The Evaluation of ICD Defibrillation Systems in a 1.5T Magnetic Resonance Imaging Environment in China
Conditions: Tachycardia
Sponsor: Abbott Medical Devices

 
Clinical Investigation Plan Cover Page 
 
 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the express 
written consent of Abbott. 
87173 CIP Posting Cover Page Ver C 
Template 
Page 1 of 1 
 
NCT Number: NCT03828357 
China MRI 
Evaluation of ICD Defibrillation Systems in a 1.5T Magnetic Resonance Imaging (MRI) Environment in 
China CIP/SAP 
Study Document No: ABT-CIP-10238/ CL1005886 
Version D/ Version C 
Date: 30-SEP-2019/ 11-MAY-2020 
 
 
Sponsor  
 
 
St. Jude Medical (now Abbott) 
Coordination Center BVBA 
The Corporate Village 
Da Vincilaan 11 Box F1 
1935 Zaventem, Belgium 
Tel: +32 2 774 68 11 
 
St. Jude Medical (now Abbott) 
Cardiac Rhythm Management Division 
15900 Valley View Court 
Sylmar, CA 91342 USA 
Tel: +1 818 362 6822 
 
 

 
 
 
Protocol No: CRD_930; Study Specific Doc No: ABT-CIP-10238 Ver. D, 30SEP2019 
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Management categories of investigational medical device: 
Class III medical device that needs NMPA approval for the conduct of clinical 
investigations in China   
Yes  No 
Similar products available in Chinese market 
Yes  No 
Protocol version No. and date: Ver. D 30SEP2019 
Lead Clinical study institution: The First Affiliated Hospital of Zhejiang Coordinating 
Investigator: 
, Professor, MD  
Sponsor: 
 
St. Jude Medical Coordination Center BVBA and St. Jude Medical 
Cardiac Rhythm Management Division (now Abbott)  
Deputy: 
 
Abbott Medical (Shanghai) Co., Ltd.  
 
 

 
 
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TABLE OF CONTENTS 
1.
SPONSOR INFORMATION ................................................................................... 6 
2.
OBJECTIVES, ENDPOINTS, AND CONTENTS OF CLINICAL STUDY .......... 7 
2.1. 
OBJECTIVES ........................................................................................................ 7 
2.2. 
PRIMARY ENDPOINTS ....................................................................................... 8 
2.3. 
DESCRIPTIVE ENDPOINT(S) ............................................................................. 8 
2.4. 
CONTENTS ........................................................................................................... 8 
3.
BACKGROUND INFORMATION OF THE CLINICAL STUDY ........................ 9 
4.
FEATURES OF PRODUCT, STRUCTURE AND COMPOSITION,
OPERATING PRINCIPLE, MECHANISM OF ACTION AND SCOPE OF STUDY .... 10 
4.1. 
FEATURES OF PRODUCT ................................................................................ 10 
4.2. 
STRUCTURE AND COMPOSITION, OPERATING PRINCIPLE AND 
FUNCTION MECHANISM OF PRODUCT ..................................................................... 10 
4.3. 
SCOPE OF STUDY ............................................................................................. 11 
5.
INDICATIONS, CONTRAINDICATIONS AND PRECAUTIONS OF
PRODUCT ......................................................................................................................... 11 
6.
DEVICE HANDLING AND STORAGE .............................................................. 11 
7.
DEVICE ACCOUNTABILITY ............................................................................. 11 
8.
OVERALL DESIGN .............................................................................................. 11 
8.1. 
CLINICAL STUDY DESIGN ............................................................................. 12 
8.1.1.   CLINICAL STUDY OBJECTIVE ..................................................................... 12 
8.1.2.   SELECTION OF CLINICAL STUDY METHOD AND RATIONALE........... 12 
8.1.3.   MEASURES FOR REDUCING AND AVOIDING BIAS ............................... 13 
8.1.4.   INVESTIGATIONAL MEDICAL DEVICE AND REFERENCE MEDICAL 
DEVICE/REFERENCE DIAGNOSIS/THERAPEUTIC METHOD (IF ANY) ............... 13 
8.1.5.   SELECTION OF SUBJECTS ............................................................................ 13 
8.1.6.   INCLUSION CRITERIA ................................................................................... 13 
8.1.7.   EXCLUSION CRITERIA .................................................................................. 14 
8.1.8.   CRITERIA AND PROCEDURES FOR STUDY/STUDY TREATMENT 
TERMINATION ................................................................................................................ 15 
8.1.9.   TIME OF ENROLLMENT ................................................................................ 16 
8.1.10.   ANTICIPATED DURATION OF CLINICAL STUDY AND THE REASONS 
FOR DETERMINATION .................................................................................................. 16 
8.1.11.   ANTICIPATED PARTICIPATION DURATION OF EACH SUBJECT ......... 16 
8.1.12. 
NUMBER OF SUBJECTS REQUIRED FOR CLINICAL STUDY ................. 16 
8.2. 
EFFECTIVENESS EVALUATION METHOD .................................................... 16 
8.2.1. 
DESCRIPTION OF THE EFFECTIVENESS ENDPOINTS .............................. 16 
8.2.2. 
SELECTION OF METHOD AND TIME FOR EVALUATION, RECORDING 
AND ANALYSIS OF THE EFFECTIVENESS ENDPOINTS ......................................... 17 
8.3. 
SAFETY EVALUATION METHOD .................................................................... 17 
8.3.1. 
DESCRIPTION OF THE SAFETY ENDPOINT ................................................ 17 
8.3.2. 
SELECTION OF METHOD AND TIME FOR EVALUATION, RECORDING 
AND ANALYSIS OF THE SAFETY ENDPOINTS ........................................................ 17 

 
 
 
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8.4. 
STUDY PROCEDURES ........................................................................................ 18 
8.4.1.  STUDY FLOW CHART ...................................................................................... 18 
8.4.2.  PATIENT RECRUITMENT ................................................................................ 19 
8.4.3.  POINT OF ENROLLMENT ................................................................................ 19 
8.4.4.  SCHEDULED PROCEDURES ........................................................................... 20 
8.4.4.1.  ENROLLMENT .................................................................................................. 24 
8.4.4.2.  IMPLANT ........................................................................................................... 25 
8.4.4.3.  BASELINE AND MRI SCAN VISIT ................................................................ 25 
8.4.4.4.  PRE-MRI SCAN TESTING .............................................................................. 26 
8.4.4.5.  MRI SCAN PROCEDURES .............................................................................. 29 
8.4.4.5.1.  DATA SUBMISSION ..................................................................................... 31 
8.4.4.6.  POST MRI SCAN TESTING ............................................................................ 31 
8.4.4.6.1.  DATA SUBMISSION ..................................................................................... 32 
8.4.4.7.  ONE (1) MONTH POST SCAN VISIT ............................................................. 32 
8.4.4.7.1.   TESTING ...................................................................................................... 32 
8.4.4.7.2.   DATA SUBMISSION ................................................................................... 33 
8.4.5. SITUATIONS WHERE SUBJECT DOES NOT MEET ENROLLMENT 
CRITERIA .......................................................................................................................... 33 
8.4.6. COMPLETE SYSTEM EXPLANTS ..................................................................... 34 
8.4.7. SYSTEM REVISIONS .......................................................................................... 34 
8.4.7.1.  REVISIONS BEFORE THE MRI SCAN .......................................................... 35 
8.4.7.2.  REVISIONS AFTER THE MRI SCAN............................................................. 35 
8.4.8.  UNSCHEDULED VISITS .................................................................................... 40 
8.4.9.  DATA SUBMISSION .......................................................................................... 40 
8.4.10.  NON-STUDY MRI SCANS ................................................................................ 40 
9. 
STANDARDS FOR DEVICE USE ....................................................................... 41 
10. 
MONITORING PLAN ........................................................................................... 41 
11. 
STATISTICAL CONSIDERATIONS ................................................................... 41 
12. 
DATA MANAGEMENT ....................................................................................... 42 
13. 
QUALITY CONTROL OF CLINICAL STUDY .................................................. 42 
13.1.  QUALITY ASSURANCE AUDITS AND REGULATORY INSPECTIONS ... 42 
13.2.  REPEATED AND SERIOUS NON-COMPLIANCE ......................................... 42 
13.3.  COMPLAINTS .................................................................................................... 43 
13.4.  TRACEABILITY OF DOCUMENTS AND DATA ........................................... 43 
13.5.  RECORDING DATA ........................................................................................... 43 
14.  ETHICAL ISSUES AND INFORMED CONSENT OF CLINICAL STUDY ........ 43 
14.1.  ETHICAL CONSIDERATIONS ........................................................................... 43 
14.2. DESCRIPTION OF THE METHODS THAT WILL BE USED TO ADDRESS 
POTENTIALLY CONFOUNDING FACTORS IN THE CLINICAL STUDY DESIGN 44 
14.3. ANY KNOWN OR FORESEEABLE FACTORS THAT MAY COMPROMISE 
THE OUTCOME OF THE CLINICAL STUDY OR THE INTERPRETATION OF THE 
RESULTS ........................................................................................................................... 44 
14.4. APPROVAL OF STUDY PROTOCOL ................................................................ 44 
14.5. INFORMED CONSENT PROCESS AND INFORMED CONSENT FORM ...... 44 

 
 
 
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14.6. CRITERIA AND PROCEDURES FOR SUBJECT WITHDRAWAL ................. 45 
15.  RISKS AND BENEFITS .......................................................................................... 46 
15.1. DESCRIPTION OF THE SUBJECT POPULATION ........................................... 47 
15.2. ANTICIPATED BENEFITS .................................................................................. 47 
15.3. RISKS ASSOCIATED WITH THE DEVICE UNDER INVESTIGATION ........ 47 
15.4. RESIDUAL RISKS ASSOCIATED WITH THE DEVICE UNDER 
INVESTIGATION ............................................................................................................. 48 
15.5. RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY 48 
15.6. POSSIBLE INTERACTIONS WITH CONCOMITANT TREATMENTS .......... 48 
15.7. RISK-TO-BENEFIT RATIONALE ....................................................................... 48 
16.  PROVISIONS FOR ADVERSE EVENT AND DEVICE DEFECT REPORTING 49 
16.1.  ADVERSE EVENTS ............................................................................................. 49 
16.1.1.  CRITERIA AND GUIDELINES FOR NON-REPORTABLE EVENTS ........... 49 
16.1.2.  CRITERIA AND GUIDELINES FOR REPORTABLE EVENTS ..................... 50 
16.1.3.  SUBJECT DEATH ............................................................................................... 53 
17.  PROVISIONS FOR DEVIATION FROM CLINICAL STUDY PROTOCOL AND 
THE REVISION OF CLINICAL STUDY PROTOCOL .................................................. 53 
17.1. DEVIATIONS FROM CIP .................................................................................... 53 
17.2. PROTOCOL REVISIONS ..................................................................................... 54 
18.  DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ....................................... 54 
18.1. RECORDS RETENTION ...................................................................................... 55 
18.2. DATA MANAGEMENT PLAN ............................................................................ 55 
18.3. DOCUMENT AND DATA CONTROL ................................................................ 55 
18.3.1.  TRACEABILITY OF DOCUMENTS AND DATA ........................................... 55 
18.3.2.  RECORDING DATA ........................................................................................... 56 
19.  FINANCE AND INSURANCE ................................................................................ 56 
20.  STUDY REPORT ..................................................................................................... 57 
21.  CONFIDENTIALITY PRINCIPLE .......................................................................... 57 
22.  AGREEMENT ON STUDY RESULTS PUBLICATION ....................................... 57 
23.  RESPONSIBILITIES ASSUMED BY EACH PARTY ........................................... 58 
23.1. SUBJECT STUDY COMPLETION ...................................................................... 59 
23.2. DESCRIPTION OF ACTIVITIES PERFORMED BY SPONSOR 
REPRESENTATIVES ....................................................................................................... 59 
APPENDIX A: DEFINITIONS ......................................................................................... 62 
APPENDIX B: CASE REPORT FORM ............................................................................ 65 
APPENDIX C: BIBLIOGRAPHY ..................................................................................... 66 
 
 
 

 
 
 
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1. Sponsor Information 
St. Jude Medical Coordination Center BVBA and St. Jude Medical Cardiac Rhythm 
Management Division (now Abbott) 
Address of Sponsor: 
 
St. Jude Medical 
Coordination Center BVBA 
The Corporate Village 
Da Vincilaan 11 Box F1 
1935 Zaventem, Belgium 
Tel: +32 2 774 68 11 
 
St. Jude Medical 
Cardiac Rhythm Management Division 
15900 Valley View Court 
Sylmar, CA 91342 USA 
Tel: +1 818 362 6822 
 
Name of Deputy: 
 
Abbott Medical (Shanghai) Co., Ltd. 
Address of Deputy: 
 
169 Taigu Road, Suite 402, Building B,  
Pilot Free Trade Zone 
Shanghai, China 
Tel: +86 21 2306 7588 
Fax: +86 21 6422 4838 
 
 
 
 

 
 
 
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2. Objectives, Endpoints, and contents of clinical study 
2.1. 
 Objectives 
The objective of this clinical study is to evaluate the safety and effectiveness of the Ellipse 
VR/DR implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac 
resynchronization therapy defibrillators (CRT-Ds), with Durata or Optisure defibrillation 
leads, Tendril STS or Isoflex pacing leads, and the Quartet quadripolar leads in a 1.5T 
MRI environment for MR-conditional labeling expansion of these market-approved 
ICD/CRT-D systems in China. 
 
There are four device combination groups in this clinical study as outlined below: 
 
• Group 1:  Ellipse VR single-chamber ICD with a Durata lead in the right ventricle 
(RV). 
• Group 2:  Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a Tendril 
STS lead in the right atrium (RA).  
• Group 3:  Ellipse DR dual-chamber ICD with a Optisure lead in the RV and a Isoflex 
lead in the RA. 
• Group 4: Quadra Assura MP CRT-D with a Durata or Optisure lead in the RV, a 
Tendril STS or Isoflex lead in the RA, and a Quartet lead in the left ventricle (LV). 
 
FIGURE 1: STUDY GROUP OVERVIEW 
 
 
 
 
 
 
ICD/ CRT-D Device Groups to be Evaluated
Single-Chamber ICD
(Ellipse VR)
Dual-Chamber ICD
(Ellipse DR)
Durata (RV)
with
with
(Group 1)
(Group 4)
Dual-Chamber ICD
(Ellipse DR)
Durata OR Optisure (RV)
AND
Tendril STS OR Isoflex 
(RA)
AND
Quartet (LV)
Durata (RV)
AND
Tendril STS (RA)
(Group 2)
(Group 3)
CRT-D
(Quadra Assura MP)
Optisure (RV)
AND
Isoflex (RA)
with
 

 
 
 
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2.2. 
 Primary Endpoints 
• Safety: Freedom from MRI-scan related complications related to the ICD/ CRT-D 
device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing. 
• Effectiveness: Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms 
for RA and RV leads and ≤1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month 
post-MRI scan testing. 
• Effectiveness: Proportion of leads with a sensing amplitude decrease of ≤ 50% from 
pre-MRI scan testing to 1-month post-MRI scan. 
2.3. 
Descriptive Endpoint(s) 
Descriptive endpoints are reported using only summary statistics and no hypothesis tests 
will be performed. 
The following data will be collected: 
1. 
Demographics: gender, age, ethnicity, race, cardiac disease history, arrhythmia 
history, indication for ICD/CRT-D implant, history of smoking, etc. 
2. 
Device electrical measurements at the MRI Scan Visit (pre- and post-scan) and 
at the 1 Month Post Scan Visit  
3. 
ADE, SADE, USADE 
4. 
Mortality 
5. 
Number of non-study MRI scans 
6. 
Summarize number of subjects that returned to usual programming after the 
MRI scan and number of subjects, if any, experiencing delays in reprogramming   
2.4. 
 Contents 
This document is a clinical investigation plan (CIP) for the observational clinical study of 
the safety and effectiveness of the Ellipse VR/DR implantable cardiac defibrillators 
(ICDs) and the Quadra Assura MP cardiac resynchronization therapy- Defibrillators 
(CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or Isoflex pacing 
leads, and the Quartet quadripolar lead in a 1.5T MRI environment in China. This clinical 
study is intended to support MR conditional labeling expansion approval from the China 
National Medical Products Administration (NMPA) for these market approved ICD/CRT-
D systems in China. This clinical study is sponsored by Abbott. 
 
This clinical study will be conducted in accordance with this CIP. All investigators 
involved in the conduct of the clinical study will be qualified by education, training, or 
experience to perform their tasks and this training will be documented appropriately. 

 
 
 
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3. Background information of the clinical study 
Magnetic resonance imaging (MRI) is a non-invasive imaging technique capable of 
providing high-quality images of the whole human body. MRI can provide images of 
excellent spatial resolution together with functional and tissue characterization 
information without the use of damaging ionizing radiation and potentially nephrotoxic 
iodinated contrast agents in two and three dimensions.1 For these reasons, MRI is the 
imaging modality of choice in a wide spectrum of diseases, not only for diagnosis but also 
for staging and follow-up of affected patients, including those with involvement of the 
neurological, musculoskeletal, oncological, and cardiovascular systems. This has led to a 
recent rapid increase of the number of MRI scans performed.2  In 2007, an estimated 27.5 
million MRI procedures were performed in the U.S. in 7,195 hospital and non-hospital 
sites.3 
According to the 2009 World Survey of cardiac pacing and cardioverter defibrillators, 
235,567 new pacemakers were implanted in the United States in 2009. When compared to 
a similar survey conducted in 2005, the 2009 survey showed an increase in the number of 
pacemakers and defibrillators implanted throughout the world, a trend that is likely to 
continue.4,5 It is estimated that 50-75% of patients with implantable cardiac devices will 
develop an indication for an MRI scan during the lifetime of their device.6  
 
Magnetic resonance imaging systems generate three electromagnetic fields that are used to 
produce an image. These include a static magnetic field, a time varying gradient magnetic 
field, and an RF field. All three of these fields interact with implanted devices and could 
create hazards for the device, the patient, or both. Examples of these hazards include 
unwanted cardiac stimulation, heating near lead electrodes, image artifacts, and forces 
being applied to implanted components.7,8 Due to these issues, certain currently marketed 
implantable cardiac device systems, including ICDs and CRT-Ds, may be contraindicated 
for use in an MRI environment. There is a specific need for device manufacturers to give 
clinical evidence that MR conditional systems provide evidence of patient safety who 
receive MRI scans. 9 
  
Over the past 10 years, there have been numerous patients with implanted devices who 
successfully underwent magnetic resonance imaging.10,11,12,13,14,15   
 
In this study, Abbott plans to evaluate the safety and effectiveness of the Ellipse VR/DR, 
ICDs, the Quadra Assura MP CRT-Ds, with Durata or Optisure defibrillation leads, 
Tendril STS or Isoflex pacing leads, and the Quartet quadripolar left heart lead in a 1.5T 
MRI environment for MR-conditional labeling expansion of these market-approved ICD 
systems in China. 

 
 
 
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4. Features of product, structure and composition, operating 
principle, mechanism of action and scope of study 
4.1. 
 Features of product 
This study involves use of market approved products that will be provided by the Sponsor. 
Although these products are already market approved to be implanted in patients who 
meet the indications for use, these products are not approved for use in an MRI 
environment. Therefore, the study procedure i.e. MRI scan, is considered investigational 
in nature.  
4.2. 
Structure and composition, operating principle and 
function mechanism of product 
• The Ellipse ICDs are intended to provide ventricular antitachycardia pacing and 
ventricular defibrillation for automated treatment of life-threatening ventricular 
arrhythmias. In cases where AF Suppression™ is available, AF Suppression pacing is 
indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with 
the above ICD indication and sinus node dysfunction. The Ellipse ICDs are supported 
by the St. Jude Medical Merlin Patient Care System (Merlin PCS) with software 
Model 3650, Software Model 3330 v. 20.X (or higher).  
• The Quadra Assura MP CRT-D devices are intended to provide ventricular 
antitachycardia pacing and ventricular defibrillation for automated treatment of life-
threatening ventricular arrhythmias, they are also intended to resynchronize the right 
and left ventricles in patients with congestive heart failure. They are equipped with an 
IS4-LLLL low voltage connector to facilitate implantation of an IS4 LV four electrode 
lead. Also, devices with a Q suffix have a high voltage DF4-LLHH bore that allows 
the use of a high voltage lead with a DF4 connector. The Quadra Assura MP CRT-D 
devices deliver 40J of energy and are supported by the St. Jude Medical Merlin Patient 
Care System (Merlin PCS) with software Model 3330 version 16.1.1 (or higher). 
• The Durata Models 7120 and 7122Q leads are 7 French, transvenous, steroid eluting, 
bipolar, DF4 compatible (single connector with four electrical terminals), active 
fixation leads intended for permanent sensing and pacing of the right ventricle and the 
delivery of cardioversion/ defibrillation therapy when used with a compatible St. Jude 
Medical pulse generator with a DF4-LLHH or DF4-LLHO lead receptacle designation. 
• The Optisure Model LDA220Q transvenous leads are market released leads indicated 
for use with compatible pulse generators (refer to the applicable defibrillator manual 
for system indications). They provide pacing and sensing and deliver cardioversion/ 
defibrillation therapy to the heart. 
• The Tendril STS Model 2088TC pacing lead is a market-released MR conditional 
active-fixation lead indicated for permanent sensing and pacing of the heart.  

 
 
 
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• The Isoflex Model 1944 is a J-shaped, market-released, passive-fixation leads 
indicated for permanent sensing and pacing of the heart. 
• The Quartet Models 1456Q, 1458Q, and 1458QL leads are 5.1 French, transvenous, 
steroid eluting, quadripolar, IS4 compatible (single connector with four electrical 
terminals), passive fixation leads intended for permanent sensing and pacing of the left 
ventricle when used with a compatible St. Jude Medical biventricular system with an 
IS4-LLLL lead receptacle designation. 
4.3. 
  Scope of study 
This is a study in at least 60 subjects from at least 6 study centers in China who provide 
consent to have any of the four defibrillation system combination groups implanted (See 
Figure 1), undergo a non-diagnostic MRI scan, and complete follow-up through 1-month 
post-MRI scan.  
5. Indications, contraindications and precautions of product 
Please refer to the products Instructions For Use (IFU) for the indications, 
contraindications, and precautions of each device. 
6. Device handling and storage 
This study involves use of market approved products; the study procedure i.e. MRI scan, 
is considered investigational in nature. Device handling and storage should be done 
according to the Instructions for Use. Due to the devices being supplied by the Sponsor, it 
is required that they be stored in a secure area to prevent unauthorized access or use. 
7. Device accountability 
Study system devices will be provided by the sponsor to study sites. The Principal 
Investigator or an authorized designee must maintain records of device information as 
defined by sponsor and such study devices can only be used in patients that are enrolled 
into the study.  
 
The Sponsor will maintain accountability documentation for all used study devices. 
8. Overall design 
This is a prospective, multi-center, single-arm study to evaluate the safety and 
effectiveness of the Ellipse VR/DR ICDs, and the Quadra Assura MP CRT-D, with Durata 
or Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the Quartet 
quadripolar LV lead in a 1.5T MRI environment for MR-conditional labeling expansion in 
China.  
 

 
 
 
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This study will be conducted in at least 6 centers in China and at least 60 subjects who 
provide consent for participation will be enrolled. Subjects will be considered enrolled 
after providing consent. Subjects will be implanted with any one of the device/lead 
combination groups outlined in Figure 1, depending on their clinical need as determined 
by the Investigators. At least 15 subjects will be enrolled in each group.  
 
• Group 1 will have at least 15 enrolled subjects with the Ellipse VR single-
chamber ICD with a Durata lead in the RV.  
• Group 2 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber 
ICD with a Durata lead in the RV and a Tendril STS lead in the RA.  
• Group 3 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber 
ICD with a Optisure lead in the RV and a Isoflex lead in the RA. 
• Group 4 will have at least 15 enrolled subjects with a Quadra Assura MP CRT-D 
and an Optisure or Durata lead in the RV, an Isoflex or Tendril STS lead in the 
RA, and a Quartet lead in the LV. 
 
The enrollment group and group 4 lead pairing will be at the discretion of the Investigator, 
dependent on patient needs in conjunction with study needs to fulfill study goals. 
 
At least forty-five (45) days after system implantation or after a system revision, subjects 
will have a baseline visit followed by an MRI visit; subjects will undergo a study-related 
MRI scan at 1.5T. Subjects will have a 1-month follow-up after the study MRI scan. The 
minimum duration of each subject’s participation is approximately 2.5 months from 
enrollment. The expected duration of enrollment is approximately 14 months. The total 
duration of clinical study is expected to be 16.5 months. 
8.1. 
 Clinical study design 
8.1.1. Clinical study objective 
The objective of this clinical study is to evaluate the safety and effectiveness of the Ellipse 
VR/DR, implantable cardiac defibrillators (ICDs), and the Quadra Assura MP CRT-Ds, 
with Durata or Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, and the 
Quartet quadripolar leads in a 1.5T MRI environment for MR-conditional labeling 
expansion of these market-approved ICD systems in China. 
8.1.2. Selection of clinical study method and rationale 
A prospective, multi-center, non-randomized, open-label, single arm clinical study design 
was chosen to generalize the study results by enrolling subjects across multiple sites and 
limit the sample size to the minimum number required by the NMPA to receive MR 
labeling approval. This study intends to provide clinical data from a local Chinese 
population to supplement IDE clinical data from a population in the United States and 

 
 
 
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Europe for submission to the NMPA in support of a marketing application of MRI 
labeling expansion for these ICD/CRT-D systems in China. 
 
The selection of this local clinical study method was based on discussions with the NMPA 
and the Sponsor during a pre-market workshop meeting held on November 9th and 10th, 
2016 in China.    
8.1.3. Measures for reducing and avoiding bias 
Measures to reduce and avoid bias in this study include: allowing all subjects who meet 
the eligibility criteria specified in this CIP may be enrolled in this study, the Sponsor will 
approach sites for participation without bias or consideration for specific demographic 
subgroups; additionally, clinical events (adverse device effects and deaths) occurring after 
the MRI settings have been programmed, will be adjudicated by an independent Clinical 
Events Committee (CEC).   
 
The CEC is an independent adjudication body comprised of qualified physicians who are 
not participants in the clinical investigation. The CEC will review and adjudicate pre-
specified events reported by investigators or identified by Safety personnel for the clinical 
investigation as defined in the CEC charter and according to definitions provided in this 
CIP. 
8.1.4. Investigational medical device and reference 
medical device/reference diagnosis/therapeutic method 
(if any) 
Devices and reference numbers are listed in Table 1: Study Device above. 
8.1.5. Selection of subjects 
The study population includes male and female Chinese nationals that meet the eligibility 
requirements and give consent for the study. Vulnerable subjects, such as minors or those 
unable to provide consent are excluded from participating. 
8.1.6.  Inclusion criteria 
Assessment for general eligibility criteria is based on medical records of the site and 
interview with a candidate patient. If some of the clinical and laboratory tests are not 
included in site standard tests, they must be done but after written informed consent is 
obtained. Patients must meet ALL the inclusion criteria to be considered for the clinical 
study. If ANY of the exclusion criteria are met, the patient is excluded from the clinical 
study and cannot be enrolled. 

 
 
 
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To participate in this clinical study, the subject must meet all the following inclusion 
criteria: 
• 
Have an approved indication for implantation of an ICD, or CRT-D 
• 
Be a Chinese national 
• 
Will be implanted with one of the following device/lead combinations evaluated 
in this study: 
o Group 1: Ellipse VR single-chamber ICD with a Durata lead in the RV 
o Group 2: Ellipse DR dual-chamber ICD, with a Durata lead in the RV and a 
Tendril STS lead in the RA 
o Group 3: Ellipse DR dual-chamber ICD with a Optisure lead in the RV and 
a Isoflex lead in the RA 
o Group 4: Quadra Assura MP CRT-D and an Optisure or Durata lead in the 
RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the LV 
• 
Be willing to undergo an elective MRI scan without sedation ≥ 45 days after 
implant 
NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as 
the patient can communicate with site personnel during the MRI scan 
• 
Be able to provide informed consent for study participation (legal guardian or 
legally authorized representative is NOT acceptable) 
• 
Be willing and able to comply with the prescribed follow-up tests and procedures 
• 
Are not contraindicated for an MRI scan (per the MRI Screening Form) 
• 
Subjects who are at least 18 years of age (or older, required by local law) 
8.1.7. Exclusion criteria 
Subjects who meet any of the following exclusion criteria must be excluded from the 
clinical investigation: 
• 
Have a competitor’s MRI compatible endocardial lead implanted or capped 
• 
Have another existing active implanted medical device, e.g., neurostimulator, 
infusion pump, etc. that has MR labeling that will not allow the MRI scans per 
this protocol to be completed. 
• 
Have other non-MRI compatible device or material implanted. The following 
examples may be included as long as labelling of these devices allow MRI scans 
conducted per this protocol: 
o MRI compatible knee replacements, hip replacements, stents, etc.  
o MRI compatible mechanical, prosthetic, and bio prosthetic heart valves 
o Non-removable dental implants 
• 
Have a lead extender, adaptor, or capped/abandoned lead 
• 
Enrolled or intend to participate in a clinical drug and/or device study 
(investigational device, investigational drug, new indication for a device or drug 
or additional testing beyond standard of care procedures), which could confound 
the results of this study as determined by Abbott. 

 
 
 
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• 
Pregnant or planning to become pregnant during the duration of the subject’s 
participation in the study 
• 
Have a life expectancy of less than 12 months due to any condition 
8.1.8. Criteria and procedures for study/study treatment 
termination 
No formal statistical rule for early termination of the clinical study for insufficient 
effectiveness of the device/ MRI procedures under investigation is defined.  
 
The Sponsor reserves the right to discontinue the clinical study at any stage or reduce the 
follow-up period with suitable written notice to the investigator. Possible reason(s) may 
include, but are not limited to: 
• 
Unanticipated adverse device effect (e.g., UADE) occurs and it presents an 
unreasonable risk to the participating subjects 
• 
Any oversight committee (e.g., Steering/Executive Committee, Data Monitoring 
Committee) makes a recommendation to stop or terminate the clinical study (such 
as higher frequency of anticipated adverse device effects) 
• 
Further product development is cancelled 
 
Should the clinical study be discontinued by the Sponsor, subjects will be followed per 
routine hospital practice with device-related AEs reported to the Sponsor as per 
vigilance/commercial reporting requirements. 
 
Should this occur, the investigator shall return all clinical investigation materials 
(including devices) to the Sponsor and provide a written statement as to why the 
premature termination has taken place to the IRB/EC (if applicable). All applicable 
clinical study documents shall be subject to the same retention policy as detailed in section 
18.1 of the CIP.  
 
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely 
terminate participation in a clinical study at the study sites for which they are responsible. 
The investigators will follow the requirements specified in the Clinical Trial Agreement.  
 
If the Sponsor suspends or prematurely terminates the clinical study at an individual site in 
the interest of safety, the Sponsor will inform all other Principal Investigators. 
 
If suspension or premature termination occurs, the Sponsor will remain responsible for 
providing resources to fulfill the obligations from the CIP and existing agreements for 
following the subjects enrolled in the clinical study, and the Principal Investigator or 
authorized designee will promptly inform the enrolled subjects at his/her site, if 
appropriate. 
 

 
 
 
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The clinical study will be concluded when: 
• 
All sites are closed AND 
• 
The final report has been provided to investigators or the Sponsor has provided 
formal documentation of clinical study closure. 
8.1.9. Time of enrollment 
The expected duration of enrollment is approximately 14 months. 
8.1.10. Anticipated duration of clinical study and the 
reasons for determination 
With an expected duration of enrollment of 14 months, the 45-day post-implant 
stabilization period, and the 1-month post-MRI scan visit, the total duration of clinical 
study is expected to be 16.5 months from the time of first enrollment.   
8.1.11. Anticipated participation duration of each subject 
Each subject is anticipated to participate in this clinical investigation for 2.5 months from 
the time of enrollment. This accounts for the 45-day post-implant stabilization period and 
30 days for completion of the 1-month post-MRI visit.  
8.1.12. Number of subjects required for clinical study 
A minimum of 60 total subjects will be enrolled in this study. Fifteen (15) subjects for 
each of the 4 main device groups (See Figure 1) will be enrolled in this study to meet the 
minimum required 10 subjects per device arm, as requested by the NMPA for each group 
accounting for attrition of anticipated 5 subjects for each group in this study. 
8.2. 
 Effectiveness evaluation method 
There are two primary effectiveness endpoints to be evaluated in this study. 
8.2.1. Description of the effectiveness endpoints 
• 
Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms for RA 
and RV leads and ≤ 1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month 
post-MRI scan testing. 
• 
Proportion leads with a sensing amplitude decrease of ≤ 50% from pre-MRI scan 
testing to 1-month post-MRI scan. 

 
 
 
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8.2.2. Selection of method and time for evaluation, 
recording and analysis of the effectiveness endpoints 
Since the objective is to evaluate the effect of MRI exposure for the ICD/ CRT-D device 
groups included in this study, the effectiveness parameters were selected to compare 
abnormal changes in device performance from pre- to 1-month post- MRI scan. The pre-
MRI measurements are collected within the same day prior to the MRI scan. The 1-month 
post-MRI scan measurements are collected at 30 days post-MRI scan (within +14 days) to 
ensure any effect of the MRI exposure is captured. 
 
The effectiveness parameters are recorded directly from the device. The device 
measurements will be obtained using the Merlin programmer to interrogate the device 
during study visits. The analysis of the effectiveness parameters will be conducted on all 
subjects with complete data from pre- to 1-month post-MRI scan. 
8.3. 
Safety evaluation method 
There is one primary safety endpoint to be evaluated in this study. 
8.3.1. Description of the safety endpoint 
Freedom from MRI-scan related complications from the time of the MRI scan to 1-month 
post-MRI scan testing. 
8.3.2. Selection of method and time for evaluation, 
recording and analysis of the safety endpoints 
Since the objective is to evaluate the effect of MRI exposure for the ICD/ CRT-D device 
groups included in this study, the safety parameters were selected to include only MRI-
scan related complications from the time of device programming for an MRI scan to 1-
month post-MRI scan. An independent physician CEC will adjudicate all adverse device 
effects during this period to determine the relatedness to the MRI scan.  
 
Safety surveillance within this study and the safety reporting, both performed by the 
investigator, starts as soon as the subject completes the pre-MRI visit testing and the MRI 
Settings have been programmed according to the protocol. The safety surveillance and the 
safety reporting will continue until the last study visit has been performed, the subject is 
deceased, the subject/investigator concludes his participation into the clinical study or the 
subject withdrawal from the clinical study. 

 
 
 
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8.4. 
 Study procedures 
The clinical study will be conducted in accordance with the CIP. All parties participating 
in the conduct of the clinical study will be qualified by education, training, or experience 
to perform their tasks and this training will be documented appropriately. 
 
The clinical study will not commence until Abbott receives written approval from the 
IRB/EC and relevant regulatory authorities and all required documents have been 
collected from the site(s). 
 
Approval from the Sponsor must be received prior to initiating study procedures. 
 
Enrolled subjects (as defined in section 8.4.3) will have undergone a successful implant 
procedure with the study ICD/ CRT-D and study leads. Forty-five (45) days after 
discharge from hospitalization post successful implant procedure, the subject will have a 
MRI Scan Visit, followed by a one-month post MRI Scan Visit. Upon completion of the 
one-month post MRI scan visit, the subject will be considered to have completed the 
follow-up requirements of this clinical study. The Principal Investigator should arrange for 
appropriate care of subjects following study completion.  
 
The following sections provide a detailed description of procedures required by this CIP. 
8.4.1. Study flow chart 
FIGURE 2: STUDY FLOW CHART 

 
 
 
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Informed Consent
(Subject Enrolled)
Implant Attempt
≤ 7 days
 Withdraw from Study
Unsuccessful Implant
Implant re-attempt 
scheduled at discharge?
NO
1- Month Post 
MRI Scan Visit
1- Month Post 
MRI Scan Visit
≤ 14 days
MRI Scan Visit
MRI Scan Visit
30 days
Participation Complete 
after completing 1 Month Post-MRI Scan Visit 
Participation Complete 
after completing 1 Month Post-MRI Scan Visit 
Successful Implant
Baseline Visit
Baseline Visit
≥ 45 days
YES
 
8.4.2. Patient recruitment 
All patients presenting at the study site may be screened by a member of the study team 
previously trained on the CIP and delegated to do so. Patients who do not meet the 
inclusion/exclusion criteria will not be eligible to participate in this study. Patients 
meeting the inclusion/exclusion criteria will be fully informed about the study and asked 
to review and sign informed consent. In case the subject agrees, a duly signed and dated 
Patient Informed Consent will be obtained. Qualifying patients will be approached with 
the study consent at all participating study centers. 
8.4.3. Point of enrollment 
Subjects are considered enrolled after the study consent has been signed (Refer to section 
14.5 for the Informed Consent Process). 

 
 
 
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The Principal Investigator or delegated study personnel will record enrollment information 
(name of the clinical investigation, date of consent and Inclusion/exclusion information) in 
the hospital records and complete and submit an applicable CRF in a timely manner. 
Notification of enrollment to the Sponsor is considered to have occurred when the Sponsor 
has received the applicable CRF. 
8.4.4. Scheduled procedures 
The Principal Investigator is responsible for ensuring all clinical study data is collected as 
required per CIP scheduled procedures. 
 
All required study procedures at each specified interval are outlined in the sections below. 
Refer to Table 2: Schedule of Evaluations Summary: Study visits, Table 3: Schedule 
of Evaluations Summary: MRI Related visits, and Table 4: Subject visit data 
collection summary for an overview of the required study procedures at each interval or 
study visit. 
 

 
 
 
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TABLE 2: SCHEDULE OF EVALUATIONS SUMMARY: STUDY VISITS 
Evaluation 
Cardiology Staff 
Study Visits 
Enrollment 
Implant  
Baseline 
MRI Scan 
1-month visit 
Unscheduled (as 
necessary)  
Time frame from previous visit (window) in 
days 
0 
≤ 7 post 
enrollment 
45 (+7) 
post 
implant 
≤ 14 post 
Baseline 
30 (+14) post 
MRI Scan 
- 
Informed Consent 
 
 
 
 
 
 
Inclusion/ Exclusion Evaluation 
 
 
 
 
 
 
Demographics and Medical History 
 
 
 
 
 
 
Verify ICD/ CRT-D and lead combination 
(group) post-implantation 
 
 
 
 
 
 
Pre-MRI Safety Screening (MRI Safety 
Screening Form) 
 
 
 
* 
 
 
Capture ICD/ CRT-D system information 
 
 
 
 
 
 
Device Interrogation/ Device Measurements** 
 
 
 
 
 
 
Collect Study Specific AEs 
 
 
 
 
 
 
* re-verify if not done same day as Baseline 
** Capture bipolar capture, sense, pacing, and HVLI impedances 
Note: RA lead capture only for subjects with Tendril STS or Isoflex leads. RA capture and sensing thresholds are not required if a 
patient is in atrial fibrillation or atrial flutter. If the RA capture and sensing thresholds could not be obtained due to a patient’s 
atrial fibrillation or flutter, and if the patient’s atrial fibrillation or flutter is transient, for data analysis purposes, the pacing 
capture threshold and sensing threshold from the most recent archival measurement, if available, will be used. 
 

 
 
 
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determining the ICD/ CRT-D lead combination (study group) for the subjects. This visit 
may occur up to or on the same day as the implant visit. The study implant ICD/ CRT-D 
and leads will be implanted within 7 days of obtaining consent. 
8.4.4.2. Implant 
Perform the device and lead implant procedure according to standard of care. Consult the 
User's Manual for implantation guidelines, appropriate lead/device connections and 
general handling information. The ICD/ CRT-D system will be considered successfully 
implanted if; at a minimum, the Ellipse VR/ DR, or Quadra Assura MP generator and a 
Durata, Optisure, Tendril STS, Isoflex, or a Quartet lead are implanted according to the 
study group for the subject. 
 
Unsuccessful Implant- if applicable 
Enrolled subjects who have an unsuccessful implantation of the study device and lead (see 
definition for successful implant above) will be withdrawn from the study unless the 
implant will be re-attempted and is scheduled at the time of discharge. The physician may 
re-attempt the implantation of study devices at his/her discretion. 
8.4.4.3.  Baseline and MRI scan visit 
The Baseline visit must occur the latter of: 
• 
≥45 days after lead implant AND 
• 
≥45 days after most recent lead revision, if applicable 
 
The MRI Scan Visit should occur ≤14 days after the baseline visit or may be performed on 
the same day as the Baseline visit. 
 
To ensure the patient meets the requirements to undergo the study MRI scan, use the MRI 
Screening Form for reverification. Prior lead measurements performed at the Baseline 
visit may be used to evaluate inclusion criteria at the MRI visit. 
 
The MRI visit is composed of 3 sections: Pre-MRI Scan Testing, MRI scan, and Post-MRI 
Scan. 
 
IMPORTANT NOTE: Before the MRI Scan Visit, if the subject underwent a system 
revision since enrollment that resulted in: 
 
• 
implant of a non-study generator or lead, or 
• 
capping/abandoning of a lead 
• 
implant of a non-MRI compatible device or material, or 
• 
any combination above 
 

 
 
 
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The subject is no longer eligible to undergo the study MRI Scan. Do not proceed with any 
of the tests listed for the MRI Scan Visit. The subject should be withdrawn. Refer to 
section 8.4.5 for further details. 
 
Otherwise, follow the procedures outlined below for the MRI Scan Visit. 
8.4.4.4. Pre-MRI scan testing 
Pregnancy Testing 
Administer a pregnancy test (per institutional standard) to all female subjects of 
childbearing potential. The pregnancy testing may be done up to 7 days before the MRI 
scan. Document the results of the test. If the subject is pregnant, do not proceed any 
further. The subject should be withdrawn. 
 
Clearing the Subject for the Study Scan  
To safely perform an MRI scan on a subject with the implanted study system, the 
physician/clinician should do the following as stated in the MRI Procedure Information 
for the St. Jude Medical® MR Conditional defibrillation system: 
• 
Confirm that the patient has an MR Conditional System   
• 
Confirm that no adverse conditions to MRI scanning are present (e.g. additional 
hardware)  
• 
Review the potential adverse events 
• 
Generate a report of the patient’s permanently programmed parameters 
• 
Select and Save MRI Settings  
• 
Review the MRI Checklist and Program the MRI Settings using the Merlin® PCS   
• 
Subject receives the MRI Scan  
• 
Disable MRI Settings Using the Merlin® PCS  
 
The radiologist or staff, a designated radiological member, must determine the subject’s 
eligibility for an MRI scan prior to the MRI scan (per standard of practice). However, the 
ICD/ CRT-D and lead (wires) contraindication item on the MRI hazard checklist do not 
apply if the subject is implanted with any one of the four main device systems included in 
this study. 
 
The study MRI Hazard Checklist may be used to document a radiologist or designated 
member of the radiology department has cleared the subject for an MRI scan.  
Alternatively, the radiology department may use its own hazard checklist in lieu of the 
study MRI Hazard Checklist. This documentation should be maintained with the subject’s 
medical and/or study records. 
 
Device Assessment and Programming 
Interrogate the ICD/ CRT-D and obtain the following for the Study leads: 

 
 
 
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8.4.4.5. MRI Scan procedures 
Monitor subject with ECG and/or pulse oximetry and verbal communication. 
 
Setting up Pulse Oximetry and/or ECG 
Set up pulse oximetry and/or an ECG per standard of care. Place the oximetry clip on the 
subject’s finger or other any other appendage that results in valid pulse oximetry readings. 
Or, position MRI compatible surface electrodes on the subject to ensure the subject’s heart 
rate can be continuously monitored during the scan. During the MRI scan, periodically 
record heart rate, and blood oxygen saturation levels. Visually examine the ECG during 
the MRI scan. After the MRI scan, remove the subject from the MRI field. 
 
MRI Scan 
After confirmation by the electrophysiologist or device specialist that all pre-MRI system 
checks (mentioned above) have been met, subjects will have their MRI scan completed by 
a radiology staff member. Note: If the subject does not pass the Pre-MRI scan System 
Check specified above, then the subject should not undergo an MRI scan. The subject can 
be rescheduled to come back to repeat the Pre-MRI scan System Check testing within the 
visit window. 
 
Protocol required MRI scan sequences for each subject undergoing an MRI scan are 
described in detail in the MRI Scan Guidelines. It is recommended that the MRI scan be 
set up on the MRI scanner in advance of the first subject scheduled for a study scan to 
ensure the scan has been appropriately programmed and to provide adequate time to 
address any questions or issues that may arise. 
 
Subjects will undergo two different scans for the study, both of which will expose the 
ICD/ CRT-D to extreme scanning conditions: (1) a thoracic scan that is RF intensive, and 
(2) a head scan that is gradient intensive. The thoracic scan should be set up to last about 6 
minutes and 15 seconds, and the head scan should be set to get as close as possible to 5 
minutes without being under 5 minutes. The thoracic scan will need to be repeated 4 times 
to ensure the subject is scanned approximately 25 minutes. Further details about the set-
up, programming and ways to adjust the parameters for MRI scans can be found in the 
MRI Scan Guidelines. 
 
The subject may be in the bore or near the vicinity of the magnet for approximately 60 
minutes. The actual amount of time the subject will be scanned is about 30 minutes: 25 
minutes for the thoracic scan, and 5 minutes for the head scan.  
 
These two MRI scans are not intended to be diagnostic in nature and therefore the 
administration of contrast fluids or sedation, or the application of water and fat saturation 
techniques are not permitted.  

 
 
 
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Consult the “MRI Ready Systems Manual. MRI Procedure Information for the St. Jude 
Medical™ MR Conditional System” for guidelines and `precautions related to conducting 
an MRI scan with the implanted study ICD/ CRT-D system. 
 
NOTE: The study MRI scan is being performed to demonstrate safety and MRI 
compatibility of the ICD/ CRT-D system being evaluated in this trial for an MRI scan, and 
is not meant to be diagnostic in nature. The MRI scan will not be read by the radiologist.   
 
If subject movement causes distortion on the MRI, do not repeat. 
 
An optional non-study MRI scan sequence may be conducted at the request of the subject 
and discretion of the Investigator and radiologist. This optional non-study MRI scan 
sequence must be done in accordance with the guidelines and precautions in the MRI 
Ready Systems Manual.  
 
Cardiac Monitoring  
During the entire MRI scan, the subject’s cardiac function must be monitored using pulse 
oximetry and/or ECG by a study trained electrophysiologist, cardiologist capable of 
delivering external cardiac pacing defibrillation and advanced cardiac life support. Verbal 
communication with the subject must also take place to assess and/or confirm any 
clinically significant changes noted in the subject’s oxygen saturation or heart rate, as well 
as any clinically significant complaints not obvious with pulse oximetry; record these 
changes and complaints during the MRI scan.   
 
Advanced cardiac lifesaving procedures must be in place to address situations where a 
life-threatening arrhythmia and/or hemodynamic collapse occurs. The programmer must 
be used outside the American College of Radiology (ACR) defined Zone 4 magnet room. 
If the subject’s hemodynamic function is compromised during the MRI scan, discontinue 
the MRI procedure and take proper measures to restore the subject’s hemodynamic 
function.   
 
Handling of Subjects Unable to Tolerate an MR Scan  
In cases where the scan cannot be tolerated by the subject, remove the subject from the 
scanner. Assess the subject for possible adverse events and treat the subject’s reported 
symptoms according to your institution’s standard of practice. Document the reason for 
the intolerance. At a minimum, information related to the sequence used to perform the 
scan, the length of time the subject was scanned, and the whole-body SAR level reached 
should be collected and submitted to Abbott. A repeat scan is not required to be completed 
but may be rescheduled. The subject is not withdrawn from the study. The subject should 
be scheduled to return for their 1-month post MRI scan visit. 

 
 
 
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8.4.4.5.1. Data Submission 
Once required testing has been performed, complete and submit the appropriate forms to 
Abbott. Refer to Table 4: Subject visit data collection summary. 
Upload the pre-MRI scan device session records through the EDC study portal. It is 
recommended that the following device printouts and measurements be maintained at the 
site. 
• 
FastPath Summary  
• 
Test Results with Freezes, Include Battery & Leads  
• 
Wrap-up Overview with full parameters 
• 
Device MRI summary report 
8.4.4.6. Post MRI scan testing 
Device Assessment and Programming 
Following the MRI Scan, remove the subject from the MRI bore. Interrogate the ICD/ 
CRT-D. Disable the MRI Settings. Note: MRI settings must be disabled to ensure that 
tachyarrhythmia therapy is turned back on. Obtain the following for the study leads: 
Interrogate the ICD/ CRT-D, and obtain the following for the Study leads: 
• 
In-clinic bipolar and unipolar* capture threshold at a pulse width of 0.5 ms. Either 
the manual decrement or automatic (in-clinic, programmer-based) method may be 
used to obtain the capture threshold.  
• 
In-clinic bipolar sensing amplitude. Either the incremental or the automatic (in-
clinic, programmer based) method may be used to obtain the sensing threshold. 
• 
In-clinic atrial and ventricular bipolar and unipolar* lead impedance 
 
*NOTE: Unipolar and bipolar configurations should be collected for LV leads 
 
NOTE: RV capture thresholds are not required to be obtained if a high ventricular rate is 
present. If available, sites should use the automatically obtained pacing capture threshold 
from the most recent archival data as a substitute for the in-clinic capture threshold. RV 
sensing measurements are not required if the subject’s intrinsic rate is established to be 
≤30 beats per minute. 
 
Reporting of MRI Scan-Related Adverse Events  
An ADE or SADE related to the following should be reported as soon as possible, but no 
later than 24 hours after the site becomes aware of the event, to Abbott: clotting, 
pulmonary embolism, or heating of the device pocket during the MRI scan. These events 
are likely to be associated with symptoms occurring during or immediately following the 
MRI scan and may manifest as chest pain, shortness of breath, or changes in vital signs 
during or immediately following the MRI scan.   
 
To ensure all ADEs or SADEs related to or caused by the MRI scan are appropriately 
captured, before starting the scan, verbally instruct the subject to report symptoms of chest 

 
 
 
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pain, shortness of breath or pocket discomfort that he/she experiences while being scanned 
or immediately after exiting the scanner. Note changes in vital signs such as changes in 
heart rate, room air blood oxygen saturation, and/or respiration rate that occur during the 
MRI scan that may suggest an ADE or SADE has occurred due to clotting, pulmonary 
embolus or related to lead tip or device pocket heating. 
 
If symptoms during or immediately after the MRI scan suggest that an ADE or SADE has 
occurred due to clotting, pulmonary embolus or related to lead tip or device pocket 
heating, test to assess possible causes. Diagnostic testing may be performed in any order 
deemed appropriate by the investigator; if any test was not performed, provide medical 
justification for not performing that test: 
 
(1) A 12 lead ECG 
(2) A 2-view chest X-ray (PA and Lateral) 
(3) Room air Oxygen saturation 
(4) A transthoracic echocardiogram 
 
If the subject reports pocket discomfort, ask the subject for additional descriptive 
information and determine if the pocket is discolored or warm to the touch. ECG, chest x-
ray, room air blood oxygen saturation, or transthoracic echocardiogram testing are not 
required to be performed for symptoms related to device pocket heating. 
 
Sites should report an ADE or SADE if the subject experiences a significant rise in pacing 
threshold (1.25V @0.5ms or greater) from pre-MRI scan to one-month post-MRI scan. 
8.4.4.6.1. Data submission 
Once required testing has been performed, complete and submit the appropriate forms to 
Abbott. Refer to  Table 4: Subject visit data collection summary. 
Export the study MRI scan onto a CD, or other form of electronic media in DICOM 
format, and send to Abbott. Upload post MRI scan device session records through the 
EDC study portal. It is recommended that the following device printouts and 
measurements be maintained at the site: 
• 
FastPath Summary  
• 
Test Results with Freezes, Include Battery & Leads  
• 
Wrap-up Overview with full parameters 
• 
Device MRI summary report 
8.4.4.7. One (1) month post scan visit 
8.4.4.7.1. Testing 
Interrogate the ICD/ CRT-D and obtain electrical lead measurements. 

 
 
 
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• 
In-clinic bipolar and unipolar* capture threshold at a pulse width of 0.5 ms. Either 
the manual decrement or automatic (in-clinic, programmer based) method may be 
used to obtain the capture threshold. If a significant rise in pacing threshold 
(1.25V @0.5ms or greater) from pre-MRI scan to one-month post MRI scan has 
occurred, then complete an AE form. 
• 
In-clinic bipolar sensing amplitude. Either the incremental or the automatic (in-
clinic, programmer based) method may be used to obtain the sensing threshold.   
• 
In-clinic atrial and ventricular bipolar and unipolar* lead impedance 
• 
Evaluate the subject for ADE and SADE and submit an AE CRF- if applicable.  
   
*NOTE: Unipolar and bipolar configurations should be collected for LV leads 
 
NOTE: RV capture thresholds are not required to be obtained if a high ventricular rate 
(e.g. 110bpm) is present. If available, sites should use the automatically obtained pacing 
capture threshold from the most recent archival data as a substitute for the in-clinic 
capture threshold. RV sensing measurements are not required if the subject’s intrinsic rate 
is established to be ≤30 beats per minute. 
8.4.4.7.2. Data submission 
Once required testing has been performed, complete and submit the appropriate forms to 
Abbott. Refer to Table 4: Subject visit data collection summary. 
It is recommended that the following device printouts and measurements be maintained at 
the site. 
• 
FastPath Summary  
• 
Test Results with Freezes, Include Battery & Leads  
• 
Wrap-up Overview with full parameters 
• 
Device MRI summary report 
 
If an ADE or SADE events has occurred, submit an AE CRF (as applicable). Report 
withdrawal and out of service as applicable. Upload device session records through the 
EDC study site portal (as applicable). 
8.4.5. Situations where subject does not meet enrollment 
criteria 
If a subject does not meet all inclusion criteria or meets any of the exclusion criteria, the 
subject cannot participate in the study and cannot be enrolled.  
 
In case the subject was already consented to participate in the study, but did not meet 
inclusion/exclusion criteria, the following actions will be taken (Table 7). The EC/IRB 
should be notified of deviations according to each respective entity’s guidelines. 
 

 
 
 
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such as generator replacement, lead replacement and lead repositioning has been 
performed. 
8.4.7.1. Revisions before the MRI scan 
A system revision is defined as a replacement of or repositioning of one or more 
components of the study ICD/ CRT-D system that occurs after the subject has been 
consented into the study. Because all components of the study ICD/ CRT-D system are 
market-released, all procedures related to the revision should be performed according to 
standard of care. The revision may be performed by either a study investigator or other 
clinician qualified to perform such procedures.   
 
Any explanted devices or leads (including damaged leads, lead segments and lead 
fragments) should be returned to Abbott promptly for analysis. Document any change to 
the status of the lead and device (e.g. capped, removed) on the Product Out of Service 
CRF. Refer to Table 4 to determine which case report forms need to be completed and 
submitted. Refer to Table 8: System Revisions Scenarios Prior to MRI Scan below to 
determine what actions need to be performed. 
8.4.7.2. Revisions after the MRI scan 
If a system revision occurs after the MRI scan, then the subject will remain in the study 
until the subject completes the 1 Month Post Scan visit.  
 
Any explanted devices or leads (including damaged leads, lead segments and lead 
fragments) should be returned to Abbott promptly for analysis. Document any change to 
the status of the lead and device (e.g. capped, removed) on the Product Out of Service 
CRF. Refer to  
 

 
 
 
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Table 9: System Revisions Scenarios After MRI Scan below to determine what actions 
need to be performed.  

 
 
 
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8.4.8. Unscheduled visits 
An unscheduled visit is defined as a visit that occurs after the MRI Scan Visit where the 
subject is seen in clinic due to an ADE or SADE associated with the study lead(s) and 
study ICD/ CRT-D. Where possible, perform a device interrogation for the applicable 
lead(s) to obtain:  
• 
In-clinic bipolar and unipolar* capture threshold at a pulse width of 0.5 ms.   
• 
In-clinic bipolar sensing amplitude. Either the incremental or the automatic (in-
clinic, programmer based) method may be used to measure the sensing threshold.    
• 
In-clinic atrial and ventricular bipolar and unipolar* lead impedance 
*NOTE: Unipolar and bipolar configurations should be collected for LV leads 
8.4.9. Data submission 
Once testing has been performed, complete and submit the appropriate forms to Abbott.  
Refer to Table 4. It is recommended that the following device printouts and measurements 
be maintained at the site: 
• 
FastPath Summary  
• 
Test Results with freezes, Include Battery & Leads  
• 
Wrap-up Overview with full parameters 
8.4.10. Non-Study MRI Scans 
A non-study MRI scan is defined as an MRI scan occurring at any time following the 
study MRI scan to the conclusion of the subject’s participation in the study. Non-study 
MRI scans should be performed per each center’s standard of care. A non-study scan may 
be performed 30 minutes after the study scan on the same day, if the Investigator and 
Subject choose to have one performed. 
 
For non-study MRI scans performed at the study center, the same safety data collection 
and safety precautions outlined at the MRI Scan Visit should be followed. However, if 
procedures or data are not followed or collected as presented on the non-study MRI Case 
report form during a non-study MRI scan, it will not be considered a protocol deviation. 
 
MRI Scan Analysis 
The MRI scan should be reviewed for obvious abnormalities by a radiologist and reported 
to the subject’s physician (per standard of care by the facility performing the MRI scan).  
 
The following data should be collected and reported to Abbott for non-study MRI scans.  
• 
Date of scan 
• 
Type of scan performed 

 
 
 
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• 
Documentation of any Adverse Device Effects 
• 
Device diagnostics, if available 
• 
MRI Scan report, if available 
• 
Fast Path Summary, if available 
9. Standards for device use 
The product labeling for the study devices, instructions for use and packaging are kept 
under a separate cover and will be provided to the NMPA in the application. 
10. Monitoring plan 
Sponsor and/or designee will monitor the clinical study over its duration according to the 
CIP-specific monitoring plan which will include the planned extent of source data 
verification.  
 
Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the 
following criteria are met:  
 
• 
The investigator understands and accepts the obligation to conduct the clinical 
study according to the CIP and applicable regulations and has signed the Clinical 
Trial Agreement.  
• 
The Investigator and his/her staff should have sufficient time and facilities to 
conduct the clinical study and should have access to an adequate number of 
appropriate subjects to conduct the clinical study.  
• 
Source documentation (including original medical records) must be available to 
substantiate proper informed consent procedures, adherence to CIP procedures, 
adequate reporting and follow-up of adverse events, accuracy of data collected on 
case report forms, and device information.  
• 
The Investigator/site will permit access to such records. A monitoring visit sign-in 
log will be maintained at the site. The Investigator will agree to dedicate an 
adequate amount of time to the monitoring process. The Investigator and/or 
research coordinator will be available for monitoring visits. It is expected that the 
Investigator will provide the monitor with a suitable working environment for 
review of clinical study-related documents. 
11. Statistical considerations 
This study is an observational study to meet the requirements for device approval by the 
NMPA. There is no endpoint hypotheses testing planned in this study. The endpoints, 
demographics, safety and device data will be summarized using descriptive statistics as 
outlined in the Statistical Analysis Plan (SAP).  
 

 
 
 
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Any major changes to the SAP will be documented in an amendment to the SAP. Less 
significant changes to the planned analyses will be documented in the final report(s). 
12. Data management 
Study data will be handled according to China Device GCP (Order 25). The Leading PI 
and his/her associated organization (leading Unit) will be responsible for compiling and 
submitting all required reports to governmental agencies.  
 
Before the submission, Leading PI and his/her associated organization (leading Unit) 
should allow sponsor to have a copy of the above reports for reviewing and providing 
comments for Leading PI and his/her associated organization consideration. 
 
Data will be analyzed by the Leading PI and his/her associated organization (leading Unit) 
and/or its affiliates. The Leading PI and his/her associated organization (leading Unit)’s 
also agree that data may be transferred to the Sponsor’s locations worldwide and/or any 
other worldwide regulatory authority in support of a market-approval application. 
13. Quality control of clinical study 
13.1. Quality assurance audits and regulatory inspections 
The investigator and/or delegate should contact the Sponsor immediately upon notification 
of a regulatory authority inspection at the site. A monitor or designee will assist the 
investigator and/or delegate in preparing for the audit. The Sponsor may perform quality 
assurance audits, as required. 
 
The investigator/institution will permit direct access to source data/documents for the 
purpose of performing clinical study-related monitoring, audits, IRB/EC review and 
regulatory inspections. 
 
Subjects providing informed consent are agreeing to allow clinical study monitors or 
regulatory authorities to review, in confidence, any records identifying the subjects in this 
clinical study. This information may be shared with regulatory agencies; however, 
Sponsor undertakes not to otherwise release the subject's personal and private information. 
13.2. Repeated and serious non-compliance 
In the event of repeated non-compliance or a one-time serious non-compliance, as 
determined by the Sponsor, a monitor or designee will attempt to secure compliance by 
one or more of the following actions: 
• 
Visiting the investigator, 
• 
Contacting the investigator by telephone, 

,
 
 
 
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• 
Contacting the investigator in writing, 
• 
Retraining of the investigator. 
If an investigator is found to be repeatedly non-compliant with the signed agreement, the 
CIP or any other conditions of the clinical study, the Sponsor will either secure 
compliance or, at its sole discretion, terminate the investigator’s participation in the 
clinical study. In case of termination, the Sponsor will inform the responsible regulatory 
authority, as required, and ensure that the IRB/EC is notified, either by the Principal 
Investigator or by the Sponsor. 
13.3. Complaints 
During the study, the investigator will be responsible for reporting all complaints. A 
complaint is defined as any written, electronic or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or 
performance of a device after it is released for distribution. 
 
If the complaint does not involve a reportable AE as defined in this protocol, the 
investigator must notify the Post Market Surveillance Department by submitting the 
information on the device via email to SVcomplaints@sjm.com or by phone toll free: 001-
800-722-3774 as soon as possible after becoming aware of the complaint. This 
information will not be collected on a CRF for the study. 
 
If the complaint involves a reportable AE as defined in this protocol, the investigator must 
complete an AE CRF, including the information on the complaint and submit to the 
Sponsor as soon as possible. 
13.4. Traceability of Documents and Data 
The investigator will ensure accuracy, completeness legibility and timeliness of the data 
reported to the Sponsor on the CRFs and in all required reports. 
13.5. Recording Data 
The CRF will be reviewed by the authorized site personnel. An appropriate comment will 
be provided to explain changes to data reported on the CRF. 
14. Ethical issues and informed consent of clinical study 
14.1. Ethical considerations 
This clinical study will be conducted in accordance with this Clinical Investigation Plan, 
the Declaration of Helsinki and the Good Clinical Practice (GCP) guidelines of the China 
National Medical Products Administration (NMPA) Order No.25. The most stringent 

 
 
 
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requirements, guidelines or regulations must always be followed. The conduct of the 
clinical study will be approved by the appropriate Ethics Committee (EC) of the respective 
clinical site and as specified by local regulations. 
 
The investigator will not start enrolling subjects or requesting informed consent from any 
subject prior to obtaining IRB/EC approval and relevant Regulatory Authority approval, if 
applicable, and authorization from the Sponsor in writing for the clinical study. If 
additional requirements are imposed by the IRB/EC or relevant Regulatory Authority, 
those requirements will be followed. If any action is taken by an IRB/EC or a relevant 
Regulatory Authority with respect to the clinical study, that information will be forwarded 
to the Sponsor. 
14.2. Description of the Methods that will be used to 
Address Potentially Confounding Factors in the Clinical 
Study Design 
The effectiveness endpoints are change in bipolar ventricular capture and sensing 
threshold from pre-MRI scan to 1 Month Post Scan for the study lead(s) implanted with 
the study ICD/ CRT-D. Each subject therefore acts as his/her own control. Therefore, 
there is no concern for confounding factors for the effectiveness endpoint 
14.3. Any Known or Foreseeable Factors that May 
Compromise the Outcome of the Clinical Study or the 
Interpretation of the Results 
There are no foreseeable factors that may compromise the outcome of the clinical study or 
the interpretation of the results. 
14.4. Approval of study protocol  
The lead Investigator and the Sponsor will give approval for this protocol in collaboration 
with the NMPA. The protocol will be submitted to the study site’s research governing 
bodies for approval and approved before any study activities occur. 
14.5. Informed consent process and informed consent form 
The Investigator or his/her authorized designee will conduct the Informed Consent 
process, as required by applicable regulations and the center’s IRB/EC. This process will 
include a verbal discussion with the subject on all aspects of the clinical study that are 

 
 
 
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relevant to the subject’s decision to participate, such as details of clinical study 
procedures, anticipated benefits, and potential risks of clinical study participation. Subjects 
must be informed about their right to withdraw from the clinical study at any time and for 
any reason without sanction, penalty or loss of benefits to which the subject is otherwise 
entitled. Withdrawal from the clinical study will not jeopardize their future medical care or 
relationship with the investigator.  
 
During the discussion, the Principal Investigator or his/her authorized designee will avoid 
any improper influence on the subject and will respect subject’s legal rights. The subject 
shall be provided with the Informed Consent form written in a language that is 
understandable to the subject and has been approved by the center’s IRB/EC. The subject 
shall have adequate time to review, ask questions and consider participation. The Principal 
Investigator or his/her authorized designee will make efforts to ensure that the subject 
understands the information provided. If the subject agrees to participate, the Informed 
Consent form must be signed and dated by the subject and thereafter by the person 
obtaining the consent prior to any clinical study-specific procedures. The signed original 
will be filed in the subject’s hospital or research charts, and a copy will be provided to the 
subject. 
 
Failure to obtain informed consent from a subject prior to clinical investigation enrollment 
should be reported to Sponsor within 5 working days and to the reviewing center’s 
IRB/EC according to the IRB’s/ EC’s reporting requirements. 
 
If, during the clinical investigation, new information becomes available that can 
significantly affect a subject's future health and medical care, the Principal Investigator or 
his/her authorized designee will provide this information to the subject. If relevant, the 
subject will be asked to confirm their continuing informed consent in writing. 
14.6. Criteria and Procedures for Subject Withdrawal  
Each enrolled subject shall remain in the clinical study until completion of the required 
follow-up period; however, a subject’s participation in any clinical study is voluntary and 
the subject has the right to withdraw at any time without penalty or loss of benefit. 
Conceivable reasons for discontinuation may include, but not be limited to, the following: 
• 
Subject death 
• 
Subject voluntary withdrawal  
• 
Subject lost-to follow-up as described below  
• 
Subject’s follow-up is terminated according to Section 23.1. 
 
The Sponsor must be notified of the reason(s) for subject discontinuation. The site will 
provide this information to the Sponsor. Investigators must also report this to their 
respective IRB/EC as defined by their institution’s procedure(s).  
 

 
 
 
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No additional follow–up will be required or data recorded from subjects once withdrawn 
from the clinical study, except for the status (deceased/alive). 
 
However, if a subject withdraws from the study due to problems related to the safety or 
performance of the device under investigation, the investigator shall ask for the subject's 
permission to follow his/her status/condition outside of the clinical study. 
 
In case of subject withdrawal, the site should make attempts to schedule the subject for a 
final clinical study visit. At this final follow-up visit, the subject will undergo the 
following assessments: 
• 
Device assessment including: 
o Fast Path Summary 
o Test results with Freezes, include battery and leads 
o Wrap-up overview with full parameters 
o Device MRI summary report (if performed) 
 
Lost-to-Follow-up 
If the subject misses two consecutive scheduled follow-up time points and the attempts at 
contacting the subject detailed below are unsuccessful, then the subject is considered lost-
to-follow-up. Site personnel shall make all reasonable efforts to locate and communicate 
with the subject (and document these efforts in the source documents), including the 
following, at each contact time point: 
• 
A minimum of two telephone calls on different days over the specified follow-up 
windows to contact the subject should be recorded in the source documentation, 
including date, time and initials of site personnel trying to make contact. 
• 
If these attempts are unsuccessful, a letter (certified if applicable) should be sent to 
the subject. 
• 
If a subject misses one or more non-consecutive follow-up contact time points, it 
will be considered a missed visit. The subject may then return for subsequent 
visits. If the subject misses two consecutive time points and the above-mentioned 
attempts at communicating with the subject are unsuccessful, the subject will be 
considered lost-to-follow-up.  
 
Note: Telephone contact with General Practitioner, non-clinical investigation cardiologist 
or relative without the presence of the subject or indirect documentation obtained via 
discharge letters will not be considered as subject contact. 
15. Risks and benefits 
The risk analysis included an objective review of published and available unpublished 
medical and scientific data. The sections below provide an overview of residual risks 
identified in the risk management report and anticipated benefits of the medical device. 

 
 
 
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15.4. Residual risks associated with the device under 
investigation 
All risk regions were evaluated, and all the system risks were deemed acceptable. While 
steps have been taken to identify risks associated with the study MRI scan and 
participation in the study, there may be risks that are unknown at this time. 
15.5. Risks associated with participation in the clinical 
study 
Potential risks associated with the study MRI scan are the same as or comparable to those 
associated with MRI scans of an implanted medical device powered by a battery or other 
electrical source of power including, but not limited to, those listed in the Adverse Events 
and Adverse Device Effects section of the protocol. 
15.6. Possible interactions with concomitant treatments 
Other than the study MRI scans, there are no treatments that the subject would not 
otherwise receive as part of the subject’s medical management related to having an 
implanted ICD/CRT-D system. While an MRI scan is not part of the usual treatment 
regimen for subjects implanted with an ICD/ CRT-D, it is an accepted imaging modality 
used in the diagnosis of diseases or other medical condition.  
The MRI scanner, methods used to scan the subject (scan sequences), and monitoring 
procedures in and of themselves are not investigational. As such, there are no anticipated 
interactions with concomitant medical treatments or concurrent medical interventions 
associated with the study MRI scan. 
The device checks at each study visit are standard of care or involve testing of the device 
and lead that are normally done at a routine device check. As such, there are no anticipated 
interactions with concomitant medical treatments or concurrent medical interventions 
associated with the study visits. 
15.7. Risk-to-benefit rationale 
There may be no direct clinical benefit to the subject for participating in this study; no 
direct therapy is being provided as part of the study procedures, i.e. the study MRI scan.  
However, these data will help to establish the safety and effectiveness of the Durata, 
Optisure, Tendril STS, Isoflex, and Quartet leads and the Ellipse VR/DR ICDs, or Quadra 
Assura MP CRT-Ds in an MRI environment, which, upon approval, will provide patients 
who need an ICD/ CRT-D to have the option to be safely scanned should these patients 
need to undergo an MRI in the future. 

 
 
 
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16. Provisions for adverse event and device defect reporting 
16.1. Adverse events  
To comply with worldwide standards and guidelines on clinical study adverse event 
reporting, the Sponsor has adopted uniform and worldwide applicable standard definitions 
and reporting timelines to be used and adhered to by the investigators. 
 
Safety surveillance within this study and the safety reporting, both performed by the 
investigator, starts as soon as the subject’s MRI Settings have been programmed during 
the MRI visit.  
 
Adverse events will be monitored until they are adequately resolved, or the subject has 
ended his/her participation in the study, whichever comes first. The status of the subject’s 
condition should be documented at each visit. 
 
Reportable events shall be submitted to the Sponsor. The Sponsor will ensure that all 
applicable events and device deficiencies are reported to the relevant authorities as per 
regulations. The sites should notify the Sponsor of reportable adverse events by creating 
and saving the applicable CRF within the electronic data capture (EDC) system. 
Additional information may be requested by the Sponsor to support the reporting of AEs 
to regulatory authorities. The investigator must notify the IRB/EC, if appropriate, in 
accordance with national and local laws and regulations, of the AEs reported to the 
Sponsor.  
 
All study related adverse events will be reported as per applicable regulatory requirements. 
The Sponsor will also notify all the other medical institutions conducting the clinical study 
and Ethics committees of the occurrence of SAEs. 
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not 
be reported. 
16.1.1. Criteria and Guidelines for Non-Reportable Events 
Except as otherwise noted in the CIP, the following events are not reportable to the 
sponsor: 
• 
Events that occur prior to the MRI settings have been programmed at the MRI 
study visit. 
NOTE:  Since all products in the study are market released and will be used per 
the approved indication prior to programming MRI settings, the Principal 
investigator will be responsible for reporting these events as device complaints as 
they would for any market approved product (See Section 13.3).   

 
 
 
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The date the site staff became aware the event met the criteria of an SAE must be recorded 
in the source document. The Investigator will further report the SAE to the local IRB/EC 
according to the institution’s IRB/EC reporting requirements. 
16.1.3. Subject Death 
Subject deaths will be documented and reported to the Sponsor as soon as possible (but no 
later than 24 hours) after becoming aware of the event via the applicable AE CRF, 
Withdrawal CRF, and Product Out of Service CRF. 
17. Provisions for deviation from clinical study protocol and 
the revision of clinical study protocol 
17.1. Deviations from CIP 
The Investigator should not deviate from the CIP for any reason except in cases of medical 
emergencies when the deviation is necessary to protect the rights, safety and well-being of 
the subject or eliminate an apparent immediate hazard to the subject. In that event, the 
Investigator will notify Sponsor immediately by phone or in writing.  
 
No waivers for CIP deviations will be granted by the Sponsor. All deviations must be 
reported to the Sponsor using the Deviation CRF. The occurrence of CIP deviations will 
be monitored by the Sponsor for evaluation of investigator compliance to the CIP and 
regulatory requirements and dealt with according to written procedures. Investigators will 
inform their IRB/EC or equivalent committee of all CIP deviations in accordance with 
their specific IRB/EC or equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s 
monitor or company representative will attempt to secure compliance by one or more of 
the following (and not limited to):  
• 
Visiting the investigator and/or delegate 
• 
Telephoning the investigator and/or delegate 
• 
Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the CIP or any other conditions of 
the clinical investigation may result in further escalation in accordance with the Sponsor’s 
written procedures, including securing compliance or, at its sole discretion, Sponsor may 
terminate the investigator's participation in the clinical investigation. 

 
 
 
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• 
Medical history/physical condition of the subject before involvement in the clinical 
study sufficient to verify CIP entry criteria 
• 
Dated and signed notes on the day of entry into the clinical study referencing the 
Sponsor, CIP number, subject ID number and a statement that informed consent 
was obtained 
• 
Dated and signed notes from each subject visit (for specific results of procedures 
and exams) 
• 
Adverse events reported and their resolution, including supporting documents, 
such as discharge summaries, catheterization laboratory reports, ECGs, and lab 
results including documentation of site awareness of SAEs and of investigator 
assessment of device relationship for SAEs. 
• 
CIP-required laboratory reports and 12-lead ECGs, reviewed and annotated for 
clinical significance of out of range results (if applicable).  
Note: With electronic medical records some clinical sites may be able to annotate 
that the labs or ECG have been reviewed in the system. For those sites that do not 
have such capability, the labs or ECG may be able to be printed or signed. Each 
project team should include CIP language regarding these processes that is most 
suitable for the specific clinical investigation.  
• 
Notes regarding CIP-required and prescription medications taken during the 
clinical study (including start and stop dates). 
• 
Subject’s condition upon completion of or withdrawal from the clinical study. 
• 
Any other data required to substantiate data entered in the CRF 
18.1.  Records retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the 
clinical study as per the applicable regulatory record retention requirements. The 
Investigator must obtain permission from Sponsor in writing before destroying or 
transferring control of any clinical study records. 
18.2. Data management plan 
A Data Management Plan (DMP) will describe procedures used for data review, data 
cleaning, and issuing and resolving data discrepancies. If appropriate, the DMP may be 
updated throughout the duration of the clinical study. All revisions will be tracked, and 
document controlled. 
18.3. Document and data control 
18.3.1. Traceability of documents and data 
Primary data collection based on source-documented hospital and/or clinic chart reviews 
will be performed clearly and accurately by site personnel trained on the CIP and CRF 

 
 
 
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completion. The investigator will ensure accuracy, completeness, legibility and timeliness 
of the data reported to the Sponsor on the CRFs and in all required reports. 
 
Only authorized site personnel will be permitted to enter the CRF data through the EDC 
system deployed by the Sponsor. An electronic audit trail will be used to track any 
subsequent changes of the entered data. 
18.3.2. Recording data 
Electronic CRFs will be used in this study, as noted below and in the data management 
plan. Informed consent documents will be provided in Chinese, according to China 
regulations. If additional documentation is required for any reason (e.g. procedural notes 
for an adverse event), it is to be appropriately redacted/de-identified prior to being sent to 
data management. Source documents will be collected and translated, as needed, for 
reporting, etc. 
 
CRF data collection will be performed through a secure web portal and only authorized 
personnel will access the Electronic Data Capture (EDC) system using a unique username 
and password to enter, review or correct data. Passwords and electronic signatures will be 
strictly confidential.   
 
The data will be subjected to consistency and validation checks within the EDC system 
and supplemental review by the Sponsor.    
 
After the clinical study, completed CRF images with the date-and-time stamped electronic 
audit trail indicating the user, the data entered, and any reason for change (if applicable) 
will be provided to the study sites, if requested. 
 
For the duration of the clinical study, the Investigator will maintain complete and accurate 
documentation including, but not limited to, medical records, clinical study progress 
records, laboratory reports, CRFs, signed ICFs, device accountability records (if 
applicable), correspondence with the IRB/EC and clinical study monitor/Sponsor, adverse 
event reports, and information regarding subject discontinuation or completion of the 
clinical study. 
19. Finance and insurance 
The Sponsor has taken up general liability insurance in accordance with the requirements 
of the applicable local laws. An appropriate Sponsor’s country representative will be 
utilized to understand the requirements for the type of insurance that will be provided for 
subjects, and such information will be incorporated into the site informed consent, as 
applicable. If required, additional subject coverage or a clinical study specific insurance 
will be provided by the Sponsor. 

 
 
 
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20. Study report 
Clinical study reports will be completed as each arm of the study finishes enrollment and 
all study procedures. Each separate clinical study report will include: 
 
• 
Description of the devices under investigation 
• 
Study design information 
• 
Subject disposition 
• 
Subject demographics 
• 
Primary safety endpoint observed throughout the study 
• 
Primary effectiveness endpoints observed throughout the study 
• 
Adverse event observations 
• 
Mortality reported 
• 
Study withdrawals 
• 
Device accountability 
• 
Protocol deviations 
• 
Summary of the study 
• 
Study conclusions 
21. Confidentiality principle 
The Sponsor respects and protects personally identifiable information collected or 
maintained for this clinical study. The privacy of each subject and confidentiality of 
his/her information will be preserved in reports and when publishing any data. 
Confidentiality of data will be observed by all parties involved always throughout the 
clinical study. All data will be secured against unauthorized access. 
22. Agreement on study results publication 
The data and results from the clinical study are the sole property of the Sponsor. The 
Sponsor shall have the right to access and use all data and results generated during the 
clinical study. The Investigators will not use this clinical study-related data without the 
written consent of the Sponsor for any purpose other than for clinical study completion or 
for generation of publication materials, as referenced in the Clinical Trial Agreement.  
 
Single-center results are not allowed to be published or presented before the multi-center 
results. Any proposals for publications or presentations by the investigators must be 
reviewed and approved by the Sponsor in a timely manner to enable Sponsor review in 
compliance with the Sponsor’s publication policy set forth in the Clinical Trial 
Agreement. 
 
The Sponsor will be responsible for determining whether to register the clinical study on 
www.clinicaltrials.gov or any other clinical studies, in accordance with the International 

 
 
 
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Committee of Medical Journal Editors guidelines, or any other applicable guidelines. In 
the event Sponsor determines that the clinical study should be registered, Sponsor shall be 
responsible for any such registration and results posting as required by the 
ClinicalTrials.gov website. Institution and/or Principal Investigator(s) shall not take any 
action to register the clinical study. 
 
For live cases at congresses, the patients need to sign a specific Live Case ICF, approved 
by the IRB/EC. The investigator must notify the Sponsor prior to performing a live case. 
23. Responsibilities assumed by each party 
This clinical study will be conducted in accordance with this CIP. All parties involved in 
the conduct of the clinical study will be qualified by education, training, or experience to 
perform their tasks and this training will be documented appropriately. 
 
The Sponsor will select investigators qualified by training and experience to participate in 
the clinical study. Sites will be selected based upon review of a recent site assessment, if 
applicable, and the qualifications of the investigators who will participate in the clinical 
study. 
 
Institutional Review Board (IRB)/ Ethics Committee (EC) approval for the CIP and 
ICF/other written information provided to the patient will be obtained by the Principal 
Investigator at each study site prior to consenting and enrolling patients in this clinical 
study. The approval letter must be received prior to the start of this clinical study and a 
copy must be provided to the Sponsor.  
 
Any amendments to the CIP as well as associated ICF changes will be submitted to the 
IRB/EC and written approval obtained prior to implementation, according to each 
institution’s IRB/EC requirements.  
 
No changes will be made to the CIP or ICF or other written information provided to the 
patient without appropriate approvals, including IRB/EC, the Sponsor, and the regulatory 
agencies (if applicable).  
 
Until the clinical study is completed, the Investigator will advise his/her IRB/EC of the 
progress of this clinical study, per IRB/EC requirements. Written approval must be 
obtained from the IRB/EC yearly to continue the clinical study, or according to each 
institution’s IRB/EC requirements.  
 
No study procedures other than those defined in this CIP will be undertaken on the 
enrolled subjects without the written agreement of the IRB/EC and the Sponsor. 

 
 
 
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23.1. Subject study completion 
The minimum duration of each subject’s participation is approximately one month from 
the MRI scan (1-Month Post Scan visit). When the subject’s participation in the clinical 
study has been completed the subject will return to standard medical care as per 
physician’s recommendation. 
23.2. Description of Activities Performed by Sponsor 
Representatives 
Trained sponsor personnel may perform certain activities to ensure compliance to the CIP 
and may provide technical expertise. Sponsor field clinical engineers may perform the 
following activities:  
• 
Interrogation of and testing the implanted ICD/ CRT-D system at any study visit 
(scheduled or unscheduled): capture, sense, pacing and HVLI measurements,  
• 
Verifying MRI scan parameters on the programmer at the MRI Scan Visit or Non-
Study MRI visit,  
• 
Programming of the ICD/ CRT-D per protocol, and/or as directed by the 
investigator/designee.   
While sponsor representatives may perform these activities, the principal investigator 
remains responsible for ensuring all study data is collected as required per protocol.  
Deviations resulting from failure to comply with protocol requirements will be reported 
through completion of a Deviation CRF. 
 
 

 
 
 
Protocol No: CRD_930; Study Specific Doc No: ABT-CIP-10238 Ver. D, 30SEP2019 
Page 61 of 67 
 
 
 
Investigator’s statement 
I agree: 
1. To conduct this clinical study in strict compliance with 
Declaration of Helsinki, current laws and regulations of 
China, and the requirements of the clinical trial protocol 
2. To accurately record all data required into the Case 
Report Form (CRF) and complete the final report of the 
clinical study on time. 
3. The medical devices are only used in this clinical trial. The 
receipt and use of the medical devices will be completely 
and accurately recorded and the records will be kept 
during the clinical study. 
4. To allow the Clinical Research Associate and inspector 
authorized or designated by the Sponsor and supervision 
department to conduct inspection, verification and 
examination on the clinical study. 
5. To strictly perform the clinical study contract and articles 
of agreement signed by all parties. 
 

 
 
 
Protocol No: CRD_930; Study Specific Doc No: ABT-CIP-10238 Ver. D, 30SEP2019 
Page 62 of 67 
I have already read the clinical study protocol, including 
above Statement and fully agree all requirements above. 
Comments of the Sponsor   
Signature (stamp)  
Date:   MM   DD     YYYY 
 
Comments of the Investigator: 
Signature: 
Date:   MM   DD     YYYY 
 
Comments of medical device clinical trial institution 
 
Signature (stamp) 
Date:   MM   DD     YYYY 
 
 

 
 
 
Protocol No: CRD_930; Study Specific Doc No: ABT-CIP-10238 Ver. D, 30SEP2019 
Page 63 of 67 
Appendix A: Definitions 
Non-study Specific Definitions 
 
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 under clinical investigation. 
Note 1: This definition includes events related to the medical device under investigation 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 medical 
devices under investigation 
 
Serious Adverse Event (SAE) 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
a) Led to a death, 
b) Led to a serious deterioration in 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 hospitalization or prolongation of existing hospitalization, or 
4. 
medical or surgical intervention to prevent life threatening illness or 
injury or permanent impairment to a body structure or a body function. 
5. 
chronic disease  
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: A planned hospitalization for pre-existing condition, or a procedure required by the 
CIP, without a serious deterioration in health, is not considered to be an SAE. 
 
Adverse Device Effect (ADE) 
An adverse event related to the use of an investigational medical device. 
 
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. 
 
This definition includes any event resulting from the use error or from intentional misuse 
of the investigational medical device. 
 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a 
serious adverse event. 
 

 
 
 
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Unanticipated Adverse Device Effect (UADE) 
As defined in 21 CFR §812.3, unanticipated adverse device effects (UADE) are defined as 
any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the CIP or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated 
with a device that relates to the rights, safety, or welfare of subjects.   
 
Anticipated Serious Adverse Device Effect (ASADE) 
A serious adverse device effect which by its nature, incidence, severity or outcome has 
been previously identified in the risk analysis report. 
 
Unanticipated Serious Adverse Device Effect (USADE) 
A serious adverse device effect which by its nature, incidence, severity or outcome has not 
been identified in the current version of the risk analysis report. 
 
Complication 
A complication is defined as an SADE that requires an invasive intervention or leads to 
death. 
 
Device Deficiency (DD) 
Device deficiency is defined as an inadequacy of a medical device related to its identity, 
quality, durability, reliability, safety or performance, such as malfunction, misuse or use 
error and inadequate labeling. This includes the failure of the device to meet its 
performance specifications or otherwise perform as intended. Note: Performance 
specifications include all claims made in the labeling of the device. 
 
Device Malfunction 
A failure of a device to meet its performance specifications or otherwise perform as 
intended, when used in accordance with the instructions for use or CIP. 
 
Device Relationship 
Determination of whether there is a reasonable possibility that an investigational product 
or device under investigation caused or contributed to an AE is to be determined by the 
Investigator and recorded on the appropriate CRF form. Determination should be based on 
assessment of temporal relationships, evidence of alternative etiology, medical/biologic 
plausibility, and patient condition (pre-existing condition). 
 
Vulnerable Subject 
Vulnerable subject is defined as individual whose willingness to volunteer in a clinical 
investigation could be unduly influenced by the expectation, whether justified or not, of 
benefits associated with participation or of retaliatory response from senior members of a 
hierarchy in case of refusal to participate. 

 
 
 
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The definition shall be applied by the investigator judgement to exclude individuals who 
are unable to fully understand all aspects of the investigation that are relevant to the 
decision to participate, or who could be manipulated or unduly influenced as a result of a 
compromised position, expectation of benefits or fear of retaliatory response. 
 
Study Specific Definitions 
 
Medical Device 
Any instrument, apparatus, implement, machine, appliance, implant, software, material or 
other similar or related article 
 
(a) Intended by the manufacturer to be used, alone or in combination, for human beings for 
one or more of the specific purpose(s) of 
 
• 
Diagnosis, prevention, monitoring, treatments or alleviation of disease, 
• 
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury, 
• 
Investigation, replacement, modification, or support of the anatomy or of a 
physiological process, 
• 
Supporting or sustaining life, 
• 
Control of conception, 
• 
Disinfection of medical devices and 
 
(b) Which does not achieve its primary intended action in or on the human body by 
pharmacological, immunological or metabolic means, but which may be assisted in its 
intended function by such means 
 
MRI Scan Related Complication 
A complication is deemed to be MRI related if it is caused by or related to the interaction 
between the ICD/ CRT-D system and the MRI system that occurs during the MRI scan 
and includes the time the subject is within the 5 Gauss line of the MRI system, or up 
through the subject’s 1-month post MRI scan follow up visit. The MRI scan related 
complications will be based on the CEC adjudication data.   
 
 
 

 
 
 
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Page 66 of 67 
 
Appendix B: Case Report Form 
The case report forms for the study are kept under a separate cover and are available upon 
request.  
 

 
 
 
Protocol No: CRD_930; Study Specific Doc No: ABT-CIP-10238 Ver. D, 30SEP2019 
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Appendix C: Bibliography 
 
1 Rogulin A, Schwitter J, Vahlhaus C, Lombardi M, Brugada J, Vardas P, et al. Magnetic resonance 
imaging in individuals with cardiovascular implantable electronic devices. Europace 2008;10:336-346. 
2 Mavrogeni SI, Poulos G, Kolovou G, Theodorakis, G. Magnetic resonance imaging-conditional devices: 
Luxury or real clinical need?. Hellenic J. Cardiol. 2017. https://doi.org/10.1016/j.hjc.2017.01.001. 
3 imv Medical Information Division. 2007 MRI Market Summary Report. Prepared for St. Jude Medical 
June 2008. 
4 Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable cardioverter-
defibrillators: calendar year 2009-a World Society of Arrhythmia’s project. Pacing Clin Electrophysiol. 
2011;34:1013-1027. 
5 Mond H G, Irwin M, Ector H, and Proclemer A. The world survey of cardiac pacing and cardioverter- 
defibrillators: calendar year 2005 an International Cardiac Pacing and Electrophysiology Society (ICPES) 
Project. PACE 2008 Sep;31(9):1202-12. 
6 Levine GN, Gomes AS, Arai AE, Bluemke DA, Flamm SD, et al. AHA Scientific Statement: Safety of 
Magnetic Resonance Imaging in Patients With Cardiovascular Devices. Circulation 2007; 116: 2878-2891. 
7 Pinski S L and Trohman R G. Interference in implanted cardiac devices, Part II. Journal of Pacing and 
Clinical Electrophysiology.  2002 Oct; 25(10): 1496-1509. 
8 Roguin A.  Magnetic resonance imaging in patients with implantable cardioverter-defibrillators and 
pacemakers.  Journal of the American College of Cardiology.  2009 Aug; 54(6): 556-557. 
9 Kalin R and Stanton R. Current Clinical Issues for MRI Scanning of Pacemaker and Defibrillator Patients. 
PACE 2005;28(4):326-328. 
10 Gimbel J R, Johnson D, Levine P A, Wilkoff  B L. Safe  performance of magnetic resonance imaging on 
five patients with permanent cardiac pacemakers. PACE 1996;19:913-919. 
11 Valhaus C, Sommer T, Lewalter T. et al. Interference with cardiac pacemakers by magnetic resonance 
imaging : Are there irreversible changes at 0.5 Tesla? PACE 2001; 24: 489-495.   
12 Luechinger R, Duru F, Scheidegger, M B, et al. Force and torque effects of a 1.5Tesla MRI scanner on 
cardiac pacemakers and ICDs. PACE 2001; 24:199-205. 
13 Loewy J, Loewy A, and Kendall EJ. Reconsiderations of pacemakers and MR imaging. RadioGraphics 
2004; 24:1257-1268. 
14 Roguin A, Zviman M M, Meininger G T, et al.  Modern pacemaker and implantable cardioverter 
defibrillator system scan be magnet safe : In vitro and in vivo assessment of safety and function at 1.5T. 
Circulation 2004; 110:475-482. 
15 Cohen JD, Costa HS, Russo RJ. Determining the Risks of Magnetic Resonance Imaging at 1.5 Tesla for 
Patients With Pacemakers and Implantable Cardioverter Defibrillators. AM J Cardiol. 2012; 110: 1631-
1636. 

 
Study Specific Doc No: CL1005886 Ver. C 
Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 1 of 11 
 
 
 
 
Protocol No.: CRD_930   ABT-CIP-10238  
 
Clinical Study Protocol for the Evaluation of ICD 
Defibrillation Systems in a 1.5T Magnetic Resonance 
Imaging (MRI) Environment in China 
 
 
Statistical Analysis Plan (SAP) 
 
 
Version C 
 
11 May 2020 
 
 
 
 
 
 
 
 
 
 
 

 
Study Specific Doc No: CL1005886 Ver. C 
Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 2 of 11 
 
 
TABLE OF CONTENTS  
 
SYNOPSIS OF STUDY DESIGN ..................................................................................................... 4 
 
Purpose of the Statistical Analysis Plan ....................................................................................... 4 
 
Clinical Investigation Objectives ................................................................................................... 4 
 
Clinical Investigation Design ......................................................................................................... 4 
 
Endpoints ...................................................................................................................................... 5 
 
Primary Safety Endpoint ........................................................................................................ 5 
 
Primary Effectiveness Endpoints ........................................................................................... 5 
 
Descriptive Endpoints ............................................................................................................ 5 
 
Randomization .............................................................................................................................. 5 
 
Blinding ......................................................................................................................................... 5 
 
ANALYSIS CONSIDERATIONS ...................................................................................................... 6 
 
Analysis Populations .................................................................................................................... 6 
 
Statistical Methods........................................................................................................................ 6 
 
Descriptive Statistics for Continuous Variables ..................................................................... 6 
 
Descriptive Statistics for Categorical Variables ..................................................................... 6 
 
Endpoint Analysis ......................................................................................................................... 6 
 
Primary Safety Endpoint ........................................................................................................ 6 
 
Primary Effectiveness Endpoints ........................................................................................... 7 
 
Sample Size Calculations ............................................................................................................. 8 
 
Interim Analysis ............................................................................................................................ 8 
 
Timing of Analysis......................................................................................................................... 8 
 
Study/Trial Success ...................................................................................................................... 8 
 
Subgroups for Analysis ................................................................................................................. 8 
 
Handling of Missing Data .............................................................................................................. 8 
 
Poolability Analysis ....................................................................................................................... 9 
 
Multiplicity Issues .......................................................................................................................... 9 
 
Adjustments for Covariates........................................................................................................... 9 
 
Exploratory Analysis ..................................................................................................................... 9 
 
DESCRIPTIVE ENDPOINTS AND ADDITIONAL DATA .................................................................. 9 
 
Baseline and Demographic Characteristics .................................................................................. 9 
 
Adverse Events ............................................................................................................................ 9 
 
Subject Early Termination............................................................................................................. 9 
 
Protocol Deviation ........................................................................................................................ 9 
 
Descriptive Endpoints or Additional Data ................................................................................... 10 

 
Study Specific Doc No: CL1005886 Ver. C 
Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 3 of 11 
 
 
 
DOCUMENTATION AND OHER CONSIDERATIONS .................................................................. 10 
 
ACRONYMS AND ABBREVIATIONS ............................................................................................ 10 
 
REFERENCES ............................................................................................................................... 11 
 

 
Study Specific Doc No: CL1005886 Ver. C 
Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 4 of 11 
 
 
 
SYNOPSIS OF STUDY DESIGN   
 
Purpose of the Statistical Analysis Plan 
This statistical analysis plan (SAP) is intended to provide a detailed and comprehensive description of 
the planned methodology and analysis to be used for Clinical Study Protocol for the Evaluation of ICD 
Defibrillation Systems in a 1.5T Magnetic Resonance Imaging (MRI) Environment in China, the CRD-930 
(ABT-CIP-10238) clinical investigation. This plan is based on the ABT-CIP-10238 Ver. D, 30SEP2019 
Clinical Investigation Plan (CIP).  
 
 
 
Clinical Investigation Objectives 
 
The objective of this clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR 
implantable cardiac defibrillators (ICDs) and the Quadra Assura MP cardiac resynchronization therapy 
defibrillators (CRT-Ds), with Durata or Optisure defibrillation leads, Tendril STS or Isoflex pacing leads, 
and the Quartet quadripolar leads  in a 1.5T MRI environment for MR-conditional labeling expansion of 
these market-approved ICD/CRT-D systems in China. 
 
 
 
Clinical Investigation Design 
 
This is a prospective, multi-center, single-arm study to evaluate the safety and effectiveness of the 
Ellipse VR/DR ICDs, and the Quadra Assura MP CRT-D, with Durata or Optisure defibrillation leads, 
Tendril STS or Isoflex pacing leads, and the Quartet quadripolar LV lead in a 1.5T MRI environment for 
MR-conditional labeling expansion in China.  
 
This study will be conducted in at least 6 centers in China and at least 60 subjects who provide consent 
for participation will be enrolled. Subjects will be considered enrolled after providing consent. Subjects 
will be implanted with any one of the device/lead combination groups outlined as following, depending on 
their clinical need as determined by the Investigators. At least 15 subjects will be enrolled in each group. 
 
• 
Group 1 will have at least 15 enrolled subjects with the Ellipse VR single-chamber ICD with a 
Durata lead in the right ventricle (RV).  
• 
Group 2 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber ICD with a 
Durata lead in the RV and a Tendril STS lead in the right atrium (RA).  
• 
Group 3 will have at least 15 enrolled subjects with the Ellipse DR dual-chamber ICD with a 
Optisure lead in the RV and a Isoflex lead in the RA. 
• 
Group 4 will have at least 15 enrolled subjects with a Quadra Assura MP CRT-D and an Optisure 
or Durata lead in the RV, an Isoflex or Tendril STS lead in the RA, and a Quartet lead in the left 
ventricle (LV). 
 
A prospective, multi-center, non-randomized, open-label, single arm clinical study design was chosen to 
generalize the study results 
 
. This study intends to provide clinical data from a local Chinese population to 
supplement IDE clinical data from a population in the United States and Europe for submission to the 

 
Study Specific Doc No: CL1005886 Ver. C 
Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 5 of 11 
 
 
NMPA in support of a marketing application of MRI labeling expansion for these ICD/CRT-D systems in 
China. 
 
 
Endpoints 
 
 Primary Safety Endpoint 
Freedom from MRI-scan related complications related to the ICD/CRT-D device and/or leads from the 
time of the MRI scan to 1-month post-MRI scan testing. 
 Primary Effectiveness Endpoints 
• #1: Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms for RA and RV leads and 
≤1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month post-MRI scan testing. 
 
• #2: Proportion of leads with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to 1-month 
post-MRI scan testing.  
 Descriptive Endpoints 
Descriptive endpoints are reported using only summary statistics and no hypothesis tests will be 
performed. 
 
The following data will be collected: 
1. 
Demographics: gender, age, ethnicity, race, cardiac disease history, arrhythmia history, indication 
for ICD/CRT-D implant, history of smoking, etc. 
2. 
Device electrical measurements at the MRI Scan Visit (pre- and post-scan) and at the 1-Month 
Post Scan Visit  
3. 
ADE, SADE, USADE 
4. 
Mortality 
5. 
Number of non-study MRI scans 
6. 
Summarize number of subjects that returned to usual programming after the MRI scan and 
number of subjects, if any, experiencing delays in reprogramming   
 
 
Randomization 
Not applicable. 
 
Blinding 
Not applicable. 
 

 
Study Specific Doc No: CL1005886 Ver. C 
Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 6 of 11 
 
 
 
ANALYSIS CONSIDERATIONS 
 
 
Analysis Populations 
In this study subjects are considered enrolled after the study consent has been signed (All Consented) 
  
 
 
 
  
 
 
 
 
 
Statistical Methods 
This study is an observational study to meet the requirements for device approval by the NMPA. There is 
no endpoint hypotheses testing planned in this study. The endpoints, demographics, safety and device 
data will be summarized using descriptive statistics.  
 Descriptive Statistics for Continuous Variables 
For continuous variables (e.g., age), results will be summarized with the numbers of observations, 
means, and standard deviations, with minimums and maximums. Two-sided 95% confidence intervals for 
the means may be presented, or otherwise will be specified.  
 Descriptive Statistics for Categorical Variables 
For categorical variables (e.g. gender, cardiac disease history), results will be summarized with subject 
(or device/lead) counts and percentages/rates. Two-sided exact 95% Clopper-Pearson confidence 
intervals may be presented, or otherwise will be specified. 
 
 
Endpoint Analysis 
 Primary Safety Endpoint 
The primary safety endpoint is freedom from MRI-scan related complications related to the ICD/CRT-D 
device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing. The CEC 
adjudicated data will be used for the primary safety endpoint analysis.  
 
 
 
 
 
  

 
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Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 7 of 11 
 
 
 
   
 
 Primary Effectiveness Endpoints 
 
Effectiveness endpoint #1:  
 
Effectiveness endpoint #1 is the proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms 
for RA and RV leads and ≤1.0V at 0.5ms for LV leads from pre-MRI scan to 1-month post-MRI scan 
testing.   
  
 
  
  
 
 
  
 
 
 
  
 
 
Effectiveness endpoint #2:  
 
Effectiveness endpoint #2 is the proportion of leads with a sensing amplitude decrease of ≤ 50% from 
pre-MRI scan testing to 1-month post-MRI scan.  
 
 
  
 
 
 
  

 
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Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 8 of 11 
 
 
 
 
 
 
Sample Size Calculations 
 
There is no hypothesis testing is planned in this study, and no sample size calculation or power analysis 
has been performed.  
 
 
 
 
 
 
Interim Analysis 
No formal interim analyses are planned for this study. As such, no formal statistical rule for early 
termination of the trial is defined. Interim study reports with descriptive analysis may be produced for 
regulatory or reimbursement purposes as needed. 
 
 
Timing of Analysis 
 
Analysis will be performed after all subjects in each device Group complete their 1-month post-MRI scan 
visit or pass their 1-month post-MRI scan follow-up visit window, and when data are available for the 
analysis for the respective device Group(s). 
 
 
Study/Trial Success 
There is no hypothesis testing planned in this study, therefore no statistical criteria are specified for 
success. Data will be summarized and presented descriptively. 
 
Subgroups for Analysis 
No subgroup analysis is planned.  
  
 
Handling of Missing Data 
A subject may discontinue from the study prior to the 1-month visit. If this situation occurs, reasons for 
missing primary endpoint data will be summarized to assess the plausibility if the missing data could affect 
subject’s endpoint results. 
 

 
Study Specific Doc No: CL1005886 Ver. C 
Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 9 of 11 
 
 
 Poolability Analysis 
No poolability analysis is planned for the study.  
 
 Multiplicity Issues 
Not applicable.  
  
 Adjustments for Covariates 
Unless otherwise specified, no adjustments for covariates will be made for any of the variables in the 
analyses. 
 
 Exploratory Analysis 
 
No exploratory analysis is planned. 
 
 
DESCRIPTIVE ENDPOINTS AND ADDITIONAL DATA 
The following data will be summarized descriptively as outlined in Section 2.2 Statistical Methods in the 
SAP, based on Analysis Cohort, or otherwise as specified.  
 
 Baseline and Demographic Characteristics 
The baseline and demographic variables such as gender, age, ethnicity, race, key cardiovascular history, 
prior cardiac interventions, arrhythmia history, primary indication for ICD/CRT-D implant, and history of 
smoking, will be summarized descriptively. 
 
Adverse Events 
CEC adjudicated ADE, SADE, USADE data will be summarized in terms of the number of events, the 
number of subjects with event(s), and the percentage of subjects with event(s).  Subjects who die or 
withdraw before 1-month post-MRI scan will be included in the denominator, and their last know status of 
event will be included in the numerator.  
 
Subject Early Termination   
Subject early termination reasons such as deaths, withdrawals, lost-to-follow-up.  will be summarized at 
scheduled visits. 
 
Protocol Deviation 
Protocol deviations will be summarized descriptively by category. 

 
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Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 10 of 11 
 
 
 
Descriptive Endpoints or Additional Data 
Following Descriptive Endpoints will be reported using only summary statistics and no hypothesis tests 
will be performed. 
 
1) Demographics:  gender, age, ethnicity, race, cardiac disease history, arrhythmia history, 
indication for ICD/CRT-D implant, history of smoking, etc. Refer to Section 3.1 for the detail. 
 
2) Device electrical measurements: device electrical measurements at the MRI Scan Visit (pre- and 
post-scan) and at the 1-Month Post Scan Visit will be summarized based on Analysis Cohort subjects 
who undergo the 1-month post-MRI scan testing, and with evaluable device data available for 
analysis to be performed.  
 
3) ADE, SADE, USADE:  Refer to Section 3.2 for the detail. 
 
4) Mortality: The number of subjects who die and the primary cause of death will be presented 
based on the CEC adjudicated data.  
 
5) Non-study MRI scan data: The number, type, available adverse event(s), and key electrical 
measurements will be summarized for non-study MRI scans performed. 
  
6) Summarize number of subjects that returned to usual programming after the MRI scan and 
number of subjects, if any, experiencing delays in reprogramming:  Data will be summarized 
descriptively based on available information from MRI Scan form. A subject with ‘Yes’ to question of 
‘Were the MRI settings disabled after MRI scan’ in MRI Scan form is considered as ‘returned to usual 
programming after the MRI scan’.     
 
In addition, the adverse events and mortality that are reported prior to the completion of the study pre-
MRI scan visit on the All Consented subjects will be summarized separately using descriptive statistics. 
Listings of the adverse events and mortality with an event description will be provided as appropriate. 
 
 
DOCUMENTATION AND OHER CONSIDERATIONS 
 
All analyses will be performed using SAS for Windows, version 9.3 or higher. 
 
 
 
ACRONYMS AND ABBREVIATIONS  
 
Acronym or Abbreviation 
Complete Phrase or Definition 
CEC 
Clinical Events Committee 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 

 
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Study Name:  China MRI ICD  
Statistical Analysis Plan  
 
                                                                                                                                     Page 11 of 11 
 
 
Acronym or Abbreviation 
Complete Phrase or Definition 
SAE 
Serious Adverse Event 
ADE 
Adverse Device Effect 
SADE 
Serious Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
SAP 
Statistical Analysis Plan 
NMPA 
China National Medical Products Administration 
MRI 
Magnetic Resonance Imaging  
ICD 
Implantable Cardiac Defibrillator 
CRT-D 
Cardiac Resynchronization Therapy Defibrillator 
 
 
 
 
REFERENCES 
CRD_930 CIP ABT-CIP-10238 Ver. D, 30SEP2019 
CRD_930 CHINA MRI ICD Case Report Form (CL1005575) 
CRD_930 CHINA MRI ICD AE Adjudication From (CL1008482)