Therapy Coil Electrogram Collection Study
Conditions: Lead Insulation Failure
Sponsor: Medtronic BRC

   
 
 
Therapy coil Electrogram Collection Study 
(TEC Study) 
 
Clinical Investigation Plan 
 
Version 2.0  
27 AUG 2014 
 
Sponsor 
Bakken Research Center BV, Medtronic 
Endepolsdomein 5, 6229 GW Maastricht, 
The Netherlands  
 
 

 
 
Clinical Investigation Plan 
 
 
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Approval sheet 
 
Author: 
 
 
 
Carolina Moltó Puigmartí 
 
Scientist 
 
(name) 
 
(functional role) 
 
 
 
 
 
 
(signature)  
 
(date) 
 
 
Author: 
 
 
 
 
Bruce Gunderson 
 
Sr. Prin Scientist 
 
(name) 
 
(functional role) 
 
 
 
 
 
 
(signature)  
 
(date) 
 
Clinical Management: 
 
 
 
Rogier Receveur 
 
Sr. Engineering Manager,  
Research and Technology  
 
(name) 
 
(functional role) 
 
 
 
 
 
 
(signature)  
 
(date) 
 
 
 
Regulatory Affairs:  
 
 
Evelien Scheepers 
 
Regulatory Affairs Specialist,  
 
 
Regulatory Affairs International West 
 
(name) 
 
(functional role) 
 
 
 
 
 
 
(signature)  
 
(date) 
 
 
 
 
Statistician: 
 
 
James Johnson 
 
Sr Prin Statistician 
 
(name) 
 
(functional role) 
 
 
 
 
 
 
(signature)  
 
(date) 
 
 

 
 
Clinical Investigation Plan 
 
 
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Change History record 
 
CIP Change History 
Version 
Summary of Changes 
Author 
1.0 
Initial Release 
Teena Bonizzi 
2.0 
• Any reference to the inclusion criterion ”less than full 
energy shock delivered” replaced with “less than 50% of 
programmed shock energy delivered”. 
• Any reference to the inclusion criterion ”Abrupt high voltage 
impedance change (75% increase or 25% decrease from 
baseline)” replaced with ”Abrupt high voltage impedance 
change (more than 75% increase or more than 25% 
decrease from baseline)”. 
• Section C.8: names of investigators have been removed to 
be provided under separate cover. 
• Section E.5: memory cards provided with Holters have 
been mentioned. 
• Section E.5: clarification made on the way of storing and 
tracking Holters and flashcards. 
• Section F.3: mention to “pre-paid postage bags” removed. 
• Section G.3.2: added requirement for the investigator to 
assess whether or not to continue the study at the 
respective investigation site. 
• Section I.3.2: mention to submission of AE and death forms 
has been removed as no AE and death forms will be used 
for this study.  
• Section I.3.2: added that Investigator will submit final report 
to EC/IRB if required. 
• Table 3 on section I.3.4: reference to the correct section 
(F.6.2) regarding Vigilance Reporting has been given.  
• Appendices: list of abbreviations updated. 
• Appendices: List of participating investigation sites and 
investigators has been removed from appendix and will be 
provided under separate cover. 
• Appendices: Case Report Forms section in the appendix 
has been added, with mention that Case Report Forms will 
be provided under separate cover. 
• Appendices: Patient Informed Consent Master version has 
been removed from appendix and will be provided under 
separate cover. 
Carolina Moltó 
Puigmartí 
 

 
 
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TABLE OF CONTENTS 
 
A 
SYNOPSIS ....................................................................................................................... 7 
B 
GENERAL INFORMATION .......................................................................................... 8 
B.1 
Introduction ......................................................................................................................... 8 
B.2 
Device information .............................................................................................................. 9 
B.3 
Digital Holter ..................................................................................................................... 10 
C 
STUDY PLAN ............................................................................................................... 10 
C.1 
Study objectives................................................................................................................ 10 
C.1.1 Primary objective .................................................................................................... 10 
C.1.2 Secondary objectives ............................................................................................. 10 
C.2 
Clinical endpoints.............................................................................................................. 10 
C.3 
Study hypothesis .............................................................................................................. 11 
C.4 
Study population ............................................................................................................... 11 
C.5 
Study design ..................................................................................................................... 11 
C.6 
Randomization and blinding ............................................................................................. 11 
C.7 
Sample size ...................................................................................................................... 12 
C.8 
Number of investigation sites and study duration ............................................................. 12 
D 
SUBJECT SELECTION ................................................................................................ 12 
D.1 
Inclusion criteria ................................................................................................................ 12 
D.2 
Exclusion criteria............................................................................................................... 13 
E 
STUDY PREPARATION PROCEDURES ................................................................... 13 
E.1 
Investigator / Investigation site selection .......................................................................... 13 
E.1.1 Clinical Investigation Agreement ............................................................................ 13 
E.1.2 Curriculum Vitae ..................................................................................................... 13 
E.2 
Ethics ................................................................................................................................ 14 
E.2.1 EC/IRB approval ..................................................................................................... 14 
E.2.2 Informed consent process ...................................................................................... 14 
E.2.3 Revisions in Patient Information and Informed Consent Form .............................. 15 
E.2.4 Regulatory notification / approval ........................................................................... 15 
E.3 
Regulatory compliance ..................................................................................................... 15 
E.4 
Training requirements ....................................................................................................... 15 
E.5 
Study materials and study-specific equipment ................................................................. 15 
F 
STUDY METHODS ...................................................................................................... 16 
F.1 
Screening .......................................................................................................................... 16 
F.2 
Point of enrollment ............................................................................................................ 16 
F.3 
Evaluation Visit ................................................................................................................. 16 
F.4 
Lead Status and Study Exit Form ..................................................................................... 17 

 
 
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F.5 
Data collection requirements ............................................................................................ 18 
F.6 
Post Market Surveillance .................................................................................................. 18 
F.6.1 Definition/classification ........................................................................................... 18 
F.6.2 Reporting of product complaints ............................................................................ 18 
F.7 
Subject accountability ....................................................................................................... 19 
F.8 
Study deviations and CIP changes................................................................................... 19 
F.8.1 Request for approval of study deviations ............................................................... 19 
F.8.2 Reporting requirements for study deviations.......................................................... 20 
F.8.3 Amendments to the Clinical Investigation Plan ...................................................... 20 
G 
QUALITY CONTROL PROCEDURES ....................................................................... 20 
G.1 
Procedures for data  management ................................................................................... 20 
G.1.1 Data collection ........................................................................................................ 20 
G.1.2 Source data to be directly recorded on the Case Report Forms............................ 20 
G.1.3 Data review and processing ................................................................................... 21 
G.2 
Monitoring procedures ...................................................................................................... 21 
G.2.1 Accessibility of investigation site staff and study materials .................................... 21 
G.2.2 Audits and investigation site inspections ................................................................ 21 
G.3 
Study suspension or early termination ............................................................................. 22 
G.3.1 Study suspension or early termination ................................................................... 22 
G.3.2 Investigation site suspension or early termination ................................................. 22 
G.4 
Study close out ................................................................................................................. 22 
H 
DATA ANALYSIS AND REPORTING ....................................................................... 22 
H.1 
Analysis of clinical data .................................................................................................... 22 
H.2 
Publication Policy.............................................................................................................. 23 
I 
STUDY MANAGEMENT ............................................................................................. 23 
I.1 
Study staff ......................................................................................................................... 23 
I.2 
Advisory committees ........................................................................................................ 23 
I.2.1 Data Monitoring Committee.................................................................................... 23 
I.3 
Records and reports ......................................................................................................... 24 
I.3.1 Investigator records ................................................................................................ 24 
I.3.2 Investigator reporting responsibilities ..................................................................... 24 
I.3.3 Sponsor records ..................................................................................................... 25 
I.3.4 Sponsor reporting responsibilities .......................................................................... 26 
I.3.5 Record retention ..................................................................................................... 27 
I.4 
Miscellaneous ................................................................................................................... 27 
I.4.1 Insurance ................................................................................................................ 27 
I.4.2 Subject confidentiality ............................................................................................. 27 
J 
RISKS AND BENEFITS ............................................................................................... 27 

 
 
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J.1 
Anticipated Clinical Benefits ............................................................................................. 27 
J.2 
Risks ................................................................................................................................. 27 
K 
REFERENCES ............................................................................................................... 27 
L 
APPENDICES ................................................................................................................ 28 
L.1 
Names and addresses ...................................................................................................... 28 
L.2 
Abbreviations .................................................................................................................... 28 
L.3 
Case Report Forms…………………………………………………………………………….. 28 
L.4 
Patient Informed Consent Master version ........................................................................ 28 
 

 
 
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A 
SYNOPSIS 
Title 
Therapy coil Electrogram Collection (TEC) Study. 
Purpose 
Collect electrograms (EGM) from patients at risk of a suspected insulation failure to the high 
voltage portion of the defibrillator lead and evaluate the electrograms for unique noise 
characteristics. 
Design 
Prospective non-randomized, multicentre, post market release study. 
Medical device 
Patients previously implanted with a commercially released Medtronic defibrillator device (ICD 
or CRT-D) connected to a market released St. Jude Medical Riata or Durata lead within 
indicated use.   
Objectives and endpoints 
The primary objective is to report the number of patients with a unique noise characteristic (e.g. 
high frequency spike) on their Far-field EGM (RV coil to SVC coil or RV coil to Can) and a high 
voltage lead failure within 1 month.  
The secondary objectives of this study are to: 
• 
Compare the proportion of patients with a unique noise characteristic (e.g. high 
frequency spike) on their Far-field EGM (RV coil to SVC coil) and a high voltage lead 
failure within 1 month to those patients with a high frequency spike and no lead failure 
within 1 month. 
• 
Identify additional characteristics in the Far-field EGM (e.g. RV coil to SVC coil) that 
may help identify patients at risk of a high voltage ICD lead failure. 
The clinical endpoint is an abnormal EGM noise signature, one instance of a noise spike during 
the 24 hour recording will be sufficient to classify the noise signature as present. 
Subject population 
It is expected only two centers will participate in this study as the population of interest is rare. 
During routine follow up, if a patient is suspected to be at risk for a high voltage lead failure they 
will be invited to participate in the study. It is estimated that approximately 50 patients will meet 
these criteria over 2 years and be enrolled in the study. 
Treatment 
All patients will have been previously implanted with an ICD or CRT-D and be attending a 
routine follow up visit. As part of the study patients will be asked to wear a 24 hour Holter. All 
treatment decisions will be at the discretion of the physician in accordance with local practice. 
Inclusion criteria 
• 
Subject is willing to sign and date the study Informed Consent form 
• 
Subject is at least 18 years of age (or older, if required by local law) 
• 
Subject is willing and able to wear a Holter monitor for up to 24-hours. 

 
 
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• 
Subject has a Medtronic ICD or CRT-D device connected to a St Jude Medical Riata or 
Durata lead AND  
One of the following events occurs: 
1) Externalized conductor with normal pacing and sensing electrical 
characteristics; or 
2) ICD or CRT-D change out with St Jude lead and normal pacing and sensing 
electrical characteristics; or 
3) Abnormal device diagnostic for high voltage portion of lead including 
• 
Abrupt high voltage impedance change (more than 75% increase or more 
than 25% decrease from baseline) 
• 
Non-physiologic noise on a high voltage EGM 
• 
 Less than 50% of programmed shock energy delivered 
Exclusion criteria 
Subjects who meet any of the following exclusion criteria are not eligible to participate in the 
study: 
• 
Subject has medical conditions that would limit study participation (per physician 
discretion) 
• 
Subject is enrolled in one or more concurrent studies that would confound the study 
results of this study as determined by Medtronic 
B 
GENERAL INFORMATION 
B.1 Introduction 
Lead problems can manifest themselves in multiple ways, including out-of-range impedance, 
failure to defibrillate, oversensing and loss of capture. Currently, there are limited means for 
identifying situations due to an insulation breach. The current method monitors for an 
abnormal high voltage impedance value which in many cases does not occur.  There is a 
clinical need for detecting insulation concerns involving the therapy coil conductors.  
 
ICD lead failures involving the insulation of the high voltage portion of the lead may cause an 
electrical short when delivering a high voltage shock.  Anecdotal data has been reported 
which shows that the St Jude Medical Riata lead can short and fail to deliver the full 
programmed shock energy [1-3].  In other reports, the far-field electrogram including the 
shocking electrogram shows unique noise spikes [3,4]. Since this electrogram is rarely used 
for sensing and detection, the noise is rarely observed. It is hypothesized that a far-field 
electrogram, specifically the RVcoil to SVCcoil or RVcoil to Can, has a high probability of 
showing noise for an insulation break.   
 
A Holter monitor (DR220, Northeast Monitoring, Inc, Maynard, MA) has the capability to 
continuously record multiple electrograms from a Medtronic device. The goal is to acquire 
electrogram recordings from patients who may be at risk for a high voltage lead failure.  The 
probability of a high voltage lead failure is low with literature containing only anecdotal cases 
of high voltage conductor failure. Because of this we will be studying a specific population 
(Medtronic defibrillator device connected to a St. Jude Medical Riata or Durata lead) to enrich 

 
 
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the sample population. In December 2010, St Jude Medical issued an advisory regarding lead 
abrasion failures in the Riata leads (Kneller, 2012).  
 
Because these failures are difficult to predict and may not show early electrical warning signs, 
the patients that will be invited to participate will be those with the unique device and lead 
configuration and have an increased probability of a lead failure. The Far-field EGMs (see 
RVcoil to SVCcoil EGMs in Figure 1) and the lead status at 1 month will be used to evaluate 
the feasibility of differentiating between a lead failure and intact lead. 
 
 
Figure 1. Schematic of Far-field and Near-field EGMs 
B.2 Device information 
The study will be conducted in subjects previously implanted with a currently commercially 
available Medtronic ICD or CRT-D device. The components of these devices consist of:  
• 
Market-released Medtronic ICD or CRT-D device 
• 
Market-released Medtronic Model 2090 Series programmer - The Medtronic Programmer 
(Model 2090 with FullView software or later Medtronic releases) is used to program the 
devices to detect and treat arrhythmias with various pre-specified characteristics. In 
addition, the programmer allows the physician to view, save, and print the records 
currently held within the devices. 
Instructions for use of the devices are provided in their respective manuals of use. Labeling is 
available in local language. 
Subjects will also be wearing a St Jude Medical Riata or Durata high voltage lead which is 
market-released.  

 
 
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B.3 Digital Holter 
The digital Holter model DR220 with market-release, manufactured by NorthEast monitoring, 
Inc. is an external, battery-powered, ambulatory recorder designed to record ECG and 
telemetered data from an implanted Medtronic device. Digital Holter monitor recordings allow 
an extensive evaluation of rhythm variations by storing continuous electrogram (EGM), 
electrocardiogram (ECG) and extended marker channel information. Data from the Holter will 
be downloaded into a chronologically readable format and analyzed off-line. Only one ECG 
signal (using 3 electrodes) will be used.  
 
C 
STUDY PLAN 
C.1 Study objectives 
The purpose of this study is to collect electrograms from patients at risk of a suspected 
insulation failure to the high voltage portion of the defibrillator lead and evaluate the 
electrograms for unique noise characteristics.  
C.1.1 
Primary objective 
The primary objective is to report the number of patients with a unique noise characteristic (e.g. 
high frequency spike) on their Far-field EGM (RV coil to SVC coil or RV coil to Can) and a high 
voltage lead failure within 1 month.  
 
C.1.2 
Secondary objectives 
The secondary objectives of this study are to: 
• 
Compare the proportion of patients with a unique noise characteristic (e.g. high 
frequency spike) on their Far-field EGM (RV coil to SVC coil) and a high voltage lead 
failure within 1 month to those patients with a high frequency spike and no lead failure 
within 1 month. 
• 
Identify additional characteristics in the Far-field EGM (e.g. RV coil to SVC coil) that 
may help identify patients at risk of a high voltage ICD lead failure. 
 
C.2 Clinical endpoints 
The clinical endpoint is an abnormal EGM noise signature. Abnormal noise is defined as an 
inflection from the standard R-wave, T-wave, and isoelectric line of a Far Field-EGM.  The Far 
Field-EGM is susceptible to low amplitude myopotentials which would be considered normal.  
An example of abnormal noise is in Figure 2 below with asterisks showing the positive noise 
spike during the normally flat isoelectric line of the RVcoil to SVC EGM signal.  This is one 
example and it is unknown whether all lead failures exhibit this same signature.   The noise 
signature will be considered present if one instance is observed during the 24 hour recording. 

 
 
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Figure 2. Example of the positive noise spike during the normally flat isoelectric line of the 
RVcoil to SVC EGM signal. 
 
C.3 Study hypothesis 
The study hypothesis is that 10 out of the 50 patients will have a high voltage lead failure, of 
which 5 of these will also have an abnormal noise, manifesting as a high frequency spike. 
C.4 Study population 
Patients with a Medtronic ICD or CRT-D and St. Jude Riata or Durata lead will be identified 
during pre-screening.  The study population of interest are those patients that satisfy one of 3 
inclusion criteria (abnormal device diagnostic such as abnormal impedance, abnormal 
fluoroscopic image, or ICD/CRT-D change out). 
C.5 Study design 
Prospective, non-randomized, multicentre, post market release study. The study will take place 
in Slovakia at two investigation sites. 
C.6 Randomization and blinding 
This is an observational study, no randomization will be used in this study. Evaluation of the 
EGM signals will be done centrally at Medtronic and the scientist determining the clinical 
endpoint (i.e. an abnormal EGM noise signature) will be blinded from the lead status during 
evaluation of the EGMs Additionally the physician will be blinded from the scientist’s evaluation 
of the Holter EGM during the study.  

 
 
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C.7 Sample size 
It is estimated that a population of 300 patients with the required combination of device and 
lead exist in Europe. Over a two year period, we expect approximately 50 patients to fulfill the 
inclusion criteria and provide analyzable Holter data. In the unlikely situation that Holter data 
from a patient is not analyzable due to signal quality they will be replaced by another patient. 
With data from these 50 patients we estimate 10 patients will have a high voltage lead failure of 
which 5 will have the unique high frequency spike. In the 40 patients without a high voltage lead 
failure we estimate 1 may also have the unique high frequency spike.  
Using a Fisher’s exact test, assuming a two-sided alpha of 0.5 we will be able to detect 
differences with power greater than 80%.  
Additionally with an estimated proportion of patients with the unique noise characteristic and a 
high voltage lead failure of 10%, 50 patients will provide a precision of +/- 7% with a confidence 
interval of 90%.  
 
C.8 Number of investigation sites and study duration 
It is anticipated that two sites will participate in this study. The first site will be the National 
Institute of Cardiovascular Diseases, Department of Arrhythmias and Cardiac Pacing, 
Bratislava, Slovakia. The second site will be the Middle Slovakia Institute of Cardiovascular 
Disease, SUSCCH a.s, Banska Bystrica, Slovakia. These sites were chosen because they 
have a unique, large pool of patients with Medtronic devices connected to St. Jude Riata leads. 
A list of investigators will be kept under separate cover.  
There will be no upper limit of subject enrollment for each investigator. Once 50 patients with 
analyzable data have been enrolled the study will stop. There will be no minimum limit that 
each investigator must enroll, however it is expected that sites will have at least 100 suitable 
patients (i.e. patients with a Medtronic ICD or CRT-D and St Jude lead) in their referring area. 
We estimate that at least 200 patients will need to be screened to identify at least 50 patients 
who fulfill the inclusion criteria.  Assuming approximately 2 patients presenting per month the 
study is expected to last 2 years. This estimate will be evaluated after 6 months and 
modifications to the study may be made if assumptions are inaccurate.  
Once patients have fulfilled the inclusion criteria they will be invited to participate in the study. 
Participation will involve wearing a Holter monitor for 24 hours. A 24 hour Holter is required to 
allow a sufficient amount of time for an abnormality to be observed on the EGM. One month 
after the return of the Holter the physician will be asked to complete a study exit form, this form 
will collect the current status of the lead and information from any additional tests that were 
performed. The patient is not required to be present when the physician completes the study 
exit form.  
 
D 
SUBJECT SELECTION 
D.1 Inclusion criteria 
• 
Subject is willing to sign and date the study Informed Consent form 
• 
Subject is at least 18 years of age (or older, if required by local law) 
• 
Subject is willing and able to wear a Holter monitor for up to 24-hours. 
• 
Subject has been implanted with a Medtronic ICD or CRT-D device and a St. Jude 
Medical Riata or Durata lead and satisfy one of three conditions: 

 
 
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1. Externalized conductor with normal P/S electrical characteristics, or 
2. ICD/CRT-D change out and normal P/S electrical characteristics, or 
3. Abnormal device diagnostics for high voltage portion of lead 
▪ 
Abrupt HV impedance change (more than 75% increase or more than 
25% decrease from baseline) 
▪ 
Non-physiologic noise on HV EGM 
▪ 
Less than 50% of programmed shock energy delivered 
D.2 Exclusion criteria 
Subjects who meet any of the following exclusion criteria are not eligible to participate in the 
study: 
• 
Subject has medical conditions that would limit study participation (per physician 
discretion) 
• 
Subject is enrolled in one or more concurrent studies that would confound the study 
results of this study as determined by Medtronic 
E 
STUDY PREPARATION PROCEDURES 
E.1 Investigator / Investigation site selection 
An investigator/investigation site may be included in the investigation if the 
investigator/investigation site complies with the following requirements:  
 
• 
Investigator has education / experience in the field of the research (implantable cardiac 
rhythm devices and cardiac rhythm disturbances) 
• 
The center has adequate resources, facilities and equipment at the center to meet the 
expected enrollment rate. Calibration and maintenance of equipment will be performed as 
per hospital practice and the responsibility of the investigator. 
• 
A quiet room suitable for attaching the Holter to the subject. 
• 
The investigator/center has at least 100 patients with the combination of Medtronic ICD or 
CRT-D and St Jude Medical Riata or Durata in their referring area.  
• 
Investigator has experience in conducting clinical research trials. 
E.1.1 
Clinical Investigation Agreement 
A Clinical Investigation Agreement shall be entered into effect by the participating investigation 
site and/or the principal clinical investigator at each investigation site as per the local legal 
requirements, and returned to Medtronic prior to the commencement of any study activities. 
The investigator is indicating approval of the Clinical Investigation Plan and subsequent 
amendments, by signing and dating the agreement. Amendments to this Clinical Investigation 
Plan shall be agreed upon between Medtronic and clinical investigator(s) and be recorded with 
a justification for the amendments. 
E.1.2 
Curriculum Vitae 
Recent signed and dated curriculum vitae from each investigator, including co-investigators 
participating in this study, evidencing the required qualifications, including the year and where 
obtained, and shall include their current position at the investigation site. The signature on the 
CV must be dated within 3 years prior to the date of activation of the site.  

 
 
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E.2 Ethics 
E.2.1 
EC/IRB approval 
Prior to enrolling subjects in this study, each investigation site’s EC/IRB must have approved 
the current study clinical investigation plan, the Patient Information and Informed Consent form, 
any other written information to be provided to the subjects and if applicable the Investigator’s 
Brochure and materials used to recruit subjects. EC/IRB approval, or documentation confirming 
that committee review is not required of the clinical study must be received in the form of a 
letter and provided to Medtronic before commencement of the study at an investigation site. 
The approval letter must contain enough information to identify the version or date of the 
documents approved. If this information is not contained in the approval letter, it must be 
retrievable from the corresponding submission letter. In addition the approval letter needs to be 
accompanied by an EC/IRB roster or letter of compliance, to allow verification that the 
investigator, other center study staff, and/or Medtronic personnel are not members of the 
EC/IRB. If they are members of the EC/IRB, written documentation is required stating that 
he/she did not participate in the approval process. If the EC/IRB imposes any additional 
requirements (e.g. safety reports, progress reports etc.), Medtronic will prepare the required 
documents and send them to the investigator for reporting to the EC/IRB. Investigators must 
inform Medtronic of any change in status of EC/IRB approval once the investigation site has 
started enrolment. If any action is taken by an EC/IRB with respect to the investigation, that 
information will be forwarded to Medtronic by the respective investigator. 
E.2.2 
Informed consent process 
The investigator or authorized designee must obtain written informed consent prior to 
subjecting the subject to any study related activity.  
Well in advance of the consent discussion, the subject should receive the EC/IRB approved 
Patient Information and Informed Consent Form. During the consent discussion the investigator 
or his/her designee must fully inform the subject of all pertinent aspects of the study including 
the approval of the EC/IRB of the written Patient Information. If a subject is illiterate, an 
impartial witness must be present during the entire informed consent discussion and the patient 
information sheet and consent form shall be read aloud to the subject. All items discussed in 
the Patient Information and the Informed Consent Form must be explained. The language used 
shall be as non-technical as possible and must be understandable to the subject and the 
impartial witness, where applicable.  
The subject must have ample time and opportunity to inquire about details of the study, and to 
decide whether or not to participate in the clinical study. All questions about the study should be 
answered to the satisfaction of the subject. 
Neither the investigator, nor the investigation site staff shall coerce or unduly influence a 
subject to participate or to continue to participate in the clinical study. The informed consent 
process shall not appear to waive the subject’s rights. 
When the subject decides to participate in the clinical study, the Informed Consent Form must 
be signed and personally dated by the subject and investigator.  
If applicable, the witness shall also sign and personally date the consent form to attest that the 
information in the Patient Information and Informed Consent Form was accurately explained 
and clearly understood by the subject, and that informed consent was freely given. When 
possible the subject should also sign the Informed Consent Form. 
After all persons have signed and dated the Informed Consent Form the investigator must 
provide the subject with a copy of the Patient Information and the signed and dated Informed 
Consent Form. 

 
 
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E.2.3 
Revisions in Patient Information and Informed Consent Form 
Medtronic will inform the investigators whenever information becomes available that may be 
relevant to the subject’s confirmed participation in the study. The investigator or his/her 
designee should inform the subject in a timely manner.  
Medtronic will revise the written Patient Information and Informed Consent Form whenever new 
information becomes available that may be relevant to the subject’s confirmed participation in 
the study. The revised information will be sent to the investigator for approval by the EC/IRB. 
After approval by the EC/IRB, a copy of this information must be provided to the participating 
subjects, and the informed consent process as described above needs to be repeated.  
E.2.4 
Regulatory notification / approval 
In countries where submission to the regulatory authority is required per local law, no patients 
will be enrolled in the study until the particular regulatory authority has approved the current 
study clinical investigation plan and other documents as required according to the local 
requirements. 
 
E.3 Regulatory compliance 
This study will be conducted in compliance with the latest version of the Declaration of Helsinki, 
laws and regulations of the country in which the study is conducted, including data protection 
laws, the clinical investigation agreement and the Clinical Investigation Plan.  
The principles of the Declaration of Helsinki have all been implemented in this study by means 
of the patient informed consent process, EC/IRB approval, study training, clinical trial 
registration, preclinical testing, risk benefit assessment, publication policy, etc.  
If the regulatory authority imposes any additional requirements (e.g. safety reports, progress 
reports etc.), Medtronic will prepare the required documents and send them to the respective 
authority. 
E.4 Training requirements 
Prior to investigation site activation or subsequent involvement in study activities, Medtronic will 
provide study training relevant and pertinent to the involvement of personnel conducting study 
activities and investigator responsibilities. Training will be given on the CIP, the informed 
Consent (IC) process, the use of the data collection tools and any applicable regulatory 
requirements. 
E.5 Study materials and study-specific equipment 
Each investigational site will be provided with study materials (e.g. Investigator Site File and 
paper case report forms (CRF)). 
The Holters (including memory cards) will be distributed to a center only when Medtronic has 
received all required documentation and has notified the center of center readiness. Distribution 
of the Holters to study centers during the clinical study will be managed by Medtronic. 
It is the responsibility of the investigator to correctly handle, store, and track the allocation of 
Holters to patients. The method of storage shall prevent the use of the Holter for other 
applications than mentioned in this Clinical Investigation Plan. Tracking will be done via 
entering the Holter serial number and flashcard ID number in the patient CRF.  
The Holter monitor and the recorded data on the flashcard from the Holter must be returned to 
Medtronic. Medtronic will facilitate Holter maintenance and retrieval. 
 

 
 
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F 
STUDY METHODS 
This section explains the study visits that are required, when they should occur and what study 
procedures should be performed during the visit. 
F.1 Screening 
Patients with a Medtronic ICD or CRT-D and a St. Jude Medical Riata or Durata lead will be 
pre-screened from medical charts for potential enrollment in the clinical investigation. A log will 
be maintained in the investigational site file 
 
F.2 Point of enrollment 
Patients will be enrolled in the study once they have provided written informed consent. At this 
point, the patient will be assigned a subject number and is considered a subject in the 
investigation.  
The investigator will maintain a log of all subjects enrolled in the clinical investigation, assigning 
an identification code linked to their names, alternative subject identification or contact 
information. 
The investigator will clearly mark clinical records to indicate that the subject is enrolled in this 
clinical study. 
 
F.3 Evaluation Visit 
During the patients routine scheduled ICD or CRT-D device follow up one of the following 
events will be required for enrollment: 
1) Externalized conductor with normal pacing and sensing electrical characteristics has been 
found; or 
2) The decision is made to schedule an ICD or CRT-D change out with St Jude lead and 
pacing and sensing electrical characteristics are normal; or 
3) Abnormal device diagnostic for high voltage portion of lead including 
• 
Abrupt high voltage impedance change (more than 75% increase or more than 25% 
decrease from baseline) 
• 
Non-physiologic noise on a high voltage EGM 
• 
Less than 50% of programmed shock energy delivered 
 
If any one of these three criteria are observed the subject will be invited to participate in the 
study.  
 
A “Save To Disk” procedure will be performed to store the initial parameter settings and device 
memory. 
 

 
 
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The following collection settings will be programmed: 
 
2 EGM devices 
Single and Dual Coil Leads 
4 EGM devices 
Single Coil Lead 
4 EGM Devices 
Dual Coil Lead 
Select Parameters>Data 
Collection Setup> 
 
EGM 1: RVtip to RVring 
EGM 2: Can to RVcoil 
 
Press “OK” 
Press “PROGRAM” 
 
Select Parameters>Data 
Collection Setup> 
 
LECG: RVcoil to Aring 
EGM 1: RVtip to RVring 
EGM 2: Can to RVcoil  
EGM 3: RVtip to RVcoil 
 
Press “OK” 
Press “PROGRAM” 
 
Parameters>Data Collection 
Setup> 
 
LECG: Can to SVC 
EGM 1: RVtip to RVring 
EGM 2: RVcoil to SVC 
EGM 3: Can to RVcoil 
 
Press “OK” 
Press “PROGRAM” 
 
 
 The Holter Telemetry will be turned on for 24 hours 
 Select Parameters>Data Collection Setup>Select Holter telemetry [24 hours] 
  Press “PROGRAM” 
 
Note: For wireless telemetry ICD devices select <find patient> then uncheck “Allow Wireless 
Communication” 
 
The Holter monitor will be attached to the subjects and they will be asked to continue wearing 
the Holter monitor to record rhythm data for up to 24 hours.   
 
The Holter monitor and the recorded data on the flashcard from the Holter must be returned to 
the study center. Medtronic will facilitate Holter retrieval for each study participant and this is 
the end of the study involvement for the patients.  
The SD Disks will be sent to Medtronic within 7 working days and at the end of the study the 
Holters must be returned to Medtronic. Medtronic will facilitate Holter retrieval from the centers. 
 
F.4  Lead Status and Study Exit Form 
One month after the evaluation visit, the physician will be asked to complete a study exit form, 
this form will collect the current status of the lead and information from any additional tests that 
were performed during routine clinical practice to determine the status of the lead.  
The status of the lead will be classified as intact or failed based on the physician’s assessment 
of the lead with supporting data. The supporting data includes the results of a full output test 
shock (if performed), returned product analysis (full lead needs to be returned of intact, partial 
lead can be returned for failure), or device diagnostics (e.g. abnormal high voltage impedance, 
less than 50% of programmed shock energy delivered for detected episodes). 

 
 
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F.5 Data collection requirements 
 
 
Screening 
Enrollment 
Evaluation Visit 
Study Exit 
Device and lead Criteria 
✓ 
 
 
 
Inclusion/Exclusion Criteria 
 
✓ 
 
 
Subject Informed Consent 
 
✓ 
 
 
Demographics, device 
history 
 
 
✓ 
 
Save-to-disk 
 
 
✓ 
 
Device Data Collection 
Settings programmed 
 
 
✓ 
 
Holter Attached 
 
 
✓ 
 
Lead Status 
 
 
 
✓ 
Exit 
 
 
 
✓ 
 
F.6 Post Market Surveillance 
F.6.1 
Definition/classification  
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. 
F.6.2 
Reporting of product complaints  
All devices used in this study are marked released. Therefore, Post Market Surveillance is 
applicable.  
The reporting of product complaints is not part of the clinical study. It is the responsibility of the 
investigator to report all product complaint(s) associated with a medical device (Medtronic or 
non-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 Authority of the following incidents immediately on 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. 
 
A serious deterioration in the state of heath includes: 
• 
Life-threatening illness or injury 
• 
Permanent impairment of a body function or permanent damage to a body structure 
• 
A condition necessitating medical or surgical intervention to prevent permanent 
impairment of a body function or permanent damage to a body structure. 

 
 
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F.7 Subject accountability 
Study Exit is defined as the moment when a subject officially stops participating in the study. If 
a subject is withdrawn from the study before the one month lead status evaluation/study exit 
visit, the reason for withdrawal shall be recorded on the study exit CRF and in the subject’s 
hospital record. If discontinuation is because of safety or performance issues of the Medtronic 
defibrillator device (ICD or CRT-D), normal vigilance reporting will be applicable.  . 
 
Reasons subject may be exited form the study include, but are not limited to: 
• 
Study completion 
• 
Subject did not provide consent 
• 
Subject did not meet inclusion/exclusion criteria 
• 
Subject chooses to withdraw (e.g., consent withdrawals, relocation to another geographic 
location)  
• 
Investigator deems withdrawal necessary (e.g., medically justified, inclusion/exclusion 
criteria not met, failure of subject to maintain adequate study compliance) 
• 
Subject death 
 
If the Holter recording fails i.e. the file becomes corrupted or the signal quality is poor, an 
additional patient may be enrolled to ensure there is at least 50 readable Holter recordings are 
available for analysis. 
 
F.8 Study deviations and CIP changes 
A study deviation is an event where the investigator or site personnel did not conduct the study 
according to the Clinical Investigational Plan or Clinical Investigation Agreement. The 
investigator is not allowed to deviate from the above mentioned documents except with prior 
approval and under emergency circumstances. All deviations shall be documented and 
explained, regardless the reason for the deviation. 
Medtronic will assess the significance of all deviations and evaluate the need to amend the 
Clinical Investigation Plan or to early terminate the investigation, in accordance with Medtronic 
SOPs. 
F.8.1 
Request for approval of study deviations 
The investigator shall obtain documented approval from Medtronic and if required EC/IRB and 
regulatory authority, before implementation, for any change in or deviation from the Clinical 
Investigation Plan. The investigator shall timely contact the Clinical Research Specialist / study 
manager for review of the proposed change/deviation. 
Prior approval is not always realistic in situations where unforeseen circumstances are beyond 
the investigator’s control. However, also in these cases the event is considered a deviation, and 
shall be reported.  
In any emergency situation the investigator shall exercise his/her judgment to safeguard the 
subject’s interest. Such deviations from the Clinical Investigation Plan do not require the prior 
approval of Medtronic. The investigator shall report the deviation as soon as possible to 
Medtronic and the reviewing EC/IRB, if applicable. Medtronic will inform the regulatory 
authorities, if required. 

 
 
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F.8.2 
Reporting requirements for study deviations 
Study deviations directly related to a subject, including informed consent violations, will be 
documented in the subject’s case history record and recorded on the Deviation CRF. Medtronic 
will be responsible for analyzing the documented deviations, assessing their significance, and 
identifying any necessary corrective and/or preventive action. Reporting of deviations must 
comply with Ethics Board policies, local laws, and or regulatory agency requirements. It is the 
investigator’s obligation to report deviations to IRB/MEC, as required. 
F.8.3 
Amendments to the Clinical Investigation Plan 
Medtronic will submit any significant amendment to the Clinical Investigation Plan, including a 
justification for this amendment, to the appropriate regulatory authorities and to the 
investigators to obtain approval from their EC/IRB, if applicable. Administrative amendments to 
the Clinical Investigation Plan will be submitted to the EC/IRB and appropriate regulatory 
authorities for notification, if applicable. 
G 
QUALITY CONTROL PROCEDURES 
G.1 Procedures for data management 
G.1.1 Data collection 
The investigator must ensure accuracy, completeness, legibility and timeliness of the data 
reported in the CRFs and in all other required reports. Data reported on the CRFs which are 
derived from source documents (e.g. hospital records, laboratory notes or fluoroscopic images) 
must be consistent with the source documents or the discrepancies need to be justified in a 
documented rationale, signed and dated by the (principal) investigator, to be filed in the patient 
medical file. 
Only authorized persons can complete CRFs. CRFs shall be signed by investigators (physician) 
as specified on the Delegated Tasks List included in the Investigator Site File. 
In order to maintain an audit trail, changes or corrections in CRFs are made by making a single 
strike-through on the wrong data and an addition of the correct data. The change in the CRF 
must be signed, dated, and explained (if necessary) by the person that made the change. If a 
person only authorized to complete CRFs made changes to an already signed CRF, the 
investigator shall re-sign this CRF. 
Beside the data on the Case Report Forms, save to disk files, Holter files and fluoroscopic 
images (if available), will also be collected.  
All data shall be secured against unauthorized access. The privacy of each subject and 
confidentiality of his/her information shall be preserved in reports and when publishing any 
data. 
Additional details regarding data management will be described in the Data Management Plan. 
G.1.2 Source data to be directly recorded on the Case Report Forms 
For all data collected on the CRF the source data will be the hospital chart, except for the serial 
number of the Holter SD disk which will be handled as source data. 
The Holter recordings and (if available) fluoroscopic images will be collected additionally to the 
CRF and handled as source data. Details of source data verification will be contained in the 
study monitoring plan. Time windows for completion and submission of Case Report Forms 
It is anticipated that CRFs will be completed and submitted to Medtronic in a timely manner.   

 
 
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G.1.3 Data review and processing 
Data management will be done according to Medtronic SOPs and the Data Management Plan 
for this study. These documents will be made available on request. 
All collected data will be reviewed for completeness, correctness and consistency. In case of 
issues, queries will be sent to the investigator to complete, correct or comment the data.  
 
G.2 Monitoring procedures 
It is the responsibility of the study sponsor to ensure that proper monitoring of this clinical 
investigation is conducted.  The Investigator Site File will be verified during the first visit by 
Medtronic personnel, which is most likely to be at time of the site initiation visit and at the end of 
the study. No additional monitoring visits are anticipated. Should additional monitoring visits be 
required the principal investigators, his delegate(s) and the study coordinator(s) shall be 
accessible to Medtronic representative. Details will be contained in the study monitoring plan. 
 
Appropriately trained personnel appointed by Medtronic will conduct monitoring activities, as 
needed, to check if the investigation is conducted in accordance with: 
• 
The signed Investigator Agreement 
• 
The Clinical Investigational Plan 
• 
Applicable local laws 
• 
Any conditions of approval imposed by the reviewing IRB/MEC 
Center activation and study closure will occur on-site or via telephone/email.  
 
G.2.1 Accessibility of investigation site staff and study materials 
The principal investigator(s), his/her delegate(s) and the study coordinator(s) shall be 
accessible to Medtronic field personnel and the Clinical Research Specialist/Study Manager. 
This accessibility is of particular importance for reviewing data in the Case Report Form (CRF). 
Direct access to patient medical files that pertain to the clinical study for source data verification 
will need to be granted and prepared prior to the monitoring visits, taking into account any 
restrictions due to local law.  
G.2.2 Audits and investigation site inspections 
Medtronic may conduct audits at participating investigation sites. The purpose of an audit is to 
verify the adequate performance of the study related activities. Independent of the employees 
involved in the study. Regulatory authorities may also perform inspections at participating 
investigation sites. Any regulatory authority inspection announcements shall be forwarded 
immediately to the Medtronic study contact person.   
The investigator and/or institution shall permit Medtronic and regulatory bodies direct access to 
source data and documents that pertain to the clinical study, taking into account any restrictions 
due to local law, to perform study-related monitoring, audits, EC/IRB review, and regulatory 
inspections. 

 
 
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G.3 Study suspension or early termination 
G.3.1 Study suspension or early termination 
Medtronic or Regulatory Authority may decide to suspend or prematurely terminate the study 
(e.g. if information becomes available that the risk to study subject is higher than initially 
indicated). If the study is terminated prematurely or suspended, Medtronic shall promptly inform the 
clinical investigators and the regulatory authority where applicable of the termination or suspension 
and the reason(s) for this. The investigator shall then promptly inform the reviewing EC/IRB, if required 
and the study subjects and general practitioner. If the study is terminated, study exit forms will be 
completed for each patient and the patients will no longer be followed. 
G.3.2 Investigation site suspension or early termination 
Medtronic, EC/IRB or Regulatory Authority may decide to suspend or prematurely terminate an 
investigation site (e.g. in case of expiring approval of the reviewing EC/IRB, non-compliance to 
the Clinical Investigation Plan or lack of enrollment). If an investigation site is suspended or 
prematurely terminated, Medtronic shall promptly inform the clinical investigator(s) of the 
termination or suspension and the reason(s) for this. The investigator shall then promptly inform 
the reviewing EC/IRB, if required (please check the regulatory affairs website), and the study 
subjects and general practitioner. If the EC/IRB decides to suspend or terminate the site the 
investigator must inform Medtronic immediately. 
When the risks are found to outweigh the potential benefits or when there is conclusive proof of 
definite outcomes, investigators must assess whether to continue, modify or immediately stop 
the clinical study in the respective investigation site and immediately inform the sponsor and 
EC/IRB, if applicable. 
 
 
G.4 Study close out 
Study closure is defined as closure of a clinical study that occurs when Medtronic and/or 
regulatory requirements have been satisfied per the Clinical Investigational Plan and/or by a 
decision by Medtronic or EC/IRB, whichever occurs first. Study Closure is a process initiated by 
distribution of a study closure letter. Ethics Board approval renewals are required until the study 
closure process is complete at the center and the final report submitted. Where applicable, 
regulator authorities will be notified upon study closure. 
H 
DATA ANALYSIS AND REPORTING 
Any deviations from this section will be described and justified in the Final Report/ publication.  
H.1 Analysis of clinical data 
Each Holter recording will be reviewed for the presence of an abnormal signal (e.g. noise) on 
the far-field (e.g. RVcoil to SVC) EGM.  Only one instance of abnormal noise (e.g. spike) will be 
needed to classify the recording as abnormal.   
 
The lead from each patient will be adjudicated as a lead failure or intact lead by the physician 
using routine current practice methods of assessing an ICD lead and recorded on the study exit 
CRF form.  The proportion of Holter recordings with abnormal noise in the lead failure group will 
be compared with the control group with intact leads.  Fisher’s exact test will be used to 
compare the proportions of the 2 independent groups.   
 

 
 
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Only patients with a good quality Holter recording (minimum 12 hours of telemetry) and a 
documented assessment of the lead status by the physician will be used in the analysis.  Other 
Holter recordings will not be used. 
H.2 Publication Policy 
Publications and presentations referring to Therapy coil Electrogram Collection Study will be 
coordinated by Medtronic to allow the use of all available data. The following publication policy 
will have to be adhered to by all participating investigation sites: 
Medtronic intends to publish the results of the study in a manner that is sensitive to the 
commercial application of the results. It is likely publication will be delayed until closer to the 
potential release of a device feature. 
Authorship on any publication(s) resulting from this study will be assigned according to 
substantial contributions to conception and design, acquisition of data, or analysis and 
interpretation of data, drafting the article or revising it critically for important intellectual content 
and final approval of the version to be published. This is in accordance with the Vancouver 
principles (The Uniform Requirements for Manuscripts Submitted to Biomedical Journals: 
Writing and Editing for Biomedical Publication, ICMJE, October 2008), as agreed upon by the 
editors of all major medical journals.  
The number of authors will be dependent on the regulations of the concerning journal with a 
maximum of 10 authors. Names of all participating investigators will appear in the 
Acknowledgment of the paper. 
There are no plans to form a publication committee. Publication activities will be assessed after 
the study is completed and any collaboration with the investigators will be determined at that 
time. 
Based on the principle that Medtronic owns the data of the Therapy coil Electrogram Collection 
Study a single investigation site may access and use the data provided by itself for scientific 
publications following prior approval by Medtronic. 
Pooling data from several investigation sites for publication purposes, national projects and 
international projects all require prior approval from Medtronic. 
Medtronic as the owner of the data can use the data and/or any results derived from the data or 
publications based on that data for marketing purposes, further research and development of 
devices or educational use. 
The study sponsor will collect data in such way that no subject can be identified, and monitor 
study records. 
Participating subjects will not be identified by name in any published reports about the study.  
I 
STUDY MANAGEMENT 
I.1 
Study staff 
A list of the sponsor’s study staff will be kept under separate cover.  
I.2 
Advisory committees 
I.2.1 
Data Monitoring Committee 
No Data Monitoring Committee will be installed for this clinical study as no interventions 
intended to prolong life or reduce risk of a major adverse health outcome (e.g., cardiovascular 
events) are evaluated, for which favorable or unfavorable study results suggest study 

 
 
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termination. Nor are there safety concerns suggesting the need for a Data Monitoring 
Committee.  
I.3 
Records and reports 
I.3.1 
Investigator records 
The investigator is responsible for the preparation (review and signature) and/or retention of the 
records cited below. All study related information and records are subject to inspection and 
must be retained for a period of two years after study termination or closure or longer if required 
by local or hospital regulations, e.g: 
 
• 
All key correspondence that pertains to the investigation 
• 
Subject’s case history records, including: completed CRFs, copy of data collected during 
study visit, signed and dated subject informed consent form, all relevant observations, 
observations of serious adverse events, records of reported adverse events,  medical 
history, and documentation of the dates and rationale for any deviation from the Clinical 
Investigational Plan or Investigator Agreement 
• 
Subject identification and screening log 
• 
Sponsor contact information 
• 
List of participating sites  
• 
The approved Clinical Investigational Plan and any amendments 
• 
Sample patient information and informed consent form 
• 
Insurance certificates 
• 
Signed and dated Investigator Agreement and compensation records 
• 
IRB/MEC approval documents and documentation that the investigator did not participate 
in the approval process  
• 
Training documentation, current, signed and dated (co-)investigator curriculum vitae, 
delegated task list and final report 
• 
Any other records that local regulatory agencies require to be maintained 
 
I.3.2 
Investigator reporting responsibilities 
The investigator is responsible for the preparation (review and signature) and submission to 
Medtronic of all case report forms and deviations from the clinical investigational plan. If any 
action is taken by an IRB/MEC with respect to the investigation, the information must be 
forwarded to Medtronic immediately. 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 Table 2. 

 
 
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Table 2: Investigator Reports 
Report 
Submit To 
Description / Constraints 
Withdrawal of IRB/MEC 
approval 
 
Medtronic 
report as required by local law 
Study Deviations 
Medtronic, 
IRB/MEC 
Any deviation from the CIP shall be 
recorded together with an explanation 
for the deviation. Deviations shall be 
reported to the sponsor who is 
responsible for analyzing them and 
assessing their significance. 
Note: When relevant, Ethics Boards, 
competent authorities or the 
appropriate regulatory bodies should 
be informed.  
 
Failure to obtain informed 
consent 
 
Medtronic, 
IRB/MEC 
Notification within five working days.   
Progress Reports and 
final report (if required) 
Medtronic, 
IRB/MEC 
Provide if required by local law or 
Ethics Board 
 
I.3.3 
Sponsor records 
Medtronic shall maintain the following accurate, complete, and current records e.g.: 
• 
All correspondence which pertains to the investigation 
• 
Signed and dated Investigator  Agreement, current signed and dated (Co-) investigator 
curriculum and delegated tasks list 
• 
All case report forms submitted by investigator and  samples of consent forms 
• 
Copies of all IRB/MEC approval letters, voting list and relevant IRB/MEC correspondence 
• 
Name of the institutions in which the clinical investigation will be conducted 
• 
Correspondence with authorities as required by national legislation 
• 
Statistical analyses and underlying supporting data 
• 
Device shipment records 
• 
Final report of the clinical investigation 
• 
All approved versions of the Clinical Investigation Plan and study related reports 
• 
Study training records for site personnel and Medtronic personnel involved in the study 
• 
Insurance certificates  
• 
Monitoring visit reports 
• 
Any other records that local regulatory agencies require to be maintained 
 

 
 
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I.3.4 
Sponsor reporting responsibilities 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed 
in the Table 3 below. In addition to the reports listed below, Medtronic shall, upon request of 
reviewing IRB/MEC or regulatory agency, provide accurate, complete and current information 
about any aspect of the investigation. 
Table 3: Sponsor Reports 
Report 
Submit To 
Description/Constraints 
Premature 
termination or 
suspension of 
the clinical 
investigation 
Investigators, IRB/ MEC, 
Regulatory Authority 
 
Provide prompt notification of 
termination or suspension and 
reason(s).  
Withdrawal of 
MEC approval 
Investigators, Regulatory Authority 
 
Medtronic will be notified. 
Progress 
Reports 
Regulatory Authority 
This will be submitted to the only 
if required  
Final Report 
Investigators, IRB/MEC 
The investigator shall have the 
opportunity to review and 
comment on the final report.  If a 
clinical investigator does not 
agree with the final report, 
his/her comments shall be 
communicated to the other 
investigator(s).  The principal 
clinical investigator at the 
centers shall sign the report.   
 
Study deviation  
Investigators 
Ensure that all deviations from 
the Clinical Investigation Plan 
are reviewed with the 
appropriate clinical 
investigator(s), are reported on 
the case report forms and the 
final report of the clinical 
investigation.   
 
Vigilance 
Reporting 
Regulatory Authorities 
 
Report incidents. Refer to 
section F.6.2 for details 
Significant New 
Evidence 
Investigator, IRB/ MEC, 
Regulatory Authorities 
 
Ensure that IRB/MEC and 
Regulatory Authorities are 
informed of significant new 
information about the clinical 
investigation. Investigator to 
inform patients. 
 
Electronic versions of Medtronic records and reports will be kept on a password-protected 
document management system during the course of the study. After closure of the study, all 
records and reports will be archived indefinitely. 
 

 
 
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I.3.5 
Record retention  
The investigator must retain the Investigator Site File, patient medical files and CRFs in 
accordance with local law and regulations.    
The investigator should take measures to prevent accidental or early destruction of the study 
related materials. 
I.4 
Miscellaneous 
I.4.1 
Insurance 
The Bakken Research Center B.V. is a wholly owned subsidiary of Medtronic Inc., which as the 
parent company of such entity maintains appropriate clinical study liability insurance coverage 
as required under applicable laws and regulations and will comply with applicable law and 
custom concerning specific insurance coverage. If required, a Clinical Trial Insurance 
statement/certificate will be provided to the EC/IRB. 
I.4.2 
Subject confidentiality 
Participating subjects will not be identified by name in any published reports about the study.  
J 
RISKS AND BENEFITS 
J.1 Anticipated Clinical Benefits 
The objective of this study is to collect data from the subjects’ device with no direct clinical 
benefit to the subject. The benefit is for future patients that may have improved lead monitoring 
diagnostics.  
J.2 Risks 
Subjects are treated according to general clinical practice, no extra tests and follow-ups are 
required other than the wearing of a Holter for 24 hours.   
There is a foreseeable inconvenience to the patient having to wear the Holter monitor for 24 
hours and there could also be irritation to the skin from the ECG electrodes.  The irritation has 
been minimized by using only 3 ECG electrodes instead of the standard 7 ECG electrodes. 
K 
REFERENCES 
1. Shah P, Singh G, Chandra S, Schuger CD.  Failure to Deliver Therapy by a Riata Lead 
with Internal Wire Externalization and Normal Electrical Parameters During Routine 
Interrogation. JCE 2013:24:94-6. 
 
2. Leong DP, Van Erven L. Unrecognized Failure of a Narrow Caliber Defibrillation Lead:  The 
Role of Defibrillation Threshold Testing in Identifying an Unprotected Individual. PACE 
2012;1-2. 
 
3. Goldstein MA, Badri M, Kocovic D, Kowey PR. Electrical Failure of an ICD Lead due to a 
Presumed Insulation Defect Only Diagnosed by a Maximum Output Shock. PACE 2013.  
 
4. Sharma, Gunderson BD. Data on file. 

 
 
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L 
APPENDICES 
L.1 Names and addresses 
A complete list of participating sites and investigators will be provided under separate cover  
 
L.2 Abbreviations  
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CRT-D 
Cardiac Resynchronization Therapy Defibrillator 
DMC 
Data Monitoring Committee 
EC 
Ethical Committee  
ECG 
Electrocardiogram 
EGM 
Electrogram 
ICD 
Implantable Cardioverter Defibrillator 
IRB  
Institutional Review Board  
MEC 
Medical Ethics Committee 
RV 
Right Ventricle 
SOP 
Standard operating procedure 
SVC 
Superior Vena Cava 
 
L.3 Case Report Forms 
Case Report Forms for this study will be provided under separate cover 
 
L.4 Patient Informed Consent Master version  
Patient Informed Consent for this study will be provided under separate cover