies: Submit to regulatory authority per local reporting requirement.
Ethics 
Committee All geographies: Submit to Ethics Committee per local reporting requirement.

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10.
RISK ANALYSIS
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a 
product, from the business analysis phase through development, market release, and post-market 
surveillance. 
There are no incremental risks introduced to the subject as a result of participation in this study. 
Risks and Risk Mitigations to the subject identified below are consistent with those outlined in the 
device manual.  
There may be other discomforts and risks related to the device system and/or this study that are not 
foreseen at this time.
Risks and Risk Mitigations
Possible risks associated with the Reveal LINQ include but are not limited to the following:

Risks associated with a minor surgical procedure (ex. Slight risk of infection)

Sensitivity to the device
10.1 Risk Minimization
The potential risks associated with the Reveal LINQ were identified and have been successfully 
mitigated. Any potential risks associated with this study are further minimized by selecting qualified 
investigators and training study personnel on the Clinical Investigation Plan. 
In addition, investigators will be actively involved in the insertion and follow-up of the subjects 
implanted with the Reveal LINQ system. 
Risks will be minimized by careful assessment of each subject prior to, during, and after insertion of 
the Reveal LINQ. Prior to insertion, it is recommended subjects undergo a complete cardiac 
evaluation.
After insertion, subjects will be followed at regular intervals. The investigator must interrogate the 
Reveal LINQ and assess for any adverse events. 

Risks associated with a minor surgical procedure 

Slight risk of infection 

Sensitivity to the device
10.2 Potential Benefits
The Reveal LINQ may offer no benefit. The potential benefits of having the Reveal LINQ include 
more intensive follow-up treatment and frequent device transmissions and/or continuous monitoring 
enabling more precise detection of arrhythmias. This better precision to detect arrhythmias may lead 
to clinicians having better data to quantify arrhythmia burden. The information gained from this study 
could result in the improved detection and management of arrhythmias. Additionally, information 
collected from this study may assist in the design of new product(s)/therapy(ies) and/or instructions 
for use. The System may not offer a direct clinical benefit to study subjects. The information collected 
from this study may assist in the design of new product(s)/therapy(ies) and/or instructions for use. 

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11.
PLANNED STUDY CLOSURE, EARLY TERMINATION OF STUDY 
OR STUDY SUSPENSION
11.1 Planned study closure
Study Closure is a process initiated by distribution of a study closure letter. Study closure is defined 
as closure of a clinical study that occurs when Medtronic and/or regulatory requirements have been 
satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority), 
whichever occurs first. The study closure process is complete upon distribution of the Final Report or 
after final payments, whichever occurs last. Ongoing Ethics Committee oversight is required until the 
overall study closure process is complete. Refer to the Study Exit section for additional information 
regarding study exit procedures.
11.2 Early termination or suspension
Medtronic may limit enrollment when sufficient enrollment to effectively evaluate product 
performance and survivability is achieved (Refer to Section 12). Any enrollment closures will be 
communicated to sites along with the rationale for closure.
To ensure a widespread distribution of data and minimize site bias in study results, the maximum 
number of subjects who may have a Reveal LINQ inserted at a single site is fifteen percent (15) of 
total projected enrollment in a given geography based on enrollment allocations. Sites that enroll 
faster than others will be allowed to do so in order to maintain an adequate overall study enrollment 
rate, but may not exceed the maximum number of insertions per site.   
Early Termination of the Study is the closure of a clinical study that occurs prior to meeting defined 
endpoints. This is possible for the whole study or a single site. Study Suspension is a temporary 
postponement of study activities related to enrollment and distribution of the product. This is possible 
for the whole study or a single site.
i.
Study-wide termination or suspension
Possible reasons for considering study suspension or termination of the study include but are not 
limited to:

Adverse events associated with the system or product under investigation which might 
endanger the safety or welfare of the subject

Observed/suspected performance different from the product’s design intent

Decision by Medtronic or regulatory body (where the study is operating under regulatory body 
authority)

Technical issues during the manufacturing process
ii.
Investigator/site termination or suspension
Possible reasons for clinical investigator or site termination or suspension include but are not 
limited to:

Failure to obtain initial Ethics Committee approval or annual renewal of the study

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
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups)

Lack of enrollment

Noncompliance to regulations and the terms of the Clinical Trial Agreement (e.g. failure to 
submit data in a timely manner, failure to follow-up on data queries and monitoring findings in 
a timely manner, etc.)

Ethics Committee suspension of the site

Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)

Investigator request (e.g. no longer able to support the study) 
11.3 Procedures for termination or suspension
iii.
Medtronic-initiated and regulatory authority-initiated

Medtronic will promptly inform the clinical investigators of the termination or suspension and 
the reasons and inform the regulatory authority(ies) where required

In the case of study termination or suspension for reasons other than a temporary 
MEC/IRB/Head of Medical Institution approval lapse, the investigator will promptly inform the 
MEC/IRB/Head of Medical Institution 

In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided

In the case of a study suspension, subject enrollment must stop until the suspension is lifted 
by Medtronic

In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare
iv.
Investigator-initiated

The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension

The investigator will promptly inform the institution (where required per regulatory 
requirements)

The investigator will promptly inform the MEC/IRB/Head of Medical Institution

The investigator will promptly inform the subjects and/or the personal physician of the 
subjects to ensure appropriate care and follow-up is provided

In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare
v.
Ethics committee-initiated

The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days

Subject enrollment must stop until the suspension is lifted

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
Subjects already enrolled should continue to be followed in accordance with MEC/IRB/Head 
of Medical Institution policy or its determination that an overriding safety concern or ethical 
issue is involved

The investigator will inform his/her institution (where required per local requirements)

The investigator will promptly inform the subjects, or legally-authorized designees or 
guardians and/or the personal physician of the subjects, with the rationale for the study 
termination or suspension

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12.
STATISTICAL METHODS AND DATA ANALYSIS
Medtronic employees or designees will perform all statistical analyses. Additionally, a separate Statistical 
Analysis Plan (SAP) will be developed to further describe statistical methods, pre-specified data handling 
rules, and pre-specified analyses that will be included in study reports. Any change to the data analysis 
methods described in the CIP will require an amendment only if it changes a principal feature of the CIP. 
Any other change to the data analysis methods described in the CIP, and the justification for making the 
change, will be described in the clinical study report. Additional exploratory analyses of the data may be 
conducted as deemed appropriate. Missing data will not contribute to the objectives unless specified 
otherwise within the analysis methods.
The study is observational in nature. Sample size calculations for the study objectives provide information 
on the reliability of the estimates. The registry data is intended to benefit and support interests of patients, 
hospitals, clinicians, payers, and industry. Overall study enrollment size is determined by number of 
engaged study centers and enrollment potential at each study center. At the same time, data analysis 
may be carried out throughout the study without having all enrolled subjects completing study required 
follow-ups.
12.1 Primary Objective #1
Characterize clinical actions initiated by Reveal LINQ arrhythmia detection.
i.
Analysis Methods
This objective is descriptive in nature. New onset of arrhythmias diagnosed as results of 
ICM data review, and the subsequent clinical actions taken are reported through CRFs.  
Study sites will review device recorded arrhythmia episodes via remote transmission or
at a regularly scheduled clinic visit. Clinical treatments may be prescribed upon
diagnosis.
Summary statistics will be obtained for frequencies of diagnosis and treatment.   
Frequencies of each action taken, such as medication changes, surgical intervention, 
new cardiac device implant, etc. will be obtained.
ii.
Determination of Subjects/Data for Analysis 
All enrolled subjects who are diagnosed with an arrhythmia detected by Reveal LINQ will be 
included in analysis. 
iii.
Sample Size
There is no statistical hypothesis formulated for this analysis therefore there is no sample size for 
this objective.

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12.2 Primary Objective #2
Estimate procedure-related acute infection rate (up to 30 days post insertion procedure).
i.
Analysis Methods
The postinsertion procedure visit can be either in office visit or CareLink visit. Infection 
events willbe reported by study sites upon awareness. The acute infection rate will be
calculated by dividing the number of subjects with infection events within 30 days post
insertion procedure by the number of subjects in the risk set (the analysis cohort). Two-
sided 95% confidence interval will be calculated using the Exact Binomial method.
Additionally, rate for infection SAE may be calculated (see Appendix for SAE definition).  
ii.
Determination of Subjects/Data for Analysis 
A subject will be included in the analysis cohort for this objective if one of the following 
criteria is met:
a) A subject who undergoes a Reveal LINQ insertion procedure (following subject’s 
consent to the study) and completes a minimum of one visit at a time point ≥30 days
post insertion procedure will be included for the analysis.
b) A subject will be included in the analysis if an infection event is reported regardless 
if the subject has completed 30 day follow-up.
c)
A subject with a Reveal LINQ device explanted after a successful implant procedure 
that occurred prior to 30 days post insertion procedure will be included in the 
analysis cohort. 
d) A subject who undergoes a Reveal LINQ implant procedure without having a
Reveal LINQ device chronically implanted will be included in the analysis with a 
confirmation of patient status at ≥30 days post implant. 
iii.
Sample Size
The study will enroll sufficient number of subject to ensure a robust sample 
size to estimate acute infection rate. It is assumed the acute infection rate will
be less than 5%. The confidence interval width (Lower limit to upper limit) for
the infection rate estimate is demonstrated in Table 8. A minimum of 1200 
subjects undergoing Real LINQ implant procedure will provide a 2-sided 95% 
confidence interval with a width of 2.6%, assuming infection rate is 5%.

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Table 8 Sample Size Calculation for Estimating Acute InfectionRate
Sample
Size
Event rate
Assumption
Lower
Limit
Upper
Limit
Confidence 
Interval 
Width
100
5%
1.6%
11.3%
9.6%
200
5%
2.4%
9.0%
6.6%
300
5%
2.8%
8.1%
5.3%
400
5%
3.1%
7.6%
4.5%
500
5%
3.3%
7.3%
4.0%
600
5%
3.4%
7.1%
3.7%
700
5%
3.5%
6.9%
3.4%
800
5%
3.6%
6.7%
3.2%
900
5%
3.7%
6.6%
3.0%
1000
5%
3.7%
6.5%
2.8%
1100
5%
3.8%
6.5%
2.7%
1200
5%
3.8%
6.4%
2.6%
1500
5%
4.0%
6.2%
2.3%
2000
5%
4.1%
6.0%
2.0%
2300
5%
4.1%
6.0%
1.8%
12.3
 
 
 
 
 
 

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o
 
 
 

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13.
DATA AND QUALITY MANAGEMENT
Data will be collected using an electronic data management system for clinical studies.  E-CRF 
data will be stored in a secure, password-protected database which will be backed up nightly.  
Data will be reviewed using programmed and manual data checks.  Data queries will be made 
available to sites for resolution.  Study management reports may be generated to assess data 
quality and study progress.  At the end of the study, the data will be frozen and will be retained 
indefinitely by Medtronic.
All records and other information about subjects participating in this study will be treated as 
confidential. Data will be transferred and processed by Medtronic or a third party designated by 
Medtronic in a key coded form, unless it’s impossible to make it anonymous, for instance, where 
the patient’s name cannot be removed from the data carrier, such as fluoroscopy images.    
Procedures in the CIP require source documentation.  Source documentation will be maintained 
at the site. Source documents, which may include worksheets, patient medical records, 
programmer printouts, and interrogation files, must be created and maintained by the 
investigational site team. 
The data reported on the e-CRFs shall be derived from source documents and be consistent with 
these source documents, and any discrepancies shall be explained in writing. 
Device data from Reveal LINQ ICM interrogations and CareLink transmissions will be uploaded to 
secure servers.  Save-to-media data collected at office visits will be sent to Medtronic.  Upon 
receipt, device data will be maintained with databases and retrieved for analysis and reporting.
The sponsor or a regulatory authority may audit or inspect the study site to evaluate the conduct 
of the study. The clinical investigator(s)/institution(s) shall allow study related monitoring, audits, 
Ethics Board review and regulatory inspection by providing direct access to source 
data/documents.

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14.
WARRANTY/INSURANCE INFORMATION
14.1 Warranty
Warranty information is provided in the product packaging for the Reveal LINQ and additional 
copies are available upon request.
Outside the US, Medtronic maintains appropriate clinical liability insurance coverage as required 
under applicable laws and regulations and will comply with applicable local law and custom 
concerning specific insurance coverage. If required, a clinical insurance statement/certificate will 
be provided to the Ethics Board.
14.2 Insurance (Europe, Middle East, Africa)
Medtronic Bakken Research Center B.V. is a wholly owned subsidiary of Medtronic, Inc., which as 
the parent company of such entity maintains appropriate clinical study liability insurance coverage 
as required under applicable laws and regulations and will comply with applicable local law and 
custom concerning specific insurance coverage. If required, a Clinical Trial insurance 
statement/certificate will be provided to the Ethics Committee.
14.3 Insurance (Japan)
Medtronic Japan Co., Ltd. is a wholly owned subsidiary of Medtronic, Inc., which as the parent 
company of such entity maintains appropriate clinical trial liability insurance coverage as required 
under applicable laws and regulations and will comply with applicable local law and custom 
concerning specific insurance coverage. If required, insurance provisions will be provided to the 
Ethics Committee/Institutional Review Board.
14.4 Insurance (Greater China)
Medtronic (Shanghai) Management Co., Ltd is a wholly owned subsidiary of Medtronic, Inc., which 
as the parent company of such entity maintains appropriate clinical trial liability insurance 
coverage as required under applicable laws and regulations and will comply with applicable local 
law and custom concerning specific insurance coverage. If required, a Clinical Trial insurance 
statement/certificate will be provided to the Ethics Committee.

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15.
MONITORING
It is the responsibility of Medtronic to ensure proper monitoring of this clinical study.  Trained 
Medtronic personnel or delegates appointed by Medtronic may perform study monitoring at 
the study site in order to ensure that the study is conducted in accordance with the CIP, the 
Clinical Trial Agreement (CTA), and applicable regulatory and local requirements. Medtronic, 
or delegates, must therefore be allowed direct access to the subjects’ case histories (clinic 
and hospital records, and other source data/documentation) upon request as per the 
PIC/DRF, Research Authorization (where applicable) and Clinical Trial Agreement.  The 
principal investigator should also be available during monitoring visits.  
The sponsor or a regulatory authority may audit or inspect the study center to evaluate the 
conduct of the study. The clinical investigator(s)/institution(s) shall allow study related 
monitoring, audits, Ethics Board review and regulatory inspection by providing direct access 
to source data/documents. If study site’s documents are electronic, these must be made 
available in their original form (or print outs signed and dated with the statement that this is 
complete and true reproduction of the original source document) if requested by the sponsor 
and/or regulatory authority. Study sites should inform Medtronic upon notification of an 
inspection by a regulatory body immediately.
15.1 Monitoring Visits
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, 
study compliance, number of adverse events, number of deviations, findings from previous 
monitoring visits and any suspected inconsistency in data that requires investigation. 
Regulatory documents may be reviewed at each study site. Monitoring for the study, 
including site qualification visits, site initiation visits, interim monitoring visits, and closeout 
visits, will be done in accordance to the study-specific monitoring plan. Monitoring will be 
planned either at the study site, via telephone, or electronically to assure compliance with the 
study clinical investigation plan. Site activation, periodic visits and study closure visits will 
occur either on-site, via email or via telephone.
Monitoring visits may be conducted periodically to assess site study progress, the 
investigator’s adherence to the CIP, regulatory compliance including but not limited to 
IRB/Ethics Committee approval and review of the study, maintenance of records and reports, 
and review of source documents against subject e-CRFs. Monitors review site regulatory and 
study compliance by identifying findings of non-compliance and communicating those 
findings along with recommendations for preventative/corrective actions to site personnel.  
Monitors may work with study personnel to determine appropriate corrective action 
recommendations and to identify trends within the study or at a particular site. 

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16.
REQUIRED RECORDS AND REPORTS
16.1 Investigator records
The investigator is responsible for the preparation and retention of the records cited below. The 
following records are subject to inspection and must be retained for a period of two years (or 
longer as local law or hospital administration requires) after the date on which the investigation is 
terminated.

All correspondence between the IRB/MEC, sponsor, monitor, and the investigator that 
pertains to the investigation, including required reports. 

Subject’s case history records, including: 
o
Signed and dated informed consent form personally signed by subject
o
Observations of adverse events/adverse device effects/device deficiencies
o
Medical history
o
Insertion and follow-up data
o
Documentation of the dates and rationale for any deviation from the protocol

List of investigation sites

All approved versions of the CIP and addendums, and PIC or DRF form (all approved 
versions).

All subject and investigator completed DRF or CF forms (Authorizations, US only)

Signed and dated Clinical Trial Agreement. 

Current curriculum vitae of principal investigators.

Documentation of delegated tasks. 

IRB/MEC approval documentation. Written information that the investigator or other study 
staff, when member of the IRB/MEC, did not participate in the approval process. Approval 
documentation must include the Ethics Board composition, where required per local law.  

Study training records for site staff. 

Subject ID log (if applicable)

Final Study Report including the statistical analysis. 

Any other regulatory authority or required records
Sites are responsible for ensuring practicing clinicians are appropriately
licensed/qualified.
16.2 Investigator reports
The investigator is responsible for the preparation (review) and submission of the reports (reported 
per the country-specific collection requirements) to Medtronic and/or the Ethics Board cited in 
Table 9. In addition, if an Ethics Board takes any action with respect to the study, copies of all 
pertinent documentation must be forwarded to Medtronic in a timely manner. Reports are subject 
to inspection and to the retention requirements as described above for investigator records.

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Investigator reporting requirements for safety data are listed in Table 7: Adverse Event Reporting 
Requirements. The investigator shall prepare and submit in a complete, accurate and timely 
manner the reports listed in this section.
Table 9: Investigator Reports applicable for all geographies per Medtronic requirements
Report 
Submit to
Description/Constraints
Withdrawal of 
IRB/EC approval
Sponsor and 
Relevant 
Authorities
The investigator must report a withdrawal of approval by 
the reviewing IRB/EC of the investigator’s part of the 
investigation as soon as possible.
Study Deviations 
Sponsor and
IRB/EC
Any deviation from the clinical investigation plan shall be 
recorded together with the explanation of the deviation.
Notice of deviations from the CIP to protect the life or 
physical well-being of a subject in an emergency shall be 
given as soon as possible.  Except in such emergency, 
prior approval is required for changes in the plan or 
deviations. 
Failure to obtain
informed consent
Sponsor and
Ethics Committee
Informed consent shall be obtained in writing and
documented before a subject is enrolled into the clinical
study.
Final Report
IRBs/ECs and 
Relevant 
Authorities
This report must be submitted within 3 months of study 
completion or termination, or per local requirements.
Table 10: Investigator reports applicable to Japan per Ethical Guidelines on Medical Research 
involving Human Beings
Report 
Submit to
Description/Constraints
Withdrawal of 
IRB/EC approval
Sponsor, IRB/EC, 
and Chief 
executive of the 
research
implementing 
entity
The principal investigator of the research shall report
to the chief executive of the research implementing entity 
with respect to matters required.
Progress Report
IRB/EC and Chief 
executive of the 
research
implementing 
entity
The principal investigator shall report to the chief executive 
of the research implementing entity, with respect to the 
progress of the research in accordance with specifications 
prescribed in the research protocol.
Study Deviations 
Sponsor, IRB/EC, 
and Chief 
executive of the 
research
implementing 
entity
The investigator shall report deviations if required.

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16.3 Sponsor records
Medtronic will maintain the following records for each site:

All correspondence which pertains to the investigation

Signed Investigator Trial Agreements and current curriculum vitae of principal investigator 
and curriculum vitae of authorized designees where required as well as delegation 
documentation

All approved informed consent templates, data review files and Authorization forms and 
other information provided to the subjects and advertisements, including translations

Copies of all IRB/MEC approval letters and relevant IRB/MEC correspondence and 
IRB/MEC voting list/roster/letter of assurance

Names of the institutions in which the clinical study will be conducted

Names/contact addresses of monitors

Statistical analyses and underlying supporting data

Final report of the clinical study

The Clinical Investigation Plan

Study training records for site personnel and Medtronic personnel involved in the study

Insurance certificates

Any other records that local regulatory agencies require to be maintained. 
16.4 Sponsor reports
Medtronic shall prepare and submit the following complete, accurate, and timely reports 
listed in the tables below (by geography).  In addition to the reports listed below, Medtronic 
shall, upon request of reviewing IRB/EC, regulatory agency or FDA, provide accurate, 
complete and current information about any aspect of the investigation. Medtronic reporting 
requirements for safety data are listed in Table 7 of the Adverse Event section.
Participating sites will have access to their own study data for ad hoc reporting.

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Table 11: Sponsor Reports 
Report
Submit to
Description
Progress Report

Regulatory 
Authority
Progress reports will be submitted to
regulatory authority as required, and to
physicians & Ethics Boards as requested.
Withdrawal of
Ethics Board
approval

Participating
Sites

Regulatory 
Authority
Notification within five working days after the
sponsor first learns of the withdrawal of approval.
To be reported to Regulatory Authorities as required.
Final report

Investigators,
IRB/MEC
A final report will be submitted to the investigators 
and IRBs/MECs within three months after 
completion or termination of this study.  
Study deviation

Investigators
Site specific study deviations will be submitted to 
investigators periodically.  
Medtronic records and reports will be maintained in a password-protected document 
management system, and paper documents (where applicable) will be stored in stored in 
secured file cabinets at Medtronic during the course of this study. After closure of the study 
Medtronic will archive records and reports indefinitely.

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Appendix A:  Draft data collection elements (Case Report Forms)
Draft Case Report Forms for the Reveal LINQ Registry will be provided under separate cover upon 
request.  Final CRFs will be provided to sites via the electronic data management system after the 
site has fulfilled all requirements for database access.

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Appendix B: Publication plan
Publications from the Reveal LINQ Registry study will be handled according to Cardiac Rhythm 
Heart Failure Standard Operating Procedures and as indicated in the Clinical Trial Agreement.
Publication Committee
The Reveal LINQ Registry study team has formed an Oversight Committee.  This committee will 
manage study publications with the goal of publishing findings from the data. The Oversight 
Committee Charter is available under separate cover. 
Membership in the Publication Committee does not guarantee authorship.  The committee will 
meet at regular intervals, as needed.
Management of Primary, Secondary and Ancillary Publications
The Oversight Committee, with Medtronic representatives will serve as the Publication Committee. 
The Publication Committee reviews, prioritizes, and manages all publications including primary, 
secondary and ancillary publications.  Primary and secondary publications are those that address 
analyses of any or all primary objectives or ancillary objectives, respectively, as specified in the 
Clinical Investigation Plan. 
An ancillary publication is any publication that does not address the study objectives identified in 
the Clinical Investigation Plan.  They include publications proposed and developed by other 
Medtronic departments or entities, clinicians participating in this clinical study, and clinicians not 
participating in this clinical study.  The committee will work with Medtronic to ensure that requests 
do not present conflicts with other proposals, are not duplicative, and to determine which ancillary 
publication proposals, if any, will be supported.  
The committee may decide that no publications, including abstracts, will be published prior to the 
end of the study or with individual site data.  Requests for publications on study objectives utilizing 
subset data (e.g., regional) will be evaluated for scientific validity and the ability of Medtronic to 
provide resources.  
Criteria for Determining Authorship
Publications will adhere to authorship criteria defined by the International Committee of Medical 
Journal Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, 
www.icmje.org) in addition to Medtronic authorship criteria.  Individual authorship criteria defined 
by the target journal or conference will be followed when it differs from ICMJE criteria.
Decisions regarding authorship and contributor-ship will be made by the committee. The selected 
authors will be responsible for drafting the publication. All selected authors must fulfill the 
authorship conditions stated above to be listed as authors, and all contributors who fulfill the 
conditions must be listed as authors.
All investigators not listed as co-authors will be acknowledged as the “Medtronic Reveal LINQ 
Registry Clinical Study Investigators” and will be individually listed according to the guidelines of 
the applicable scientific journal when possible and affiliation. Any other contributors will be 
acknowledged by name with their specific contribution indicated.

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Transparency
Transparency of study results will be maintained by the following means:

a final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, MECs and Competent Authorities of participating countries when required by 
local law

registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated as well as local regulatory databases where required by local law

disclosing conflicts of interest of the co-authors of publications according to the policies set 
forth by the corresponding journals and conferences 

making an individual sites study data accessible to the corresponding investigator after the 
completion of the study, if requested

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Appendix C: Informed consent templates and Data Review 
Files
Geography-specific PIC and DRF templates will be provided under separate cover.

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Appendix D: Participating Investigators and Institutions
A complete list of participating investigators and institutions where the study activities will be 
conducted will be provided under a separate cover.

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Appendix E: Ethics Committee List
A complete list of participating Ethics Committees and their Chairperson(s) will be distributed 
under a separate cover when available.

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Appendix F: Additional information for Japanese centers
Other required information for Japanese centers, such as detailed contact information of Medtronic 
Japan, names of monitors, detailed CRF instruction, etc. not outlined in the Clinical Investigational 
Plan will be provided under a separate cover.

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Appendix G: Committees
The Reveal LINQ Registry study will utilize an Oversight Committee to manage study publications. 
Committee membership rosters will be maintained at Medtronic and will be made available upon 
request.
A Data Monitoring Committee (DMC) is not needed for this study.  The study is considered non-
significant risk for study participants, thus the need for additional safety oversight beyond 
Medtronic’s already rigorous safety monitoring processes is not required.

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Appendix H: Labeling
Labeling and package for all products used in this study will follow the local regulatory 
requirements.
Labeling and reference/technical manuals for the Reveal LINQ will be provided under separate 
cover. Labeling for all other market approved system components can be found with each package 
insert.

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Appendix I: Definitions
Abnormal Battery Depletion: Any battery depletion rate which is faster than expected given an 
implanted devices programmed settings or usage conditions.
Atrial Fibrillation:  Atrial Fibrillation is a supraventricular tachyarrhythmia characterized by 
uncoordinated atrial activity with consequent deterioration of atrial mechanical function. On the 
electrocardiogram (ECG), atrial fibrillation is characterized by the replacement of consistent P 
waves with rapid oscillations or fibrillation waves that vary in amplitude, shape and timing, 
associated with an irregular, frequently rapid ventricular response when atrioventricular 
conduction is intact.
Atrial Flutter: Atrial Flutter is characterized by a sawtooth pattern of regular atrial activation 
called flutter waves on the ECG, particularly visible in leads II, III, aVF and v1
Bleeding Event- An episode of internal or external bleeding classified into the 
following categories:
Life-threatening/disabling – fatal bleeding (BARC type 5) or bleeding in a
critical organ, such as intracranial, intraspinal, intraocular, or pericardial
necessitating pericardiocentesis, or intramuscular with compartment 
syndrome (BARC type 3b and 3c) or bleeding causing hypovolemic shock or 
severe hypotension requiring vasopressors or surgery (BARC type 3b) or 
overt source of bleeding with drop in hemoglobin of > 5g/dL or whole blood or 
packed red blood cells (RBCs) transfusion >4 units (BARC type 3b)
Major bleeding (BARC type 3a) – overt bleeding either associated with a drop
in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 
units of whole blood/RBC, or causing hospitalization or permanent injury, or
requiring surgery AND does not meet the criteria of life-threatening or 
disabling bleeding
Minor bleeding (BARC type 2 or 3a depending on severity) – any bleeding
worth of clinical mention (e.g. access site hematoma) that does not qualify as
life- threatening, disabling, or major
Cardiac Arrest: cardiac arrest is the sudden cessation of cardiac activity so that the
victim becomes unresponsive, with no normal breathing and no signs of circulation. If
corrective measures are not taken rapidly, this condition progresses to sudden death.
Cardiac arrest should be used to signify an event as described above that is
reversed, usually by CPR, and/or defibrillation or cardioversion, or cardiac pacing. 
Sudden cardiac death should not be used to describe events that are not fatal.
Cardiovascular Mortality:  Any of the following criteria:

Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac
tamponade, worsening heart failure)

Death caused by non-coronary vascular conditions such as neurological events,
pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other
vascular disease

All procedure-related deaths, including those related to a complication of the
procedure or treatment for a complication of the procedure

All valve related deaths including structural or nonstructural valve dysfunction or

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other valve related adverse events

Sudden or unwitnessed death

Death of unknown cause
Non-Cardiovascular Morality: Any death in which the primary cause of death is clearly
related to another condition (e.g. trauma, cancer, suicide)
Clinical Performance (ISO14155-2011): Behavior of a medical device or response of
the patient(s) to the medical device in relation to its intended use, when correctly 
applied to appropriate patient(s).
Data Query:  A standard form used to request clarification of Registry collected data
Death:

Sudden cardiac: Witnessed instantaneous in a previously stable subject. This
may occur with or without preceding signs or symptoms, or may occur
immediately following sudden dyspnea, lightheadedness, or palpitations.
Unwitnessed. Subject found dead who at time of last witnessed contact was in
usual state of health without medical complaints or obvious difficulty. This
applies to subjects dying during sleep. Note: Whereas most sudden deaths 
seem to result from cardiac arrhythmias, sudden death may also result from
non-cardiac processes (e.g., acute pulmonary embolus, rupture of abdominal
aortic aneurysm). In most cases, documentation of the actual cause of death
is missing.

Non-sudden cardiac. Includes deaths of subjects in acute pulmonary edema;
with severe, progressive HF; cardiogenic shock; or after recent cardiac
surgical procedure.

Non-cardiac. Vascular death (thromboembolic event, acute hemorrhage, CVA,
dissecting aneurysm), or non-cardiovascular death (e.g., trauma, renal failure,
cancer, sepsis, suicide).

Unknown. No information available regarding death event.
Deviation: instance(s) of failure to follow, intentionally or unintentionally, the
requirements of the clinical plan (Protocol and associated Addendum (if applicable)).
Device Data: stored data from a medical device saved to a media (e.g. USB, floppy
disk) which is transferable to a data management system or data directly transferred
to a data management system via a direct upload or transmission e.g. pacemaker,
ICD, neurostimulator, etc.
Echocardiography (Echo): Diagnostic method which uses sound waves to record
imaging of the heart and the heart’s movement. Transthoracic Echo is done through
the chest wall while transesophageal echo is done through the esophagus
Electrical Data: Data that describes the electrical characteristics of some medical
devices including, but not limited to: impedance, threshold, and sensing amplitude
measurements e.g. implanted cardiac rhythm devices
Failure to Sense/Undersensing (cardiac): Intermittent or complete loss of sensing or
failure to detect the intended intrinsic cardiac signals (atrial or ventricular) during non-
refractory periods at programmed sensitivity settings.

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Heart Failure: Heart failure is defined as physician documentation or report of any of
the following clinical symptoms of heart failure described as unusual dyspnea on light
exertion, recurrent dyspnea occurring in the supine position, fluid retention; or the
description of rales, jugular venous distension, pulmonary edema on physical exam,
or pulmonary edema on chest x-ray. A low ejection fraction alone, without clinical
evidence of heart failure does not qualify as heart failure.
Hospitalization: An overnight hospital admission, where admission date and
discharge date are different
Implanted: When surgical incisions are closed (implant pocket closed).
Insertable/Implantable Loop Recorder (ILR) / Insertable Cardiac Monitor: A
programmable device which continuously monitors a patient’s ECG and other
physiological parameters and used to aid in the diagnosis of a suspected cardiac
arrhythmia
Lost to Follow-Up: A subject who will no longer be followed in the Registry due to
unwillingness or inability to return to the clinic for follow-up or a subject who cannot be
located for subsequent follow-up
Oversensing (cardiac): Misinterpretation of cardiac or non-cardiac events as cardiac
depolarization, (e.g. T-waves, skeletal muscle potentials, lead noise, and extra
cardiac electromagnetic interference (EMI)).
Procedure-Related Event: An adverse event that occurs that is directly related to the 
implantation or modification of the Reveal LINQ system.
Programmer Upload: The electronic transfer of device data from a device programmer
to the data management system.
Remote Data Transmission: secure transmission of stored medical device data to
clinics, physicians, and/or Medtronic, i.e. Medtronic's CareLink Network
Stroke: Loss of neurological function caused by an ischemic or hemorrhagic event
with residual symptoms lasting at least 24 hours after onset or leading to death
Syncope: Sudden loss of consciousness with loss of postural tone, not related to
anesthesia, with spontaneous recovery as reported by patient or observer. Patients
may experience syncope when supine.
Transient Ischemic Attack: A focal neurological deficit (usually corresponding to the
territory of a single cerebral vessel) that resolves spontaneously with any evidence of
residual deficient at 24 hours.
Undersensing: Intermittent or complete loss of sensing or failure to detect the
intended intrinsic cardiac signals (atrial or ventricular) during non-refractory periods at
programmed sensitivity settings, see also Failure to Sense.
Ventricular Tachycardia: Ventricular Tachycardia is a cardiac arrhythmia of 3 or more
consecutive complexes in duration emanating from the ventricles at a rate of >100
bpm (cycle length: <600 ms).

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Appendix J: Modifications to the clinical investigation 
plan
Change from Post Surveillance Registry (PSR) CIP V4.0 to 
Reveal LINQ Registry CIP V1.0
Applicable Sections
Change
Rationale
Section 2.2
Study Description: The 
study is expected to be 
conducted at approximately 
100 study sites globally with 
approximately 2,300 
subjects contributing to total 
enrollment numbers. 
Participating geographies 
are expected to include, but 
are not limited to: the United 
States, Europe Middle East 
and Africa (EMEA), China 
and Japan. 
Description of sites, subjects 
and geographies within the 
Reveal LINQ Registry
Section 6.1 
Primary Objective:
V.4: Characterize 
clinical actions initiated 
by Reveal LINQ AF 
detection. 
V.1: Characterize 
clinical actions initiated 
by Reveal LINQ 
arrhythmia detection.
To support reporting on 
clinical actions initiated by 
Reveal LINQ for all 
arrhythmias detected
Section 6.3
Inclusion criteria: 

Subject or legally 
authorized representative 
provides written 
authorization and/or 
consent per institution 
and geographical 
requirements 

Subject is intended to 
have a Reveal LINQ ICM 
inserted in the next 30 
days

Subject consent prior to 
Reveal LINQ ICM 
insertion
Specific to Reveal LINQ 
product and consent prior to 
insertion for data collection 
and reporting 

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Section 7.3
Site activation:
Additional document 
collection requirements 
added
Business requirement
Section 7.9
Follow-up: 

Changed from 
required at minimum 
every 12 months to 
every 6 months 
post-insertion.

Added: Medtronic 
requests that the site 
send any copies of 
imaging testing 
results completed as 
part of standard of 
care by the time the 
subject is exited 
from the study
Added section for 
Arrhythmia Event and 
Action Taken Assessment 
(ongoing)
More frequent and robust 
data collection/reporting
Section 9
Adverse Events: Device 
deficiency collection added
Added safety collection
Change from Reveal LINQ Registry CIP V1.0 to V2.0
Applicable Sections
Change
Rationale
Table 6
System-related description 
List of options errant