Monitoring QT Intervals Using LINQ/LINQII in Patients Undergoing Antiarrhythmic Drug Loading
Conditions: Atrial Arrhythmia, QT Interval, Variation in, Arrhythmias, Cardiac
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

LINQ QT Study Clinical Investigation Plan 
21 SEP 2022 
Version 2  
Page 1 of 48 
Medtronic Business Restricted 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
Clinical Investigation Plan 
Clinical Investigation Plan/Study Title LINQ QT Study 
Clinical Investigation Plan Identifier MDT CTMS Protocol # MDT22018 
Study Product Name LINQTM and LINQIITM Insertable Cardiac Monitor 
(ICM) System 
Sponsor/Local Sponsor Medtronic CRM 
8200 Coral Sea Street NE 
Mounds View, MN 55112 
Document Version 2.0 
Version Date 21 SEP 2022 
Lead Principal Investigator(s) Antony Chu, MD, FACC, FHRS, FAHA, FACP 
Warren Alpert School of Medicine 
Brown University 
225 Dyer Street, 2nd Floor 
Providence RI 02903 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 2 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
Table of Contents 
Table of Contents ...................................................................................................................... 2 
1. 
Glossary .............................................................................................................................. 5 
2. 
Synopsis ............................................................................................................................. 6 
3. 
Introduction ....................................................................................................................... 8 
3.1 Background .......................................................................................................................... 8 
3.2 Purpose ................................................................................................................................ 9 
4. 
Objectives and/or Endpoints ............................................................................................. 9 
4.1 Objectives ............................................................................................................................ 9 
4.1.1 
Primary Objective .................................................................................................................. 9 
5. 
Study Design ...................................................................................................................... 9 
5.1 Duration ............................................................................................................................. 13 
5.2 Rationale ............................................................................................................................ 13 
6. 
Product Description.......................................................................................................... 13 
6.1 General .............................................................................................................................. 13 
6.2 Shipment of Study Components ............................................................................................ 18 
6.3 Product Accountability ......................................................................................................... 18 
7. 
Selection of Subjects ........................................................................................................ 19 
7.1 Study Population ................................................................................................................. 19 
7.2 Subject Enrollment .............................................................................................................. 19 
7.3 Inclusion Criteria ................................................................................................................. 19 
7.4 Exclusion Criteria................................................................................................................. 19 
8. 
Study Procedures ............................................................................................................. 20 
8.1 Schedule of Events .............................................................................................................. 20 
8.2 Data Collection .................................................................................................................... 20 
8.3 Subject Screening ............................................................................................................... 22 
8.4 Subject Consent .................................................................................................................. 22 
8.5 Enrollment .......................................................................................................................... 23 
8.6 Baseline ............................................................................................................................. 24 
8.7 Index Antiarrhythmic Loading Event ..................................................................................... 24 
8.8 Follow-up Visits ................................................................................................................... 25 
8.9 Nightly CareLink Data Transmissions ..................................................................................... 26 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 3 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
8.10 Recording Data ................................................................................................................... 27 
8.11 Deviation Handling .............................................................................................................. 27 
8.12 Subject Exit, Withdrawal or Discontinuation ........................................................................... 28 
9. 
Risks and Benefits ............................................................................................................ 29 
9.1 Potential Risks .................................................................................................................... 29 
9.2 Risk Minimization ................................................................................................................ 29 
9.3 Potential Benefits ................................................................................................................ 29 
10. 
Adverse Events and Complaint Reporting .................................................................... 30 
10.1 Definitions/Classifications ..................................................................................................... 30 
10.2 Reporting of Adverse Events ................................................................................................ 31 
10.3 Product Complaint Reporting ................................................................................................ 33 
11. 
Statistical Design and Methods .................................................................................... 34 
11.1 General Aspects of Analysis .................................................................................................. 34 
11.2 Analysis Execution ............................................................................................................... 34 
11.2.1 
Primary Objective #1 ........................................................................................................... 34 
11.3 Sample Size Determination .................................................................................................. 35 
11.4 Minimization of Bias ............................................................................................................. 35 
12. 
Ethics ............................................................................................................................ 35 
12.1 Statement(s) of Compliance ................................................................................................. 35 
13. 
Study Administration .................................................................................................... 36 
13.1 Monitoring .......................................................................................................................... 36 
13.2 Data Management ............................................................................................................... 37 
13.3 Direct Access to Source Data/Documents .............................................................................. 37 
13.4 Confidentiality ..................................................................................................................... 37 
13.5 Liability/Warranty/Insurance Information .............................................................................. 38 
13.6 CIP Amendments ................................................................................................................ 38 
13.7 Record Retention ................................................................................................................ 38 
13.7.1 
Investigator Records ........................................................................................................... 38 
13.7.2 
Sponsor Records ................................................................................................................. 39 
13.8 Reporting Requirements ...................................................................................................... 40 
13.8.1 
Investigator Reports ............................................................................................................ 40 
13.8.2 
Sponsor Reports .................................................................................................................. 41 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 4 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
13.9 Publication and Use of Information ....................................................................................... 42 
13.9.1 
Publication Committee ....................................................................................................... 42 
13.9.2 
Management of Primary and Ancillary Publications ........................................................... 43 
13.9.3 
Criteria for Determining Authorship ................................................................................... 43 
13.9.4 
Transparency ....................................................................................................................... 43 
13.10 
Suspension or Early Termination ................................................................................... 44 
13.10.1 
Planned Study Closure .................................................................................................... 44 
13.10.2 
Early Termination or Suspension .................................................................................... 44 
13.10.3 
Procedures for Termination or Suspension .................................................................... 45 
14. 
Version History ............................................................................................................. 47 
15. 
References .................................................................................................................... 48 
 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 5 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
1. Glossary 
 
Term 
Definition 
AE 
Adverse Event 
MyCareLink® 
Network (registered trademark of Medtronic) 
designed to receive and store transmitted 
LINQTM/LINQIITM ICM data 
CFR 
Code of Federal Regulation 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
CV 
Cardiovascular 
eCRF 
Electronic Case Report Form 
EC/IRB/HREB/Ethics Board 
Ethics Committee 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICD 
Implantable Cardiac Defibrillator 
ICF 
 Informed Consent Form 
ICM 
 Insertable Cardiac Monitor 
ms 
milliseconds 
SAE 
Serious Adverse Event 
VitalPatch® RTM  
External, wearable patch (registered trademark of 
Vital Connect, Inc.) that provides up to 7 days of 
monitoring in order to monitor parameters such as 
ECG, heart rate variability, respiratory rate, 
temperature, activity, and posture. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 6 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
2. Synopsis 
Title 
LINQ QT Study 
Clinical Study Type 
Prospective, non-randomized, multi-center, observational, post-market clinical study.  
Product Name 
LINQTM, LINQIITM 
Sponsor  
Medtronic  
8200 Coral Sea Street NE 
Mounds View, MN 55112  
Local Sponsor 
Medtronic Research and Technology 
8200 Coral Sea Street NE 
Mounds View, MN 55112 
Indication under 
investigation  
QT interval changes due to antiarrhythmic drug loading 
Investigation 
Purpose 
The purpose of this study is to determine if QT interval changes are detected during and 
after antiarrhythmic drug loading by the designed QT detection algorithm from 
LINQTM/LINQIITM ECG. The QT intervals before and after antiarrhythmic loading will be 
compared for all patients to analyze QT changes that may be caused due to antiarrhythmic 
drugs.  
Product Status 
Market-Released 
Primary 
Objective(s) 
and/or 
Endpoint(s)s 
The primary objective of the study is to determine if QT changes can be detected from 
LINQTM ECG that may occur during and after antiarrhythmic loading. The QT intervals before 
and after antiarrhythmic loading will be compared for all patients to analyze QT changes 
that may be caused due to antiarrhythmic drugs. 
Study Design 
The LINQTM QT Study is a prospective, non-randomized, multi-center, observational, post-
market clinical study. 
Randomization 
Non-randomized 
Sample Size 
The study is expected to be conducted at up to three study sites located in the United States 
and will enroll up to twenty study subjects.  It is anticipated that if one study site cannot 
enroll at least 3 subjects per month, that additional study sites will be included to meet the 
total enrollment target of twenty subjects. 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria: 
• 
Patients implanted with LINQTM/LINQIITM prior to the study enrollment (no more than 
50% patients implanted with LINQIITM), but no greater than 2 years for LINQTM or 3 
years for LINQIITM, or patients who are indicated to receive a LINQTM/LINQIITM implant 
at least 7 days prior to antiarrhythmic drug loading 
• 
Patients who are scheduled to receive antiarrhythmic drug loading  
• 
Up to 20% of patients enrolled in the study can have permanent and persistent AF 
• 
Age 18-80 
• 
Patient is willing and able to comply with the protocol, including follow-up visits, and 
performing Holter recordings and patient activation transmissions 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 7 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
Exclusion Criteria: 
• 
Patients who have a contraindication to long-term antiarrhythmic therapy 
• 
Patients not suitable for long-term antiarrhythmic therapy 
• 
Patients with a previous, existing cardiac implantation (i.e., cardiac pacemaker or 
cardiac resynchronization requiring > 40% pacing, implantable cardioverter 
defibrillator (ICDs)) 
• 
Co-enrollment in another study or planning to participate in a concurrent device study 
during the course of this clinical study that could confound the results 
Study Procedures 
and Assessments 
Study Procedure 
Baseline 
Index 
Antiarrhythmic 
Loading Event 
 
(Optional) 2, 
4, 8 week 
90-day 
Visit/Study Exit 
Patient Informed Consent 
X 
 
 
 
Inclusion/Exclusion 
Assessment 
X 
 
 
 
Cardiovascular (CV) and 
Medical History 
X 
 
 
 
Demographics 
X 
 
 
 
Physical Exam 
X 
X 
X 
X 
Blood Labs 
X 
X 
X 
X 
CV Symptoms*optional 
X 
X 
X 
X 
Medications 
X 
X 
X 
X 
12-Lead ECG 
X 
X 
X 
X 
2D Echocardiogram*optional 
X 
 
 
 
Holter/ VitalPatch® RTM 
 
X 
X 
X 
MyCareLink® Daily Manual 
Transmissions 
   X 
X 
X 
X 
Patient Activations 
 
X 
X 
X 
Study exit 
 
 
 
X 
Serious, Cardiovascular-
related Adverse Events 
 
X 
X 
X 
Study deviations 
Report upon occurrence 
Safety 
Assessments 
There are no defined safety endpoints in the LINQ QT study as the purpose of the study is 
not to demonstrate safety or effectiveness.  Cardiovascular-related (CV) adverse events that 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 8 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
result in hospitalization due to anti-arrhythmic loading will be collected throughout the 
duration of the subject’s participation in the study, beginning after the initial in-
hospital/out-patient anti-arrhythmic loading. 
 Statistics 
Since the study will be exploratory in nature and the study objectives are descriptive, no 
clinical endpoints will be developed.  LINQ™/LINQIITM derived data will be summarized using 
descriptive statistics. 
 
3. Introduction 
3.1 Background 
The QT interval on the electrocardiogram (ECG) has gained clinical importance, primarily because 
prolongation of this interval can predispose to a potentially fatal ventricular arrhythmia known as 
torsades de pointes, which could in turn lead to sudden cardiac death [1].  Multiple factors have been 
implicated in causing QT prolongation and torsades de pointes. Among these, an important risk factor 
for long QT syndrome is the use of QT prolonging drugs. A QT interval greater than 500 milliseconds (ms) 
has been shown to correlate with higher risk of torsades de pointes.  
There are several commonly used medications that could lengthen QT and cause QT prolongation. One 
such class of medications are antiarrhythmic drugs which are used to treat heart rhythm disorders. 
These drugs are frequently prescribed in everyday clinical practice for the management of atrial 
fibrillation (AF) that affects nearly 1–2% of the general population [2,3]. The commonly used 
antiarrhythmics for AF rhythm control management belong to Vaughan Williams’ classes, Ic and III. Both 
these medication categories are well known to influence ventricular depolarization and repolarization, 
alter QT and corrected QT interval (QTc) intervals on surface ECG and affect to variable extents the left 
ventricular (LV) function [4–10]. 
There are several studies which have assessed the effect of antiarrhythmic drugs on QT interval 
prolongation. One such study [11] revealed significant QTmax and QTc interval prolongation following 
Sotalol (from 424 ± 40 ms to 460 ± 57 ms and from 446 ± 35 ms to 474 ± 48 ms, respectively, both p < 
0.01) and Amiodarone (from 437 ± 41 ms to 504 ± 39 ms and from 469 ± 35 ms to 527 ± 50 ms, 
respectively, both p < 0.01). Another study [12] revealed a significant mortality benefit when dofetilide 
was used in patients with baseline QTc intervals less than 429 ms (risk ratio 0.3), while an increase in 
mortality was seen with dofetilide therapy in patients with baseline QTc intervals greater than 429 ms 
(risk ratio 1.3) [13]. 
Currently, there is no reliable way for continuous and long-term monitoring of QT intervals in patients 
undergoing antiarrhythmics drug loading. An implantable cardiac monitor which can continuously 
monitor QT intervals in patients taking QT prolonging drugs can enable clinicians to track day-to-day 
variability in the QT intervals and also study long-term QT trends in patients.  

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 9 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
The Reveal LINQTM and LINQIITM devices are small, leadless cardiac monitoring systems that can be 
inserted subcutaneously in the chest with a minimally invasive procedure and provide continuous 
monitoring of diagnostic parameters for up to 3 years and 4 years respectively. An algorithm [14] has 
been developed and validated which can continuously measure QT intervals for every beat using LINQTM 
ECG. This study is aimed at determining if QT interval changes can be detected during and after 
antiarrhythmic drug loading by the designed QT detection algorithm from LINQTM ECG. 
3.2 Purpose 
The purpose of this study is to determine if QT interval changes are detected during and after 
antiarrhythmic drug loading by the designed QT detection algorithm from LINQTM ECG. The QT intervals 
before and after antiarrhythmic loading will be compared for all patients to analyze QT changes that 
may be caused due to antiarrhythmic drugs. 
4. Objectives and/or Endpoints 
4.1 Objectives 
4.1.1 Primary Objective 
The primary objective of the study is to determine if QT changes can be detected from LINQTM ECG that 
may occur during and after antiarrhythmic loading. The QT intervals before and after antiarrhythmic 
loading will be compared for all patients to analyze QT changes that may be caused due to 
antiarrhythmic drugs. 
5. 
Study Design 
The LINQTM QT Study is a prospective, non-randomized, multi-center, observational, post-market clinical 
study. The study is expected to be conducted at up to three study sites located in the United States and 
will enroll up to twenty study subjects.  It is anticipated that if one study site cannot enroll at least 3 
subjects per month, then additional study sites will be included to meet the total enrollment target of 
twenty subjects. 
Study subjects implanted with LINQTM/LINQIITM (no more than 50% patients implanted with LINQIITM), 
but no greater than 2 years for LINQTM or 3 years for LINQIITM, or patients who are indicated to receive a 
LINQTM/LINQIITM implant at least 7 days prior to antiarrhythmic drug loading will be considered for 
enrollment in this study.

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 10 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Figure 1:  Study Flow Diagram

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 11 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
I. 
Index Antiarrhythmic Loading Event 
 
1. Subjects with LINQTM Implants 
During the index clinic or hospital visit for antiarrhythmic drug loading, the patient will be requested to 
use a DR220 Holter for 24-48 hours after hospital or clinic admission in order to telemeter up to 48 
hours of continuous LINQTM ECG data as well as surface ECG during the hospitalization period. A DR220 
can be used to continuously telemeter LINQTM ECG data from the device for up to 48 hours. In parallel to 
obtaining the DR220 recording, the standard of care in-hospital or in-clinic 12-lead ECG recordings and 
the corresponding expert (preferably an electrophysiologist) measured QT interval values will also be 
obtained for analysis for the entire period covering the hospital or clinic stay. 
In addition, patients will also be optionally provided with VitalPatch® RTM for continuous monitoring for 
up to 7 days following the hospital or clinic discharge.  VitalPatch® RTM is an external wearable patch 
that provides up to 7 days of monitoring in order to monitor parameters such as ECG, heart rate 
variability, respiratory rate, temperature, activity, and posture.  This can be optionally used to provide 
continuous monitoring of these parameters during the week following index hospital or clinic discharge, 
after follow-up clinic visits, after any medication or dosage changes, etc. 
 
2. Subjects with LINQIITM Implants 
If the patient has LINQIITM, during the index clinic or hospital visit for antiarrhythmic drug loading, a 
continuous surface ECG will be collected for 24-48 hours during the hospitalization period. In parallel to 
obtaining the surface ECG, the standard of care in-hospital or in-clinic 12-lead ECG Holter recordings and 
the corresponding expert (preferably an electrophysiologist) measured QT interval values may also be 
obtained for analysis for the entire period covering the hospitalization or clinic stay.  If the patient has a 
LINQIITM implant, daily PVC burden will also be obtained from the LINQIITM device during both the 
hospitalization period and during the entire follow up period. 
In addition, patients will also be optionally provided with VitalPatch® RTM for continuous monitoring for 
up to 7 days following the hospital or clinic discharge.  VitalPatch ® RTM is an external wearable patch 
that provides up to 7 days of monitoring in order to monitor parameters such as ECG, heart rate 
variability, respiratory rate, temperature, activity, and posture.  This can be optionally used to provide 
continuous monitoring of these parameters during the week following index clinic or hospital discharge, 
after follow-up clinic visits, after any medication or dosage changes, etc. 
II. 
Follow up period 
Study subjects will be requested to use the LINQTM patient activation feature a minimum of 3 days prior 
to the scheduled index antiarrhythmic loading event.  
During the follow up period after the discharge, in patients with LINQTM implants, the patients will be 
requested to use patient activation 4 times a day for the first 15 days after discharge, then at least 2 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 12 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
times a day for the next 45 days. For the last 30 days of the study, the patient will be requested to use 
patient activation between 1-4 times daily. Patients will need to be instructed to perform a manual 
transmission every night using the MyCareLink® home monitor. 
For patients with LINQIITM implants, the patients will be requested to use patient activation 2-3 times a 
day throughout the follow up period of 90 days.  
Note:  The preferred daily timings to perform the patient activations would be immediately before 
and then 2 hours after the medication intake. In addition, daily 10-second nightly transmitted 
episodes from LINQTM will also be obtained during this time period.   
 
III. 
Follow up clinic visits 
 
1. Subjects with LINQTM Implants 
After the index antiarrhythmic drug loading event, for patients with LINQTM implants, additional LINQTM 
DR220 Holter recordings, as well as surface ECG of up to 3 hours may be collected during follow up clinic 
visits (2-week, 4-week, 8-week follow up) including the available standard of care in-clinic 12-lead ECG 
recordings and the corresponding expert measured QT interval values during follow up visits. 
In addition, patients will also be optionally provided with VitalPatch® RTM for continuous monitoring for 
up to 7 days after the follow up clinic visit in order to monitor parameters such as ECG, heart rate 
variability, respiratory rate, temperature, activity, and posture.   
If an antiarrhythmic dosage change is recommended by the physician any time during the 90-days follow 
up period, a LINQTM Holter recording, and a surface ECG recording of up to 3 hours may be obtained if an 
in-clinic visit occurs. In the case of an antiarrhythmic dose change in the 16-90 days following the index 
hospital or clinic discharge, the patient will be requested to perform 4 patient activations daily for the 
period of 5 days after dosage change. The preferred daily timings to perform the patient activations 
would be immediately before and then 2 hours after the medication intake. Patients will need to be 
instructed to perform a manual transmission every night using the MyCareLink® home monitor. 
At the in-clinic visits, physicians will be requested to record on the eCRF, any arrhythmias detected from 
LINQTM or any external monitoring devices. The physician will also be requested to record the dosage 
levels and the times when the dosage levels are changed. All health care data regarding any 
hospitalizations, ER and clinic visits, and medication changes will be collected along with any physician 
notes during the follow up visits. 
2. Subjects with LINQIITM Implants 
After the index antiarrhythmic drug loading event, for patients with LINQIITM implants, surface ECG 
recordings of up to 3 hours may be collected during follow up clinic visits (2-week, 4-week, 8-week 
follow up) including the available standard of care in-clinic 12-lead ECG recordings and the 
corresponding expert measured QT interval values during follow up visits. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 13 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
In addition, patients will also be optionally provided with VitalPatch® RTM for continuous monitoring for 
up to 7 days after the follow up clinic visit in order to monitor parameters such as ECG, heart rate 
variability, respiratory rate, temperature, activity, and posture.   
If an antiarrhythmic dosage change is recommended by the physician any time during the 90-days follow 
up period, surface ECG recording of up to 3 hours may be obtained if an in-clinic visit occurs.  
At the in-clinic visits, physicians will be requested to record on the eCRF, any arrhythmias detected from 
LINQIITM or any external monitoring devices. The physician will also be requested to record the dosage 
levels and the times when the dosage levels are changed. All health care data regarding any 
hospitalizations, ER and clinic visits, and medication changes will be collected along with any physician 
notes during the follow up visits. 
 
5.1 Duration 
Subjects will be followed until their 90 -day visit or until official study closure defined as when study 
data requirements have been satisfied per the Clinical Investigation Plan (CIP) and/or by a decision by 
Medtronic or the applicable external parties (i.e., IRB/Ethics Committee (EC) Regulatory Authority) 
whichever occurs first. The estimated total study duration is approximately 13 months, representing a 7-
month enrollment period, at least 3 months of follow-up per subject and at least 3 months for data 
analysis. 
5.2 Rationale 
Safety will not be a primary focus of this study as 1) the study is only collecting observational data, 2) 
data collected will not be used to manage the treatment of subjects in the study, 3) data collection 
procedures other than those related to the LINQTM/LINQIITM are not outside standard of care and 4) the 
safety profile of LINQTM/LINQIITM is already well known. 
6. Product Description 
6.1 General  
The Medtronic LINQTM/LINQIITM ICM is an approved, programmable device that continuously monitors a 
patient’s electrocardiogram (ECG) and other physiological parameters. The device records cardiac 
information in response to automatically detected arrhythmias and patient activation. The 
LINQTM/LINQIITM device is indicated in the following: 
US Indications: 
• 
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. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 14 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
The study will be conducted using the components described in Table 1 below. All components of the 
LINQTM/LINQIITM system are manufactured by Medtronic, Inc. Instructions for use of the devices used in 
this study are provided within their respective manuals. 
Table 1: Study Components 
Model Number  
Component 
Manufacturer 
Investigational or Market-
released 
LINQTM/LINQIITM 
Reveal LINQTM/LINQIITM 
Insertable Cardiac Monitor 
Medtronic 
Market-Released 
SW026 
2090 Programmer  
Medtronic 
Market-Released 
MSW002  
IOS (Apple)  
LINQTM Mobile Manager (LMM)  Medtronic 
Market-Released 
MSW003 
(Android) 
MSW004 IOS 
(Apple) 
My CareLink HeartTM App 
Medtronic 
Market-Released 
24960 
MyCareLink RelayTM Home 
Communicator 
Medtronic 
Market-Released 
PA96000 
Patient Assistant 
Medtronic 
Market-Released 
24950 
MyCareLink® Home Monitor 
Medtronic 
Market-Released 
DR220 
Holter 
NorthEast 
Monitoring, Inc. 
Market-Released 
 
Descriptions of each component of the system are provided in the sections below.  
 
6.1.1 
Reveal LINQTM/LINQIITM II Insertable Cardiac Monitor (ICM) 
 
The Reveal LINQTM/LINQIITM ICM is a small, leadless device that is inserted under the skin, in the chest. A 
specific recommended location is provided within the product manual. The device uses two electrodes 
on the body of the device to continuously monitor the patient’s subcutaneous ECG. The device can store 
up to 30 min of ECG recordings from the patient-activated episodes and up to 27 min of ECG recordings 
from the automatically detected arrhythmias. Documentation of episode occurrence will be retained.  
 
Figure 2: Reveal LINQTM/LINQIITM ICM 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 15 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
6.1.2 
2090 Programmer 
 
The Medtronic CareLink® Programmer is used to program the Reveal LINQTM/LINQIITM ICM to detect 
arrhythmias with various pre-specified characteristics. In addition, the programmer allows the physician 
to view, save, and print the ECG records currently held within the Reveal LINQTM/LINQIITM ICM.  
 
Figure 3: Medtronic 2090 Programmer 
 
6.1.3 
LINQTM Mobile Manager (LMM) and Patient Connector Head  
 
The Reveal LINQTM Mobile Manager (LMM) clinician app is an application downloaded onto the clinic’s 
tablet that communicates with the LINQIITM ICM using BLE (the tablet downloaded with the clinician app 
is also referred to as the “LMM” within this document). The LMM provides the operator an interface to 
change device settings (programming), interrogate the collected data, and display real-time data such as 
ECG, telemetered EGM and Marker Channel information. The LMM can also be used to assess the 
system. The LMM uses the 24967 Patient Connector Head for communication. 
 
6.1.4. My CareLink HeartTM App  
 
The MyCareLink Heart™ mobile app (also referred to as “patient app”) is an application downloaded 
onto the patient’s smartphone/tablet (Android or IOS). The patient app installed on a mobile device 
transfers encrypted ICM device data between the inserted LINQ II™ device and the CareLink® Network. 
The patient interacts with the patient app for initial setup, viewing status information, and recording 
symptoms. The patient app can be enabled to record cardiac information in the LINQ II™ ICM while the 
patient is experiencing symptoms or immediately after a symptomatic event. The clinician uses the 
recorded information to determine if the symptoms were associated with a cardiac event.  

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 16 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
6.1.5. MyCareLink RelayTM Home Communicator  
 
The MyCareLink RelayTM Home Communicator (also referred to as “home communicator”) is a stationary 
device that transfers encrypted data from/to the patient’s inserted LINQ II™ device to the CareLink® 
Network for patients unwilling or unable to use a smartphone/tablet. Data communication is via 
Bluetooth Low Energy (BLE) to the LINQ IITM ICM and wireless GSM network to the CareLink® Network. 
 
6.1.6 
Patient Assistant 
 
The Patient Assistant is a hand-held, battery-operated telemetry device that enables the subject, on 
experiencing symptoms potentially indicative of a cardiac event, to manually trigger the LINQ™ ICM to 
collect and store an ECG record. 
The Reveal Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The 
Patient Assistant activates the data management feature in the Reveal LINQ™ ICM to initiate recording 
of cardiac event data in the implanted device memory. 
The subjects will be asked to press the Patient Assistant whenever they experience increased difficulty 
of breathing not related to an activity. 
 
Figure 4: Patient Assistant 
 
6.1.7 
MyCareLink® Home Monitor 
 
The MyCareLink® Home Monitor is a device that enables the device diagnostic data (which includes ECG 
data) to be transmitted directly from the implanted Reveal LINQ™ device to the Medtronic CareLink® 
Network for review by the physician.  
 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 17 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Figure 5: MyCareLink® Patient Monitor 
 
6.1.8 
DR 220 Holter Monitor 
 
The NorthEast Monitoring, Inc. DR220 Digital Recorder is a Holter monitor that is commercially available 
and designed to facilitate the ambulatory cardiac monitoring of those subjects who may benefit from 
such monitoring on the order of a physician, including but not limited to those with complaints of 
palpitations, syncope, chest pains, shortness of breath, or those who need to be monitored to judge 
their current cardiac function, such as subjects who have recently received pacemakers. The DR220 
Digital Recorder is intended for use with Medtronic System-B compatible implantable pulse generators, 
implantable cardiac defibrillators, cardiac resynchronization therapy devices and implantable cardiac 
monitors.  A Holter monitor is an external box used to record electrical heart signals from electrode 
patches attached to the skin (ECG) as well as from the cardiac device (EGM).  There are no 
contraindications for the use of a DR220 Holter monitor. The Holter monitor will be used in accordance 
with its labeling.  Only trained study personnel should apply the monitors.  
The data obtained by monitoring is not analyzed at the time of recording. After the recording is 
complete, the data must later be downloaded to a compatible NorthEast Monitoring, Inc. Holter analysis 
system to be analyzed. No personal information will be entered and collected by DR220 recorder. 
The DR220 Holter Recorder used in this study is a portable ECG device able to collect telemetry signals 
and marker channel information from any Medtronic device for up to 48 hours. The Holter Recorder has 
application for any subject with a Medtronic ICM.  For the purposes of this study, the intended use of 
the Holter Recorder is to collect LINQTM ECG recordings in order to measure QT intervals.  
 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 18 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 
Figure 6: DR220 Holter 
 
 
6.2 Shipment of Study Components 
Medtronic will only allow shipment of the study device and components to the hospital or investigator 
when Medtronic has received all required documentation and has notified the site of readiness. Products 
shall be used in these centers only and according to the CIP. Clinical that are used for purposes of the 
study only will be provided at no cost by Medtronic. Distribution of the study device and components to 
centers during the study will be managed by Medtronic. 
6.3 Product Accountability 
Commercially available product supply will be managed in a manner consistent with other market-
released products. 
All products used in this study will be market released in the geographies they are used. Device 
Traceability may be required per local laws and regulations. If there are additional local requirements 
related to the LINQ QT study components beyond what is collected by Medtronic on the eCRF, this is the 
Investigator’s responsibility and should be recorded in the subject’s medical records, but will not be 
collected by Medtronic (e.g., national registration card number, identification code linked to names and 
contact information, log of all subjects enrolled in the study, lot, or batch number).  

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 19 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
7. Selection of Subjects 
7.1 Study Population 
The subject population for the LINQ QT Study are patients implanted with LINQTM/LINQIITM prior to the 
study enrollment (no more than 50% patients implanted with LINQIITM), but no greater than 2 years for 
LINQTM or 3 years for LINQIITM, or patients who are indicated to receive a LINQTM/LINQIITM implant at least 
7 days prior to antiarrhythmic drug loading and who are scheduled to receive an antiarrhythmic drug 
loading, may undergo this study. 
7.2 Subject Enrollment 
Ethics Board/IRB and Medtronic approval of this Clinical Investigation Plan, the informed consent form 
and any other applicable documents must be obtained prior to enrolling subjects in the study. Medtronic 
will provide each study center with documentation of study center/investigator readiness; this letter must 
be received prior to subject enrollment.  
When a patient and the principal investigator or authorized designee, as required, have personally signed 
and dated the informed consent form, the patient is considered a subject enrolled in the study. Subjects 
must provide informed consent before any study related procedures occur. The date the subject signed 
the informed consent form and data protection authorization as required by local law must be 
documented in the subject’s medical records. 
 
7.3 Inclusion Criteria 
• 
Patients implanted with LINQTM/LINQIITM prior to the study enrollment (no more than 50% 
patients implanted with LINQIITM), but no greater than 2 years for LINQTM or 3 years for LINQIITM, 
or patients who are indicated to receive a LINQTM/LINQIITM implant at least 7 days prior to 
antiarrhythmic drug loading 
• 
Patients who are scheduled to receive antiarrhythmic drug loading  
• 
Up to 20% of patients enrolled in the study can have permanent and persistent AF 
• 
Age 18-80 
• 
Patient is willing and able to comply with the protocol, including follow-up visits, and performing 
Holter recordings and patient activation transmissions 
7.4 Exclusion Criteria 
• 
Patients who have a contraindication to long-term antiarrhythmic therapy 
• 
Patients not suitable for long-term antiarrhythmic therapy 
• 
Patients with a previous, existing cardiac implantation (i.e., cardiac pacemaker or cardiac 
resynchronization requiring > 40% pacing, implantable cardioverter defibrillator (ICDs)) 
• 
Co-enrollment in another study or planning to participate in a concurrent device study during the 
course of this clinical study that could confound the results 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 20 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
8. Study Procedures 
8.1 Schedule of Events 
A patient will be considered enrolled in the study once they sign and date the Informed Consent. The 
subjects will be followed at in-office visits during study participation. In addition, the subjects will be 
completing daily manual device transmissions. The requirements for data collection and study 
procedures by visit are summarized in Table 2 below. 
8.2 Data Collection 
Data collection requirements are summarized in Table 2 below.

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 21 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Table 2: Data collection and study procedure requirements at subject visits 
Study Procedure 
Baseline 
Index 
Antiarrhythmic 
Loading Event 
 
(Optional) 2, 4, 8 
week 
90-day Visit/Study 
Exit 
Patient Informed 
Consent 
X 
 
 
 
Inclusion/Exclusion 
Assessment 
X 
 
 
 
Cardiovascular (CV) and 
Medical History 
X 
 
 
 
Demographics 
X 
 
 
 
Physical Exam 
X 
X 
X 
X 
Blood Labs 
X 
X 
X 
X 
CV Symptoms*optional 
X 
X 
X 
X 
Medications 
X 
X 
X 
X 
12-Lead ECG 
X 
X 
X 
X 
2D 
Echocardiogram*optional 
X 
 
 
 
Holter/ VitalPatch® RTM 
 
X 
X 
X 
Patient Activations 
 
X 
X 
X 
MyCareLink® Daily 
Manual Transmissions 
            X 
            X 
            X 
X 
Study exit 
 
 
 
X 
Serious, Cardiovascular-
related Adverse Events 
 
X 
X 
X 
Study deviations 
Report upon occurrence 
 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 22 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
8.3 Subject Screening 
Subjects will be screened to ensure they meet all the inclusion criteria and none of the exclusion criteria 
prior to study enrollment. The subject will be considered enrolled after both the subject and the 
investigator (or authorized designee as required by the informed consent form [ICF]) have each personally 
signed and dated the ICF. 
8.4 Subject Consent 
The ICF is defined as a legally effective documented confirmation of a subject’s voluntary agreement to 
participate in a particular clinical study after information has been given to the subject on all aspects of 
the clinical study that are relevant to the subject’s decision to participate. This process includes obtaining 
an ICF and an Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language as required by law that has been approved by the study site’s 
Institutional Review Board/Ethics Committee (IRB/EC) and signed and dated by the subject.  
Investigators shall consider all subjects who meet eligibility requirements for study participation to avoid 
any bias in the subject population.  Prior to enrolling subjects, approval of the CIP, ICF, and any other 
written study information to be provided to the subjects must have been obtained from each site’s IRB/EC.  
The document(s) must be controlled (i.e., versioned and dated) to ensure it is clear which version(s) were 
approved by the IRB/EC.  Any adaptation of the sample ICF must be reviewed and approved by Medtronic 
and the IRB/EC reviewing the application prior to enrolling the subject. 
The investigator must notify the subject of any significant new findings about the study that become 
available during 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.  If relevant, approval may be requested from 
subjects to confirm their continued participation. 
The informed consent form template will be sent under a separate cover.   
Prior to initiation of any study-specific procedures, informed consent must be obtained from the subject.  
Likewise, privacy or health information protection regulation may require subjects to sign additional forms 
to authorize sites to submit subject information to the study sponsor.  The informed consent process must 
be conducted by the principal investigator or his/her authorized designee, and the ICF and Authorization 
to Use and Disclose Personal Health Information/Research Authorization/other privacy language as 
required by law must be given to the subject in a language, he/she is able to read and understand.  The 
process of obtaining informed consent must be conducted without using coercion or undue improper 
influence on or inducement of the subject to participate by the investigator or other site personnel.  The 
informed consent process shall not waive or appear to waive subject’s legal rights.  The language used 
shall be as non-technical as possible and must be understandable to the subject and the impartial witness, 
where applicable. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 23 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
The subject must have ample time and opportunity to read and understand the ICF, to inquire about 
details of the study, and to decide whether to participate in the clinical study.  All questions about the 
study should be answered to the satisfaction of the subject. 
When the subject decides to participate in the clinical study, the ICF must be signed and personally dated 
by the subject acknowledging that their participation is voluntary and signed and personally dated by the 
investigator or authorized designee as required by the ICF. If applicable, the witness shall also sign and 
personally date the ICF to attest that the information in the ICF was accurately explained and clearly 
understood by the subject, and that informed consent was freely given. 
A copy of the ICF and the Authorization to Use and Disclose Personal Health Information/Research 
Authorization/other privacy language, signed and dated as required by law, must be provided to the 
subject. 
If informed consent 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.  It is best practice for the informed consent process to be documented in 
the subject’s case history, regardless of circumstance. 
In the event the subject cannot read and/or write, a witnessed (impartial third party) informed consent 
will be allowed.  In this situation, an independent witness must be present throughout the informed 
consent process.  The written informed consent form and any other information shall be read aloud and 
explained to the prospective subject.  The subject should “make his/her mark” (sign or otherwise 
physically mark the document so as to indicate consent) on the ICF as well.  The witness must also sign 
and personally date the ICF attesting that the information was accurately explained, and that informed 
consent was freely given.  Detailed documentation of the consent process must be recorded in the 
subject’s case history.  The ICF should document a supervised oral process was used for communication 
with the prospective subject and the specific means by which the prospective subject communicated 
agreement to participate in the study.  
The ICF 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 Medtronic Field 
personnel who support the Reveal LINQTM/LINQIITM ICM insertion procedure must be able to review the 
subject’s original signed and dated ICF and verify its completeness prior to proceeding with the insertion.  
In the event the Medtronic Field personnel identify informed consent as being incomplete, the study 
procedure will not be allowed to occur until the consent of the subject can be adequately and 
appropriately obtained.   
 
8.5 Enrollment 
A subject is considered enrolled when the consent process has been finalized. The date the subject (or the 
subject’s authorized/designated representative or guardian) signed the IC and Data Protection 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 24 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
Authorization, as required by law, must be documented in the subject’s medical records. Enrollment can 
occur no greater than 2 years after a LINQTM implant, or no greater than 3 years for LINQIITM.  Subjects can 
also be enrolled who will be receiving a LINQTM/LINQIITM implant at least 7 days prior to anti-arrhythmic 
drug loading. 
8.6 Baseline 
Following subject enrollment, a baseline assessment will be performed. The baseline visit can be a 
standalone visit or can be performed prior to the index antiarrhythmic medication loading event.  
The following information is required to be collected at the baseline visit: 
• 
Patient demographics (age, gender, ethnicity)  
• 
BMI (weight, height)  
• 
Left ventricular ejection fraction  
• 
12-lead ECG  
• 
LINQTM/LINQIITM patient activated episode  
• 
Previous medical/surgical history (specifically diabetes mellitus, hypertension, coronary artery 
disease, myocardial infarction, congestive heart failure, hypertrophic cardiomyopathy, QT 
prolongation, coronary artery bypass surgery)  
• 
CHA₂DS₂-VASc score if >2  
• 
Arrhythmia history (e.g., atrial fibrillation, flutter, ventricular tachycardia)  
• 
Medication history (concomitant medications e.g., Digoxin, calcium channel blockers, warfarin, 
direct oral anticoagulants, loop/thiazide diuretic, natural/dietary supplements)  
• 
Baseline laboratory values (creatinine, potassium, calcium, magnesium, BMP, BNP)  
 
2D echocardiogram and cardiovascular symptoms will also be collected if available. 
 
8.6.1 Device Programming Recommendation 
Once the LINQ™ device is inserted into the subject, the physician is recommended to choose "AF 
management.” This will automatically program the device to the nominal settings for the different 
detectors. 
 
8.7 Index Antiarrhythmic Loading Event  
 
1. Subjects with LINQTM Implants 
During the index clinic or hospital visit for antiarrhythmic drug loading, the patient will be requested to 
use a DR220 Holter for 24-48 hours after hospital or clinic admission in order to telemeter up to 48 hours 
of continuous LINQTM ECG data as well as surface ECG during the hospitalization period. A DR220 can be 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 25 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
used to continuously telemeter LINQTM ECG data from the device for up to 48 hours. In parallel to 
obtaining the DR220 recording, the standard of care in-hospital or in-clinic 12-lead ECG recordings and 
the corresponding expert (preferably an electrophysiologist) measured QT interval values will also be 
obtained for analysis for the entire period covering the hospital or clinic stay. 
In addition, patients will also be optionally provided with VitalPatch® RTM for continuous monitoring for 
up to 7 days following the hospital or clinic discharge.  VitalPatch® RTM is an external wearable patch that 
provides up to 7 days of monitoring in order to monitor parameters such as ECG, heart rate variability, 
respiratory rate, temperature, activity, and posture.  This can be optionally used to provide continuous 
monitoring of these parameters during the week following hospital or clinic discharge, after follow-up 
clinic visits, after any medication or dosage changes, etc. 
 
2. Subjects with LINQIITM Implants 
If the patient has LINQIITM, during the index clinic or hospital visit for antiarrhythmic drug loading, a 
continuous surface ECG will be collected for 24-48 hours during the hospitalization period. In parallel to 
obtaining the surface ECG, the standard of care in-hospital or in-clinic 12-lead ECG Holter recordings and 
the corresponding expert (preferably an electrophysiologist) measured QT interval values may also be 
obtained for analysis for the entire period covering the hospitalization or clinic stay.  If the patient has a 
LINQIITM implant, daily PVC burden will also be obtained from the LINQIITM device during both the 
hospitalization period and during the entire follow up period. 
 
In addition, patients will also be optionally provided with VitalPatch® RTM for continuous monitoring for 
up to 7 days following the hospital or clinic discharge.  VitalPatch® RTM is an external wearable patch that 
provides up to 7 days of monitoring in order to monitor parameters such as ECG, heart rate variability, 
respiratory rate, temperature, activity, and posture.  This can be optionally used to provide continuous 
monitoring of these parameters during the week following index clinic or hospital discharge, after follow-
up clinic visits, after any medication or dosage changes, etc. 
8.8 Follow-up Visits 
 
1. Subjects with LINQTM Implants 
After the index antiarrhythmic drug loading event, for patients with LINQTM implants, additional LINQTM 
DR220 Holter recordings, as well as surface ECG of up to 3 hours may be collected during follow up clinic 
visits (2-week, 4-week, 8-week follow up) including the available standard of care in-clinic 12-lead ECG 
recordings and the corresponding expert measured QT interval values during follow up visits. 
In addition, patients will also be optionally provided with VitalPatch® RTM for continuous monitoring for 
up to 7 days after the follow up clinic visit in order to monitor parameters such as ECG, heart rate 
variability, respiratory rate, temperature, activity, and posture.   

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 26 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
If an antiarrhythmic dosage change is recommended by the physician any time during the 90-days follow 
up period, a LINQTM Holter recording, and a surface ECG recording of up to 3 hours may be obtained if an 
in-clinic visit occurs. In the case of an antiarrhythmic dose change in the 16-90 days following the index 
hospital or clinic discharge, the patient will be requested to perform 4 patient activations daily for the 
period of 5 days after dosage change. The preferred daily timings to perform the patient activations 
would be immediately before and then 2 hours after the medication intake. Patients will need to be 
instructed to perform a manual transmission daily using the MyCareLink® home monitor. 
At the in-clinic visits, physicians will be requested to record on the eCRF, any arrhythmias detected from 
LINQTM or any external monitoring devices. The physician will also be requested to record the dosage 
levels and the times when the dosage levels are changed. All health care data regarding any 
hospitalizations, ER and clinic visits, and medication changes will be collected along with any physician 
notes during the follow up visits. 
 
2. Subjects with LINQIITM Implants 
After the index antiarrhythmic drug loading event, for patients with LINQIITM implants, surface ECG 
recordings of up to 3 hours may be collected during follow up clinic visits (2-week, 4-week, 8-week 
follow up) including the available standard of care in-clinic 12-lead ECG recordings and the 
corresponding expert measured QT interval values during follow up visits. 
In addition, patients will also be optionally provided with VitalPatch® RTM for continuous monitoring for 
up to 7 days after the follow up clinic visit in order to monitor parameters such as ECG, heart rate 
variability, respiratory rate, temperature, activity, and posture.   
If an antiarrhythmic dosage change is recommended by the physician any time during the 90-days follow 
up period, surface ECG recording of up to 3 hours may be obtained if an in-clinic visit occurs.  
At the in-clinic visits, physicians will be requested to record on the eCRF, any arrhythmias detected from 
LINQIITM or any external monitoring devices. The physician will also be requested to record the dosage 
levels and the times when the dosage levels are changed. All health care data regarding any 
hospitalizations, ER and clinic visits, and medication changes will be collected along with any physician 
notes during the follow up visits. 
 
NOTE:  Subjects may be compensated for completing the required daily activations. 
8.9 Nightly CareLink Data Transmissions 
 
Subjects will be provided with a MyCareLink® Patient Monitor and enrolled in the Medtronic CareLink 
network and will be instructed on how to set up their monitor to support automatic nightly transmission 
of their device data from the time they are enrolled in the study until they are exited from the study. 
 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 27 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
8.10 Recording Data 
 
Subject data will be collected on electronic case report forms (eCRFs) via a web-based remote data 
capture (RDC) system. The investigator must ensure accuracy, completeness and timeliness of the data 
reported in the eCRFs. Only authorized persons can complete and sign e-CRFs, as specified on the 
Delegated Tasks List included in the Investigator Site File.  
Procedures in the CIP require source documentation. Source documents, which may include worksheets 
and subject medical records, must be created, and maintained by the investigational site team. Subject 
records must be clearly marked to indicate that subject participates in the study. When copies or printouts 
of source documents are made, these must be signed and dated by a member of the investigational site 
team with a statement that it is a true reproduction of the original source document.  
Device data from transmissions will be uploaded to secure servers.  Media/USB 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. 
8.11 Deviation Handling 
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. If an infringement remains unresolved, multiple 
deviations need not be completed. 
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, right 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 and reason for deviation must be recorded. Multiple deviations of 
the same type at the same visit may be reported on one e-CRF. 
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 IRB/EC as well as 
Medtronic within five (5) working days.  Reporting of all other study deviations must comply with IRB/EC 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 28 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
policies and/or local laws and/or regulatory agency requirements and must be reported to Medtronic as 
soon as possible upon the center becoming aware of the deviation.  Refer to Table 12 for geography 
specific deviation reporting requirements and timeframes for reporting to Medtronic and/or regulatory 
bodies.  
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. 
8.12 Subject Exit, Withdrawal or Discontinuation 
 
Study exit is defined as the moment when a subject officially stops participating in the study. Subjects will 
be considered exited upon completion of the study exit e-CRF. Prior to exiting a subject from the study, it 
is recommended to follow the subject until any ongoing AEs are resolved/unresolved with no further 
actions planned, or until official study closure, whichever occurs first. The date and reason for subject exit 
must be reported to Medtronic at the earliest opportunity via eCRF. Exited subjects will not be replaced. 
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 are 
urged to remain in the study as long as possible but may be exited from the study for any of the following 
situations:  
• 
Subject did not meet inclusion/exclusion criteria  
• 
LINQTM/LINQIITM ICM explanted and not replaced with a new LINQTM/LINQIITM ICM (e.g., diagnosis 
determined, suspected infection, subject request, physician determination) 
• 
Subject chooses to withdraw (e.g., consent withdrawal, relocation to another geographic 
location) 
• 
Investigator chooses to withdraw a subject (e.g., medically justified, inclusion/exclusion criteria 
not met, failure of subject to maintain adequate study compliance) 
• 
Subject lost to follow-up 
• 
Death 
• 
Study completion or termination 
 
The following information/procedure is to be collected/performed at study exit: 
• 
Date of exit 
• 
Reason for exit 
 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 29 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
In the case that the subject is determined 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 recorded. In addition, follow the regulations set forth by the governing IRB/EC. 
9. Risks and Benefits 
9.1 Potential Risks 
 
There are no incremental risks introduced to the subject as a result of participation in this study. 
9.2 Risk Minimization 
 
Any potential risks associated with this study are further minimized by selecting qualified investigators 
and training study personnel on the CIP.  
9.3 Potential Benefits 
 
The LINQ QT Study may offer no direct personal benefit to individual subjects.  
Subjects may benefit from continuous arrhythmia monitoring with the LINQTM/LINQIITM ICM, as this 
monitoring could result in diagnosis of Atrial Fibrillation (or other arrhythmias) and comprehensive 
evaluation of symptoms on an earlier and more conclusive basis than what would be possible without 
an implantable cardiac monitor. Subjects may also benefit from being evaluated more frequently in the 
office according to the study visit schedule. 
The information gained from this study could result in the improved management of other patients 
receiving a LINQTM/LINQIITM device in the future. Additionally, information collected from this study may 
assist in the design of new product(s)/therapy(ies) and/or instructions for use. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 30 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
10. Adverse Events and Complaint Reporting 
All products used are approved, not investigational and the purpose of the LINQ QT study is not to 
demonstrate safety or effectiveness. Cardiovascular-related or serious adverse events that result in a 
hospitalization due to anti-arrhythmic loading will be collected throughout out the duration of the 
subject’s participation in the study, beginning after the initial in-hospital/out-patient anti-arrhythmic 
loading. Deaths will not be collected unless it resulted in a CV-related hospitalization related to the anti-
arrhythmic loading.  
10.1 Definitions/Classifications 
 
For the purposes of clinical report, event definitions align with the International Organization for 
Standardization standard 14155 (ISO 14155). Where the definition indicates “device”, it refers to any 
device used in the study. This might be the device under investigation, or any market released 
component of the system. For the purposes of the clinical report, Medtronic will classify each adverse 
event according to ISO 14155:2020 definitions. The study will follow the definitions, however, is not 
claiming full compliance to ISO 14155:2020. 
Table 3: Adverse Event Definitions 
General 
Adverse Event (AE) 
Untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or 
unanticipated 
NOTE 1: This definition includes events related to the 
investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to 
events related to investigational medical devices. 
(ISO 14155:2020, 3.2) 
Relatedness 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 31 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
Cardiovascular Related  
 
An adverse event relating to the heart and the blood vessels or 
the circulation (e.g., atrial fibrillation, myocardial infarction, 
stroke, peripheral vascular disease, heart failure).  
 
Seriousness 
Serious Adverse Event (SAE)  
(ISO 14155) 
Adverse event that led to any of the following  
a) death,  
b) serious deterioration in the health of the subject, users, or 
other persons as defined by one or more of the following:  
1) a life-threatening illness or injury, or  
2) a permanent impairment of a body structure or a body 
function including chronic diseases, or  
3) in-patient or prolonged hospitalization, or  
4) medical or surgical intervention to prevent life-
threatening illness or injury, or permanent impairment to 
a body structure or a body function,  
c) foetal distress, foetal death, a congenital abnormality, or birth 
defect including physical or mental impairment  
 
Note 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the CIP, without serious deterioration in 
health, is not considered a serious adverse event. (ISO 
14155:2020, 3.45) 
Other 
Hospitalization 
A therapeutic inpatient hospitalization (excludes observation unit, 
emergency room and outpatient visits) lasting greater than or 
equal to 24 hours. 
 
10.2 Reporting of Adverse Events 
 
Cardiovascular-related, serious adverse events will be reported on the AE eCRF, including a description 
of the event, the diagnosis, the date of event onset, the date the site became aware of the event, the 
diagnostic tests and procedures performed, actions taken as a result of the event, and outcome of the 
event. Reporting of these events to Medtronic will occur on an AE eCRF. Each event must be reported 
separately. Documented pre-existing conditions are not considered AEs unless the nature or severity of 
the condition has worsened.  
 
For all reportable events, initial reporting may be done by phone, fax, or on the CRF completing as much 
information as possible. The completed AE CRF must be submitted to Medtronic as soon as possible. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 32 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
For any changes in status of a previously reported adverse event (i.e., change in actions taken, change in 
outcome, change in relatedness), information needs to be updated on, or added to the original AE form. 
All AEs must be followed until the AE has been resolved, is unresolved with no further actions planned, 
the subject dies or exits the study, or study closure, whichever occurs first. 
10.2.1 
Adverse Event Classification 
 
All reportable AE will be reviewed by a Medtronic representative. AEs will be classified according to the 
definitions provided. Upon receipt of AE at Medtronic, a Medtronic representative will review the AE for 
completeness and accuracy and when necessary, will request clarification and/or additional information 
from the Investigator. Medtronic will utilize MedDRA for Regulatory Activities, to assign a MedDRA term 
for each AE based on the information provided by the investigator. 
 
AEs will be classified according to the standard definitions as outlined below: 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 33 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Table 4 Adverse Event Classification Responsibilities 
What is classified? 
Who classifies? 
Classification Parameters 
Relatedness 
Investigator 
CV Related, resulting from anti-
arrythmia loading 
hospitalization 
Sponsor 
Resulting from anti-arrythmia 
loading hospitalization 
Serious 
Investigator 
SAE 
Sponsor 
SAE 
Diagnosis 
Investigator 
Based on presenting signs and 
symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based 
on the data provided by 
Investigator 
 
 
10.2.2 
Adverse Event and Device Deficiency Reporting Requirements 
 
Regulatory reporting of AEs will be recorded and reported according to local regulatory requirements. It 
is the responsibility of the Investigator and the sponsor to abide by the AE reporting requirements 
stipulated by local law and the study site’s IRB. 
Device deficiencies will not be reported as part of this study. 
 
10.3 Product Complaint Reporting 
In geographies where devices are market-released, product complaint reporting is applicable.  The 
reporting of product complaints is not part of the clinical study and should be done in addition to the 
Adverse Event reporting requirements.  Refer to local regulations for reporting requirements. 
Product Complaint: Any written, electronic, or oral communication that alleges deficiencies related to the 
identity, quality, durability, reliability, safety, effectiveness, or performance of a medical device that has 
been placed on the market. 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless of 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. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 34 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
Medtronic will notify the regulatory authorities, as applicable for the following incidents immediately 
upon learning of them: 
• 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as 
any inadequacy in the labeling or instructions for use which led or might have led to the death or 
serious deterioration in the state of health of a patient, user, or other person. 
• 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
11. Statistical Design and Methods 
This is a feasibility study that is exploratory in nature and with no hypothesis. Therefore, justification on 
sample size is not required. 
 
11.1 General Aspects of Analysis 
Data analysis will be performed by Medtronic-employed statisticians or designees.  The LINQ QT Study is 
exploratory in nature and no hypothesis will be tested with no corresponding power calculations for this 
sample size. The study is expected to be conducted at up to three study sites and will enroll up to twenty 
study subjects.   
The subjects’ baseline status will be summarized with standard descriptive summary statistics, including 
counts and percentages for categorical variables, and mean, standard deviation, median, quartiles and 
range for continuous variables. For each of the objectives the available data will be summarized, and 
missing data will be discussed. The main analysis of the study objectives will be based on available data 
and missing data will not be imputed. 
 
11.2 Analysis Execution 
Analysis for the LINQ QT Study will occur when data collection has been completed.  Analysis will include 
the primary objective.  A final report will be prepared once all data collection has ended and all subjects 
have completed the study. 
 
11.2.1 
Primary Objective #1  
 The primary objective of the study is to determine if QT changes can be detected from LINQTM/LINQIITM 
ECG that may occur during and after antiarrhythmic loading. The QT intervals before and after 
antiarrhythmic loading will be compared for all patients to analyze QT changes that may be caused due 
to antiarrhythmic drugs. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 35 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
 Analysis Methods: Descriptive summary statistics will be used for this objective. 
 
Determination of Subjects/Data for Analysis: All subjects with data available will be included for this 
objective. 
 
11.3 Sample Size Determination 
 
There are no sample size requirements as this is an observational study with no hypothesis for the study 
objective. A sample size of up to 20 enrolled subjects was selected assuming sufficient data can be 
collected from this cohort to explore the relationship between measured QT intervals from 
LINQTM/LINQIITM before and after antiarrhythmic drug intake.  
 
11.4 Minimization of Bias 
 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias. 
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
 
Subjects will undergo screening to confirm eligibility with defined inclusion/exclusion criteria prior 
to enrollment. 
 
All sites will use the same version of the Clinical Investigation Plan and electronic case report forms 
(eCRFs). 
 
All investigational site personnel and Medtronic personnel will be trained using standardized training 
materials. 
 
In summary, potential sources of bias that may be encountered in this clinical study have been 
considered and minimized by careful study design. 
 
12. Ethics 
12.1 Statement(s) of Compliance 
The LINQ QT Study will be conducted according to the Declaration of Helsinki, Clinical Investigation Plan, 
Good Clinical Practice (GCP) and in accordance to the national and local laws, regulations, standards, and 
requirements of the countries/geographies in which the study is conducted. The principles of the 
Declaration of Helsinki are implemented in this study by means of the informed consent process, Ethics 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 36 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
Board approval, study training, and risk benefit assessment. The sponsor shall avoid improper influence 
on, or inducement to, the subject, monitor, any investigator(s) or other parties participating in, or 
contributing to, the LINQ QT Study. 
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 IRB/Ethics 
Board before initiating a study, continuing review of an ongoing study by an IRB/Ethics Board and 
obtaining and documenting the freely given informed consent of a subject before initiating the study. 
Ultimately, all sites in all geographies will follow and comply with: 
• 
Principles of Declaration of Helsinki 
• 
21 CFR Part 11: Electronic Records, Electronic Signatures 
• 
The Clinical Trial Agreement 
• 
The procedures described within this CIP 
• 
Local IRB/Ethics Board Requirements 
 
In addition to the regulatory requirements outlined above, 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. These include but are not limited to the following:  
In the US, the study will be conducted in compliance with: 
• 
21 CFR Part 50: Protection of Human Subjects 
• 
21 CFR Part 56: Institutional Review Boards 
• 
21 CFR Part 803: Medical Device Reporting 
 
The study will not begin until IRB/EC approvals/notification, as appropriate, are received. 
 
13. Study Administration 
13.1 Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this 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 CTA, and the 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 IC, Research Authorization (where applicable) and CTA.  The principal investigator should also 
be available during monitoring visits.   

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 37 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
13.1.1 
Monitoring Visits 
Frequency of monitoring visits may be based upon subject enrollment, study compliance, number of 
adverse events, number of deviations, observations from previous monitoring visits and any suspected 
inconsistency in data that requires investigation. Regulatory documents will be reviewed at each study 
site. Monitoring for the study, including site initiation visits, interim monitoring visits, and closeout visits, 
will be done in accordance with the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess study site progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to IRB/EC approval and review of 
the study, maintenance of records and reports, and review of source documents against subject CRFs in 
accordance with the study-specific monitoring plan. Monitors review study site regulatory and study 
compliance by identifying observations of non-compliance and communicating those observations along 
with recommendations for preventative/corrective actions to study 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 study site. 
13.2 Data Management 
Electronic case report form (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 monitor 
data quality and study progress.   
All non eCRF data will be uploaded to Medtronic via secure servers. Upon receipt, device data will be 
maintained within databases and retrieved for analysis and reporting.   
Changes to the data elements in the electronic system will retain the original data and an audit trail (date, 
time, and originator of the change and reason).  It is possible that AE and device data files may be provided 
to Medtronic before the PI has reviewed and released the e-CRF.  At the end of the study, the data will be 
frozen and will be retained indefinitely by Medtronic 
13.3 Direct Access to Source Data/Documents 
The sponsor or a regulatory authority, including the FDA, may audit or inspect the study site to evaluate 
the conduct of the study. The clinical investigator(s)/institutions(s) shall allow study related monitoring, 
audits, IRB/Ethics Board review and regulatory inspection by providing direct access to source 
data/documents. 
13.4 Confidentiality 
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. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 38 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
13.5 Liability/Warranty/Insurance Information 
Warranty information will be provided in the product packing and will be available upon request. 
Insurance information for participating geographies is provided below.  
Medtronic 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 study insurance statement/certificate will be provided to the IRB/EC. 
13.6 CIP Amendments 
Approval of the CIP is required from the following groups prior to any study procedures at a study center:  
• 
Medtronic  
• 
An independent Institutional Review Board / Ethics Committee 
Similarly, approval of subsequent revisions to the CIP from the above-mentioned groups is required at 
each study center prior to implementation of the revised CIP at that center. 
 
13.7 Record Retention 
 
13.7.1 
Investigator Records 
The investigator is responsible for the preparation and retention of the records including, but not limited 
to those cited below. All of the below records, with the exception of case history records and case report 
forms (CRFs), should be kept in the Investigator Site File (i.e., the study binder provided to the investigator) 
or Subject Study Binder. CRFs must be maintained and signed electronically within the electronic data 
capture system during the study. 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. Measures shall be taken to avoid loss or premature destruction. 
• 
All correspondence between the IRB/EC, sponsor, monitor, regulatory authority and/or 
the investigator that pertains to the investigation, including required reports  
• 
Subject’s case history records, including:   
 
Signed and dated informed consent form 
 
Observations of adverse events/adverse device effects/device deficiencies 
 
Medical history 
 
Baseline, DR Holter, and LINQTM/LINQIITM follow-up data (if applicable) 
 
Documentation of the dates and rationale for any deviation from the protocol 
• 
List of investigation sites  
• 
Insurance certificates (if applicable) 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 39 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
• 
All approved versions of the CIP and Informed Consent Form 
• 
Fully executed Clinical Trial Agreement 
• 
Curriculum Vitae of principal investigator and all co-investigators/sub-investigators 
• 
Documentation of delegated tasks 
• 
Study training records for site personnel involved in the study 
• 
IRB/EC approval documentation, including the IRB/EC composition where required by 
law, and written information that the investigator or other study staff, when member of 
the IRB/EC, did not participate in the approval process 
• 
Regulatory authority correspondence, notification, and approval, where required by 
national legislation 
• 
Any other records that local regulatory agencies require to be maintained 
• 
Final Study Report including the statistical analysis 
13.7.2 
Sponsor Records 
 
Medtronic shall maintain the following accurate, complete, and current records which include, but are 
not limited to: 
• 
All correspondence which pertains to the investigation 
• 
Executed Clinical Trial Agreement for all participating sites 
• 
Curriculum vitae (signed and dated as required by local law) of principal investigator and all co-
investigators/sub-investigators at participating sites 
• 
Documentation of delegated tasks for all participating sites 
• 
Study training records for site personnel and Medtronic personnel involved in the study 
• 
All approved informed consent versions, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all IRB/EC approval letters and relevant IRB/EC correspondence and IRB/EC voting 
list/roster/letter of assurance, if applicable 
• 
Electronically signed and dated eCRFs 
• 
List of names, addresses, telephone numbers and professional position of the clinical investigators 
and coordinating clinical investigator(s), if appointed 
• 
Names and addresses of the institutions in which the clinical study will be conducted 
• 
Regulatory authority correspondence, notification and approval as required by national 
legislation 
• 
Names/contact addresses of monitors 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 40 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
• 
Monitoring reports 
• 
Site qualification visit reports 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the clinical study 
• 
The Clinical Investigation Plan and study related reports, and revisions 
• 
Sample of CRFs 
• 
Any other records that local regulatory agencies require to be maintained 
 
13.8 Reporting Requirements 
13.8.1 
Investigator Reports 
 
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all case report forms, adverse events (reported per the country-specific collection requirements), and 
any deviations from the Clinical Investigation Plan.  If any action is taken by an IRB/EC with respect to this 
clinical 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. The investigator shall prepare and submit in a complete, accurate and timely manner the reports 
listed in this section.  

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 41 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Table 5: Investigator reports 
Report  
Submit to 
Description/Constraints 
Withdrawal of 
IRB/EC Approval 
(either suspension 
or termination) 
Sponsor and 
Relevant 
Authorities, if 
applicable 
The investigator must report a withdrawal of 
approval by the reviewing IRB/EC of the 
investigator’s part of the investigation within 5 
working days. 
Study Deviations  Sponsor and 
IRB/EC 
Notice of deviations from the CIP to protect the life 
or physical wellbeing of a subject in an emergency 
shall be given as soon as possible, but no later than 5 
working days after the emergency occurred. 
Reporting of all other study deviations must comply 
with IRB/EC policies and/or local laws and/or 
regulatory agency requirements and must be 
reported to Medtronic as soon as possible upon the 
center becoming aware of the deviation.    
Progress Report  
Sponsor and 
IRB/EC and 
relevant 
authorities if 
applicable 
The investigator must submit this report to the 
sponsor and IRB/EC at regular intervals, but in no 
event less than yearly.  
Final Report 
Sponsor and 
IRB/EC and 
relevant 
authorities if 
applicable 
This report must be submitted within 3 months of 
study completion or termination of the investigation 
or the investigator’s part of the investigation.  
 
13.8.2 
Sponsor Reports 
Required sponsor reports are listed in Table 6 below. 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 42 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
Table 6: Sponsor reports for the United States 
Report  
Submit to 
Description/Constraints 
Study deviation  
Investigators 
Ensure that all deviations from the CIP are reviewed with the 
appropriate clinical investigator(s), are reported on the CRFs 
and the final report of the clinical investigation.  
Study site specific study deviations will be submitted to 
investigators periodically.   
Premature 
termination or 
suspension of clinical 
study 
IRB/EC, 
Investigators, and 
regulatory 
authorities, where 
applicable 
Medtronic will provide prompt notification of termination or 
suspension and reason(s) to investigator and where required 
to IRB/EC and RAs. 
 
 
13.9 Publication and Use of Information 
Publications from the LINQ QT Study will be handled according to Medtronic’s Policies and Standard 
Operating Procedures and as indicated in the CTA. 
13.9.1 
Publication Committee  
The LINQ QT Study will utilize a Publication Committee which will include the study Principal 
Investigator, primary Medtronic personnel, and may include additional study investigators.  This 
committee will manage study publications with the goal of publishing findings from the data.  
The Publication Committee’s role is to:   
• 
Manage elements addressed in the publication plan as outlined in this section 
• 
Develop the final Publication Plan under a separate cover 
• 
Execute the Publication Plan 
• 
Oversee the publication of primary, and ancillary study results 
• 
Review and prioritize publication proposals 
• 
Provide input on publication content, and 
• 
Apply and reinforce the authorship guidelines set forth in the Publication Plan. 
Membership in the Publication Committee does not guarantee authorship.  The committee will meet as 
needed. 
 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 43 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
13.9.2 
Management of Primary and Ancillary Publications 
The Publication Committee reviews, prioritizes, and manages all publications including primary and 
ancillary publications.  Primary publications are those that address analyses of the primary objective as 
specified in the Clinical Investigation Plan. An ancillary publication is any publication that does not 
address the primary study objective identified in the Clinical Investigation Plan.  They include 
publications proposed and developed by the Publication Committee, 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 the 
primary results, 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.   
13.9.3 
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).  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 Publication Committee. The 
selected authors will be responsible for drafting the publication. All selected authors must fulfill ICMJE 
authorship conditions to be listed as authors. 
All investigators not listed as co-authors will be acknowledged as the “Medtronic LINQ QT Study 
Investigators” and will be individually listed according to the guidelines of the applicable scientific 
journal when possible. Any other contributors will be acknowledged by name with their specific 
contribution indicated. 
13.9.4 
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 and IRBs/ECs 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  
• 
Submitting for publication the primary study results after the study ends  
• 
Disclosing conflicts of interest (e.g., financial) of the co-authors of publications according to the 
policies set forth by the corresponding journals and conferences  
• 
Making an individual site’s study data accessible to the corresponding investigator after the 
completion of the study, if requested 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 44 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
13.10 
Suspension or Early Termination 
 
13.10.1 
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 CIP 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 IRB/EC oversight is required until the overall study closure process is complete. Upon study 
closure, subjects should be managed and followed per physician discretion. 
13.10.2 
Early Termination or Suspension 
Early Termination 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.  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.  
In the event the whole study or a single site is terminated, subjects will be exited.  
13.10.2.1 
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 
13.10.2.2 
Investigator/study site termination or suspension 
Possible reasons for investigator or study site termination or suspension include but are not limited to: 
• 
Failure to obtain initial IRB/EC approval or annual renewal of the study 
• 
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 CTA (e.g., failure to submit data in a 
timely manner, failure to follow-up on data queries and monitoring observations in a 
timely manner, etc.)  
• 
EC suspension of the study site 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 45 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)  
• 
Investigator request (e.g., no longer able to support the study) 
13.10.3 
Procedures for Termination or Suspension 
13.10.3.1 
Medtronic-initiated and regulatory authority-initiated 
• 
Medtronic will promptly inform the clinical investigators of the termination or suspension 
and the reasons and inform the RAs where required 
• 
In the case of study termination or suspension for reasons other than a temporary IRB/EC 
approval lapse, the investigator will promptly inform the IRB/EC  
• 
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 
13.10.3.2 
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 IRB/EC 
• 
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 
13.10.3.3 
IBR/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 
• 
Subjects already enrolled should continue to be followed in accordance with IRB/EC 
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)  

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 46 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
• 
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 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 47 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
14. Version History 
 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
• 
Not Applicable, New Document 
Amy Lautenbach, Sr. Clinical 
Research Specialist 
2.0 
• 
Updated inclusion criteria 
• 
Added system descriptions for My CareLink 
HeartTM App and MyCareLink RelayTM Home 
Communicator 
• 
Clarified LINQTM / LINQIITM   follow-up 
requirements  
• 
Made minor formatting and grammar changes 
• 
Added language for potential subject 
compensation for daily activations 
Amy Lautenbach, Sr. Clinical 
Research Specialist 

LINQ QT Study Clinical Investigation Plan 
 
 
21 SEP 2022 
Version 2  
Page 48 of 48 
 
Medtronic Business Restricted 
 
 
CONFIDENTIAL 
056-F275 Rev E Clinical Investigation Plan Template 
 
15. References 
1. Al-Khatib SM, LaPointe NM, Kramer JM, Califf RM. What clinicians should know about the QT 
interval. JAMA. 289(16), 2120–2127 (2003). 
2. European Heart Rhythm Association (EHRA), European Association for Cardio-Thoracic Surgery, 
Camm AJ et al. Guidelines for the management of atrial fibrillation: The Task Force for the 
Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur. Heart J. 
31(19), 2369–2429 (2010). 
3. Vardas P, Andrikopoulos G, Baroutsou B, ODYSSEY Investigators. A Greek prospective 
observational study of cardiovascular morbidity and mortality in patients with atrial fibrillation. 
Hellenic J. Cardiol. 56(6), 475–494 (2015). 
4. Shantsila E, Watson T, Lip GY. Drug-induced QT-interval prolongation and proarrhythmic risk in 
the treatment of atrial arrhythmias. Europace 9, iv37–iv44 (2007). 
5. Kaufman ES, Zimmermann PA, Wang T et al. Risk of proarrhythmic events in the atrial fibrillation 
follow-up investigation of rhythm management (AFFIRM) study. J. Am. Coll. Cardiol. 44(6), 
1276–1282 (2004). 
6. Peters RW, Byington RP, Barker A, Yusuf S. Prognostic value of prolonged ventricular 
repolarization following myocardial infarction: the BHAT experience. The BHAT Study Group. J. 
Clin. Epidemiol. 43(2), 167–172 (1990). 
7. Straus SMJM, Kors JA, De Bruin ML et al. Prolonged QTc interval and risk of sudden cardiac 
death in a population of older adults. J. Am. Coll. Cardiol. 47(2), 362–367 (2006). 
8. Cintron G, Johnson G, Francis G, Cobb F, Cohn JN. Prognostic significance of serial changes in left 
ventricular ejection fraction in patients with congestive heart failure. The V-HeFT VA 
Cooperative Studies Group. Circulation 87(Suppl. 6), VI17–VI23 (1993). 
9. Kramer DG, Trikalinos TA, Kent DM, Antonopoulos GV, Konstam MA, Udelson JE. Quantitative 
evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic 
effects on mortality in patients with heart failure and reduced ejection fraction. J. Am. Coll. 
Cardiol. 56(5), 392–406 (2010). 
10. Maeder MT, Ammann P. Changes in BNP and QTc for prediction of sudden death in heart failure. 
Future Cardiol. 9(3), 317–320 (2013). 
11. Chouchoulis k, Chiladakis J, Koutsogiannis N et al. Impact of QT interval prolongation following 
antiarrhythmic drug therapy on left ventricular function. Future Cardiol. 13(1), 13-22 (2016). 
12. Brendorp B, Elming H, Jun L, et al. QTc interval as a guide to select those patients with 
congestive heart failure and reduced left ventricular systolic function who will benefit from 
antiarrhythmic treatment with dofetilide. Circulation. 103, 1422–1427 (2001). 
13. Aktas MK, Shah AH, Akiyama T. Dofetilide-induced long QT and torsades de pointes. Ann 
Noninvasive Electrocardiol. 12(3), 197-202 (2007).  
14. Chu AF, Rajagopal G, Sarkar S. The missing link: Unlocking the power of cardiac rhythm 
monitoring device -based QT interval detection. Pacing Clin Electrophysiol. 45, 401– 409 (2022).