Tachy Prediction Download Study
Conditions: Ventricular Tachycardia
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Tachy Prediction Download Clinical Study Report 
Version 1.0 
This document is electronically controlled 
Medtronic Confidential 
056-F277, v3.0  Clinical Study Report Template 
 Cover Page
Clinical Investigation Plan Title 
Tachy Prediction Download (TPD) Study 
Clinical Investigation Plan Identifier 
MDT16067 
Study Product 
EveraMRI 
Tachy Prediction Download Algorithm 
CareLink Monitor 
ClinicalTrials.gov Identifier 
NCT03402126 
Sponsor/Local Sponsor 
Medtronic, Inc. 
Cardiac Rhythm and Heart 
Failure Clinical Research   
8200 Coral Sea Street NE 
Mounds View, MN 55112 
1-800-328-2518
Medtronic Hong Kong Medical 
Limited 
1104-11, 11/F, Tower 1 The Gateway, 
Harbour City, Tsim Sha Tsui, Kowloon 
(+852)-2919-1300 
Medtronic, Bakken Research Center 
B.V. Endepolsdomein 5
6229 GW Maastricht
The Netherlands
(+31)-43-35-66-566
Key Entities 
Katy Muckala, Clinical Study Manager, Cardiac Rhythm and Heart 
Failure Clinical Research Department 
Lou Sherfesee, Biostatistician, Cardiac Rhythm and Heart Failure 
Clinical Research Department 
Mark Brown, Distinguished Scientist, Cardiac Rhythm and Heart 
Failure Research Department  
Document Version 
Version 1.0/01 August 2017 
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. 

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 1 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
Clinical Investigation Plan
Clinical Investigation Plan/Study Title Tachy Prediction Download (TPD) Study
Clinical Investigation Plan Identifier
Not Yet Assigned
Study Product Name
EveraMRI
Tachy Prediction Download Algorithm
CareLink Monitor
Sponsor/Local Sponsor
Medtronic, Inc.
Cardiac Rhythm and Heart Failure Clinical Research  
8200 Coral Sea Street NE, MS: MVS33
Mounds View, MN 55112
1-800-328-2518
Medtronic Hong Kong Medical Limited
1104-11, 11/F, Tower 1,
The Gateway,
Harbour City, Tsim Sha Tsui, Kowloon
(+852)-2919-1300
Medtronic, Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
(+31)-43-35-66-566
Monitoring Contact
Taryn Randall, Clinical Monitoring Manager
Email: taryn.randall@medtronic.com
Document Version
Version 1.0
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.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 2 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
Table of Contents 
Table of Contents ...................................................................................................................... 2
1.
Glossary.............................................................................................................................. 5
2.
Synopsis ............................................................................................................................. 7
3.
Introduction ....................................................................................................................... 9
3.1. Background .............................................................................................................................9
3.2. Purpose.................................................................................................................................10
4.
Objectives and Endpoints................................................................................................. 10
4.1. Objectives .............................................................................................................................10
4.1.1.
Primary Objective..................................................................................................................10
4.1.2.
Endpoint................................................................................................................................11
5.
Study Design .................................................................................................................... 11
5.1. Duration................................................................................................................................11
5.2. Rationale...............................................................................................................................11
6.
Product Description.......................................................................................................... 11
6.1. General .................................................................................................................................11
6.1.1.
Evera MRI™ ICD.....................................................................................................................12
6.1.2.
Market-Released Medtronic CareLink Monitor and Medtronic CareLink Network .............12
6.1.3.
Market-Released Medtronic CareLink Programmer.............................................................13
6.1.4.
TPD Software.........................................................................................................................13
6.1.5.
RAMware...............................................................................................................................13
6.2. Intended Population...............................................................................................................14
6.3. Equipment.............................................................................................................................14
6.4. Product Training Requirements...............................................................................................14
6.5. Product Receipt and Tracking .................................................................................................14
6.6. Product Storage.....................................................................................................................15
6.7. Product Return ......................................................................................................................15
7.
Selection of Subjects........................................................................................................ 16
7.1. Study Population....................................................................................................................16

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 3 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
7.2. Subject Enrollment.................................................................................................................16
7.3. Inclusion Criteria....................................................................................................................16
7.4. Exclusion Criteria ...................................................................................................................16
7.5. Selection Criteria....................................................................................................................17
8.
Study Procedures ............................................................................................................. 17
8.1. Investigator/Investigation Site Selection..................................................................................17
8.2. Site Initiation.........................................................................................................................18
8.3. Schedule of Events.................................................................................................................18
8.4. Subject Consent.....................................................................................................................19
8.5. Enrollment/Baseline ...............................................................................................................21
8.5.1.
Subject History ......................................................................................................................21
8.5.2.
Prior and Concomitant Medications .....................................................................................22
8.5.3.
Initial Interrogation and Save-to-media/USB........................................................................22
8.5.4.
Device Programming Prior to Installation of the TPD...........................................................22
8.5.5.
TPD Download.......................................................................................................................22
8.5.6.
Post-Download TPD Parameters...........................................................................................23
8.5.7.
Final Interrogation and Save-to-media/USB.........................................................................23
8.6. Study Follow-up/Exit ..............................................................................................................23
8.6.1.
Initial Interrogation and Save-to-media/USB........................................................................23
8.6.2.
RAMware Removal................................................................................................................23
8.6.3.
Uninstall Software from Programmer...................................................................................24
8.6.4.
Final Interrogation and Save-to-media/USB.........................................................................24
8.6.5.
Device Programming Post TPD Removal...............................................................................24
8.7. Other Cardiovascular Visit.......................................................................................................24
8.8. System Modifications..............................................................................................................25
8.9. Subject Consent.....................................................................................................................25
8.10.
Assessment of Safety .......................................................................................................25
8.11.
Recording Data ................................................................................................................26
8.12.
Deviation Handling ...........................................................................................................26
8.13.
Subject Withdrawal or Discontinuation...............................................................................26
8.13.1.
Lost to Follow-Up...............................................................................................................27

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 4 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
8.13.2.
Subject Withdrawal ...........................................................................................................27
9.
Risks and Benefits............................................................................................................ 27
9.1. Potential Risks .......................................................................................................................27
9.2. Risk Minimization ...................................................................................................................28
9.3. Potential Benefits...................................................................................................................28
9.4. Risk-Benefit Rationale ............................................................................................................29
10.
Adverse Events and Device Deficiencies ....................................................................... 29
10.1.
Definitions/Classifications..................................................................................................29
10.1.1.
Adverse Event Definitions .................................................................................................29
10.1.2.
Device Deficiencies............................................................................................................30
10.1.3.
Event Updates and Resolution ..........................................................................................30
10.2.
Definitions/Classifications..................................................................................................30
10.3.
Reporting of Adverse Events .............................................................................................32
10.3.1.
Adverse Events and Device Deficiency Reporting Requirements .....................................33
10.4.
Subject Death ..................................................................................................................34
10.4.1.
Death Data Collection........................................................................................................34
10.4.2.
Death Classification and Reporting ...................................................................................35
10.5.
Product Complaint Handling..............................................................................................36
11.
Statistical Design and Methods ..................................................................................... 36
12.
Ethics ............................................................................................................................. 36
12.1.
Statement(s) of Compliance..............................................................................................36
13.
Study Administration..................................................................................................... 37
13.1.
Monitoring .......................................................................................................................37
13.2.
Data Management............................................................................................................38
13.3.
Direct Access to Source Data/Documents...........................................................................38
13.4.
Confidentiality..................................................................................................................38
13.5.
Liability............................................................................................................................39
13.6.
CIP Amendments .............................................................................................................39
13.7.
Record Retention .............................................................................................................39
13.7.1.
Investigator Records..........................................................................................................39
13.7.2.
Investigator Reports ..........................................................................................................40

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 7 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
2. Synopsis
Title
Tachy Prediction Download (TPD) Study
Clinical Study Type
The TPD study is a prospective, non-randomized, non-interventional, 
multi-site passive data collection study. The data collected will be used 
to evaluate the feasibility of new algorithms to predict the imminent 
onset of ventricular arrhythmias. In the United States, this study will be 
executed as a non-significant risk investigational device exemption (NSR 
IDE)
Product Name
Evera MRI ICDs (with TPD investigational RAMware)
Medtronic CareLink Monitor
Medtronic 2090 Programmer (with TPD investigational software 
application)
Sponsor 
Medtronic Inc.
Local Sponsor
Medtronic, Inc.
Cardiac Rhythm and Heart Failure Clinical Research  
8200 Coral Sea Street NE, MS: MVS33
Mounds View, MN 55112
1-800-328-2518
Medtronic Hong Kong Medical Limited
1104-11, 11/F, Tower 1,
The Gateway,
Harbour City, Tsim Sha Tsui, Kowloon 
(+852)-2919-1300
Medtronic, Bakken Research Center B.V. Endepolsdomein  5 
6229 GW Maastricht 
The Netherlands 
(+31)-43-35-66-566 
Indication under 
investigation 
The study data is collected from ICD indicated patients. No new 
indications are being explored in this study.
Investigation Purpose
The purpose of the Medtronic Tachy Prediction Download (TPD) study 
is to collect data from an implantable cardiac defibrillator (ICD) device 
that will be used to identify markers for imminent onset of ventricular 
arrhythmias.
Product Status
All hardware used in the TPD study is market released, however 
investigational TPD RAMware will be installed on the Evera MRI ICDs 
and the TPD investigational software application will be loaded onto 
the 2090 programmer. The Evera MRI ICD will therefore be considered 
investigational while the TPD is present on the ICD and the 2090 

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 8 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
programmer will be considered investigational when the TPD software 
application is active.
Primary Objective(s)
The primary objective of this study is to collect data that can be used to 
predict the imminent onset of ventricular arrhythmias.
Study Design
The TPD Study is a prospective, non-randomized, non-interventional, 
multi-site data collection clinical study to collect ICD longitudinal data 
that may be used to develop a VT/VF prediction algorithm. The study 
subjects will include patients currently implanted, or who will be 
implanted with a market-approved Medtronic Evera MRI® ICD. The 
expected study duration is 3 years, with an enrollment period of 
approximately 2 years and a follow-up period of approximately 1 year.
Sample Size
Up to 300 subjects at up to 20 sites in the US and Hong Kong may 
participate in this study.
Inclusion/Exclusion Criteria
Inclusion Criteria

Subject is implanted or will be implanted, with an Evera MRI 
device with properly functioning Medtronic tachycardia lead placed 
in the right ventricle (with or without atrial lead) with remaining 
device longevity of 4 years or more for:
o
Secondary Prevention or,
o
Primary Prevention and has had a device 
treated VT/VF or a device recorded episode of 
sustained VT/VF

Subject is ≥ 18 years old

Subject has previously documented history of VT/VF  

Subject must be willing and able to use Medtronic CareLink 
network monitoring system

Subject provides signed and dated authorization and/or consent 
per institution and local requirements

Subject is willing and able to comply with the protocol
Exclusion Criteria

Subject who received device for Primary Prevention indication and 
who has not had either a device treated VT/VF episode or a device 
recorded episode of sustained VT/VF   

Subject is enrolled in a concurrent study that may confound the 
results of this study, without documented pre-approval from a 
Medtronic study manager

Subject has chronic AF

Subject has inherited disorders of ion transport mechanisms that 
predispose the subject to sudden death (“Channelopathies”): Long 
QT and Brugada Syndromes

Subject with multiple implanted active devices that may cause an 
interruption of a transmission of device data to CareLink 

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 9 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template

Subject has active electronic medical device other than an ICD

Subject requires more than 25% atrial or ventricular pacing

Subject has medical conditions that would limit study participation 
(per investigator judgment)

Subject has projected life expectancy of less than 1 year

Subject is pregnant or plans to be pregnant over the next year 
(females of child-bearing potential must have a negative pregnancy 
test within one week of enrollment and must practice a reliable 
form of birth control while enrolled in the study)
Subject meets exclusion criteria required by local law (e.g. age, 
breastfeeding, etc.)
Study Procedures and 
Assessments

The TPD study requires a baseline visit and a follow up visit. At the 
baseline visit, baseline characteristics will be recorded and the TPD 
investigational RAMware will be installed onto the Evera MRI ICD. 
At the follow up visit (ideally 365-400 days later) the TPD RAMware 
will be removed from the ICD and the device programming will be 
evaluated and adjusted as needed. Required study data will be 
transmitted over the CareLink Network as it is collected. At any visit 
not required by the study occurring between baseline and follow 
up, it is recommended to confirm that the TPD RAMware is 
installed on the device and that the parameters are appropriately 
configured.
Safety Assessments
No significant risks have been identified in this study design.
3. Introduction 
3.1.
Background 
Clinical studies demonstrate that ICDs can reduce mortality in selected patient populations by treatment 
of ventricular tachyarrhythmia by defibrillation.  However, defibrillation shock therapy is applied after 
the development of VF (or fast VT) and may not prevent the morbidity of syncope during the event nor 
the pain and potential injury of the shock itself.  Significant effort has been focused on reducing the 
need for defibrillation with ICDs by reducing inappropriate shocks and applying anti-tachycardia pacing 
(ATP) to prevent a slow ventricular tachycardia from developing into FVT or VF. Although these clinical 
studies were successful and shock rates were reduced, the need for defibrillation still exists.  One 
strategy to reduce the need for shock therapy further is to prevent monomorphic ventricular 
arrhythmias (which can develop into VF) or idiopathic VF from developing.  This might be accomplished
by monitoring a marker in real time to predict the imminent onset of VT/VF in the seconds to minutes 
before it starts and inhibiting the arrhythmia by applying an intervention.  Alternatively, if the 
arrhythmia cannot be successfully prevented from initiating, the patient might be warned that an 
arrhythmia is imminent to avoid injury from syncope or to provide time for medical intervention.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 10 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
In a Medtronic internal research report entitled “Prediction and Prevention of Imminent Ventricular 
Arrhythmias-Review” compiled by Scheiner, Musley, and Kornet. (2016), the following 
recommendations were made, based on the literature search: All previous research has been population 
based.  Because there are large variations in the underlying mechanism and trigger for VT/VF from 
patient to patient, none of the studies has shown high enough accuracy of prediction to use for 
imminent patient or caregiver interdiction.  We should, therefore, consider studying individual patients 
who have serial arrhythmias to identify markers specific to a patient.  Using that dataset, develop an 
algorithm to identify which repolarization markers of impending arrhythmias are most accurate 
predictors in an individual patient. It may be possible to identify marker changes that have useful 
prognostic value in individual patients, even though they fail to accurately correlate with initiation of an 
event on a population level. The research study would consist of:
1.
Taking serial ECG or EGM measurements for multiple VT/VF episodes in multiple patients of a 
certain patient group.
2.
Evaluating parameters that are known to have some predictive value for VT/VF in a time period of 
several hours before the VT/VF episode.  Determine if there is a consistent change for any of the 
parameters before a VT/VF episode in each particular patient for this specific patient group.
3.
Determining if the next episode can be predicted using the identified parameter(s) or combination 
of parameters for a particular patient?
4.
Determining if exogenous factors may contribute to arrhythmia risk and trigger and if they can be 
used to identify subgroups of patients in which prediction is more accurate
3.2.
Purpose
The purpose of the Medtronic Tachy Prediction Download (TPD) study is to collect data that can be used 
to determine if an ICD device algorithm can be developed to predict the imminent onset of ventricular 
arrhythmias. 
4. Objectives and Endpoints
4.1.
Objectives
4.1.1.
Primary Objective
The primary objective of this study is to collect data that can be used to predict the imminent onset of 
ventricular arrhythmias. These data will include pre-storage device EGMs, RR intervals, PVC density, 
activity and other physiologic variables before these ventricular arrhythmias, and matching control data.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 11 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
4.1.2.
Endpoint
Due to the feasibility nature of this trial, there is no sample size requirement for this objective. Up to 
300 subjects will be enrolled in the study to ensure sufficient data sets (at least 50 VT/VF events 
collected from unique subjects) are collected for analysis.
5. Study Design 
The TPD Study is a prospective, non-randomized, non-interventional, multi-site data collection clinical 
study to collect ICD longitudinal data that may be used to develop a VT/VF prediction algorithm. The 
study subjects will include patients currently implanted, or who will be implanted with a market-
approved Medtronic Evera MRI® ICD. Up to 300 subjects at up to 20 sites in the US and Hong Kong may 
participate in this study.
5.1.
Duration
It is expected that study subjects will remain in the study for 12 months, then be seen in-office for 
follow-up and study exit. Study data will be collected from enrollment until exit via CareLink® such that 
study involvement will not affect the normal follow-up practice or schedule.
5.2.
Rationale 
Sparse long-term pre-VT/VF onset EGM, RR interval, activity, and PVC density data exists because it is 
hard to collect. Ideally, Holter recordings could provide this data without altering the function of the ICD 
under investigation. Unfortunately, the yield of spontaneous VT/VF events on Holter recording is 
minuscule due to the relatively short-term monitoring provided by Holter and the scarcity of VT/VF 
events in most patients. The best method for collecting periodic and longer pre-onset data is to modify 
an ICD’s RAMware to allow it to collect the desired EGM, RR interval, and other data prior to VT/VF and 
HF events. This can be done without affecting device therapy.  The data will later be used to determine if 
there are algorithmic indications that can predict imminent VT/VF.
6. Product Description
6.1.
General
Market-released Medtronic Evera MRI™ ICD, Medtronic CareLink Programmer, CareLink® Network and 
the CareLinkMonitor will be used. These components are described in the following sections. Please 
note, each ICD may only be used in the geographies in which it is market released.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 13 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
6.1.3.
Market-Released Medtronic CareLink Programmer
Medtronic’s market-released Model 2090 CareLinkProgrammer must be available at each site to 
support study visits.  Programmers will be used to interrogate devices, collect lead electrical data, 
program devices, and save device data. They will also be used to install the RAMware into the ICD.
6.1.4.
TPD Software
Investigational TPD Software will be distributed via Medtronic’s Software Distribution Network (SDN) to 
the 2090 programmer. Further details on this process can be found in the TPD User Manual. 
Investigational device tracking is covered in Section 6.5.
6.1.5.
RAMware
Investigational RAMware enables the Evera MRI device to save the following data continuously and, 
when triggered, to transmit data to CareLink. RAMware usage is controlled by a Medtronic provided 
access key derived from the ICD serial number.
Expanded EGM data 
Minimum 30 seconds of EGM data from 2 EGM channels for one and six hour data
Minimum duration of 2 minutes, 20 seconds of EGM data from 2 EGM channels for event trigger stored 
data
Expanded Interval and EGM amplitude data
Minimum of 5 minutes of data from immediately prior to the data storage time
PVC Density data
The number of PVCs in the hour immediately prior to the data storage time
Subject Activity data
Sum of 2 second activity counts for the 15 minutes immediately prior to the data storage time
Optivol data
Minimum of 1 day of TPD OptiVol data stored prior to the event (no one hour or six hour data)
CareLink Transmission of Data: 
Control data transmissions are triggered by a countdown timer at programmable intervals.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 14 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
Once an event occurs or control data collection completes, the study data will be frozen and the 
RAMware will trigger a CareAlert to send the collected data to the CareLink Network. Once the device 
has transmitted the data to the patient monitor or a CareLink Express monitor, the RAMware will clear 
the CareAlert and reset the study data collection. The minimum frequency of transmission is every 3 
months.
6.2.
Intended Population
All subjects in this investigation have received or will receive a Medtronic Evera MRI® ICD for approved 
indications and have a documented history of ventricular arrhythmias.
6.3.
Equipment
The following equipment must be available at each site to support study activities:

Site has access to high-speed internet to submit data

The subject must have CareLink equipment, properly working with access to a cellular network

Site must have 2090 CareLink Programmer
6.4.
Product Training Requirements
At a minimum, documented training on the TPD CIP and User Manual for the Principal Investigator (PI) is 
required prior to the clinical site’s first enrollment. Prior to subject enrollment, Medtronic will train site 
personnel on the Clinical Investigation Plan, relevant standards and regulations, if needed, informed 
consent, and on data collection and reporting tools. If new members join the study center team 
afterwards, they will receive training on the applicable clinical study requirements relevant to their role 
before contributing to the clinical study.
6.5.
Product Receipt and Tracking
A device disposition log will be maintained at each investigational site to track all investigational 
components and will be available within the electronic data management system (see section 17.2). 
These records will consist of:

TPD Software Application/Programmer Disposition Log (eCRF)

RAMware/ICD Device Disposition Log (eCRF)
The TPD Software Application will be distributed to a site only when Medtronic has received all required 
documentation and has notified the site of site activation. Distribution of the TPD Software Application 
to study sites during the clinical study will be managed by Medtronic. The TPD Software Application will 
be distributed via the SDN. Software distributed via the SDN will be installed onto study programmers 
over a secure internet connection.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 15 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
The TPD Software Application is considered investigational in all geographies. Once the TPD Software 
Application is installed on a programmer, the presence of that application on that programmer will need
to be tracked until the TPD Software Application is removed. While the TPD software is installed on the 
2090 Programmer, the programmer will contain a statement indicating the presence of the 
investigational software application including any statements required by law. This label will be removed 
once the TPD Software Application is removed from the programmer.
The disposition logs should also be updated in the event the programmer is returned to MDT for 
software removal.
The TPD RAMware is considered investigational in all geographies. Once the TPD RAMware is installed 
on an Evera MRI ICD, that ICD is considered investigational and must be tracked as an investigational 
device until the RAMware is removed. The disposition logs should also be updated in the event a device 
is explanted and still contains the TPD RAMware.
In the event that a subject does not come in for the follow-up/exit visit within 400 days of TPD RAMware 
installation, the TPD RAMware will self-terminate. The disposition log should be updated accordingly.
In summary, a device disposition log will be maintained at each investigational site and will be updated 
appropriately whenever the status of a component has changed.
6.6.
Product Storage
The investigational components are programmer software and device RAMware only. The 
investigational software application will be distributed through a software distribution network, so there 
are no media storage requirements. Once the investigational components are loaded, the programmer 
will carry a label indicating the investigational application is installed as described in section 6.5. The 
device RAMware is loaded onto the ICD by the programmer equipped with the TPD Software 
Application. There are no changes to the physical components of the system and therefore no new 
storage requirements.
It is the responsibility of the investigator to correctly handle, store, and track the investigational 
components (programmers containing the investigational TPD Software Application and ICDs with TPD
RAMware installed). Further details can be found in the TPD User Manual.
For additional product handling and storage requirements, please refer to the original packaging and 
manuals for each piece of equipment (Programmer, ICD, etc.). 
6.7.
Product Return
The TPD data collection RAMware will be removed from devices at study exit (or self-terminated at 400 
days). The TPD Software Application will subsequently be removed from the 2090 programmers.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 16 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
7. Selection of Subjects
7.1.
Study Population
This study will enroll subjects who have a Medtronic Evera MRI® ICD system per local guidelines and who 
meet all of the specific study inclusion criteria and none of the exclusion criteria. 
7.2.
Subject Enrollment
Subjects are considered enrolled in the study upon signing the Medtronic & IRB-approved IC Form.  
Informed consent must be obtained prior to performing any of the study-related procedures.  The 
complete informed consent process will include giving the subject adequate information about the 
study and ensuring that there is sufficient time to comprehend the information in the IC Form and have 
all questions answered before making a decision to participate in the study.
7.3.
Inclusion Criteria
Subjects must meet all of the inclusion criteria and none of the exclusion criteria below to be eligible for 
this study:
•
Subject is implanted or will be implanted with an Evera MRI device with properly functioning 
Medtronic tachycardia lead placed in the right ventricle (with or without atrial lead) with remaining 
device longevity of 4 years or more for:
o
Secondary Prevention or
o
Primary Prevention and has had a device treated VT/VF or a device recorded episode of 
sustained VT/VF

Subject is ≥ 18 years old

Subject has previously documented history of VT/VF  

Subject must be willing and able to use Medtronic CareLink network monitoring system

Subject provides signed and dated authorization and/or consent per institution and local 
requirements

Subject is willing and able to comply with the protocol
7.4.
Exclusion Criteria
The following are the exclusion criteria for the study:

Subject who received device for Primary Prevention indication and who has not had either a device 
treated VT/VF episode or a device recorded episode of sustained VT/VF   

Subject is enrolled in a concurrent study that may confound the results of this study, without 
documented pre-approval from a Medtronic study manager

Subject has chronic AF

Subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden 
death (“Channelopathies”): Long QT and Brugada Syndromes

Subject with multiple implanted active devices that may cause an interruption of a transmission of 
device data to CareLink 

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 17 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template

Subject has active electronic medical device other than an ICD

Subject requires more than 25% atrial or ventricular pacing

Subject has medical conditions that would limit study participation (per investigator judgment)

Subject has projected life expectancy of less than 1 year

Subject is pregnant or plans to be pregnant over the next year (females of child-bearing potential 
must have a negative pregnancy test within one week of enrollment and must practice a reliable 
form of birth control while enrolled in the study)

Subject meets exclusion criteria required by local law (e.g. age, breastfeeding, etc.)
7.5.
Selection Criteria
The inclusion and exclusion criteria are designed to include subjects that are at elevated risk for 
additional ventricular arrhythmias, as defined by either a secondary prevention indication or a primary 
prevention indication with subsequent history of VT/VF, who will be able to successfully complete study 
participation.
8. Study Procedures 
Prior to performing study related procedures, all sites must have Institutional Review Board (IRB)/Ethics 
Committee (EC) approval and documentation of site readiness from Medtronic.
Medtronic representatives may perform the following activities at the study sites during the study if 
appropriately trained and under the supervision of the PI and/or appropriate delegate (e.g. 
appropriately trained and delegated sub-investigator):

Study training relevant and pertinent to the involvement of personnel conducting study 
activities and Investigator responsibilities

Technical support at all visits (e.g. programming of the ICDs according to study requirements, 
performing device interrogations/save-to-media, etc.), but no electronic case report form (eCRF) 
data entry shall be performed by Medtronic personnel 

Monitoring activities

Auditing activities
8.1.
Investigator/Investigation Site Selection
The PI will provide oversight for the entire study team at his/her site, implement and manage the day-
to-day conduct of the clinical study, ensure data integrity, and the rights, safety, and well-being of the 
subjects involved in the clinical study.
The PI shall be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical study. Additional, the site must demonstrate it has the required number of 
eligible subjects needed within the recruitment period, has one or more qualified Investigators, a 
qualified study team, and adequate facilities for the foreseen duration of the clinical study.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 18 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
8.2.
Site Initiation
During the initiation process (prior to subject enrollment), Medtronic will train site personnel on the 
Clinical Investigation Plan, relevant standards and regulations (if needed), informed consent, and data 
collection and reporting tools.  If new members join the study site team, they will receive training on the 
applicable clinical study requirements relevant to their role before contributing to the clinical study.
A Clinical Trial Agreement (CTA) or Work Order (WO) shall be entered into effect by Medtronic, the 
participating investigation site and/or the PI (PI) at each investigation site (per the local legal 
requirements), and returned, fully executed, to Medtronic prior to the commencement of any study 
activities.  Financial aspects of conducting and reporting a study will be specified in the agreement.  By 
signing and dating the agreement, the Investigator indicates approval of the CIP.
Prior to performing study related activities, all sites must have IRB/EC approval, as applicable for that 
geography.
All local and regional regulatory requirements must be fulfilled prior to site initiation and enrollment of 
subjects into the study.  Each study site must have written documentation of site and Investigator 
readiness before beginning any study-related activities.  Requirements for initiation vary by geography, 
and may include, but are not limited to:

Written documentation of IRB/EC approval of the current versions of the CIP and IC Form 
(approved versions must be retrievable from the IRB/EC approval letter or submission letter) 
and the corresponding voting list (as required per local law)

Regulatory authority approval or notification (as required per local law) 

Executed CTA or WO on file with Sponsor

Current Curriculum Vitae (CV) of Investigators 

Documentation of delegated tasks

Documentation of study site personnel training 
Additional requirements imposed by the IRB/EC and regulatory authority shall be followed, if 
appropriate.  Medtronic will provide each study site with documentation of study site/Investigator 
readiness; this letter must be received prior to subject enrollment.
8.3.
Schedule of Events
Clinical data will be collected at the Baseline and Exit visits, as well as any unscheduled cardiovascular 
(CV) visits, as applicable. Device data will be collected from Carelink transmissions received during the 
period between the enrollment and exit until study closure.  Data will be collected using eCRFs using an 
electronic data management system for clinical studies.  In addition to eCRF data, non-eCRF data will be 
collected including device interrogation files and CareLink transmission files.  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 study sites for resolution.  
Study management reports will be generated by Medtronic to monitor data quality and study progress.  
At the end of the study, the data will be frozen and retained indefinitely by Medtronic. Data Collection 
requirements are summarized in the table below.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 20 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
authorization) as required by law that has been approved by the study site’s IRB/EC, and Medtronic, and 
personally signed and dated by the subject and the PI or an authorized designee.
Prior to enrolling subjects, each site must have documented IRB/EC approval of the IC Form (and data 
protection authorization, where applicable) as required by law. Any changes to a previously approved IC 
Form throughout the course of the study must be reviewed and approved by Medtronic and the IRB/EC 
reviewing the application before being used to obtain consent or re-consent a study subject. The 
document(s) must be controlled (i.e. versioned and dated) to ensure it is evident which version(s) were 
approved by Medtronic and the IRB/EC. All important new information should be provided in written 
form to new and existing subjects throughout the study. If relevant, all affected subjects must be asked 
to confirm their continuing informed consent in writing.  
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. Obtaining 
informed consent must be conducted by the PI or an authorized designee, and the IC Form and a data 
protection authorization, 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 shall:

Ensure that the PI or an authorized designee conducts the informed consent process.

Include all aspects of the clinical study that are relevant to the subject's decision to participate 
throughout the clinical study.

Avoid any coercion or undue improper influence on, or inducement of the subject to participate.

Not waive or appear to waive the subject’s legal rights.

Ensure the IC Form and a data protection authorization as required by law, are given to the subject 
in a non-technical language the subject is able to read and understand.

Provide ample time and opportunity for the subject to read and understand the Informed Consent 
Form to inquire about details of the study, and to consider participation. All questions about the 
study should be answered to the satisfaction of the subject.

Include a personally dated signature of the subject acknowledging that their participation in the 
study is voluntary.

Include a personally dated signature by the PI, or authorized designee responsible for obtaining the 
informed consent, as required by local law.

Provide the subject with a copy of the IC Form and a data protection authorization as required by 
law.

Ensure subjects are notified of any significant new findings about the study that become available 
during the course of the study which are pertinent to the safety and well-being of the subject, as 
this could impact a subject’s willingness to participate in the study.
If the informed consent is obtained the same day the subject begins participating in study-related 
procedures, it must be documented that consent was obtained prior to participation in any study-
related procedures. It is best practice for the process of obtaining the informed consent to be 
documented in the subject’s case history, regardless of circumstance.
In the event the subject cannot read and/or write, witnessed (impartial third party) informed consent 
will be allowed, provided detailed documentation of the process of obtaining the informed consent is 
recorded in the subject’s case history and the witness signs and dates the Informed Consent Form. 

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 21 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
Informed consent shall be obtained through a supervised oral process. An independent witness must be 
present throughout the process. The IC Form and any other information must be read aloud and 
explained to the prospective subject if allowed by local law. The witness signs and personally dates the 
IC Form attesting that the information was accurately explained and that informed consent was freely 
given. The subject should “make his mark” (sign or otherwise physically mark the document so as to 
indicate consent) on the IC Form as well. The IC Form should document the method used for 
communication with the prospective subject and the specific means by which the prospective subject 
communicated agreement to participate in the study. 
The original of the signed IC Form must be filed in the hospital/clinical chart and/or with the subject’s 
study documents. 
The IC Form and a data protection authorization as required by law must be available for monitoring, 
auditing, and regulatory inspections. Any Medtronic personnel who support the initial programming of 
the TPD study RAMware download must be able to review the subject’s signed and dated IC Form and 
verify its completeness prior to proceeding with the programming. In the event the designated 
Medtronic personnel identify the IC Form as being incomplete, the programming will not be allowed to 
occur until the consent of the subject can be adequately and appropriately obtained.
8.5.
Enrollment/Baseline
When a patient and the PI or authorized designee (if applicable) signs and dates the IC Form, the patient 
is considered a subject enrolled in the study.  The date the subject signed the IC Form and data 
protection authorization must be documented in the subject’s medical records.  Enrollment can be a 
stand-alone visit or can occur on the same day as the baseline visit.  Medtronic should be notified (via 
Enrollment eCRF) as soon as possible to aid in enrollment tracking. Once consent is obtained, report 
adverse events, device deficiencies, study deviations, system modifications, and subject exits or deaths 
as they occur.  
The following information is required to be collected at the baseline visit:

Patient Informed Consent Date (Enrollment Date)

Eligibility Verification (Inclusion/Exclusion Assessment)

Patient Demographics

Medications

Relevant Medical History

Device Characteristic (including presence of atrial lead, if applicable)

Device Interrogation (Initial and Final) and Save-to-media/USB

Device Disposition Log

Adverse Event Assessment
8.5.1.
Subject History
Demographic, medical history, and cardiac arrhythmia/intervention information will be collected at the 
Baseline Visit.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 22 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
8.5.2.
Prior and Concomitant Medications
There are no medications or treatments that are required for this study. In addition, there are no 
medications or treatments that are excluded from this study.
8.5.3.
Initial Interrogation and Save-to-media/USB
An initial device interrogation is recommended. If completed, save the data via save-to-media/USB and 
submit the data to Medtronic.
8.5.4.
Device Programming Prior to Installation of the TPD
The following device conditions must be satisfied before the TPD feature set can be installed on a 
device:

Device cannot have a projected longevity of less than 4 years

Must be one of the Evera MRI models found in Table 1 System Component Information

Must not have an active electrical reset
8.5.5.
TPD Download
The investigational TPD Software Application is used to install the TPD RAMware into an Evera MRI 
device.  The TPD Research System requires an access code to be entered before the investigational 
RAMware can be installed on the device.
The TPD Research System uses the source and range of one of the EGM channels (EGM1) and will lock 
the desired configuration for the TPD study.  The TPD Software Application will add the RVcoil-Can 
programmable option to EGM1 such that the TPD Software Application will properly display the EGM1 
source and EGM1 signal data. If the EGM1 source is programmed to something other than RVcoil-Can 
during the programmer session, the RAMware will program the EGM1 source to RVcoil-Can upon 
session end.
The EGM source TPD Research System is using (RVcoil-Can) is not an available option for EGM1 in the 
market-released software. Therefore, if the device with RAMware is interrogated by the standard 
market released Evera MRI 2090 programmer software, “???” will display for the EGM1 source.
The TPD Research System will not control the EGM2 source and range.  This EGM configuration is 
reserved for the Wavelet feature, and TPD will not impact this feature.  It is recommended that, during 
the study, the EGM2 configuration remains at nominal: Can to RVcoil.  
Refer to the TPD User Manual for instructions on how to download the TPD RAMware onto the 
Medtronic ICD.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 23 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
8.5.6.
Post-Download TPD Parameters
The functions of the installed TPD parameters are described in the TPD User Manual. 
8.5.7.
Final Interrogation and Save-to-media/USB
Perform an “Interrogate all” with the device using the TPD RAMware download. Save the data via save-
to-media and submit the data to Medtronic.
8.6.
Study Follow-up/Exit
Whenever possible, subjects should remain in the study for 365 days or until all data required to meet 
study objectives has been collected (whichever comes first). An in-office visit is required for study exit 
and must be completed within 400 days of TPD RAMware download to the device to ensure all required 
study data is collected and that the subject’s device is optimally programmed at the time of study exit. 
The list below outlines the required data to be collected at study exit:
•
Device Interrogation (Initial and Final) and Save-to-media/USB
•
Device Disposition 
•
RAMware Removal (In-Office)
•
Adverse Event Assessment
•
Exit CRF 
Table 3 Follow-Up/Exit Window
Window Start
Target
Window End
365 Days
383 Days
400 Days
If a subject fails to return for study exit before 400 days post-RAMware installation on their device, the 
TPD RAMware will self-terminate 400 days after installation. If the RAMware self-terminates, it is 
imperative that the subject’s device programming is reviewed and optimized as soon as possible to 
ensure optimal device performance.
8.6.1.
Initial Interrogation and Save-to-media/USB
It is recommended to complete an initial interrogation using the programmer. If completed, save the 
data via save-to-media/USB and submit the data to Medtronic.
8.6.2.
RAMware Removal
The investigational RAMware is intended to be uninstalled at study exit. Refer to the User Manual for 
instructions on how to remove the RAMware from the Medtronic ICD. 

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 24 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
8.6.3.
Uninstall Software from Programmer
The investigational TPD Software Application hosted on the Medtronic 2090 programmer will be 
uninstalled using the Desktop software maintenance functions after all TPD RAMware has been 
removed from the implantable devices and prior to study closure. 
8.6.4.
Final Interrogation and Save-to-media/USB
Perform a device interrogation by selecting “Interrogate All.” Save the data via save-to-media and 
submit the data to Medtronic.
8.6.5.
Device Programming Post TPD Removal
At the time of exiting the subject optimize device programming via market released software.
Patient Home Monitor parameter was programmed to “Yes” at the time of TPD installation, but will not 
revert to pre-study programming after Removal of TPD Feature Set.  Ensure this parameter is 
programmed appropriately at the study exit.
All Therapies in a Zone Exhausted for an Episode parameter was programmed to “On” at the time of TPD 
installation, but will not revert to pre-study programming after Removal of TPD Feature Set.  Ensure this 
parameter is programmed appropriately at the study exit.
Using the Non-TPD, Market Released Evera MRI programmer software application, choose and program 
an available option for the EGM1 source and range.  
Confirm the Monitored configuration is programmed as appropriate, since this may have been modified 
in response to the TPD Study configuration.
Confirm device programming on the Data Collection Setup screen.  
8.7.
Other Cardiovascular Visit
“Other Cardiovascular Visit” is defined as a cardiovascular visit not required by the protocol that occurs 
between enrollment and exit.
If such a visit occurs, the following information, if applicable is recommended to be collected. 
Data collected may include, but is not limited to:

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 25 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template

Device Interrogation and Save-to-media

Confirm TPD Parameters

System Modification, if applicable

Document any reportable AEs
8.8.
System Modifications
A system modification will be reported in the event the device and/or leads require invasive 
modification (e.g., generator or lead explant, generator or lead replacement, lead repositioning).  In the 
event of a system modification, the follow-up schedule for the subject will remain unchanged and will 
continue to be followed until the subject is exited. For a system modification, the following activities are 
required:

Complete a system modification eCRF

Initial Device Interrogation and Save-to-media 

Download of TPD RAMware, as applicable (e.g., ICD changeout for new Evera MRI device)

Final Device Interrogation “Interrogate All” and Save-to-media 
If the device is taken out of service (e.g., explanted) and there is a possible replacement Evera MRI at a 
later date, the subject should remain in the study if possible. If a replacement Evera MRI device is 
received, the TPD RAMware should be loaded on it, as applicable. If the device is taken out of service 
and a replacement will not be implanted or the replacement is not a study approved device, the subject 
will be exited from the study.
All explanted product (device, leads, etc.) should be returned to the respective manufacturer for analysis 
when permissible by local laws and regulations. 
In the event that a subject has a re-attempt after a previous unsuccessful system modification, the 
subsequent attempt(s) must be reported via eCRF as separate system modifications.
8.9.
Subject Consent
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. Additional 
information is found in Section 8.4.
8.10. Assessment of Safety
Medtronic has established procedures to ensure appropriate reporting of safety information, further 
detailed in Section 10.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 26 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
8.11. Recording Data
Data will be collected using Oracle Clinical, an electronic data management system for clinical studies.  
eCRF data will be stored in a secure, password-protected database which will be backed up nightly. 
More details are provided in Section 13.2.
8.12. Deviation Handling
The investigator may not deviate from the CIP, unless the deviation is necessary in an emergency 
situation to protect the rights, safety and wellbeing of the subject. Procedures for documenting, 
reporting, and analyzing of deviations should be included. Notification requirements and timeframes for 
reporting by region are included in Section 13.7.
8.13. Subject Withdrawal or Discontinuation 
A study exit eCRF is required for all subjects except in the case of death.  Prior to exiting a subject from 
the study, it is recommended to follow the subject until all AEs are resolved. Following exit, subjects will 
continue to receive standard medical care.  Upon exiting from the study, no further study data will be 
collected or study visits will occur for the subject.  Exited subjects will not be replaced with newly 
enrolled subjects.
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:

Study closure

Subject lost to follow-up (refer to Section 8.13.1)

Subject did not meet inclusion/exclusion criteria 

Subject did not provide consent or data use protection authorization

Subject chooses to withdraw (refer to section 8.13.2 for more information) 

Investigator deems withdrawal necessary (e.g., medically justified, inclusion/exclusion criteria 
not met)

Subject completed study

Medtronic may recommend subject exit at any time if the assessment of accumulated episodes 
per subject is high.
For study exit visits the following information is required:   

Document any reportable AEs (refer to section 10Error! Reference source not found.).

Perform a device interrogation and save on a USB flash drive.  Device interrogation data must be 
sent to Medtronic, with a copy being maintained at the site in the subject’s file.  A deviation is 
required if a device interrogation is missed. RAMware should be removed from the device and 
programming reviewed and optimized for the patient. 

Document the reason for subject exit or withdrawal.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 27 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
8.13.1.
Lost to Follow-Up
In the case that the subject is determined to be lost to follow-up, a minimum of two attempts to contact 
the subject must be documented.  The recommended method of contact is one letter and one phone 
record or two letters.  In addition, follow the regulations set forth by the governing IRB/EC. 
8.13.2.
Subject Withdrawal
A subject will be exited from the study in the event that he or she is unable to participate, expresses a 
desire to withdraw, or is unwilling to continue participation in the study.  In addition, a subject may be 
exited from the study if an investigator feels it is necessary to withdraw the subject from the study due 
to a medical condition, if the inclusion/exclusion criteria are not met, or other reason.  In such cases, the 
subject will be notified and provided an explanation regarding the reason for the study exit. If the TPD 
RAMware has been installed on the subject’s ICD, the subject should have the TPD RAMware removed,
and their device programming reviewed and optimized.
The subject should be informed that their future care or treatment will not be affected in any way as a 
result of choosing to not participate in this study.  Furthermore, alternative treatments and medical 
consequences of exiting the study should be discussed with the subject.  Any significant new findings 
related to the study that may develop, which may relate to the subject’s willingness to continue 
participation, should be communicated to the subject.
9. Risks and Benefits
9.1. Potential Risks
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of the 
product, from the research and development phase through the study phase. 
Although the rate of occurrence is expected to be low, a detailed review of potential hazards associated 
with the TPD Research System identified possible scenarios that could occur. 
First and foremost, the study personnel and a Medtronic representative will be properly trained on the 
investigational TPD system and study protocol. In addition, the TPD User Manual will provide the proper 
instructions. Risks normally associated with device follow-ups will be minimized by selecting 
investigators that have demonstrated previous experience with the programming, interrogation, and 
monitoring of these devices. 
The TPD Research System will cause an increase in current drain on the device battery resulting in a 
device longevity reduction of six months or fewer during 400 days of TPD operation, with 95% of 
patients having less than 5.33 months of reduction. 

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 28 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
Because the TPD feature changes the source and range of one of the EGM channels, the EGM source 
value will appear as invalid (“???”) to a clinician using the market released software. This could present a 
risk to the subject by delaying appropriate action when receiving emergency care. 
To transmit data in a timely manner, the TPD feature uses an existing CareAlert to trigger data 
transmission. This may cause additional burden when triaging CareLink data. This could present a risk to 
the subject by being called in for in-office follow-up when it is not necessary. This could also present the 
risk of becoming desensitized to the CareAlert with a potential to miss a non-study cause for the alert. In 
addition, the CareAlert will be reset by the TPD feature once it is transmitted to the monitor. As such, 
the alert may not be presented as being active when interrogated by a programmer, either by study 
personnel or other clinicians.
There may be additional risks related to study participation that are unknown at this time. 
9.2. Risk Minimization
Medtronic has minimized the risks to the subject by the following:

Implementing quality control measures into development and production processes.

Providing guidelines for subject selection and evaluation, and subject inclusion and exclusion 
criteria.

Providing adequate instructions and training.

Selecting Investigators that have demonstrated previous experience with the programming, 
interrogation, and monitoring of pacemaker devices.

After enrollment in the clinical study, at each protocol required follow-up, the Investigator must 
evaluate the subject’s health, assess for any adverse events, and interrogate the study device to 
verify appropriate study device function.

Providing notification on the market released software indicating the subject’s participation in a 
study.

Providing the subject with a card indicating participation in the study and impact to the 
displayed data

If the subject is lost to follow-up, the investigational software system has an internal timer
that automatically deactivates the software 400 days after the date of installation.

Additionally, subjects cannot be in concurrent studies as the device will allow the
download and operation of only one investigational feature at a time.
9.3. Potential Benefits
The TPD data collection RAMware download in the Evera MRI device offers no direct/immediate benefit. 
The potential benefits of having the TPD data collection RAMware download in the Evera MRI device 
include:

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 29 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template

Closely monitoring the patient which may lead to more prompt follow-up following clinical 
events.

Additionally, information collected from this study may assist in the design and improvements of 
new product(s)/therapy(ies) and/or instructions for use. 
9.4. Risk-Benefit Rationale
All identified risks as described in the previous sections have been mitigated to as low as possible. While
there may be minimal or no benefit of participation in the study, there is the potential to aid in 
collecting information that may lead to more prompt follow-up following clinical events.
10. Adverse Events and Device Deficiencies
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are 
crucial for the protection of subjects. Medtronic has established procedures to ensure appropriate 
reporting of safety information.
10.1. Definitions/Classifications
10.1.1.
Adverse Event Definitions
Adverse Event definitions are provided in Table 4 Adverse Event and Device Deficiency Definitions. To 
ensure that all AEs that are potentially relevant are collected, the following will be collected throughout 
the study duration, starting at the time of signing the Informed Consent Form:

All potential TPD RAMware Related AEs

All potential TPD Software Application Related AEs

All subject deaths (regardless of relatedness)
Reporting of these events to Medtronic will occur on an AE Form, including date of AE, treatment, 
resolution, assessment of both the seriousness of the AE and the relatedness.  Each AE must be 
recorded on a separate AE eCRF. 
For AEs that require immediate reporting (see Table 6 Reporting Requirements) initial reporting may be 
done by phone, fax, or on the eCRF completing as much information as possible. The original completed 
AE eCRF must be submitted to Medtronic as soon as possible.  
Each AE must be reported separately. Any medication, whether cardiovascular or not, associated with 
the treatment of an adverse event must be reported on the medication log. 
Subject deaths are also required to be reported. Refer to Section 10.4 for Subject Death collection and 
reporting requirements. 

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 36 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
10.5. Product Complaint Handling
In geographies where devices are market-released, product complaint reporting is applicable. This 
includes when an AE is related to a market-released device during the study. The reporting of product 
complaints is not part of the clinical study and should be done in addition to the Clinical 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 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. 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 the withdrawal of a device from the market by the 
manufacturer.

A serious deterioration in the state of heath includes:

Life-threatening illness or injury, or

Permanent impairment of a body structure function or a body function, or

In-patient or prolonged hospitalization, or

Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function.
11. Statistical Design and Methods
The purpose of the study is data collection for future research and development. Therefore, the TPD 
study is not powered to formally test a hypothesis.
12. Ethics
12.1. Statement(s) of Compliance 
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as good clinical practice (GCP). GCP includes review and approval by an independent IRB/EC 
before initiating and obtaining and documenting the freely given patient informed consent of a subject 
before initiating the study.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 37 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
•
The study will be conducted according to federal, national and local laws, regulations, standards, 
and requirements where the study is being conducted. The principles of the Declaration of 
Helsinki have been implemented through the patient informed consent process, IRB/EC 
approval, study training, clinical trial registration, preclinical testing, risk-benefit assessment, 
and publication policy. In the US, the study will be conducted in compliance with 21 CFR Parts 
11, 50, 54, 56 and 812.2(b)(abbreviated requirements).

In Hong Kong, the study will be conducted in compliance with the Declaration of Helsinki version 
2013
o
The study will be publicly registered prior to first enrollment in accordance with the 
2007 Food and Drug Administration Amendments Act (FDAAA PL 110-85, section 810(a)) 
and Declaration of Helsinki on http://www.clinicaltrials.gov.
o
Approval of the CIP and CIP amendments is required from the following groups prior to 
any study procedures at a study center:
•
Medtronic
•
PIs (where required by local law/regulations)
•
Geography-specific regulatory authorities (if regulatory approval is required) 
•
An Independent Ethics Committee
13. Study Administration
13.1. Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this clinical study.  Trained 
Medtronic personnel or delegates appointed by Medtronic may perform study monitoring at the study 
site in order to ensure that the study is conducted in accordance with the CIP, the Clinical Trial 
Agreement or Work Order, and applicable regulatory and local requirements. Medtronic, or delegates, 
must therefore be allowed access to the subjects’ case histories (clinic and hospital records, and other 
source data/documentation) upon request as per the Informed Consent Form and Authorization to Use 
and Disclose Personal Health Information/Research Authorization/other privacy language (data 
protection authorization) as required by law and Clinical Trial Agreement or Work Order.  The PI should 
also be available during monitoring visits. 
Monitoring for the study will be done in accordance with the study-specific monitoring plan.
Monitoring visits may be conducted periodically to assess site study progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to IRB/EC approval and review of 
the study, maintenance of records and reports, and review of source documents against subject eCRFs. 
Monitors review site regulatory and study compliance by identifying findings of non-compliance and 
communicating those findings along with recommendations for preventative/corrective actions to site 
personnel.  Monitors may work with study personnel to determine appropriate corrective action 
recommendations and to identify trends within the study or at a particular site. Regulatory documents 
may be reviewed at each study site.  
The frequency of monitoring visits may be based upon subject enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, findings from previous monitoring visits 
and any suspected inconsistency in data that requires investigation.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 38 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
13.2. Data Management
Data will be collected using Oracle Clinical, an electronic data management system for clinical studies.  
eCRF 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.  At the end of the study, the data will be frozen and will be retained indefinitely by Medtronic.
All records and other information about subjects participating in this study will be treated as 
confidential. Data will be transferred and processed by Medtronic or a third party designated by 
Medtronic in a key coded form, unless it’s impossible to make it anonymous, for instance, where the 
subject’s name cannot be removed from the data carrier.
Procedures in the CIP require source documentation.  Source documentation will be maintained at the 
site. Source documents, which may include worksheets, patient medical records, echo data, 
programmer printouts and device interrogation files, must be created and maintained by the 
investigational site team. 
The data reported on the eCRFs shall be derived from source documents and be consistent with these 
source documents, and any discrepancies shall be explained in writing. The eCRF may be considered the 
source for the following data collection elements:
•
Enrollment Notification
o
Site assigned patient reference
•
Baseline
o
Administrative information
•
Adverse Event eCRF
o
Date study site became aware of event
o
Relatedness of adverse event
•
Device Deficiency eCRF
•
System Modification
o
Reason for system modification
•
Deviations
o
Reason for Deviation
Save-to-media data collected via CareLink visits will be sent to Medtronic. Upon receipt, device data will 
be maintained within a Medtronic device database and retrieved for analysis and reporting.
13.3. Direct Access to Source Data/Documents 
The sponsor or a regulatory authority may audit/inspect and/or monitor the study site to evaluate the 
conduct of the study. The Clinical Investigator(s)/institution(s) shall allow study related monitoring, 
audits, IRB/EC 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.

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 39 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
13.5. Liability
Medtronic maintains appropriate Clinical Trial liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a Clinical Trial insurance statement/certificate will be provided to the Ethics Board.
13.6. CIP Amendments
Approval of subsequent revisions to the CIP is required at each study site from the following groups 
prior to implementation of the revised CIP at the site:
•
Medtronic
•
PIs (where required by local law)
•
An independent IRB/EC.
If a CIP amendment occurs, site personnel will need to be re-trained as necessary and will need to 
submit any changes to their IRB/EC.
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, should be 
kept in the Investigator Site File (i.e., the study binder provided to the Investigator) or Subject Study Binder. eCRFs 
must be maintained and signed electronically by an Investigator within the electronic data capture system during 
the study. Medtronic will provide electronic copies of CRFs (i.e. Patient Data Report) from the database upon 
request following study closure. 
The following records are subject to inspection and must be retained for a period of two years (or longer as local 
law/regulation or hospital administration requires) after study conclusion. Measures shall be taken to avoid loss or 
premature destruction.

All correspondence between the IRB/EC, sponsor, monitor, and/or the Investigator that pertains to the 
investigation, including required reports. 

Subject’s case history records, including: 
o
Signed and dated Informed Consent Form, in accordance with local requirements 
o
Observations of adverse events/Unanticipated adverse device effects/device deficiencies
o
Medical history
o
Baseline and follow-up data (if applicable)
o
Documentation of the dates and rationale for any deviation from the protocol

Electronically signed and dated eCRFs and a blank set of eCRFs where required by local law

All approved versions of the CIP and IC Form 

Signed and dated CTA or WO

IRB/EC approval documentation. Written information that the Investigator or other study staff, when a 
member of the IRB/EC, did not participate in the approval process. Approval documentation must include the 
IRB/EC composition, where required per local law.  

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 41 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
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. Except in such emergency, prior approval is required 
for changes in the plan or deviations. If the deviation may affect 
the scientific soundness of the plan or the rights, safety, and 
welfare of the subjects, the deviation must be approved by 
Medtronic and the IRB/EC. If the deviation does not affect these 
issues then only Medtronic must approve it. (21 CFR 
812.150(a)(4))
Final report
Sponsor and
IRBs/ECs
This report must be submitted within 3 months of study 
completion or termination of the investigation or the 
Investigator’s part of the investigation. (21 CFR 812.150(a)(6))
Failure to obtain 
informed consent prior 
to investigational 
device use
Sponsor and
IRB/EC
If an investigator uses a device without obtaining informed 
consent, the investigator shall report such use within 5 working 
days after device use. (21 CFR 812.150(a)(5))
Other
IRB/EC 
An Investigator shall, upon request by a reviewing IRB/EC or any 
other regulatory agency, provide accurate, complete, and 
current information about any aspect of the investigation. (21 
CFR 812.150(a)(7))
Reports are subject to inspection and to the retention requirements as described above for Investigator 
records. Investigator reporting requirements for safety data are listed in Table 6 Reporting 
Requirements. 
13.7.3.
Sponsor Records
Medtronic shall maintain the following accurate, complete, and current records including, but not limited to:

All correspondence which pertains to the clinical study

Executed Clinical Trial Agreement

Current curriculum vitae of PIs 

Electronically signed and dated eCRFs

All approved informed consent templates, 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

Names of the institutions in which the clinical study will be conducted

Names/contact addresses of monitors

Monitoring reports (interim monitoring visit reports, follow-up letters, and close-out visit reports)

Site qualification visit reports

Statistical analyses and underlying supporting data

Final report of the clinical study

The approved Clinical Investigation Plan, study related reports, and revisions

Documentation of delegated tasks

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 44 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template
closure process is complete. Upon study closure, subjects should be managed and followed per 
physician discretion.
13.8.2
Early Termination or Suspension
Early Termination of the Study is the closure of a clinical study that occurs prior to meeting defined 
endpoints. This is possible for the whole study or a single site. In the event the whole study or a single 
site is terminated, subjects will be exited. Study Suspension is a temporary postponement of study 
activities related to enrollment and distribution of the product. This is possible for the whole study or a 
single site.  
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 
Investigator/Site Termination or Suspension
Possible reasons for Clinical Investigator or site termination or suspension include but are not limited to:

Failure to obtain initial 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 with regulations and the terms of the CTA or WO (e.g. failure to 
submit data in a timely manner, failure to follow-up on data queries and monitoring 
findings in a timely manner, etc.) 

IRB/EC suspension of the site

Fraud or fraudulent misconduct is discovered (as defined by local law and regulations) 

Investigator request (e.g. no longer able to support the study) 
13.8.3
Procedures for Termination or Suspension
Medtronic-Initiated and Regulatory Authority-Initiated

Medtronic will promptly inform the Clinical Investigators of the (early) termination or 
suspension and the reasons and inform the regulatory authority(ies) where required

In the case of study termination or suspension for reasons other than a temporary 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

Tachy Prediction Download Clinical Investigation Plan 
Version 1.0
Page 45 of 51
Medtronic Confidential
This document is electronically controlled
056-F275, v3.0 Clinical Investigation Plan Template

In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights, and welfare
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
IRB/EC-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) 

The Investigator will promptly inform the subjects, and/or the personal physician of the 
subjects, with the rationale for the study termination or suspension
14. Publication and Use of Information
In the event a publication committee is formed during the course of the study, a publication plan will be 
developed which may include, but is not limited to, description of committee member criteria and 
management of publications.  MDT will be furnished with a copy of any proposed publication for review 
and comment prior to submission for publication.  Manuscripts will be forwarded to MDT at least thirty 
(30) days prior to submission and abstracts at least seven (7) days prior to submission.  At the expiration 
of the thirty (30) or seven (7) day period, the investigator may proceed with submission for publication. 
In addition, each investigator must agree that no publications will be submitted that will jeopardize a 
multi-center publication and all clinical data gathered during the study will be pooled into a common 
database that is the property of MDT. 
The first author will be selected on the basis of the following:
•
A significant contribution to the design of the clinical study and/or development of the product
•
A significant contribution to subject enrollment in the clinical study
•
High procedure volume and quality of data as determined by the clinical study requirements.