Improve Sudden Cardiac Arrest (SCA) Bridge Study
Conditions: Sudden Cardiac Arrest, Acute Myocardial Infarction
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Improve SCA Bridge Study 
Clinical Study Protocol -  Version 2.0 
01-May-2019 
NCT03715790 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© 2021 Medtronic. No use of any Medtronic trademark may be made except to identify the product or 
services of the company or as otherwise authorized in writing by Medtronic. All rights reserved. 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Improve SCA Bridge 
Sponsor/Local Sponsor Medtronic, Inc. (Worldwide Sponsor) 
Cardiac Rhythm and Heart Failure Clinical 
Research   
8200 Coral Sea Street NE, MS: MVS33 
Mounds View, MN 55112 
 
Medtronic (Shanghai) Management Co., Ltd. 
3rd Floor, No. 180. Rijing Road, China 
(Shanghai) Pilot Free Trade Zone, 
200131, Shanghai, P.R.China  
 
Medtronic (Taiwan) Ltd. 
2F, No.2, Sec.1, Dunhua S. Rd. Songshan Dist. 
Taipei City 105, Taiwan (R.O.C.) 
 
Medtronic Malaysia Sdn Bhd 
B-23-1 Level 23, The Ascent, Paradigm 
No 1 Jalan SS7/26A Kelaena Jaya 46301 Petaling 
Jaya, Selangor, Malaysia 
 
PT Medtronic Indonesia 
Gandaria 8 Office Tower, 36th Floor Unit A 
Jl. Sultan Iskandar Muda, Kebayoran Lama 
Jakarta 12240 - Indonesia  
 
Medtronic Philippines Inc. 
29th Floor One World Place, 32nd St., City Center 
North, 
Bonifacio Global City Taguig City, 1634 Philippines 
 
Medtronic International Ltd (Singapore Branch) 
49 Changi South Avenue 2   
Singapore 486056 
 
 
 
 

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Medtronic Thailand (Limited) 
319 Chamchuri Square 27th Floor, Unit 1-16, 
Phayathai Road, Pathumwan  
Bangkok 10330, Thailand 
 
Medtronic Korea Co. Ltd  
 17F, Glass Tower, #534 
 Teneran-ro, Gangnam-gu 
 Seoul, 06181, Korea  
 
India Medtronic Private Ltd. 
1241, Solitaire Corporate Park, 
Building No 12, 4th Floor, 
Andheri-Ghatkopar Link Road, Andheri (E) 
Mumbai MH 400093, India 
 
Medtronic META FZ-LLC 
Injaz Building l Third floor l Dubai Knowledge Park 
l Dubai, United Arab Emirates | P.O. Box 500638  
 
Document Version Version 2.0; 1 MAY 2019 
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. 

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1. Table of Contents  
 
1. 
Table of Contents  .............................................................................................................. 3 
2. 
Glossary .............................................................................................................................. 7 
3. 
Synopsis ............................................................................................................................. 9 
4. 
Introduction ..................................................................................................................... 12 
4.1. Background ........................................................................................................................ 12 
4.2. Purpose .............................................................................................................................. 14 
5. 
Objectives and Endpoints ................................................................................................. 14 
5.1. Objectives .......................................................................................................................... 14 
5.1.1. 
Primary Objective .......................................................................................................... 14 
5.1.2. 
Secondary Objectives .................................................................................................... 14 
5.2. Endpoints ........................................................................................................................... 14 
5.2.1. 
Primary Endpoint .......................................................................................................... 14 
5.2.2. Secondary Endpoints .............................................................................................. 15 
6. 
Study Design .................................................................................................................... 15 
6.1. Duration ............................................................................................................................. 18 
6.2. Rationale ............................................................................................................................ 18 
6.3. Study oversight ................................................................................................................... 18 
7. 
Product description .......................................................................................................... 20 
7.1. General .............................................................................................................................. 20 
8. 
Selection of Subjects ........................................................................................................ 20 
8.1. Study Population ................................................................................................................. 20 
8.2. Subject Enrollment .............................................................................................................. 20 
8.3. Inclusion Criteria ................................................................................................................. 21 
8.4. Exclusion Criteria................................................................................................................. 21 
9. 
Study Procedures ............................................................................................................. 21 
9.1. Investigator/Investigation Site Selection ................................................................................ 22 
9.2. Site Initiation ...................................................................................................................... 22 
9.3. Schedule of Events .............................................................................................................. 23 

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9.4. Subject Consent .................................................................................................................. 24 
9.5. Enrollment/Baseline ............................................................................................................. 26 
9.6. Follow-Up Visits .................................................................................................................. 27 
9.6.1. 
Information Collected .................................................................................................... 27 
9.6.2. 
Subjects with Medtronic device ..................................................................................... 28 
9.7. Study Exit ........................................................................................................................... 28 
9.8. Assessment of Safety .......................................................................................................... 29 
9.9. Recording Data ................................................................................................................... 29 
9.10. 
Deviation Handling ........................................................................................................ 29 
9.11. 
Subject Withdrawal or Discontinuation ............................................................................. 30 
9.11.1. Lost to Follow-Up .......................................................................................................... 30 
9.11.2. Subject Withdrawal ....................................................................................................... 30 
10. 
Risks and Benefits ......................................................................................................... 31 
10.1. 
Potential Risks ............................................................................................................... 31 
10.2. 
Potential Benefits ........................................................................................................... 31 
10.3. 
Risk-Benefit Rationale .................................................................................................... 31 
11. 
Adverse Events .............................................................................................................. 31 
11.1. 
Definitions/Classifications ............................................................................................... 32 
11.2. 
Reporting of Adverse Events ........................................................................................... 33 
11.2.1. 
Adverse Events Reporting Requirements ...................................................................... 33 
11.3. 
Subject Death ............................................................................................................... 34 
11.3.1. Death Data Collection .................................................................................................... 34 
11.3.2. Death Classification and Reporting ................................................................................ 34 
11.4. 
Product Complaint Handling ............................................................................................ 35 
12. 
Statistical Design and Methods ..................................................................................... 36 
12.1. 
General Considerations .................................................................................................. 36 
12.2. 
Primary Objective .......................................................................................................... 36 
12.2.1. Hypothesis .................................................................................................................... 36 
12.2.2. Endpoint definitions ...................................................................................................... 36 
12.2.3. Analysis Methods .......................................................................................................... 36 
12.2.4. Determination of Patients/Data for Analysis ................................................................. 37 

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12.2.5. Sample Size ................................................................................................................... 37 
12.3. 
Secondary Objectives ..................................................................................................... 37 
12.3.1. Proportion of post-acute MI patients who are indicated for an ICD/CRT-D .................... 37 
12.3.3. Referral and implant refusal rationale ........................................................................... 38 
12.3.4. Incidence of CV Mortality .............................................................................................. 39 
12.3.5. Change in LVEF Over Time ............................................................................................. 40 
12.4. 
Interim analysis ............................................................................................................. 41 
12.5. 
Missing data .................................................................................................................. 41 
12.6. 
Subgroup analysis.......................................................................................................... 41 
13. 
Ethics ............................................................................................................................. 41 
13.1. 
Statement(s) of Compliance ........................................................................................... 41 
14. 
Study Administration ..................................................................................................... 42 
14.1. 
Monitoring .................................................................................................................... 42 
14.2. 
Data Management ......................................................................................................... 43 
14.3. 
Direct Access to Source Data/Documents ......................................................................... 44 
14.4. 
Confidentiality ............................................................................................................... 44 
14.5. 
Liability ......................................................................................................................... 44 
14.6. 
CIP Amendments ........................................................................................................... 44 
14.7. 
Record Retention ........................................................................................................... 44 
14.7.1 Investigator Records ...................................................................................................... 44 
14.7.2 Investigator Reports ...................................................................................................... 45 
14.7.3 Sponsor Records ............................................................................................................ 46 
14.7.4 Sponsor Reports ............................................................................................................ 47 
14.8. 
Publication and Use of Information .................................................................................. 47 
14.9. 
Suspension or Early Termination ..................................................................................... 48 
14.9.1 
Planned study closure .................................................................................................... 48 
14.9.2 Early Termination or Suspension ................................................................................... 48 
14.9.3 Procedures for Termination or Suspension .................................................................... 49 
15 
Reference ....................................................................................................................... 50 
16 
Appendices .................................................................................................................... 51 
Appendix A: Case report forms ............................................................................................... 51 

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Appendix B: Informed consent template ................................................................................ 52 
Appendix C: Participating investigators and institutions ....................................................... 53 
Appendix D: Study Sponsor Contact Information ................................................................... 54 
Appendix E: Investigator Reporting Requirements ................................................................ 55 
17 
Version History .............................................................................................................. 57 
 
 
 

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2. Glossary 
 
Term 
Definition 
AE  
Adverse Event  
ADE 
Adverse Device Effect 
CIP  
Clinical Investigation Plan  
CRT-D 
Cardiac Synchronization Therapy- Defibrillator  
CTA  
Clinical Trial Agreement  
Data Protection authorization  
Authorization to Use and Disclose Personal 
Health Information/Research Authorization/other 
privacy language  
DM  
Data Management  
eCRF  
Electronic Case Report Form  
EC  
Ethics Committee  
EP 
Electrophysiologist 
GCP  
Good Clinical Practice  
IC  
Interventional Cardiologist  
ICD  
Implantable Cardioverter-Defibrillator  
IRB  
Institutional Review Board  
LVEF 
Left Ventricular Ejection Fraction 
MEC 
Medical Ethics Committee 
MI 
Myocardial Infarction 
MSM 
Medtronic Secure Messaging 
NSTEMI 
Non ST-Elevation Myocardial Infarction 
PI  
Principal Investigator  

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Term 
Definition 
RA 
Right Atrial 
RV 
Right Ventricular 
SAE  
Serious Adverse Event  
SADE 
Serious Adverse Device Effect 
SAP  
Statistical Analysis Plan  
SCA 
Sudden Cardiac Arrest 
SCD 
Sudden Cardiac Death 
SOC 
Standard of care 
STEMI 
ST-Elevation Myocardial Infarction 
USADE 
Unanticipated Serious Adverse 
Device Effect 
 
 

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3. Synopsis 
Title 
Improve SCA Bridge 
Sponsor  
Medtronic Inc. 
Cardiac Rhythm and Heart Failure Clinical Research   
8200 Coral Sea Street NE, MS: MVS33 
Mounds View, MN 55112 
55112 
Local Sponsor 
Medtronic (Shanghai) Management Co., Ltd. 
3rd Floor, No. 180. Rijing Road, China 
(Shanghai) Pilot Free Trade Zone, 
200131, Shanghai, P.R.China  
 
Medtronic (Taiwan) Ltd. 
2F, No.2, Sec.1, Dunhua S. Rd. Songshan Dist. 
Taipei City 105, Taiwan (R.O.C.) 
 
Medtronic Malaysia Sdn Bhd 
B-23-1 Level 23, The Ascent, Paradigm 
No 1 Jalan SS7/26A Kelaena Jaya 46301 Petaling 
Jaya, Selangor, Malaysia 
 
PT Medtronic Indonesia 
Gandaria 8 Office Tower, 36th Floor Unit A 
Jl. Sultan Iskandar Muda, Kebayoran Lama 
Jakarta 12240 - Indonesia   
 
Medtronic Philippines Inc. 
29th Floor One World Place, 32nd St., City Center North, 
Bonifacio Global City Taguig City, 1634 Philippines 
 
Medtronic International Ltd (Singapore Branch) 
49 Changi South Avenue 2   
Singapore 486056 
 
Medtronic Thailand (Limited) 
319 Chamchuri Square 27th Floor, Unit 1-16, Phayathai Road, 
Pathumwan  
Bangkok 10330, Thailand 
 
Medtronic Korea Co. Ltd  
17F, Glass Tower, #534 
Teneran-ro, Gangnam-gu 
Seoul, 06181, Korea  

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India Medtronic Private Ltd. 
1241, Solitaire Corporate Park, 
Building No 12, 4th Floor, 
Andheri-Ghatkopar Link Road, Andheri (E) 
Mumbai MH 400093, India 
 
Medtronic META FZ-LLC 
Injaz Building l Third floor l Dubai Knowledge Park l Dubai, United 
Arab Emirates | P.O. Box 500638  
 
Investigation Purpose 
The purpose of the Improve SCA Bridge study is to characterize the 
care pathway flow of post-acute myocardial infarction (MI) patients 
as a result of standard assessments of left ventricular ejection fraction 
(LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase 
(≥40-90 days post-acute MI). 
Product Status 
There is no investigational device under evaluation; subjects may be 
implanted, if referred and indicated, with any brand or model of 
market released Implantable Cardioverter-Defibrillator (ICD)/ Cardiac 
Synchronization Therapy- Defibrillator (CRT-D). 
Primary Objective 
Characterize the proportion of post-acute MI patients who are 
referred for sudden cardiac death (SCD) risk stratification and 
management. 
Secondary Objective(s) 
• 
Characterize the proportion of post-acute MI patients who are 
known to be indicated for an ICD/CRT-D within 12 months post-
acute MI.   
• 
Characterize the proportion of post-acute MI patients who 
receive an ICD/CRT-D within 12 months post- acute MI.  
• 
Summarize the referral and implant refusal rationale. 
• 
Characterize the proportion of post-acute MI patients who 
experience cardiovascular mortality. 
• 
Determine how the ejection fraction evolves over 3 months 
following an acute MI. 
Study Design 
This study is a prospective, non-randomized, multi-site, global, post-
market study.   
 
After enrollment, subjects will be followed up at 3-, 6- and 12-
months. The 6- and 12-month follow up maybe completed either in-
person or via phone.   
 
There is no investigational device; subjects can be implanted, if 
indicated and referred, with any brand or model of a market released 
ICD/CRT-D.  The study is expected to be conducted at approximately 
50 sites worldwide.  Participating geographies are: China, India 

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Subcontinent (including India, Bangladesh), Korea, Middle East, Africa, 
Central Asia, & Turkey (MEACAT) (including Egypt, Pakistan, Saudi 
Arabia, South Africa and Tunisia), South East Asia (SEA) (including 
Brunei, Indonesia, Malaysia, Philippines, Singapore and Thailand) and 
Taiwan. Additional countries could participate within these 
geographies.   
 
Each geography is expected to enroll approximately 200 subjects, 
with a total of approximately 1,200 subjects from 6 geographies. The 
sample size may vary by geographies, as it will depend on the 
mortality and drop-out rates and on the reason for referral at 3 
months, which will differ across geographies and will be continuously 
monitored. The actual sample size may increase up to 2,400 subjects, 
depending on the observed mortality and drop-out rate between 
enrolment and 3-month visit, and on the observed proportion of 
subjects with a reason for referral at the 3-month visit. 
 
The study duration is expected to be approximately 24 months. This 
represents an estimated 12 months for subject enrollment and 12 
months for subject follow-up for the last subject enrolled. Subjects 
are anticipated to be in the study for approximately 12 months.  
 
Prior to study site initiation, current referral information will be 
collected from sites, and investigators and other site clinical 
personnel will be provided with educational materials that address 
the importance of EF measurement and care pathway for post-MI 
patients. 
 
Sample Size 
Approximately 200 subjects per geography, with a total of 
approximately 1,200 subjects from 6 geographies.   
 
The sample size might be increased up to a maximum of 2,400 
subjects, depending on the observed mortality and drop-out rates 
and on the observed proportion of subjects with reason for referral at 
3-month. 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
• 
Age 18 and above (or meet age requirements per local law) 
• 
Patients who have an acute Myocardial Infarction (MI) (STEMI 
or Non-STEMI) ≤ 30 days of study enrollment and have a LVEF 
<50% measurement ≤ 14 days post-acute MI 
• 
Willing and able to give valid Informed Consent 
 
 
 

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4. Introduction  
4.1. Background  
Acute myocardial infarction (MI) is a life-threatening condition that occurs when the blood flow to the 
heart muscle is abruptly cut off, causing tissue damage. Fibrinolytic (thrombolytic) therapy, which 
prevents blood clots from growing and becoming problematic, may be used within the first few hours of 
symptom onset. Coronary revascularization, including percutaneous coronary intervention (PCI) and 
Coronary Artery Bypass Grafting (CABG) has been shown to improve patient symptoms from myocardial 
ischemia, increase long term survival, and is recommended as part of professional clinical guidelines1. 
However, if there is substantial damage to the heart muscle, the heart may be unable to pump an 
adequate amount of blood, which can lead to heart failure. Left ventricular dysfunction following an 
Exclusion Criteria 
• 
Patient has previously received or currently implanted with an 
ICD or CRT-D 
• 
Patient has any contraindication for ICD/CRT-D 
• 
Patient has a life expectancy of less than 12 months 
• 
Patient who has had an EP referral within the last 12 months  
• 
Any exclusion criteria required by local law (e.g. pregnancy, 
breast feeding etc.) 
• 
Patient is unable (e.g. mental disorder) or unwilling to be 
compliant with the responsibilities as specified in the informed 
consent form.  
• 
Patient is enrolled in a concurrent study that has not been 
approved for concurrent enrollment by the Medtronic Clinical 
Trial Leader* 
 
*Concurrent enrollment with observational registry is allowed without 
approval from the Medtronic Clinical Trial Leader if the Principal 
Investigator confirms that the registry has no intervention beyond 
standard of care and may not confound study results prior to 
enrollment. 
Study Procedures and 
Assessments 
The study requires an Enrollment/ Baseline visit, and 3-month, 6-
month and 12-month follow-up visits.  
 
Safety Assessments 
Cardiovascular Adverse Events (AE) and all deaths will be collected 
(refer to Section 11 for AE Assessment) 
 Statistics 
The purpose of the study is to characterize treatment patterns in 
different geographies for this population, and so descriptive statistics 
will primarily be used, and reported by geography.  For the primary 
objective, a confidence interval will be reported. 
 

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acute MI identifies patients at higher risk of sudden cardiac arrest (SCA) and sudden cardiac death 
(SCD)2. SCD remains a leading cause of death in those who received revascularization, accounting for up 
to 40% of total deaths3,4,5. It is well established that the use of Implantable Cardioverter Defibrillators 
(ICDs) reduces the risk of mortality in patients with reduced LVEF. However, low ICD utilization in ICD-
indicated patients worldwide (ranging from 30 to 50% in USA, 24% in Europe, 12% in Asia)6 and 
persistent high post-PCI mortality rates suggest that barriers in this patient care pathway exist. In the 
U.S. from the National Cardiovascular Data Registry in 2001, the proportion of PCI cases to ICD cases is 
4.5:17; in China in 2013, the proportion of PCI cases to ICD and CRT-D cases is 148:18. Considering that 
patients without PCI are even less likely to have an ICD implanted, the disparity in ratios will be at least 
as bad as the above when all MI patients are considered. 
 
Known barriers to ICD utilization include reimbursement (by government or insurance) of devices, lack 
of evidence awareness by healthcare providers, and limited ability and willingness to pay due to 
patients’ socioeconomic status and attitudes6. Greater uptake and patient acceptance generally occurs 
in regions with government reimbursement of ICDs and lower out-of-pocket patient cost; however, even 
in regions where this financial barrier is reduced, ICD referral rates remain low, suggesting challenges 
further upstream in the patient care pathway. Out of 2,000 ICD nonrecipients surveyed in a recent 
study6, 55% of them were unaware of the benefits or needed more information on device therapy. 
Previous studies also suggested that physicians’ awareness on the indications for ICD therapy is low6. 
This leads to low referral rates for ICD implantation which is noted to be an important barrier to ICD 
utilization. In addition to education and awareness, there is evidence that adherence to guidelines on 
post-MI care is variable.   
 
Efforts have been made to improve and align guidelines-based clinical practice for prevention of SCD 
post-MI.  For example, the ACC/AHA/ HRS guidelines for post-MI care9 are widely accepted. In 2016, the 
Society of Cardiac Pacing and Electrophysiology, Chinese Society of Cardiology, Chinese Medical 
Association, and Heart Rhythm Committee of Chinese Medical Doctor Association jointly published an 
Expert Consensus Guideline for China: “Prevention of Sudden Cardiac Death after Revascularization to 
Coronary Heart Disease” 8 that details post-MI care and emphasizes the importance of regular 
evaluation of the LVEF, but adherence has been low.   
 
Ways in which the upstream care pathway can be improved have not been effectively implemented to 
date. A reduced LVEF (LVEF ≤ 40%) for more than 40 days after a MI identifies patients at higher risk of 
SCD and current guidelines recommend LVEF reassessment during the convalescent months post-MI10. 
However, current practice is suboptimal, patient-reported LVEF reassessment at 6-month after acute MI 
was <40% in TRIUMPH registry that included patients with LVEF <40% at time of MI11. AMIQA study also 
shows LVEF reassessment was <50% during the convalescent post-MI months and 25% of post-MI 
patients with reduced LVEF had either no increase or a decline in LVEF2. Additionally, it is not known 
how many patients post MI have a LVEF that qualifies them for an ICD. This information is important 
because it provides visibility on areas to improve current revascularization approaches and sheds 
greater awareness on the magnitude of the ICD utilization problem in patients with reduced LVEF after 
MI.  
 

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This Improve SCA Bridge study will assess the care pathway for post-acute MI patients through standard 
assessment of LVEF and implementation of an educational tool to bridge the treatment pathway for 
patients who are indicated for an ICD/CRT-D as per AHA/ACC/HRS guideline9. This will help to 
understand the cause of low adherence of guidelines-based clinical practice and low ICD utilization, and 
to identify targets for action to improve guideline adherence.   
4.2. Purpose 
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute MI 
patients as a result of standard assessments of left ventricular ejection fraction in acute phase (≤14 days 
post- acute MI) and chronic phase (≥ 40-90 days post-acute MI). Specifically, how many patients are 
referred for sudden cardiac death (SCD) risk stratification and management, indicated for ICD/CRT-D 
implant, and how many receive such devices within 12 months of experiencing an MI. In addition, the 
current trial will characterize the impact from execution of the above-mentioned guidelines. 
5. Objectives and Endpoints 
5.1. Objectives 
5.1.1. 
Primary Objective 
To characterize the proportion of post-acute MI patients who are referred for sudden cardiac death 
(SCD) risk stratification and management. 
 
5.1.2. 
Secondary Objectives 
• 
Characterize the proportion of post-acute MI patients who are known to be indicated for an 
ICD/CRT-D* within 12 months post-acute MI.  
• 
Characterize the proportion of post-acute MI patients who receive an ICD/CRT-D within 12 
months post-acute MI.  
• 
Summarize the referral and implant refusal rationale. 
• 
Characterize the proportion of post-acute MI patients who experience cardiovascular mortality 
• 
Determine how the ejection fraction evolves over 3 months following an acute MI. 
 
* Indication as per the current AHA/ACC/HRS Guideline for ICD (or CRT-D) implant9 
5.2. Endpoints 
5.2.1. 
Primary Endpoint 
The endpoint will be defined as the clinician’s determination to refer the subject for an SCD stratification 
and management.  The reason for this referral could be any of the following: 
• 
Subject’s LVEF at 3 months determined to be up to 40% 

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• 
Subject experiences unexplained syncope, ventricular arrhythmia, AV block, clinically significant 
palpitations, new onset bundle branch block, conduction abnormalities, or symptomatic 
bradycardia.    
5.2.2. 
Secondary Endpoints 
• 
For the objective “Characterize the proportion of post-acute MI patients who are known to be 
indicated for an ICD/CRT-D within 12 months post-acute MI” the endpoint will be defined as 
whether a subject was indicated for an ICD/CRT-D device during follow-up.     
• 
For the objective “Characterize the proportion of post-acute MI patients who receive an 
ICD/CRT-D within 12 months post-acute MI” the endpoint will be defined as whether a subject 
received an ICD/CRT-D device during follow-up.     
• 
For the objective “Summarize the referral and implant refusal rationale” the outcome measure 
will be the proportion of patients with ICD indication, who were not referred, refused referral     
or refused implant. The denominator will count all patients with at least one of the below: 
(a) a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) 
being lower or equal than 40%.  
(b) ventricular arrhythmia, AV block, new onset bundle branch block, or conduction 
abnormalities as measured by ECGs. 
(c) unexplained syncope, clinically significant palpitations or symptomatic bradycardia as 
assessed by the physician 
The numerator will count the patients included in the denominator who were not referred, 
refused referral or refused implant of an ICD/CRT-D. 
• 
For the objective “Characterize the proportion of post-acute MI patients who experience 
cardiovascular mortality” the endpoint will be defined as cardiovascular mortality.   
• 
For the objective “Determine how the ejection fraction evolves over 3 months following an 
acute MI” each subject’s LVEF will be measured at hospital discharge (i.e. within 14 days of MI), 
and at chronic phase (40-90 days post MI). The endpoint will be the change between the acute 
and the chronic measurement. 
6. Study Design  
This study is a prospective, non-randomized, multi-site, global, post-market study.  There is no 
investigational device; subjects can be implanted, if indicated and referred, with any brand or model of a 
market released ICD/CRT-D.   
 
The study is expected to be conducted at approximately 50 sites worldwide.  Participating geographies 
are: China, India Subcontinent (including India, Bangladesh), Korea, Middle East, Africa, Central Asia, & 
Turkey (MEACAT) (including Egypt, Pakistan, Saudi Arabia, South Africa and Tunisia), South East Asia 
(SEA) (including Brunei, Indonesia, Malaysia, Philippines, Singapore and Thailand) and Taiwan. Additional 

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countries could participate within these geographies. Each geography is expected to enroll  
approximately 200 subjects, with a total of approximately 1,200 subjects from 6 geographies.  
The actual sample size may increase up to 2,400 subjects, depending on the observed mortality and 
drop-out rate between enrolment and three months follow-up and on the observed proportion of 
subjects with a reason for referral at the three months visit. 
 
 
Prior to study site initiation, current referral information will be collected from sites, and investigators 
and other site clinical personnel will be provided with educational materials (available under a separate 
cover) that address the importance of EF measurement and care pathway for post-MI patients.  
 
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
• 
Subject demographics will be collected at baseline for potentially analyzing differences that may 
affect the endpoints. 
• 
All study clinicians and Medtronic personnel will be trained on the corresponding aspects of the 
study using standardized training materials. 
• 
All study clinicians and Medtronic personnel will be trained on and required to follow the Protocol. 
• 
Sites will be encouraged to approach any eligible patients meeting inclusion/exclusion criteria  
• 
Each geography is expected to enroll an approximate 200 subjects to have at least 80% power to 
achieve a moderate to high number of patients referred for SCD risk stratification and management.  
• 
For each geography, sites where the same physician acts both as an interventional cardiologist and 
as an electrophysiologist will be limited to a maximum of 20% of the total sites in the geography, 
and approximately 20% of the total expected enrollments in the geography will be enrolled in these 
sites. 
• 
To ensure a wide distribution of data between sites, the maximum enrollments per site will be no 
more than 20% of the total expected enrollment in the geography. 
See Figure 1 and Section 9 for further detail on study procedures and data collection as well as 
timepoints for data collection. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1 Study Flow 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*For patient enrollment: Patients must be enrolled ≤ 30 days post-acute MI and must have an EF < 50% 
measured ≤ 14 days post-acute MI. 
 
**Referral Criteria: sustained VT, cardiac or unexplained syncope, clinically significant palpitations, new 
onset bundle branch block, conduction abnormalities, or symptomatic bradycardia.  
3 MONTH VISIT 
LVEF assessment and ECG  
12 MONTH VISIT (phone/ in person): 
EP REFERRED GROUP 
• 
LVEF assessment and ECG (if performed as 
per standard of practice) 
• 
Implant status  
• 
Exit the subject 
Exit Patients with 
 EF ≥50% 
12 MONTH VISIT (phone/ in-person): 
NON-REFERRED GROUP  
• 
LVEF assessment and ECG (if performed as 
per standard of practice) 
• 
Referral status based on EF and referral 
criteria**  
• 
Exit the subject 
BASELINE 
• 
Consent  
• 
Post-acute MI patients (STEMI or Non-STEMI)* 
• 
LVEF assessment and ECG  
EF ≤ 40% or 
Referral criteria** 
Patients with 40%< EF <50% 
Patients with EF ≤ 40% or meeting one 
of the referral criteria 
6 MONTH VISIT (phone/ in-person): 
NON-REFERRED GROUP  
• 
LVEF assessment and ECG (if performed as 
per standard of practice) 
• 
Referral status based on EF and referral 
criteria** 
6 MONTH VISIT (phone/ in-person): 
EP REFERRED GROUP  
• 
LVEF assessment and ECG (if 
performed as per standard of practice) 
• 
Implant status  

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6.1. Duration 
The study duration is expected to be approximately 24 months. The first enrollment is projected in Nov 
2018. This represents an estimated 12 months for subject enrollment and 12 months for subject follow-
up for the last subject enrolled. At approximately 12 months past the final study enrollment, centers will 
be notified that study closure is about to occur. 
6.2. Rationale 
This study is characterizing the care pathway of post MI patients and understanding the evolution of 
LVEF for post MI patients, which will improve the management of this group of patients in prevention of 
SCD.  
6.3. Study oversight   
The study will utilize a Steering Committee (SC). The SC is responsible for the scientific content of the 
study and for providing input for the execution of the study. Members of the SC are study site 
investigators. The purpose of the SC is to provide unbiased opinions and expertise to Study design and 
process; support the execution of Study and provide guidance, feedback and direction to the clinical 
study. The SC is comprised of the members as indicated in Table 1 below. 
 
Table 1: Steering Committee Members 
Committee Member 
Contact Information 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
  
 

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7. Product description 
7.1. General 
There are no requirements for model or manufacturer of ICD/CRT-Ds implanted during the patient’s 
follow-up. These devices can be any brand or model of market released ICD/CRT-D, and should be 
implanted as per the current AHA/ACC/HRS Guideline9.  
 
Subjects receiving a Medtronic device will have device data retrieved and analyzed by Medtronic as part 
of the study. 
8. Selection of Subjects 
8.1. Study Population 
Patients of both genders who have had an acute MI ≤ 30 days of enrollment and have a LVEF <50% 
measurement ≤ 14 days post-MI will be approached regarding enrollment in the study. Patients 
implanted with ICDs or CRT-Ds or who have had an EP referral in the last 12 months will not be 
approached for this study. 
8.2. Subject Enrollment 
Subjects are considered enrolled in the study upon signing the Medtronic & Medical Ethics Committee 
(MEC)-approved Informed Consent Form.  Informed consent must be obtained prior to performing any 
of the study-related procedures or entering any subject data in the eCRF.  The complete informed 
consent process will include giving the patient 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. Each site will be responsible for maintaining subject 
identification records (e.g. subject identification log).  

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8.3. Inclusion Criteria 
The inclusion criteria are as follows: 
• 
Age 18 and above (or meet age requirements per local law) 
• 
Patients who have an acute Myocardial Infarction (MI)* (STEMI or non-STEMI) ≤ 30 days of study 
enrollment and have a LVEF <50% measurement ≤ 14 days post- MI 
• 
Willing and able to give informed consent 
 
* Strongly recommend following the ESC guideline12 for acute MI definition.  
8.4. Exclusion Criteria 
The exclusion criteria are as follows: 
• 
Patient has previously received or currently implanted with an ICD or CRT-D  
• 
Patient has any contraindication for ICD/CRT-D 
• 
Patient’s life expectancy of less than 12 months 
• 
Patient who has had an EP referral within the last 12 months  
• 
Any exclusion criteria required by local law (e.g. pregnancy or breast feeding etc.) 
• 
Patient is unable (e.g. mental disorder) or unwilling to be compliant with the responsibilities 
as specified in the informed consent form. 
• 
Patient is enrolled in a concurrent study that has not been approved for concurrent 
enrollment by the Medtronic Clinical Trial Leader* 
 
*Concurrent enrollment with observational registry is allowed without approval from the Medtronic 
Clinical Trial Leader if the Principal Investigator confirms that the registry has no intervention beyond 
standard of care and may not confound study results prior to enrollment. 
9. Study Procedures  
Prior to performing study related procedures, all sites must have EC approval and documentation of site 
initiation 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. performing device interrogations/save-to-media), but no 
electronic case report form (eCRF) data entry shall be performed by Medtronic personnel  
• 
Monitoring activities 
• 
Auditing activities 

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9.1. 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. 
• 
Be qualified practitioners and experienced in the management of post-MI subjects  
• 
Be able to comply with applicable Institutional Review Board (IRB)/Ethics Committee (EC) and 
regulatory requirements  
• 
If applicable, not to be debarred, disqualified, or working under sanctions in applicable regions 
 
Additionally, the site: 
• 
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 
• 
Needs to have specialized practitioners (e.g. Interventional Cardiologist and Electrophysiologist) 
to participate in the study and be complaint with this study protocol. 
9.2. Site Initiation 
During the initiation process (prior to subject enrollment), Medtronic will provide clinical study materials 
(e.g. Investigator Site File, database access codes etc.) and train site personnel on the Clinical 
Investigation Plan (CIP), relevant standards and regulations (if needed), informed consent, and data 
collection and reporting tools.   
A Clinical Trial Agreement (CTA) shall be entered into effect by Medtronic, the participating investigation 
site and/or the Principal Investigator (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 compliance to 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 
initiation before beginning any study-related activities.  Requirements for initiation vary by geography, 
and may include, but are not limited to: 
• 
Written documentation of 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) 

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• 
Regulatory authority approval or notification (as required per local law)  
• 
Executed CTA on file with Sponsor 
• 
Current Curriculum Vitae (CV) of Investigators and key members of the investigation site team  
• 
Documentation of delegated tasks 
• 
Documentation of study site personnel training  
 
Additional requirements imposed by the EC and regulatory authority shall be followed, if appropriate.  
Medtronic will provide each study site with documentation of study site/Investigator initiation; this 
letter must be received prior to subject enrollment. If new members join the study site team after site 
initiation, they will receive training on the applicable clinical study requirements relevant to their roles 
before contributing to the clinical study. Medtronic will provide the study site with documentation of 
the investigation site team initiation upon receipt of all required documentation. 
 
In addition, all participating site staff must be trained on the current version of the CIP pertinent to their 
role in the study and must be delegated by the principal investigator to perform study related activities, 
which must be documented on the Delegated Task List. Site personnel performing only standard of care 
procedures and no study related activities throughout the study (including but not limited to ICD/ CRT-D 
implant) do not need to be trained on the CIP and delegated on the Delegated Task List. 
9.3. Schedule of Events 
Clinical data will be collected at the Baseline 3 month, 6 month, 12 month, and exit visits.  In addition if 
applicable, clinical data will be collected with an exit or death, as well as unscheduled visits. Device data 
will be collected from device interrogations on Medtronic devices received during the period between 
the enrollment and exit until study closure; for non-Medtronic devices, device data will not be collected.  
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 (for Medtronic 
implanted devices only).  Surveys may also be used throughout the study. 
 
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 2 below. 
 
 
 
 
 
 
 
 

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Table 2 Data Collection and study procedure requirements at subject visit 
Study Procedure 
Baseline 
3 month 
visit 
6 month  
visit 
12 month 
visit 
Study Exit 
Patient informed consent 
X 
 
 
 
 
Eligibility Verification 
(Inclusion/ exclusion 
assessment) 
X 
 
 
 
 
Subject Demographics 
X 
 
 
 
 
Acute MI information 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
Cardiovascular Medications 
X 
X 
 
 
 
LVEF measurement  
X 
X ⃰ 
X 
(collect if 
performed as 
per SOC) 
X 
(collect if 
performed 
as per SOC) 
 
ECG 
X 
X 
(collect if 
performed as 
per SOC) 
X 
(collect if 
performed as 
per SOC) 
X 
(collect if 
performed 
as per SOC) 
 
Referral Status  
 
X 
X 
X 
X 
Implant Status (if applicable) 
 
X 
(if subject 
receives or 
has received 
device 
implant) 
X 
(if subject 
receives or 
has received 
device 
implant) 
X 
(if subject 
receives or 
has received 
device 
implant) 
X 
(if subject 
receives or 
has received 
device 
implant) 
Device Interrogation File 
(pdd) or CareLink 
Transmission for subjects 
implanted with Medtronic 
device only 
 
X 
X 
X 
X 
Adverse Event  
As they occur 
System Modification 
Study Deviation 
Subject Death 
* The LVEF measurement needs to be performed ≥40 days post-acute MI for MI subjects without 
revascularization, or ≥90 days post-revascularization for post-MI subjects with revascularization done. 
9.4. Subject Consent 
Informed consent is defined as a legally effective documented confirmation of a patient’s voluntary 
agreement to participate in a particular clinical study after the information has been given to the patient 
on all aspects of the clinical study that are relevant to the patient’s decision to participate. This process 

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includes obtaining an Informed Consent Form (IC Form) and an Authorization to Use and Disclose 
Personal Health Information/Research Authorization/other privacy language (data protection 
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 patient and the PI or an authorized designee. 
Prior to enrolling patients, 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 
patient. Likewise, privacy or health information protection regulation may require patients 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 patient 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 patient's decision to participate 
throughout the clinical study. 
• 
Avoid any coercion or undue improper influence on, or inducement of the patient to participate. 
• 
Not waive or appear to waive the patient’s legal rights. 
• 
Ensure the IC Form and a data protection authorization as required by law, are given to the 
patient in a non-technical language the patient is able to read and understand. 
• 
Provide ample time and opportunity for the patient 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 patient. 
• 
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. 

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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. 
Informed consent shall be obtained through a supervised oral process. An impartial 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. Whenever possible, 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.  
9.5. 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 where applicable) must be documented in the subject’s medical records.  
Enrollment will occur ≤ 30 days of post-acute MI. Medtronic should be notified (via Enrollment eCRF) as 
soon as possible to aid in enrollment tracking. Once consent is obtained, report cardiac adverse events, 
study deviations, system modifications, and subject deaths as they occur.   
 
The following information is required to be collected at Baseline: 
• 
Patient Informed Consent Date (Enrollment Date) 
• 
Eligibility Verification (Inclusion/Exclusion Assessment) 
• 
Subject Demographics 
• 
Acute MI information 
• 
Medical History 
• 
Cardiovascular Medication categories including Angiotensin-converting enzyme (ACE) Inhibitors,  
angiotensin receptor blocker (ARB), Beta blockers, Vasodilators, Diuretics, Aldosterone receptor 
antagonists, Digoxin, Anticoagulation agents, anti-platelet agents, statin, anti-arrhythmics, or 
any cardiovascular medication categories that will become available during the course of the 
study. 
• 
LVEF measurement (≤14 days post -acute MI) and ECG done as per standard practice. For LVEF, 
it is recommended to measure by echocardiography (for example Simpson’s method) and to use 
the same method when assessing the same subject at Baseline and 3-month follow-up visit.   

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9.6. Follow-Up Visits  
Table 3 below specifies permitted time windows for the required subject visits. Subject visit target dates 
and windows for each follow-up will be made available to the study site. Follow-up visit windows are 
based on days post-acute MI, and the follow-up visit can be performed either in person or via phone. If a 
subject visit fall outside the pre-specified window, a study deviation must be reported and the original 
follow-up schedule maintained for subsequent visits.  
Data analyses will include follow-up visits, regardless of whether the visits occur within the time 
window. Therefore, a late visit is preferred over a missed visit but must be accompanied by a deviation.  
Table 3: Follow-up windows 
Study Follow-up Visit 
Window (Calculated days post-acute MI) 
Window Start 
(days post-MI) 
Target 
(days post-MI) 
Window End 
(days post-MI) 
3 month 
40 
90 
120 
6 month 
150 
180 
210 
12 month 
335 
365 
395 
 
Complete a Subject Visit CRF for each follow-up visit. 
At 3-month follow-up visit, LVEF will be assessed as per standard practice: 
• 
As per Investigator’s discretion, if the subjects have LVEF ≤ 40% or meeting one of the referral 
criteria (sustained VT, cardiac or unexplained syncope, clinically significant palpitations, new 
onset bundle branch block, conduction abnormalities, or symptomatic bradycardia), the subjects 
can be referred for SCD risk stratification and management (EP Referred Group). If the referral 
does not take place, it is not a study deviation.  
• 
If the subjects have LVEF >40% but <50% (between 41%- 49%), the subjects will remain in the 
Non-Referred Group.  
• 
If the subjects have LVEF ≥ 50%, they shall be exited from the study.  
For the Non-Referred Group, a Referral Status CRF is needed for each subsequent visit unless the subject 
is referred to the EP Referred Group. During study follow-up visits, the Non-Referred Group subjects can 
be referred to the EP Referred Group if their LVEF is ≤ 40% or meets one of the referral criteria (as listed 
above).  
9.6.1. 
Information Collected 
The following information is required to be collected at follow-up visits: 
• 
Referral status 
• 
Implant status  
• 
Cardiovascular Medication categories as listed under Enrollment/ Baseline (for 3-month visit 
only)  

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• 
LVEF measurement as per standard practice.  
o For 3-month visit, the LVEF measurement needs to be performed ≥40 days post-acute 
MI for MI subjects without revascularization, or ≥90 days post-revascularization for 
post-MI subjects with revascularization done.  
• 
ECG as per standard practice 
• 
Cardiovascular Adverse events, Study Deviations and System Modification.  
9.6.2. 
Subjects with Medtronic device  
Subjects who are indicated for a device and ultimately receive an implant will not be required to be 
implanted with a Medtronic device.  However, if the subject is implanted with a Medtronic ICD or CRT-D, 
a device interrogation (save-to-disk) will be performed at implant and study follow-up visits, or via 
CareLink transmission as applicable.  
It is recommended that data are not cleared during any interrogation or save-to-disk. Retain one copy at 
site for the subject file and submit the other copy to Medtronic via Medtronic Secure Messaging (MSM). 
9.7. Study Exit 
At 3-month follow-up, if a subject has an LVEF ≥ 50%, the subject will be exited from the study. Subject 
who remain in the study after 3-month follow-up should remain in the study until the 12-month follow-
up is completed or until all data required to meet study objectives have been collected (whichever 
comes first). Either an in-office visit or phone call is required for study exit.  
 
A study exit eCRF is required for all subjects.  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 9.11.1) 
• 
Subject did not meet inclusion/exclusion criteria  
• 
Subject did not provide consent or data use protection authorization 
• 
Subject chooses to withdraw (refer to section 9.11.2 for more information)  
• 
Investigator deems withdrawal necessary (e.g. medically justified, inclusion/exclusion criteria 
not met) 
• 
Subject exited  study at the 3 months visit if the 3-month LVEF is ≥ 50%  
• 
Subject completed study after 12 months visit  
• 
Subject Death 
 

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For study exit visits the following information is required:    
• 
Reason for exit 
• 
Final interrogation file (or CareLink transmission) for subjects implanted with Medtronic device 
• 
Cardiovascular Adverse events, Study Deviations and System Modification  
9.8. Assessment of Safety 
This study is related to guideline-based care, using only market approved therapies, and so there are no 
pre-specified objectives relating to patient safety.  Deaths and cardiovascular related adverse events, 
will be collected.  See section 11 for further details. 
9.9. Recording Data 
The study will collect data using Oracle Clinical, an electronic data management system for clinical 
studies. Sites will enter data onto electronic case report forms (eCRFs), and the principal investigator or 
his/her authorized designee(s) will sign off the data entered.   
Device interrogation files collected via electronic media at office visits will be sent to Medtronic. Device 
data from CareLink transmissions will be uploaded to secure servers. Upon receipt via transmissions or 
electronic media, device data will be maintained with databases and retrieved for analysis and 
reporting. 
Data reported on the CRFs shall be derived from source documents, which may include worksheets, 
patient medical records and device interrogation/save-to-media files. These source documents must be 
created and maintained by the investigational site team. Further detail on data management is provided 
in Section 14.2.  
9.10. Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the Clinical 
Investigation Plan or the Clinical Trial Agreement. 
Prior approval by the Medtronic study manager is expected in situations where the investigator 
anticipates, contemplates, or makes a conscious decision to deviate.  Prior approval is not required 
when a deviation is necessary to protect the life or physical wellbeing of a subject in an emergency or in 
unforeseen situations beyond the investigator’s control (e.g. subject failure to attend scheduled follow-
up visits, inadvertent loss of data due to computer malfunction, inability to perform required procedures 
due to subject illness, etc.).  
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to complete only one deviation Case Report Form which will apply to all 
visits going forward.  This may also apply for other unforeseen situations (e.g. the subject permanently 
refuses to complete a study required procedure and the data will not contribute to the primary end 
point analysis, etc.).  However, prior approval from Medtronic is required for such situations.   
All study deviations must be reported on the Case Report Form regardless of whether medically 
justifiable, pre-approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an 

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emergency.  Please refer to the Case Report Form Completion Guideline for the examples of deviations. 
The deviation must be recorded with an explanation for the deviation and corrective/ preventative 
action(s).   
In the event the deviation involves a failure to obtain a subject’s consent, or is made to protect the life 
or physical wellbeing of a subject in an emergency, the deviation must be reported to the MEC/IRB 
(where applicable) as well as Medtronic within five (5) working days. Reporting of all other study 
deviations should comply with MEC/IRB policies and/or local laws and must be reported to Medtronic as 
soon as possible upon the center becoming aware of the deviation.  Reporting of deviations must 
comply with IRB/ MEC policies, local laws, and or regulatory agency requirements.  Refer to Investigator 
Reports (Table 8) for geography/country-specific deviation reporting requirements and timeframes for 
reporting to Medtronic and/or regulatory bodies. 
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the Clinical Investigation Plan, conduct 
additional training, terminate the investigation, etc.).  Repetitive or serious investigator compliance 
issues may represent a need to initiate a corrective action plan with the investigator and site, and in 
some cases, necessitate freezing enrollment until the problem is resolved or ultimately terminating the 
investigator's participation in the study.  Medtronic will provide center-specific reports to investigators 
summarizing information on deviations that occurred at the investigational site on a periodic basis.   
9.11. Subject Withdrawal or Discontinuation  
9.11.1. 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.  
9.11.2. 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. 
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.  

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10. Risks and Benefits 
10.1. Potential Risks 
While the study is characterizing the post-MI patient care pathway who may be referred and indicated 
for ICD therapy, there is no required study product for this study.  In fact, this study does not require the 
administration of any pharmacological or device medical treatment, and required testing is restricted to 
standard LVEF measurement.  Subjects are treated according to standard practice and there are no 
required additional procedures outside of standard of care. If the patients are indicated and receiving an 
ICD implant, the risks associated will be consistent with market-released ICD therapies. There may be 
other discomforts and risks related to the ICD and/or this study that are not foreseen at this time such 
as movement of the device from its original implant location, device prominence or protrusion under 
the skin, device requiring repositioning, wearing away of the skin in the area of device implant, 
awareness of device discomfort with certain types of pacing, pain when receiving a shock, the ICD 
batteries deplete and may require replacement of the ICD. 
10.2. Potential Benefits 
Participation in this study may offer no benefit. Subjects enrolled in the study may have additional 
contact with their physicians or other medical care staff beyond their normal standard of care visits, 
which may provide benefit from a patient care perspective. The information gained from this study 
could result in the improved management post-MI patients through bridging referral linkages, 
reimbursement coverage, and user adoption.  
10.3. Risk-Benefit Rationale 
Subjects may be identified as being indicated for ICD therapy regardless of their participation in this 
study.  While subjects not indicated for ICD therapy may derive minimal or no benefit of participation in 
the study in terms of long term treatment, there is a potential for better acute care due to the protocol-
required repeat diagnostic imaging and referral pathway. 
11. Adverse Events  
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are 
crucial for the protection of subjects. Medtronic has established procedures in conformity with 
worldwide regulatory requirements to ensure appropriate reporting of safety information. The products 
used in the clinical trial are market approved and used within the current Indications for use as indicated 
in the product labeling.  It is the responsibility of the Investigator to abide by any adverse event 
reporting requirements stipulated by local laws and regulations and the site’s IRB or MEC.  
User (Investigator) reporting of events to regulatory authorities related to market approved products 
may be required as per local law requirement.  

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11.1. Definitions/Classifications 
Adverse Event definitions are provided in Table 4. Sites are required to report the following throughout 
the study duration, starting at the time the informed consent form is signed:  
• 
Deaths 
• 
Cardiovascular related Adverse Events including Cardiovascular related Serious Adverse Events and 
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) 
 
For the purposes of the clinical report, Medtronic will classify each adverse event according to 
ISO14155:2011 definitions. The term “investigational medical device” is part of ISO14155 definitions. 
This study is not using any devices that are considered to be investigational. Where the definition indicates 
“device”, it refers to any device used in the study.  
 
Table 4 Adverse Event Definitions 
Event Type 
Definition 
Cardiovascular 
Related AE 
An AE relating to the heart and the blood vessels or the circulation. This includes 
but is not limited to syncope, stroke/TIA (Transient Ischemic Attack), myocardial 
infarction, heart failure, atrial or ventricular arrhythmia, and peripheral vascular 
disease. 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device.  
NOTE 1: This definition includes events related to the investigational medical 
device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
(ISO 14155:2011 section 3.2) 
Adverse Device 
Effect (ADE) 
Adverse event related to the use of an investigational medical device. 
 
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from an error use or from 
intentional misuse of the investigational medical device. 
(ISO 14155:2011, 3.1) 
Serious Adverse 
Event (SAE) 
Adverse event that  
a) 
led to death, 
b) 
led to serious deterioration in the health of the subject, that either 
resulted in  
1) 
a life-threatening illness or injury, or  
2) 
a permanent impairment of a body structure or a body function, or 
3) 
in-patient or prolonged hospitalization, or  

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Event Type 
Definition 
4) 
medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function, 
c) 
led to fetal distress, fetal death or a congenital abnormality or birth 
defect.   
NOTE: Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not considered a 
serious adverse event. 
(ISO 14155:2011 section 3.37) 
Serious Adverse 
Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic 
of a serious adverse event. 
(ISO 14155:2011, 3.36) 
11.2. Reporting of Adverse Events  
All reported Adverse Events will be reviewed by a Medtronic representative. AEs will be classified 
according to the definitions provided. 
 
Upon receipt of an Adverse Event at Medtronic, a Medtronic representative will review the Adverse 
Event for completeness and accuracy and when necessary will request clarification and/or additional 
information from the Investigator. Medtronic will utilize MedDRA, the Medical Dictionary for Regulatory 
Activities, to assign a MedDRA term for each adverse event based on the information provided by the 
Investigator. 
 
Adverse Events and deaths will be classified according to the standard definitions as outlined below:  
 
Table 5 Adverse Event Classification Definition Responsibilities 
What is classified 
Who classifies? 
Classification Parameters 
Relatedness 
Investigator  
Device, Right Atrial (RA) Lead, Right Ventricular (RV) 
Lead, LV Lead  
Sponsor 
Device, RA Lead, RV Lead, LV Lead 
Seriousness  
Investigator  
SAE 
Sponsor 
SAE 
Diagnosis  
Investigator  
Based on presenting signs and symptoms and other 
supporting data 
Sponsor 
MedDRA term assigned based on the data provided by 
Investigator 
11.2.1. Adverse Events Reporting Requirements  
Regulatory reporting of AEs will be recorded and reported according to local regulatory requirements. It 
is the responsibility of the Investigator to abide by any additional adverse event reporting requirements 

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stipulated by local law and the site’s IRB/EC. Please refer to Appendix E for the investigator reporting 
requirements for countries where there are specific requirements.  
 
Table 6 Reporting Requirements 
All Cardiovascular related Adverse Events  
Investigator submit to: 
Medtronic 
Submit in a timely manner after the investigator first learns of the event. 
Regulatory authorities 
Submit to regulatory authority per local reporting requirement. 
Ethics Committee 
Submit to Ethics Committee per local reporting requirement. 
 
11.3. Subject Death 
11.3.1. Death Data Collection 
All subject deaths must be reported by the investigator to Medtronic on an AE (AE with the outcome of 
fatal) and Death CRFs as soon as possible after the investigator first learns of the death. Exit CRF also 
needs to be completed. 
If any Medtronic system component is returned to Medtronic, internal return product reporting systems 
may be used to gather additional information about the returned device/component. 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic study team.  When a death occurs in a hospital, a copy of the death summary report and all 
relevant hospital records should be sent to the Medtronic study team, if available.  If an autopsy is 
conducted, the autopsy report should also be sent to the Medtronic study team if available and allowed 
by state/local law.  When the death occurs at a remote site, it is the investigative site’s responsibility to 
attempt retrieval of information about the death.  Additionally, device disposition information should be 
updated.  In summary, the following data will be collected: 
• 
Date of death 
• 
Detailed description of death 
• 
Cause of death  
• 
Device interrogation (or CareLink transmission) for subjects implanted with Medtronic device 
• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and allowed by state/local law) 
11.3.2. Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. The Investigator 
shall classify each subject death per the following definitions: 

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• 
Sudden Cardiac Death (SCD): Natural death due to cardiac causes, indicated by abrupt loss of 
consciousness within one hour of the onset of acute symptoms; preexisting heart disease may 
have been known to be present, but the time and mode of death are unexpected. If the time of 
onset cannot be determined, SCD will alternatively be defined as any unexpected cardiac death 
occurring out of the hospital or in the emergency room as dead on arrival. 
• 
Non-sudden Cardiac Death: All cardiac deaths that are not classified as sudden deaths, including 
all cardiac deaths of hospitalized subjects on inotropic support. 
• 
Non-cardiac Death: A death not classified as a cardiac death. 
• 
Unknown Classification: Unknown death classification is intended for use only when there is 
insufficient or inadequate information to classify the death. 
Table 7 Subject Death Classification Responsibilities 
What is 
classified?  
Who 
classifies? 
Classification Parameters 
Death Classification Investigator 
Sudden Cardiac, Non-sudden Cardiac, Non-cardiac, 
Unknown 
Regulatory reporting of subject deaths will be completed according to local regulatory requirements.  
11.4. Product Complaint Handling 
In geographies where Medtronic devices are market-released, product complaint reporting to 
Medtronic is applicable. This includes when an AE is related to a market-released Medtronic 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.  
 
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 

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Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function. 
12. Statistical Design and Methods 
12.1. General Considerations  
Medtronic statisticians or designee will conduct all statistical analyses.  The purpose of the study is to 
characterize treatment patterns in different geographies for this population, and so descriptive statistics 
will primarily be used, and reported by geography.  A separate Statistical Analysis Plan (SAP) will be 
developed and include a comprehensive description of the statistical methods to be included in the final 
study report.  Any change to the data analysis methods described in the protocol will require an 
amendment only if it changes a principal feature of the protocol.  Any other change to the data analysis 
methods described in the protocol or the SAP, and the justification for making the change, will be 
described in the clinical study report. 
12.2. Primary Objective  
Characterize the proportion of post-acute MI patients who are referred for sudden cardiac death risk 
(SCD) stratification and management.  
12.2.1. 
Hypothesis 
This is a characterization study, and so there are no hypotheses for this objective. 
12.2.2. 
Endpoint definitions 
The endpoint will be defined as the clinician’s determination to refer the subject for SCD risk 
stratification and management.  The pre-defined reasons for this referral are: 
• 
Subject’s LVEF at 3 months determined to be up to 40% 
• 
Subject experiences unexplained syncope, ventricular arrhythmia, AV block, clinically significant 
palpitations, new onset bundle branch block, conduction abnormalities, or symptomatic 
bradycardia.    
12.2.3. 
Analysis Methods 
Subjects will be evaluated during their chronic phase (≥40-90 days after MI) for determination of the 
need for SCD risk stratification and management.  As of this visit, subjects may be partitioned into 
several groups:  died of cardiovascular causes prior to reaching the 3 months visit, exited or died of non-
cardiovascular causes prior to reaching 3 months visit, reached the 3 months visit and were not referred 
for SCD risk stratification and management, reached the 3 months visit and were referred for SCD risk 
stratification and management.  Descriptive statistics will be used to summarize these groups. Among 

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the subjects with a reason for referral during their chronic phase (≥40-90 days after MI) as described in 
Section 12.2.2, the proportions and Wilson score 95% CI of those who were referred will be computed.  
A subject not referred for SCD risk stratification and management during their chronic phase (≥40-90 
days after MI) may later be referred.  Thus, similar descriptive statistics may be generated at 6 and 12 
months post-baseline visits.  The analyses will be performed separately for each geography/country.  
12.2.4. 
Determination of Patients/Data for Analysis 
All subjects enrolled will be included in the analysis. 
12.2.5. 
Sample Size 
The sample size calculation was based on the width of the 95% confidence interval for the proportion of 
subjects that is referred for SCD risk stratification and management among subjects who have a reason 
for referral at the 3 months visit (see Section 12.2.2). The following assumptions were made: 
• 
Drop-out and mortality rate combined from enrollment to 3 months visit of 10%, 
• 
At the 3 months visit, 30% of subjects will have a reason for referral. 
Under these assumptions, enrollment of approximately 200 patients per geography is needed, to have 
at least 80% power to achieve a 95% confidence interval width of 25% when 70% of patients is referred 
for SCD risk stratification and management.  
12.3. Secondary Objectives 
12.3.1. Proportion of post-acute MI patients who are indicated for 
an ICD/CRT-D 
Characterize the proportion of post-acute MI patients who are known to be indicated for an ICD/CRT-D 
within 12 months post-MI. 
12.3.1.1. Hypothesis 
There are no hypotheses for this objective, as this is a characterization objective. 
12.3.1.2. Endpoint definitions 
The endpoint will be defined as whether a subject was indicated for an ICD/CRT-D device during follow-
up.     
12.3.1.3. Analysis methods 
The proportion and Wilson score 95% CI of subjects recommended for ICD/CRT-D during their chronic 
phase (≥40-90 days after MI), at the 6 months and at the 12 months visits will be computed. Further, in 

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case any subject will be indicated for ICD/CRT-D at the 6 months or the 12 months visits, a competing 
risk analysis with accompanying 95% confidence bounds and mortality accounted for, will be produced 
to assess a subject’s time to recommendation of ICD/CRT-D therapy, in months from date of enrollment 
to date of recommendation. Results will be determined separately for each relevant geography/country. 
12.3.1.4. Determination of Patients/Data for Analysis 
All subjects enrolled will be included in the analysis. 
12.3.2. Proportion of post-acute patients who receive an 
ICD/CRT-D 
Characterize the proportion of post-acute MI patients who receive an ICD/CRT-D within 12 months post-
MI.  
12.3.2.1. Hypothesis 
There are no hypotheses for this objective, as this is a characterization objective. 
12.3.2.2. Endpoint definitions 
The endpoint will be defined as whether a subject received an ICD/CRT-D device during follow-up.     
12.3.2.3. Analysis methods 
The proportion of subjects who received an ICD/CRT-D during each of their follow-up visits will be 
computed. Further, a competing risk event curve with accompanying 95% confidence bounds and 
mortality accounted for, will be produced, to assess a subject’s time to receiving ICD/CRT-D therapy. 
Results will be determined separately for each relevant geography/country. 
12.3.2.4. Determination of Patients/Data for Analysis 
All subjects enrolled will be included in the analysis. 
12.3.3. Referral and implant refusal rationale 
Summarize the referral and refusal implant rationale. 
12.3.3.1. Hypothesis 
There are no hypotheses for this objective, as this is a characterization objective. 

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12.3.3.2. Endpoint definitions 
The outcome measure will be the proportion of patients with ICD indication, who were not referred, 
refused referral or refused implant. The denominator will count all patients with at least one of the 
below: 
 
a. a reduced ejection fraction, as measured by the Left Ventricular Ejection Fraction (LVEF) being 
lower or equal than 40%.  
b. ventricular arrhythmia, AV block, new onset bundle branch block, or conduction abnormalities 
as measured by ECGs. 
c. unexplained syncope, clinically significant palpitations or symptomatic bradycardia as assessed 
by the physician 
The numerator will count the patients included in the denominator who were not referred, refused 
referral or refused implant of an ICD/CRT-D. 
12.3.3.3. Analysis methods 
Descriptive statistics will be used to summarize the proportion of subjects who meet any of the referral 
criteria but are not referred for SCD risk stratification and management and the proportion of subjects 
refusing an ICD/CRT-D implant. The reasons for not having referred to subject for SCD stratification and 
for refusal of implant will also be summarized. All summary statistics will be produced overall and by 
geography. 
12.3.3.4. Determination of Patients/Data for Analysis 
All subjects enrolled will be included in the analysis at that time point. 
12.3.4. Incidence of CV Mortality  
Characterize the proportion of post-acute MI patients who experience cardiovascular mortality. 
12.3.4.1. Hypothesis 
There are no hypotheses for this objective, as this is a characterization objective. 
12.3.4.2. Endpoint definitions 
The endpoint will be defined as cardiovascular mortality.   
12.3.4.3. Analysis methods 
At each follow-up visit, the cumulative proportion of subjects who experienced cardiovascular mortality 
between each visit will be computed. 

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Further, for subjects who experience cardiovascular mortality, a subject’s time to death will be 
computed in months from enrollment to date of death. If a subject does not meet the endpoint, the 
subject will be censored at the later of their last follow-up visit or exit.  A competing risks event curve 
will be generated with accompanying 95% confidence bounds and non-cardiovascular mortality 
accounted for.   
Results will be determined separately for each relevant geography/country. 
12.3.4.4. Determination of Patients/Data for Analysis 
All subjects enrolled will be included in the analysis. 
12.3.5. Change in LVEF Over Time 
Determine how the ejection fraction evolves over the immediate period of post MI. 
12.3.5.1. Hypothesis 
There are no hypotheses for this objective, as this is a characterization objective. 
12.3.5.2. Endpoint definitions 
The Left Ventricular Ejection Fraction (LVEF) will be measured acutely post MI (≤14 days after MI onset) 
and chronically (40-90 days). The endpoint will be the change between the acute and the chronic 
measurement. 
12.3.5.3. Analysis methods 
Descriptive statistics (e.g.: mean, standard deviation, median, range) will be used to summarize the LVEF 
during the acute phase and the chronic phase post-MI.  Similar statistics will be provided for subjects 
with LVEF measured at the 6 months and at the 12 months visits. Additionally, the proportion and 
associated 95% CI of subjects whose LVEF measurement was at most 40% will also be computed, in both 
the acute and chronic phases.  The average change in LVEF between the acute phase and the chronic 
phase, will be estimated using the ANCOVA method. The model will contain LVEF measurement as an 
outcome and visit (acute phase and chronic phase) and baseline LVEF as covariates, the latter to adjust 
the estimated difference by the effect of their baseline measure (eg regression to the mean).  
Results will be determined separately for each relevant geography/country. 
12.3.5.4. Determination of Patients/Data for Analysis 
All subjects enrolled and for whom LVEF will be available will be used in the analysis at that time point. 

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12.4. Interim analysis 
No interim analysis is planned for this study. However, drop out, mortality rates and reason for referral 
at the chronic phase visit will be monitored on an ongoing basis to account for possible heterogeneity in 
drop-out rate, mortality rate and reason for referral across geographies, which may require a different 
number of patients than expected to be enrolled in certain geographies. 
In geographies where the drop-out and mortality rates and the reasons for referral are different than 
expected, enrollment may continue beyond 200 subjects to account for their specific drop-out rate, 
mortality rates and reasons for referral, while it may be stopped at approximately 200 subjects in other 
geographies.  
12.5. Missing data 
Missing data will not be imputed.  For survival endpoints, subjects who do not meet the endpoint and 
exit or die prior to completing follow-up will be censored at the date of death or exit for endpoints that 
do not include the type of death the subject experienced (e.g. cardiovascular death). 
12.6. Subgroup analysis  
The following pre-defined subgroup will be investigated: clinic types (Interventional Cardiologist and 
Electrophysiologist are the same physician versus Interventional Cardiologist and Electrophysiologist are 
different physicians), PCI versus non-PCI, all objectives stratified by LVEF at baseline, STEMI vs non-
STEMI. Details of their analysis will be described in the SAP.  
13. Ethics 
13.1. 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. 
 
The study will be conducted according to national and local laws, regulations, standards, and 
requirements where the study is being conducted. The principles of the Declaration of Helsinki version 
2013 or the most updated version have been implemented through the patient informed consent 
process, IRB/EC approval, study training, clinical trial registration, risk-benefit assessment, and 
publication policy.  
 
The study will be publicly registered prior to first enrollment in accordance with Declaration of Helsinki 
on http://www.clinicaltrials.gov. 
• 
In China, applicable local regulations will be followed. 

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• 
In Taiwan, applicable local regulations will be followed. 
• 
In Middle East and Africa, local regulations will be followed. 
• 
In India Subcontinent, applicable local regulations will be followed 
• 
In Korea, Standards for Management of Clinical Trials for Medical Devices (KGCP) (Attachment 2-2 
of Enforcement Regulations of the Medical Device Act, Ministerial Decree No.1512) and other 
applicable Korean regulations will be followed. 
• 
In Singapore, Health Products (Medical Devices) Regulations 2010 and other local applicable 
regulations will be followed.  
• 
In Malaysia, National Medical Research Register (NMRR) requirements are applicable although the 
medical device is not regulated in Malaysia. In addition, applicable local regulations will be 
followed. 
• 
In Indonesia, MoH Decree No. 63 2017 and other local regulations will be followed 
 
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 
14. Study Administration 
14.1. Monitoring  
It is the responsibility of Medtronic to ensure proper monitoring of this clinical study per regulations. 
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, 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 Patient Informed Consent, and Clinical Trial Agreement. 
The consent form or other privacy language where required by law must be available for monitoring and 
auditing. The principal investigator should also be available during monitoring visits.   
The Principal Investigator and site personnel will provide the Medtronic monitor(s) with complete access 
to primary source data (e.g., paper and electronic hospital/clinical charts, appointment books, 
laboratory records) that support the data on the eCRFs as well as other documentation supporting the 
conduct of the study. The monitor will perform source data verification and routine reviews of study 
related regulatory documents during scheduled monitoring visits, and work to secure compliance. 
Planned extent of source data verification will be performed in accordance to the study- specific 
monitoring plan. Frequency of monitoring visits may be based upon subject enrollment, duration of the 
study, study compliance, number of deviations, findings from previous monitoring visits and any 
suspected inconsistency in data that requires investigation. Regulatory documents (e.g., Ethics 
Committee approval letters, Clinical Trial Agreements) may be reviewed at each study site. Monitoring 

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for the study, including site qualification visits, site initiation visits, interim monitoring visits, and 
closeout visits, will be done in accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess site study progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to Ethics Committee approval and 
review of the study, maintenance of records and reports, and review of source documents against 
subject CRFs. Monitors review site regulatory and study compliance by identifying findings of non-
compliance and communicating those findings along with recommendations for preventative/corrective 
actions to site personnel. Monitors may work with study personnel to determine appropriate corrective 
action recommendations and to identify trends within the study or at a particular site.  
Further details of monitoring will be given in the study monitoring plan. 
14.2. 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. 
Only authorized persons can complete eCRFs. eCRFs shall be signed by the Principal Investigator. The 
Principal Investigator can delegate the CRF sign off task to Sub-Investigators only. Delegation of 
authority will be specified on the appropriate documentation. 
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 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  
o Date study site became aware of event 
o Relatedness of adverse event 
• 
Deviations 

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o Reason for deviation 
 
14.3. 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. 
14.4. Confidentiality 
All records and other information about subjects participating in this study will be treated as 
confidential. 
14.5. 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.  
14.6. 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) 
• 
Regulatory authorities (where required by local law) 
• 
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. 
14.7. Record Retention 
14.7.1 
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.  

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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. 
• 
Essential 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 
o Medical history 
o Baseline and follow-up data (if applicable) 
o Documentation of the dates and rationale for any deviation from the protocol 
• 
Subject identification records 
• 
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  
• 
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.   
• 
Regulatory authority notification, correspondence and approval, where required per local law. 
• 
Current curriculum vitae of PIs and key members of investigation site team 
• 
Documentation of delegated tasks 
• 
Study training records for site staff  
• 
Study reports including Final Study Report 
14.7.2 
Investigator Reports 
The Investigator is responsible for preparing and submitting the following complete, accurate, and 
timely reports as listed in the following tables (as applicable per geography). 
Table 8: Investigator Reports applicable for all geographies per Medtronic requirements 
Report 
Submit to 
Description/ Constraints 
Withdrawal of Ethics 
Committee approval 
Sponsor and Regulatory 
Authority (as per local law) 
The investigator must report a withdrawal of 
approval by the reviewing Ethics Committee 
of the investigator’s part of the investigation 
within 5 working days. 
Study Deviations 
Sponsor, Ethics Committee 
and Regulatory Authority (as 
per local law) 
Any deviation from the Clinical Investigation 
Plan shall be reported together with the 
explanation of the deviation as soon as 

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possible upon the center becoming aware of 
the deviation. 
Notice of deviations from the CIP involving a 
failure to obtain a subject’s consent, or is 
made to protect the life or physical well-
being of a subject in an emergency shall be 
given within 5 working days, or sooner if 
required by local requirements. Except in 
such emergency, prior approval is required 
for changes in the plan or deviations. 
Progress Report 
Ethics Committee 
Provide if required by local Ethics 
Committee 
Final Report 
Ethics Committee and 
Regulatory Authority (as per 
local law) 
This report must be submitted within 3 
months of study completion or termination, 
or as per local requirement. 
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 Section 11. 
14.7.3 
Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records including, but not 
limited to: 
• 
Essential correspondence which pertains to the clinical study 
• 
Executed Clinical Trial Agreement 
• 
Current curriculum vitae of PIs and key member of investigation site team  
• 
Electronically signed and dated eCRFs 
• 
All approved informed consent versions, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all IRB/EC approval letters and relevant IRB/EC correspondence and IRB/EC voting 
list/roster/letter of assurance 
• 
List of names, addresses, and professional position of the clinical investigators and   coordinating 
clinical investigators if appointed. 
• 
Names, addresses and contact information of the institutions in which the clinical study will be 
conducted 
• 
Regulatory authority notification, correspondence and approval, if applicable. 
• 
Insurance Certificates 
• 
Names/contact addresses of monitors 
• 
Monitoring reports (interim monitoring visit reports, follow-up letters, and close-out visit 
reports) 

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• 
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 
• 
Study training records for site personnel and Medtronic personnel involved in the study 
• 
Sample of CRFs 
• 
Any other records that local regulatory agencies require to be maintained 
14.7.4 
Sponsor Reports 
Medtronic shall prepare and submit the following complete, accurate, and timely reports listed in the 
tables below. In addition to the reports listed below, Medtronic shall, upon request of reviewing IRB/EC 
or regulatory authorities, provide accurate, complete and current information about any aspect of the 
clinical study. Medtronic reporting requirements for safety are listed in 11.2.1. 
Table 9 Sponsor Reports for all geographies 
Report  
Submit to 
Description/Constraints 
Premature termination 
or suspension of the 
clinical study 
Investigators, 
Ethics Committee 
and Regulatory 
Authorities 
Provide prompt notification of termination or suspension and 
reason(s) per Ethics Committee or per local requirement.  
Withdrawal of Ethics 
Committee approval 
Investigators, 
Ethics Committee 
and Regulatory 
Authorities 
Investigators and other Ethics Committees will be notified only if 
required by the Ethics Committee or local law. 
Progress Reports, if 
applicable 
Ethics Committee 
and Regulatory 
Authorities 
This will be submitted to the Ethics Committee as required by 
Ethics Committee or local law. 
Final report 
Investigators, 
Ethics Committee 
and Regulatory 
Authorities 
This will be submitted to the Ethics Committee as required by 
Ethics Committee or local law 
Study deviation  
Investigators 
Site-specific study deviations will be submitted to Investigators 
periodically.   
Medtronic electronic records and reports will be maintained in a password-protected document 
management system.  After the closure of the study, Medtronic will archive records and reports in 
accordance with local laws and current standard operating procedures. 
14.8. Publication and Use of Information 
Results may be submitted for publication. Additional analyses may be published in relation to the 
learnings and understanding of topics related to the objectives. If results from the Improve SCA Bridge 

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study will be published, they will be handled according to Medtronic Standard Operating Procedures 
and as indicated in the Clinical Trial Agreement.  
 
Publications from the Improve SCA Bridge Study will be handled according to Medtronic Policies and 
Standard Operating Procedures and as indicated in the CTA.  
 
The Improve SCA Bridge Study will utilize a Publication Committee which will including the Steering 
Committee members as well as Medtronic personnel. This committee will manage study publications 
with the goal of publishing findings from the data. The Publication Committee will develop the final 
Publication Plan as a separate document. The publication plan may include, but is not limited to, 
description of committee member criteria and management of publications.  
14.9. Suspension or Early Termination 
14.9.1 
Planned study closure  
Study Closure is a process initiated by the distribution of a study closure letter. Study closure is defined 
as closure of a clinical study that occurs when Medtronic and/or regulatory requirements have been 
satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, 
whichever occurs first. The study closure process is complete upon the distribution of the Final Report or 
after final payments, whichever occurs last. Ongoing IRB/EC oversight is required until the overall study 
closure process is complete. Upon study closure, subjects should be managed and followed per 
physician discretion. 
 
14.9.2 
Early Termination or Suspension 
Early Termination is the closure of a clinical study that occurs prior to meeting defined endpoints. This is 
possible for the whole study or a single site. 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. 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 

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• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to inclusion/exclusion 
criteria, failure to follow subjects per scheduled follow-ups)  
• 
Lack of enrollment 
• 
Noncompliance 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)  
 
14.9.3 
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 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights, and welfare 
• 
In case the suspension is lifted, the investigator should assess whether or not to continue the study 
at the respective site 
 
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 

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• 
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 
• 
In case the suspension is lifted, the investigator should assess whether or not to continue the study 
at the respective site 
15 Reference 
1. Yancy C, et al.  2013 ACCF/AHA Guideline for the Management of Heart Failure: Executive 
Summary.  JACC 2013;62(16):1495–539. 
2. Chew D. et al. Left Ventricular Ejection Fraction Reassessment Post-Myocardial Infarction: 
Current Clinical Practice and Determinants of Adverse Remodeling. American Heart Journal 
2018; 198: 91-96       
3. Pedersen F, et al. Short- long-term cause of death in patients treated with primary PCI for 
STEMI. JACC 2014; 64: 2101-2108. 
4. Adabag AS, et al. Sudden death after myocardial infarction. JAMA 2008; 300: 2022-2029. 
5. Ottervanger JP, et al. Mortality in patients with left ventricular ejection fraction ≤30% after 
primary percutaneous coronary intervention for ST-elevation myocardial infarction. Am J 
Cardiol 2007; 100: 793-797. 
6. Chia Y, et al. Disparity between indications for and utilization of implantable cardioverter 
defibrillators in Asian patients with heart failure. Circulation 2017; 10 (11) 
7. Masoudi FA, et al. Cardiovascular care facts: a report from the national cardiovascular data 
registry 2011. J Am CollCardiol 2013; 62: 1931-1947.  
8. Huang D, et al. Prevention of sudden cardiac death after revascularization for coronary heart 
disease 2017. China J Cardiac Arrhyth 2017; 21(1): 9-21 
9. Al-Khatib SM, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With 
Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A 
Report of the American College of Cardiology/American Heart Association Task Force on 
Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. Published online 
October 30, 2017. 
10. O'Gara PT, et al. 2013 ACCF/AHA guideline for themanagement of ST-elevation myocardial 
infarction: a report of the American College of Cardiology Foundation/American Heart 
Association Task Force on Practice Guidelines. Circulation 2013;127:e362-425. 
11. Miller AL, et al. Failure to reassess ejection fraction after acute myocardial infarction in 
potential implantable cardioverter/defibrillator candidates: insights from the Translational 
Research Investigating Underlying disparities in acute Myocardial infarction Patients' Health 
Status (TRIUMPH) registry. Am Heart J 2013;166:737-43. 
12. Ibanez B et al. 2017 ESC Guidelines for the management of acute myocardial infarction in 
patients presenting with ST-segment elevation: The Task Force for the management of acute 
myocardial infarction in patients presenting with ST-segment elevation of the European 
Society of Cardiology (ESC) European Heart Journal 2018; 39(2) 119-177 
 
 

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16 Appendices 
Appendix A: Case report forms 
Case report forms will be provided under separate cover upon request. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix B: Informed consent template 
Informed Consent form templates will be provided under separate cover. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix C: Participating investigators and institutions 
A complete list of participating investigators and institutions where study activities are conducted will be 
maintained by the Sponsor and distributed under separate cover upon request. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix D: Study Sponsor Contact Information 
The study sponsor contact list will be provided in the site’s study documents binder/investigator site file. 
Sponsor will maintain this list and send update if necessary.  
 
 
 
 
 
 
 
 
 
 
 

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Appendix E: Investigator Reporting Requirements 
 
Investigator Reporting Requirements for India 
Events to Report 
Reporting Requirement and Timeframe 
Submit 
to 
Cardiovascular Related SAE/SADE/USADE 
Investigator submit to: 
All SAE, SADE, USADE 
Investigator shall report all SAEs, SADEs and USADEs to the 
Ethics Committee, monitor and Sponsor promptly of their 
occurrence. (Indian GCP section 3.3.4.3) 
For reported deaths the investigator shall supply any additional 
information (e.g., autopsy report and terminal medical reports.) 
(Indian GCP section 3.3.4.5) 
It is recommended for investigator to report all SAEs, SADEs 
and USADEs to the sponsor within 24 hours. 
It is recommended for investigator to report all SAEs, SADEs and 
USADEs to EC within 7 working days unless the stricter timeline is 
required by the EC. 
Medtronic 
Monitor  
EC 
New information that 
may adversely affect 
safety of the subjects or 
the conduct of the 
study 
Investigator shall promptly report new information that may 
adversely affect safety of the subject or the conduct of the         
study. (Indian GCP section 3.3.4.4) 
EC 
Medtronic 
Monitor 
Investigator Reporting Requirements for Korea 
Events to Report 
Reporting Requirement and Timeframe 
Submit 
to 
Cardiovascular Related SAE/SADE/USADE 
Investigator submit to: 
All SAE 
 The investigator shall create and submit relevant document for all 
SAEs (excluding what classified in the protocol or the IB as ones not 
requiring immediate report) to the sponsor within the period 
provided in the protocol. 
(KGCP Article 7 item 11) 
Medtronic 
SADEs, USADEs 
causing death or life 
threatening 
Within 7 calendar days from the date when the investigator had 
relevant effects reported or informed. In this case, the investigator 
shall make a detailed report of the SADEs, USADEs causing death or 
life threatening within 8 calendar days from the initial report. 
 
For Death, investigator shall submit additional information, such as 
IRB 

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Investigator Reporting Requirements for Taiwan 
Events to Report 
Reporting Requirement and Timeframe 
Submit 
to 
Cardiovascular Related SAE 
Investigator submit to: 
SAE 
The investigator should report SAEs to the sponsor immediately. A 
detailed written report should be provided to the sponsor as soon as 
possible. 
(Medical Device GCP Guidance (2016-01-01) Article 67) 
It is recommended for investigator to report all SAEs to the sponsor 
within 48 hours. 
Medtronic 
SAE 
Report within 7 calendar days of first acknowledged of death and 
life-threatening SAEs, SADEs and USADEs, make a report and 
submit to TFDA and ADR center, submit a copy to the sponsor. 
If the information of the report mentioned in the preceding 
paragraph is not complete, it should be supplied within 15 calendar 
days. 
If the information of the report mentioned in the preceding 
paragraph requires the sponsor to provide information relevant to 
the products, the sponsor should not refuse. 
Note: The requirement is not applicable if MDT is not the product 
license holder. 
(Procedure for Reporting Severe Adverse Reactions to Medicines 
(2004-8-31) Article 5) 
It is recommended to report all non-fatal or non-life- threatening 
SADEs and USADEs following the same requirements mentioned 
above. 
TFDA 
 
 
 
 
 
 
 
 
an autopsy report (only if an autopsy was performed) and a death 
certificate. 
Other SADEs, USADEs 
excluding death or life 
threatening 
Within 15 calendar days from the date when the investigator had 
relevant effects reported or informed. 
 
IRB