China Micra Transcatheter Pacing Study
Phase: NA
Conditions: Bradycardia
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

China MicraTM Transcatheter Pacing Study 
Clinical Investigation Plan (Version 3.0 19/Apr/2018) 
NCT No.: NCT03624504 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title China MicraTM Transcatheter Pacing Study 
Protocol No.
China Micra 
Study Product Name
MicraTM Transcatheter Pacemaker System  
Study Product Model/specification
MC1VR01 
Category of investigational medical device
Class Ⅲ 
Class Ⅲ medical devices requiring clinical trial 
approval
Yes 
Similar product in China
No 
Sponsor
Medtronic Inc.  
710 Medtronic Parkway N.E., Minneapolis, MN 
55432, U.S.A 
Locol Sponsor(Agent)
Medtronic (Shanghai) Management Co., Ltd. 
3rd Floor, No. 180. Rijing Road, China (Shanghai) 
Pilot Free Trade Zone, 200131, Shanghai, 
P.R.China 
Document Version/Version Date
3.0/19/Apr/2018 
Lead Principal Investigator(s)/Lead Study Site
Dr. Shu Zhang,  
Fuwai Hospital CAMS&PUMC 
No.167, Beilishi Road, Xicheng District, Beijing, 
China, 100037 
Clinical Trial Institutions and Investigators Refer to Appendix B-Clinical Trial Institutions and 
Investigators List 
 

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Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. Any 
distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it may 
not be further disclosed by them. 
 
 

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2. Investigator Statement 
Study product Name 
MicraTM Transcatheter Pacemaker System 
Sponsor 
Medtronic Inc.  
Locol Sponsor(Agent) 
Medtronic (Shanghai) Management Co., Ltd. 
Version Number/Date  
3.0/ 19/Apr/2018 
I agree that:  
1. I will conduct this clinical trial in strict compliance with the Declaration of Helsinki, current laws and 
regulations of China, and the requirements of the protocol; 
2. And record all required data accurately on the Case Report Form (CRF) and complete the final report 
of the clinical trial on time; 
3. The investigational medical device will be used only for this clinical trial and the receipt and use of the 
investigational medical device will be recorded completely and accurately and the records will be retained 
during the process of the clinical trial; 
4. The monitor and verifier authorized or designated by the Sponsor and the regulatory authorities are 
allowed to conduct monitoring, verification and inspection for the clinical trial; 
5. The clinical trial should be conducted in strict compliance with contract/articles of agreement signed by 
all parties. 
I have already read the clinical study protocol, including the above statement and I fully agree all the 
above requirements. I agree to ensure that the confidential information contained in this document will 
not be used for any purpose other than the evaluation and conduct of the clinical investigation without 
the prior written consent of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s Signature: 
 
Investigator’s Name: 
 
Institution: 
 
Date:  
 
 
 

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Table of Contents  
 
1. 
Version History .............................................................................................................. 3 
2. Investigator Statement .................................................................................................... 4 
Table of Contents ................................................................................................................. 5 
3. Glossary .......................................................................................................................... 8 
4. Synopsis ....................................................................................................................... 16 
5. Introduction ................................................................................................................. 18 
5.1. 
Background ................................................................................................................. 18 
5.2. 
Purpose ........................................................................................................................ 19 
6. Objectives and Endpoints ............................................................................................ 20 
6.1. 
Objectives ................................................................................................................... 20 
6.1.1. 
Primary Objective ........................................................................................................... 20 
6.1.2. 
Secondary Objective ...................................................................................................... 20 
6.1.3. 
Ancillary objective .......................................................................................................... 20 
6.2. 
Endpoints .................................................................................................................... 20 
6.2.1. 
Primary Endpoint ............................................................................................................ 20 
6.2.2. 
Sencondary Endpoint ..................................................................................................... 22 
7. Study Design ................................................................................................................ 23 
7.1. 
Duration ....................................................................................................................... 25 
7.2. 
Rationale ........................................................................................................................... 25 
8. Product Description ..................................................................................................... 25 
8.1. 
MicraTM Implantable Device .................................................................................... 27 
8.2. 
Micra Introducer ........................................................................................................ 30 
8.3. 
Transfemoral Catheter Delivery System .......................................................................... 30 
8.4. 
Programmer Software and Medtronic 2090 Programmer ................................................. 31 
8.5. 
Investigational Product Receipt/Tracking/Storage/Accountability ............................... 31 
8.6. 
Investigational Product Return ....................................................................................... 31 
8.7. 
Product Training Requirements ............................................................................. 32 
9. Selection of Subjects ..................................................................................................... 32 
9.1. 
Study Population ....................................................................................................... 32 
9.2. 
Subject Enrollment .................................................................................................... 32 
9.3. 
Inclusion Criteria ....................................................................................................... 33 
9.4. 
Exclusion Criteria ....................................................................................................... 33 
9.5. 
Minimization of Bias.................................................................................................. 35 
10. 
Study Procedures ....................................................................................................... 36 

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10.1. 
Schedule of Events .................................................................................................... 36 
10.1.1. 
Enrollment .................................................................................................................... 36 
10.1.2. 
Baseline ......................................................................................................................... 36 
10.1.3. 
Procedure/Pre Hospital Discharge .................................................................................. 36 
10.1.4. 
Subject Follow up .......................................................................................................... 37 
10.1.5. 
System Modification ....................................................................................................... 37 
10.1.6. 
Electrical Measurement Requirements ............................................................................. 38 
10.2. 
Subject Consent ......................................................................................................... 38 
10.3. 
Assessment of Safety................................................................................................ 39 
10.4. 
Recording Data .......................................................................................................... 40 
10.5. 
Deviation Handling .................................................................................................... 41 
10.6. 
Subject Withdrawal or Discontinuation ............................................................... 42 
11. 
Risks and Benefits ..................................................................................................... 43 
11.1. 
Potential Risks ........................................................................................................... 43 
11.2. 
Potential Benefits ...................................................................................................... 44 
11.3. 
Risk-Benefit Rationale.............................................................................................. 45 
12. 
Adverse Event Assessments....................................................................................... 45 
12.1. 
Definitions/Classifications ...................................................................................... 45 
12.1.1. 
Relatedness .................................................................................................................... 47 
12.1.2. 
Complication ................................................................................................................. 48 
12.1.3. 
Subject Death ................................................................................................................ 49 
12.2. 
Reporting of Adverse Events and Device Deficiency ......................................... 50 
12.3. 
Documentation and Reporting of Device Deficiencies ...................................... 52 
13. 
Data Review Committees .......................................................................................... 52 
13.1. 
Clinical Events Committee (CEC) Review ...................................................................... 52 
14. 
Statistical Design and Methods ................................................................................. 53 
14.1. 
Primary Objective ........................................................................................................... 53 
14.1.1. 
Statistical Design, Methods and Anlysis Procedures ................................................ 53 
14.1.2. 
Sample Size Calculation .................................................................................................. 54 
14.1.3. 
Significant Level and Statistical Power ............................................................................. 55 
14.1.4. 
Projected Attrition ......................................................................................................... 55 
14.1.5. 
Pass/Fail Criteria ........................................................................................................... 56 
14.1.6. 
Stopping Rule ................................................................................................................ 56 
14.1.7. 
Anlaysis Data Set, handling of missing data, non compliance, error or non reasonable data 
entry. 
56 
14.1.8. 
Deviation from Pre specified Analysis Plan ..................................................................... 56 
14.1.9. 
Criteria and Rationale for Selection of Subjects for Analysis ............................................. 56 
14.1.10. 
Justification for Exclusion of Special Information from the Analysis (if applicable) ............ 57 
14.2. 
Secondary Objectives ..................................................................................................... 57 
14.2.1. 
Secondary Objectives #1 ................................................................................................ 57 
14.2.2. 
Secondary Objectives #2 ................................................................................................ 57 

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14.4. 
Handling of Missing Data .............................................................................................. 58 
14.5. 
Reporting of procedure deviations from the original statistical plan ................................ 58 
15. 
Ethics ........................................................................................................................ 58 
15.1. 
Statement(s) of Compliance ................................................................................... 58 
16. 
Study Administration ................................................................................................. 60 
16.1. 
Monitoring ................................................................................................................... 60 
16.2. 
Data Management ..................................................................................................... 60 
16.3. 
Confidentiality ............................................................................................................ 61 
16.4. 
CIP Amendments ....................................................................................................... 61 
16.5. 
Record Retention ....................................................................................................... 61 
16.5.1. 
Investigator Records....................................................................................................... 61 
16.5.2. 
Investigator Reports ....................................................................................................... 62 
16.5.3. 
Medtronic Records ......................................................................................................... 64 
16.5.4. 
Medtronic Reports ......................................................................................................... 65 
16.6. 
Preliminary Publication Plan ...................................................................................... 66 
16.7. 
Suspension or Early Termination ........................................................................... 68 
16.7.1. 
Planned Study Closure .................................................................................................... 68 
16.7.2. 
Early Termination or Suspension .................................................................................... 68 
16.7.3. 
Procedures for Suspension or Termination ...................................................................... 69 
16.8. 
Clinical Study Report ................................................................................................ 70 
16.9. 
Insurance .................................................................................................................... 70 
16.10. 
Probability analysis of success ............................................................................... 70 
16.11. 
Probability analysis of failure ................................................................................. 70 
16.12. 
Responsibilities of all parties .......................................................................................... 70 
17. 
References ................................................................................................................. 70 
18. 
Appendices ................................................................................................................ 71 
 
 
Appendix B: Clinical Trial Institutions and Investigators List ...................................................... 75 
Appendix C: ................................................................................................................................. 76 
Appendix D: Proposed Implant Procedure Steps ......................................................................... 77 
Appendix E: Informed Consent Templates .................................................................................. 80 
Appendix F: Relevant qualification document(s) of the Sponsor/Local Sponsor(Agent) .............. 80 
 
 
 

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4. Synopsis 
Title 
China MicraTM Transcatheter Pacing Study 
Clinical Study Type 
Pre-Market Approval  
Product Name 
MicraTM Transcatheter Pacemaker System 
Sponsor  
Medtronic Inc.  
710 Medtronic Parkway N.E., Minneapolis, MN 55432, U.S.A 
Local Sponsor(Agent) 
Medtronic (Shanghai) Management Co., Ltd.  
3rd Floor, No. 180. Rijing Road, China (Shanghai) Pilot Free Trade Zone, 
200131, Shanghai, P.R.China 
Investigation Purpose 
To confirm the safety and efficacy of the MicraTM Transcatheter Pacing 
System in human use in China. 
Product Status 
CE mark was obtained in April 2015; 
FDA approval was obtained in April 2016. 
Investigational status in China 
Primary Objective(s) 
To demonstrate the MicraTM Transcatheter Pacing System (TPS) is safe by 
estimating the MicraTM TPS implant procedure and/or system related 
major complications free survival probabilities. 
Secondary Objective(s) 
1) 
To demonstrate the effectiveness of MicraTM Transcatheter Pacing 
System. 
2) 
To summarize all adverse device effect throughout the study 
 
 
Study Design 
The China MicraTM Transcatheter Pacing Study is a prospective, multi-
center, single arm human clinical trial utilizing Objective Performance 
Criterion(OPC)  to confirm the safety and efficacy profile of the Micra 
system for regulatory approval in China.  All study sites will be in China. 
Subjects successfully implanted with the Micra system in all sites will be 
followed at implant/pre-discharge, 1-month, 3-months, and 6-months, 
and at 6-month intervals thereafter (if applicable) through study closure. 
The overall follow-up period of China MicraTM Transcatheter Pacing Study 
will end when the last enrolled patient has 6 month follow-up. 

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Sample Size 
Based on statistical calculations, the study will enroll 82 subjects in total. 
(The definition of subject enrolled is that subject signed on the Informed 
Consent Form and the subject met all the inclusion criteria and none of 
the exclusion criteria.)All implanted subjects are expected to  complete 6 
months post implant follow-up visits.  
Inclusion/Exclusion 
Criteria 
Inclusion Criteria 
1) 
Subjects who have a Class I or II indication for implantation of a 
single chamber ventricular pacemaker according to ACC/AHA/HRS 
2008 guidelines and China guideline 
2) 
Subjects who are willing to participate in study through consent and 
willing to undergo study specific required procedures with 
expectancy of geographically stable for follow up duration. 
3) 
Subjects who are at least 18 years of age. 
Exclusion Criteria 
1) 
Subject has an existing or prior pacemaker, ICD or CRT device 
implant. 
2) 
Subject has unstable angina pectoris or has had an acute myocardial 
infarction (AMI) in the 30 days prior to eligibility assessment. 
3) 
Subjects with current implantation of neurostimulator or any other 
chronically implanted device which uses current in the body.  Note 
that a temporary pacing wire is allowed. 
4) 
Subjects with a mechanical tricuspid valve, implanted vena cava 
filter, or left ventricular assist device (LVAD). 
5) 
Subjects who are morbidly obese and physician believes telemetry 
communication of ≤5 inches (12.5 cm) could not be obtained with 
programmer head. 
6) 
Subjects whose femoral venous anatomy is unable to accommodate 
a 23 French introducer sheath or implant on the right side of the 
heart (for example, due to obstructions or severe tortuosity) in the 
opinion of the implanter. 
7) 
Subjects who are considered as unable to tolerate an urgent 
sternotomy 
8) 
Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy. 
9) 
Subjects for whom a single dose of 1.0mg dexamethasone acetate 
may be contraindicated. 
10) Subjects with a life expectancy of less than 12-months. 
11) Subjects who are currently enrolled or planning to participate in a 

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potentially confounding drug or device trial during the course of this 
study.  Co-enrollment in concurrent trials is only allowed when 
document pre-approval is obtained from the Medtronic study 
manager. 
12) Pregnant women or breastfeeding women, or women of child 
bearing potential and who are not on a reliable form of birth 
regulation method or abstinence. 
13) Subjects with exclusion criteria required by local law (age or other). 
14) Subjects with medical condition which precludes  patient from 
participation in the opinion of the Investigator 
Study Procedures and 
Assessments 
Subjects successfully implanted with the Micra system in all sites will be 
followed at implant/pre-discharge, 1-month, 3-months, and 6-months, 
and at 6-month intervals thereafter (if applicable) through study closure. 
Safety Assessments 
Adverse Events will be recorded and reported according to local 
regulatory requirements. It is the responsibility of the Investigator to 
abide by the adverse event reporting requirements stipulated by local law 
and the sites’ Ethics Committee. 
5. Introduction  
5.1. 
Background  
Since their introduction in the 1960s, pacemakers have steadily shrunk in size and grown in sophistication, 
yet their basic function remains the same. The job of the pacemaker is to provide life-sustaining therapy 
by sustaining a normal heart rhythm when the heart rhythm gets too slow. Pacemaker treatment for 
bradycardia is frequently used, with more than 600,000 people worldwide receiving a cardiac pacemaker 
each year.1 Pacemakers remain the only known, long term effective treatment for bradycardia.2 
Conventional pacing systems consist of a pacemaker device containing the electronics and battery 
typically implanted in a subcutaneous pocket in the chest region, and a lead threaded from the device 
pocket through veins into the heart, that conducts the pacing therapy to the desired pacing site. 
Technology advances in electronics miniaturization and battery chemistries have now made it possible for 
                                               
 
1 Mallela et al, Indian Pacing Electrophysiol J. 2004 Oct-Dec; 4(4): 201–212.  
2 Gilles et al, HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection, Heart Rhythm Volume 9, Issue 8 , 
Pages 1344-1365, August 2012 

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Medtronic to develop a device small enough to implant within the heart while still providing similar 
battery longevity. 
The Micra system leverages both existing and new technologies. The basis for the pacemaker capsule 
comes from a long history of providing basic bradycardia pacing therapy via transvenous lead based 
systems. The new technology in the Micra system is made possible due to market advances in 
miniaturization technologies (high density battery), catheter delivery systems, novel materials (nitinol), 
and placing the electrodes directly on the pacemaker capsule. 
The Micra Transcatheter Pacing System is a miniaturized single chamber pacemaker system that is 
delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the 
heart.  The Micra device eliminates the need for a device pocket and insertion of a pacing lead, thereby 
potentially eliminating complications associated with traditional pacing systems while providing similar 
pacing benefits. 
Extensive pre-clinical testing has been conducted to mitigate risks for potential hazards / risks from a 
product lifecycle perspective.  A summary of pre-clinical testing results is provided in the Investigator 
Brochure (provided under separate cover), showing acceptable electrical and mechanical performance.  
The primary supporting body of preclinical testing evidence which demonstrates safety to begin 
implanting in humans includes the Inc2 GLP animal study, bench testing and modeling.  
A comprehensive risk assessment identified all potential hazards / risks associated with the Micra system 
throughout the product life cycle compared to existing single chamber pacemakers.  The comparison 
found there are many similarities between an existing single chamber pacemaker and Micra system; 
however, the Micra system reduces or eliminates a number of risks that are primarily attributed to 
elimination of the need for a device pocket and lead, with the tradeoff of a limited number of new risks 
introduced by the Micra system. The results of pre-clinical testing demonstrate the probable benefits of 
the Micra system outweigh potential risks, demonstrating reasonable assurance of safety to proceed with 
implanting in humans.  The findings from pre-clinical testing were confirmed in the global human study. 
In the global human study, 719 patients were implanted from 725 implant attempts.  The Micra 
pacemaker performed as expected, and the primary efficacy objective was passed, demonstrating low 
and stable thresholds from implant to 6 months.  The primary safety objective was also met, 
demonstrating a low rate of major complications.  The safety profile of Micra was compared to a historical 
control comprised of six previous pacing studies.  Micra safety appeared to be as good as or better than 
the historical control.  Based on the results from the global human study, CE mark was obtained in April 
2015, and FDA approval was obtained in April 2016. 
5.2. 
Purpose 
Medtronic (Shanghai) Management Co., Ltd. is sponsoring the China MicraTM Transcatheter Pacing (Micra 
system) study in China.  This study is a prospective, multi-site, single arm human clinical trial utilizing 
Objective Performance Criterion (OPC) to confirm the safety and efficacy of the MicraTM Transcatheter 
Pacing System in human use in China. This study is expected to begin as a pre-market study using 
investigational product in China. 

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6. Objectives and Endpoints 
6.1. 
Objectives 
The analysis for the MICRA study objectives will be conducted when study required minimum sample size 
is reached. The study will have one primary objective ,two secondary objectives and 
 
 to provide summary statistics on safety and efficacy of the MicraTM Transcatheter Pacing system 
in human use in China. 
6.1.1. 
Primary Objective 
To demonstrate the MicraTM Transcatheter Pacing System (TPS) is safe by estimating the Micra TPS 
implant procedure and/or system related major complications free survival probability through 6 month 
post implant. 
6.1.2. 
Secondary Objective 
1) 
To demonstrate the effectiveness of MicraTM Transcatheter Pacing System 
2) 
To summarize all adverse device effect throughout the study 
 
 
 
 
 
 
 
 
  
6.2. 
Endpoints 
6.2.1. 
Primary Endpoint 
The study primary endpoint is defined as a subject’s first occurrence of a major complication related to 
the Micra system and/or Micra procedure as determined by the CEC that occurs on or prior to 6-months 
(183-days) post-implant. 
Major complications are those adverse events resulting in: 
• 
Death 
• 
Permanent loss of device function due to mechanical or electrical dysfunction of the device (e.g. 
pacing function disabled, leaving device abandoned electrically) 
• 
System revision (reposition, replacement, explant) 
• 
Hospitalization 
• 
Prolonged Hospitalization by 48 hours or more 

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NOTE: Only system or procedure related AEs will be classified as a major complication, minor 
complication or an observation 
In the Micra TPS Global clinical study, a total of 725 subjects underwent Micra TPS implant attempt with 
719 subjects successfully implanted with the Micra system. There were a total of 28 system/procedure 
related major complications (in 25 subjects) reported. The Kaplan-Meier estimate for the freedom from 
major complications related to Micra system or procedure at 6-months (183 days) post-implant was 96.0% 
(98.66% CI: 93.3% - 97.6%). Table 1 provides a summary of all reported complications and the 28 
major complications that counted against the study primary endpoint. 
Table 1: System and/or Procedure Related Complications Observed in the Micra TPS Global 
clinical sStudy 
 
No. Events 
(No. Subjects, %) 
Adverse Event Keyterm 
All Complications 
Major Complications 
TOTAL EVENTS 
54 (48, 6.62%) 
28 (25, 3.45%) 
CARDIAC ARRHYTHMIAS 
7 (7, 0.97%) 
0 (0, 0%) 
ATRIOVENTRICULAR BLOCK COMPLETE 
5 (5, 0.69%) 
0 (0, 0%) 
VENTRICULAR FIBRILLATION 
1 (1, 0.14%) 
0 (0, 0%) 
VENTRICULAR TACHYCARDIA 
1 (1, 0.14%) 
0 (0, 0%) 
EMBOLISM AND THROMBOSIS 
3 (3, 0.41%) 
2 (2, 0.28%) 
DEEP VEIN THROMBOSIS 
2 (2, 0.28%) 
1 (1, 0.14%) 
PULMONARY EMBOLISM 
1 (1, 0.14%) 
1 (1, 0.14%) 
EVENTS AT GROIN PUNCTURE SITE 
11 (11, 1.52%) 
5 (5, 0.69%) 
ARTERIAL INJURY 
1 (1, 0.14%) 
0 (0, 0%) 
ARTERIOVENOUS FISTULA 
4 (4, 0.55%) 
4 (4, 0.55%) 
INCISION SITE HAEMATOMA 
1 (1, 0.14%) 
0 (0, 0%) 
INCISION SITE HAEMORRHAGE 
2 (2, 0.28%) 
0 (0, 0%) 
INCISIONAL DRAINAGE 
2 (2, 0.28%) 
0 (0, 0%) 
VASCULAR PSEUDOANEURYSM 
1 (1, 0.14%) 
1 (1, 0.14%) 
TRAUMATIC CARDIAC INJURY 
12 (12, 1.66%) 
11 (11, 1.52%) 
CARDIAC PERFORATION 
3 (3, 0.41%) 
3 (3, 0.41%) 
PERICARDIAL EFFUSION 
9 (9, 1.24%) 
8 (8, 1.10%) 

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No. Events 
(No. Subjects, %) 
Adverse Event Keyterm 
All Complications 
Major Complications 
PACING ISSUES 
2 (2, 0.28%) 
2 (2, 0.28%) 
DEVICE DISLOCATION 
1 (1, 0.14%) 
1 (1, 0.14%) 
DEVICE PACING ISSUE 
1 (1, 0.14%) 
1 (1, 0.14%) 
OTHER 
19 (19, 2.62%) 
8 (8, 1.10%) 
ACUTE MYOCARDIAL INFARCTION 
1 (1, 0.14%) 
1 (1, 0.14%) 
CARDIAC FAILURE 
3 (3, 0.41%) 
3 (3, 0.41%) 
HYPOTENSION 
3 (3, 0.41%) 
0 (0, 0%) 
MEDICATION ERROR 
2 (2, 0.28%) 
0 (0, 0%) 
METABOLIC ACIDOSIS 
1 (1, 0.14%) 
1 (1, 0.14%) 
NON-CARDIAC CHEST PAIN 
1 (1, 0.14%) 
0 (0, 0%) 
OSTEOARTHRITIS 
1 (1, 0.14%) 
0 (0, 0%) 
PACEMAKER SYNDROME 
1 (1, 0.14%) 
1 (1, 0.14%) 
PERICARDITIS 
1 (1, 0.14%) 
0 (0, 0%) 
PRESYNCOPE 
3 (3, 0.41%) 
1 (1, 0.14%) 
SYNCOPE 
1 (1, 0.14%) 
1 (1, 0.14%) 
URINARY RETENTION 
1 (1, 0.14%) 
0 (0, 0%) 
1Increased pacing capture threshold described as micro-dislodgement by investigator.  Chest X-ray showed 
device was in place.  
6.2.2. 
Sencondary Endpoint 
• 
Secondary Endpoint #1 
The effectiveness of the Micra TPS will be characterized by pacing capture thresholds, impedance and 
sensing amplitudes at implant and all follow-up visits (i.e. 1 month, 3 months and 6 months).  
It is expected that majority of the subjects will have pacing capture thresholds ≤ 2 Volts at all visits. 
Pacing impedance and sensing amplitude will be stable over time. 
 
• 
Secondary Endpoint #2 

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All procedure and/or system related adverse events are collected throughout the duration of this study.   
Adverse events will be reported by event term, and based on relatedness to procedure/system and event 
severity. 
7. Study Design  
The China MicraTM Transcatheter Pacing Study is a prospective, multi-center, single arm human clinical 
trial ultizing OPC to confirm the safety and efficacy profile of the Micra system for regulatory approval in 
China.  All study sites will be in China. All study sites and Investigators are listed in Appendix B.  Subjects 
successfully implanted with the Micra system in all sites will be followed at implant/pre-discharge, 1-
month, 3-months, and 6-months, and at 6-month intervals thereafter (if applicable) through study closure. 
The overall follow-up period of China MicraTM Transcatheter Pacing Study will end when the last enrolled 
patient has 6 month follow-up.  
 
  
Figure 1: Study Flow Chart 
 

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7.1. 
Duration 
The China MicraTM Transcatheter Pacing study will be conducted at 7 sites in China.  The study will enroll 
82 subjects in total. All subjects with chronically implanted Micra are expected to complete 6 months post 
implant follow-up visits for the study objective analyses.   
It is estimated that study enrollment will be completed in 6 months.   The estimated participation 
duration of each subject will be from 6 month to 12 month if the enrollment can be completed within 6 
months. The estimatied duration of whole clinical trial will be approximately 1 year including 6 months 
enrollment and 6 months follow-up.  
7.2. 
Rationale  
Extensive pre-clinical testing has been conducted to mitigate risks for potential hazards / risks from a 
product lifecycle perspective.  A summary of pre-clinical testing results is provided in the Investigator 
Brochure (provided under separate cover), showing acceptable electrical and mechanical performance.  
The primary supporting body of preclinical testing evidence which demonstrates safety to begin 
implanting in humans includes the Inc2 GLP animal study, bench testing and modeling.  
A comprehensive risk assessment identified all potential hazards / risks associated with the Micra system 
throughout the product life cycle compared to existing single chamber pacemakers.  The comparison 
found there are many similarities between an existing single chamber pacemaker and Micra system; 
however, the Micra system reduces or eliminates a number of risks that are primarily attributed to 
elimination of the need for a device pocket and lead, with the tradeoff of a limited number of new risks 
introduced by the Micra system. The results of pre-clinical testing demonstrate the probable benefits of 
the Micra system outweigh potential risks, demonstrating reasonable assurance of safety to proceed with 
implanting in humans.  The findings from pre-clinical testing were confirmed in the global human study. 
In the global human study, 719 patients were implanted from 725 implant attempts.  The Micra 
pacemaker performed as expected, and the primary efficacy objective was passed, demonstrating low 
and stable thresholds from implant to 6 months. The primary safety objective was also met, 
demonstrating a low rate of major complications. The safety profile of Micra was compared to a historical 
control comprised of six previous pacing studies. Micra safety appeared to be as good as or better than 
the historical control.  Based on the results from the global human study, CE mark was obtained in April 
2015, and FDA approval was obtained in April 2016. 
8. Product Description 
The study will be conducted using the components described in the table below. Instructions for use are 
provided in the respective device manuals; each of the system components are manufactured by 
Medtronic.  Refer to the respective manuals for any possible interaction with concurrent medical 
interventions. 

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Instructions for intended use, including indications and contraindications of the components used in this 
study, as well as medical procedures and information regarding material in contact with tissues or body 
fluids are provided in their respective manuals. The methods used to diagnose, indicate and treat a 
patient with the Micra device are similar to those for commercially-available single chamber pacemakers. 
Detailed descriptions of the system and accessory components are listed in the sections below. And the 
labeling will be developed according to local requirements 
8.1. 
MicraTM Implantable Device 
The MicraTM implantable device is a self-contained, hermetically enclosed, miniaturized single chamber 
pacemaker.  The device is fixated via four electrically inactive nitinol tines, located on the distal end of 
the device.  
Figure 3: MicraTM Implantable Device 
 
 
Table 3: MicraTM Implantable Device Specifications 
Volume 
1.0 cc 
Length 
25.9 mm 
Outer diameter 
6.7 mm 
Mass 
1.75 g 

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Volume (cc) 
9.7  
1.0 cc 
Mass (g) 
21.5 
1.75  
Connector 
IS-1 
Integrated Pacing Electrode 
Battery Chemistry/Capacity 
Lithium-iodine, 830 mA-hr 
Lithium silver vanadium oxide/carbon 
monoflouride, 120 mA-hr 
Ventricular High Rate 
Episodes with EGM 
Yes 
No 
Magnet Mode 
Yes 
No magnet mode* 
Prolonged Service Period 
3 months 
6 months 
Rate Response 
Single axis accelerometer 
within subcutaneous pocket 
Three individually selectable axes within 
right ventricle.   
Capture Management 
Periodic 
Periodic, Hourly safety margin 
confirmation 
Threshold Measurement and 
Tracking 
Measure 1/day,  
Output  Max. of 2X 
threshold or 2.0V 
Measure 1/day,   
Verify 1/hour. 
Output  Threshold + 0.5V 
Maximum Pacing Output  
7.5V  
5. 0V 
EOS Behavior  
Pace until Battery Depleted  
Mode-switch to OOO at EOS 
Ability to inactivate device 
at EOS  
No  
Yes---with programmer 
* The purpose of magnet mode is to allow a clinician to evaluate the sufficiency of the safety margin and the status of the device’s battery 
longevity in the absence of a programmer. This is not necessary in Micra as the device automatically conducts safety margin confirmations 
on an hourly basis. Device longevity estimates are available via programmer. 
 
Micra device longevity is equal or better than predicate devices at low thresholds but is more sensitive to 
higher thresholds.  It is important to ensure low pacing outputs to optimize Micra longevity.  Micra 

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capture management will run an hourly threshold verification test and have a nominal pulse width 
threshold setting of 0.24ms (chronaxie) to maximize longevity.  Micra device longevity is estimated at: 
• 
7.1 years at a 2.0V output, 60bpm, 100% paced, or  
• 
9.6 years at 1.5V output, 60bpm, 100% paced   
8.2. 
Micra Introducer 
The Micra Introducer is a single-use, disposable, hydrophilic coated sheath that will be used in this study 
to provide a flexible and hemostatic conduit for the insertion of the Micra device.  The introducer system 
is comprised of 2 components: a dilator which accommodates a 0.035 in (0.89 mm) guide wire, and an 
introducer sheath.  The introducer is comprised of a hydrophilic, coil-reinforced sheath that is attached to 
a rigid seal housing containing the hemostatic valve assembly. A side port extension with a 3-way valve is 
permanently attached to the seal housing. A radiopaque marker band is located at the distal tip of the 
sheath. The Micra introducer also has a suture loop for attaching it to the patient. 
Figure 4: Micra Introducer 
 
8.3. 
Transfemoral Catheter Delivery System 
The Micra device is placed via a catheter delivery system through the femoral vein.  This delivery 
approach is similar to other devices which are commonly placed in many geographies today via large 
caliber catheter systems in the femoral vein, such as: 
• 
Medtronic’s Melody transcatheter valve (pulmonic valve), delivered via the 22 French Ensemble 
delivery system 
• 
Abbott Vascular’s MitraClip Delivery System for mitral valve repair, delivered via 24 French Steerable 
guide catheter  
The single use Micra transfemoral catheter delivery system consists of the delivery catheter required to 
deliver, deploy, and test the Micra device placement.  It is constructed of two braided shaft assemblies, 
one placed inside another and attached to a handle at the proximal end. The distal end of the system can 
be articulated by activating a button on the handle. The MicraTM device sits inside a cup at the distal end 
of the catheter and is deployed by activating a button on the handle. The MicraTM device is locked to the 
delivery system by means of a tether that goes through the proximal end of the device, through the 
braided shafts to the handle, and can be released (or locked) by means of a button on the handle.  The 
delivery system is used in conjunction with a 23Fr introducer sheath. 
Key characteristics of the delivery system include: 
• 
23Fr delivery system with fixed shape distal curve 

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• 
Inner and outer braided shafts attached to handle 
• 
Device Cup to hold device with a recapture cone on the inner shaft 
• 
Tether lock mechanism for Micra device  
• 
Flushing port on handle 
• 
Off-plane distal articulation 
8.4. 
Programmer Software and Medtronic 2090 Programmer 
The Micra device communicates with the programmer using the standard Medtronic Model 2090 
Programmer. A standard programming head, Model 2067 or Model 2067L, using standard telemetry B is 
required for communication from the device to the programmer.  
Unique SW022 software, needs to be installed on the programmer.  This software can be installed on the 
programmer via an installation kit or through the Medtronic Software Distribution Network (SDN). Using 
the SDN requires the site and/or Medtronic support to provide the study sponsor with the serial number 
of the programmer(s) that are planned to be used in the Micra Transcatheter Pacing Study.   
In China, the Micra application software is investigational, and loaded on the Medtronic 2090 programmer, 
that programmer will be labeled to indicate that it contains investigational software.  The Micra 
application software that was installed with investigational status will continue to be considered 
investigational when used to support the investigational Micra devices. 
8.5. 
Investigational Product Receipt/Tracking/Storage/Accountability 
Device and Software Disposition logs will be provided to the site and will be used for tracking of all 
investigational products.  
These logs must be maintained at each investigational site to ensure traceability via assigned lot or serial 
numbers. It is the responsibility of the investigator to correctly handle, store, and track the investigational 
products. Disposition of investigational product will be reported when any of these investigational 
products are received, opened, implanted, explanted, disposed of or returned to Medtronic and will be 
sent to Medtronic each time it is updated. 
Investigational product will be distributed to a site only when Medtronic has received all required 
documentation, has notified the site of site activation and the site has been authorized to enroll in the 
study. Distribution of the investigational product to study sites during the clinical study will be managed 
by Medtronic. Investigational product can only be ordered by Medtronic personnel. Investigational 
product must be stored in a secure location at the site. Investigational products will be used only in the 
study according to the CIP.  
8.6. 
Investigational Product Return 
All explanted product should be returned to Medtronic for analysis when permissible by local laws and 
regulations. If the products are explanted but not returned, a justification is required to be reported on 
the appropriate case report form(s) or disposition log(s). To receive a Returned Product Mailer Kit, please 
contact your local Medtronic field personnel. All unused investigational product must be returned to 
Medtronic upon study closure at the site, The Investigational Product Disposition Log must be updated 
with the final device disposition. 

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8.7. 
Product Training Requirements 
All implanters in the study will be experienced in the implant of pacemaker systems and receive 
standardized training for the implant of the Micra system. Prior to performing the implant procedure, it is 
important that all implaters read and understand the Instructions for Use that accompanies the device. 
They must also undergo documented training by Medtronic. A summary of the implant procedure steps is 
provided in Appendix D. 
9. Selection of Subjects 
9.1. 
Study Population 
China MicraTM Transcatheter Pacing study will be conducted in China, thus, the study population to be 
enrolled in the study will be only from Chinese patient.  
9.2. 
Subject Enrollment 
• 
Ethics Committee approval of the China MicraTM Transcatheter Pacing Study Clinical Investigation 
Plan and Informed Consent Form must be obtained prior to enrolling patients in the study.  
• 
Subjects are considered enrolled in the study upon signing the informed consent and meet all of the 
inclusion and none of the exclusion criteria.  Informed consent must be obtained prior to performing 
any study-related procedures. Subjects will be assessed to ensure that they meet all of the inclusion 
and none of the exclusion criteria 

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Subjects with current implantation of neurostimulator or 
any other chronically implanted device which uses 
current in the body.  Note that a temporary pacing wire 
is allowed.   
Necessary to avoid any possible electrical 
interference with Micra device. 
Subjects with a mechanical tricuspid valve, implanted 
vena cava filter, or left ventricular assist device (LVAD). 
 
Necessary to avoid electrical or mechanical 
interference when placing Micra device. 
Subjects who are morbidly obese and physician believes 
telemetry communication of ≤5 inches (12.5 cm) could 
not be obtained with programmer head. 
 
Necessary to ensure ability to communicate 
with programmer. 
Subjects whose femoral venous anatomy is unable to 
accommodate a 23 French introducer sheath or implant 
on the right side of the heart (for example, due to 
obstructions or severe tortuosity) in the opinion of the 
implanter. 
 
Necessary to place Micra introducer sheath. 
Subjects who are considered as unable to tolerate an 
urgent sternotomy 
 
Necessary in case of emergency where 
urgent vascular surgery would be required  
Subjects with a known intolerance to Nickel-Titanium 
(Nitinol) Alloy. 
 
Necessary since Micra tines are comprised of 
Nitinol material. 
Subjects for whom a single dose of 1.0mg 
dexamethasone acetate may be contraindicated. 
Necessary due to steroid material on Micra 
electrode (standard exclusion for all pacing 
studies with steroid on the electrode). 
Subjects with a life expectancy of less than 12-months. 
 
Standard exclusion criteria to ensure study 
cohort is expected to survive to the time of 
endpoint evaluation. 
Subjects who are currently enrolled or planning to 
participate in a potentially confounding drug or device 
trial during the course of this study.  Co-enrollment in 
concurrent trials is only allowed when document pre-
approval is obtained from the Medtronic study manager. 
 
Standard exclusion criteria to avoid 
confounding procedural requirements due to 
multiple experimental studies. 
Pregnant women or breastfeeding women, or women of 
Pregnant women are excluded to avoid harm 

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child bearing potential and who are not on a reliable 
form of birth regulation method or abstinence. 
 
to the fetus caused by fluoroscopy 
requirements. 
 
Subjects with exclusion criteria required by local law (age 
or other). 
 
Standard exclusion criteria to comply with 
any additional local requirements which may 
apply. 
Subjects with medical condition which precludes  patient 
from participation in the opinion of the Investigator 
Standard exclusion criteria to apply medical 
discretion in subject selection. 
9.5. 
Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias. 
Below are methods incorporated in the study design to minimize potential bias include (but are not 
limited to): 
• 
Subjects will be screened to confirm eligibility for enrollment with protocol pre-defined 
inclusion/exclusion criteria (see Table 5 and Table 6) 
• 
Demographics and medical history will be collected at baseline in order to assess possible 
characteristics that may influence endpoints 
• 
Data collection requirements and study procedures will be standardized across all study 
sites 
• 
All study sites will follow the same version(s) of the CIP and CRFs. 
• 
The maximum enrollment number from a single site should not exceed 50% of the total 
study size 
• 
All study site and Medtronic personnel will be trained using standardized training materials 
• 
Regular monitoring visits will be conducted to verify adherence to the Clinical Investigation 
Plan and source data 
• 
An independent CEC will be utilized to regularly review and adjudicate reported adverse 
events 
• 
All implanters in the study will be experienced in the implant of pacemaker systems and 
receive standardized training for the implant of the Micra system 
• 
Final analysis of the study objectives will be carried out as pre-specified in this protocol. 
The analysis cohort is defined in the statistical method section (see Section 14 for details)   

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10. Study Procedures  
10.1. Schedule of Events 
10.1.1. 
Enrollment 
Enrollment of a subject is complete once the potential patient has signed an Informed Consent and 
passed the screening assessment. All subjects are required to be enrolled prior to the implant 
procedure/exposure to the investigational product.  Once consent has been obtained and the screening 
assessment has been passed, the individual is considered as enrolled in the study. It is recommended 
that consent be obtained no earlier than 30 days prior to procedure. Informed consent must be obtained 
prior to performing any study related procedures. 
10.1.1.1. Screening  
Consented patients will be considered as screen failure and will be exluded from all study analyses if the 
subject is deemed to be not suitable for undergoing Micra implant procedure based on study defined 
inclusion/exclusion criteria. 
10.1.2. 
Baseline 
The enrollment and baseline visit can occur at the same time. Information collected at baseline will 
include the date the consent was signed, verification of eligibility, demographics and medical history,in 
addition, cardiovascular medications will be collected at baseline.  Centers are to report study enrollments 
as soon as possible upon patient consent into the study database. Per CFDA requirement for pre-market 
studies, the sponsor will provide the investigational device free-of-charge to the study institution. This will 
be outlined in the clinical trial agreement. 
10.1.3. 
Procedure/Pre Hospital Discharge 
Information collected at implant will include data from the day of the implant procedure and device 
testing including:   
• 
Device information e.g. model, serial number, etc. 
• 
Name of implanting physician 
• 
General relevant procedure information:  e.g. placement methods & location, technique 
• 
Electrical measurements (pacing threshold, lead impedance, and sensing amplitude) submit 
device data e.g. uploads or transmissions.  Report if measurements can’t be reported due 
subject condition (i.e. heart block, atrial fibrillation, etc.)  
• 
Anticoagulation Strategies 
• 
Implant Tools 
• 
Fixation confirmation method 
10.1.3.1. Unsuccessful Implant Detail  
If a Micra device is not successfully implanted, subjects will be exited from the study within 30-days post 
the date of implant procedure unless a study system and/or implant procedure related Adverse Event (AE) 
is identified.  If a study system and/or implant procedure related AE is identified, the subject will be 
followed until the event is resolved or no further actions need to be taken.   

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principal investigator or his/her authorized designee will conduct the informed consent process. Refer to 
Appendix E: Informed Consent Templates. 
The process for obtaining informed consent shall: 
• 
Avoid any coercion of, or undue influence of subjects to participate 
• 
Not waive or appear to waive subject’s legal rights 
• 
Provide documents to the subject in a language s/he is able to read and understand 
• 
Use language that is non-technical and understandable to the subject or legal representative 
• 
Provide ample time for the subject to consider participation 
• 
Include a dated signature of the subject or legal representative acknowledging their participation 
in the study is voluntary. Include personally dated signatures of the principal investigator or an 
authorized designee responsible for conducting the informed consent process. 
• 
The informed consent shall be documented before any procedure specific to the clinical 
investigation is applied to the subject. 
In the event that the subject can’t read or write, a witnessed (impartial third party) consent form and 
authorization/data protection will be allowed (as determine by local law), provided detailed 
documentation of the process is recorded in the subject’s case history and the witness signs and dates 
the appropriate consent form and authorization.   
The signed ICF and the authorization must be filed at the site.  A copy of the ICF must be provided to the 
subject.  The original signed ICF and the authorization or other privacy language where required by law 
must be retained and made available for review by site monitors, auditors, or inspectors. 
The consent process should be documented at each site in source documents which may include Medical 
charts, progress notes of medical history sheets, etc. Any changes to a previously approved Informed 
Consent Form throughout the course of the study must be approved by Medtronic and then by the Ethics 
Committee reviewing the application before being used to consent a prospective study subject. The 
document(s) must be controlled (i.e. versioned and/or dated, per local law) to ensure it is clear which 
version(s) were approved by the Ethics Committee. All important new information should be provided to 
new and existing subjects throughout the study, and if relevant, all affected subjects shall be asked to 
confirm their continuing informed consent in writing. 
10.3. Assessment of Safety 
Timely, accurate, and complete reporting and analysis of safety information is crucial for the protection of 
subjects, clinicians, and the sponsor.  Reporting and analysis of safety data are mandated by regulatory 
authorities worldwide.  Medtronic has established Standard Operating Procedures (SOPs) to ensure 
compliance with global regulatory safety reporting requirements.  Study activities are conducted in 
accordance with these SOPs. 
Procedure and device related adverse events are collected throughout the duration of this study, starting 
from the time of signing the CF through study closure.  Adverse Events are to be reported upon site 
awareness using an event form, capturing date of the event; date site became aware of the event, 
diagnosis of the event, actions taken, assessment of seriousness, relatedness and outcome.     

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Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g., amend the CIP, conduct additional training, and 
terminate the investigation).  Repetitive or serious investigator compliance issues may represent a need 
to initiate a corrective action plan with the investigator and site, and in some cases, necessitate 
suspending enrollment until the problem is resolved or ultimately terminating the investigator's 
participation in the study.   
10.6. Subject Withdrawal or Discontinuation  
Every attempt should be made to follow all Micra subjects through study closure.  
Upon exiting from the study, no further study data will be collected or study visits will occur for the 
subject.  All data available through the time of the subject’s exit will be used for analysis.. In the event of 
study exit, the investigator should discuss with the subject the plans for future care and treatment. The 
investigator should explain that the subject will continue to receive standard medical care.  Alternative 
treatment, such as medication options, implant of a commercially available system or follow-up through 
standard of care procedures instead of study procedures, and medical consequences should also be 
discussed. The investigator must notify the subject of any significant new findings that may become 
available during the course of the study, which are pertinent to the safety and well-being of the subject. 
Exit 
Subjects may be exited from the study for any of the following situations: 
• 
Subject does not meet inclusion/exclusion criteria and was not implanted with investigational 
device of interest 
• 
No implant attempted 
• 
Implant attempted but was not implanted 
• 
Explant of the investigational device with no planned replacement  
• 
Lost to follow-up 
• 
Subject chooses to withdraw from the study 
• 
Investigator deems withdrawal necessary (medically justified or inclusion/exclusion criteria not 
met, failure of subject to maintain adequate study compliance ) 
In the event that a subject is exited from the study prior to study closure, all efforts should be made to 
continue following the subject until all unresolved procedure or device related adverse events are 
resolved or they are ongoing and no further actions will be taken. 
It is recommended to perform a full device interrogation prior to the study exit.  A copy of the 
interrogation files should be sent to Medtronic, with a copy also being maintained at the site. 
Lost to Follow-up 
In the case that the subject is determined to be lost to follow-up, details of a minimum of two attempts 
and the method of attempt (e.g., one letter and one phone record or two letters) to contact the subject 
must be recorded. In addition, the requirements set by the governing EC/IRB for subjects lost to 
follow-up must be followed. 

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11. Risks and Benefits 
11.1. Potential Risks 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a product, 
from the business analysis phase through development, market release, and post-market surveillance.  A 
summary of the risk analysis and risk assessment specific to this study is included in the corresponding 
Micra IDE study Investigator Brochure or Report of Priors. 
Potential risks and side effects associated with a device implant and follow up procedures are documented in 
the product labeling. 
Table 10 provides a listing of potential Micra AEs and is not intended to be a comprehensive listing of all 
reportable Adverse Events. This listing is provided to facilitate more complete and consistent event 
reporting.  
Table 10: Potential Micra system related Adverse Events included but are not limited to: 
air embolism 
myocardial damage 
aneurysm or pseudoaneurysm 
nerve damage 
bleeding or hematoma 
nerve or extracardiac stimulation 
cardiac or vascular trauma 
oversensing, undersensing, or loss of pacing therapy 
device dislodgment or migration 
pacemaker syndrome 
device embolization 
pain at access site or chest 
endocarditis 
pericarditis, pericardial effusion, or pericardial rub 
fluid accumulation 
peripheral ischemia 
heart, vessel, or valve tissue damage 
reduced device longevity 
impaired cardiac function due to device 
tissue necrosis such as myocardial infarction 
incision site complication 
threshold elevation 
incision site infection or other infection 
thrombus which may result in embolism, such as DVT, 
PE, or CVA 
induction or acceleration of arrhythmias 
toxic/allergic reactions 
ineffective rate response 
venous occlusion 

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11.2. Potential Benefits 
The potential benefits of the Micra implantable device are consistent with the bradycardia therapy 
provided by similar currently approved single chamber pacemakers.  Patients experiencing untreated 
bradycardia may get an inadequate supply of oxygen to their brain or other organs. This may result in 
debilitating symptoms, including syncope, weakness, fatigue, shortness of breath, chest pains, and 
confusion or memory problems. Pacemakers remain the only known, long term effective treatment for 
bradycardia.5. 
In addition to the standard benefits which apply to all pacemakers for bradycarida, there may be 
additional benefits specific to the Micra system due to its design.  With no device pocket, risk of infection, 
vascular complications and device pocket complications (hematoma, erosion, pain) may be reduced or 
eliminated. Pacing leads are currently regarded as the weakest link in the implanted system as they can 
lead to lead failure and system reliability issues lead fracture and lead insulation defects.  There is no 
similar technology available to deliver pacing therapy without a lead.  Therefore, possible additional 
benefits specific to the Micra system include: 
 
Avoid certain complications associated with traditional pacemakers due to Micra design: 
• 
Subclavian access complications (pneumothorax, occlusion) 
• 
Pocket complications (Hematoma, Erosion, infections) 
• 
Lead complications (dislodgement, fracture, infections, connection errors, interaction with 
vasculature & heart structures, extraction complications) 
 
Satisfy patient preferences: 
• 
Cosmetic appeal (lack of pocket) 
• 
Minimally invasive approach 
• 
Avoid pain and discomfort  associated with pocket  
 
Efficiency: 
• 
Faster procedural time 
 
Increased Access to Brady Therapy 
• 
More patients have access to pacing therapy since Micra implant isn’t limited by number of 
available specialists in emerging markets 
The information gained from this study could result in the improved management of patients with the 
Micra system. Additionally, information collected from this study may assist in the design of new 
product(s)/therapy(ies) and/or instructions for use. 
It is possible that the Micra Transcatheter Pacing System may offer no benefit.  
                                               
 
5 Lancet 2004; 364: 1701–19 

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Micra Implantable Device Related:  An adverse event that results from the presence or 
performance (intended or otherwise) of the Micra device 
Delivery Catheter Related: An adverse event that results from the presence or performance 
(intended or otherwise) of the delivery catheter 
Software Related:  An adverse event that results from the performance (intended or otherwise) 
of the Micra software 
Accessory / Tool Related 
Programmer Related:  An adverse event that results from the presence or performance (intended 
or otherwise) of the programmer 
Introducer Related  An adverse event that results from the presence or performance of the 
introducer 
Implant Tool Related: An adverse event that results from the presence or performance of the 
implant tool (excluding delivery catheter and introducer)  
Extraction Tool Related  An adverse event that results from the presence or performance of the 
extraction tool 
Note: If an event occurs as a result of a system component but it is unclear which component it is related 
to, the default will be to the last component used prior to the event being observed. 
Hospitalization: An overnight hospital admission, where admission date and discharge date are different 
An unsuccessful implant is not considered an adverse event; however any adverse events occurring 
during an unsuccessful implant attempt (e.g. dissection, perforation) must be recorded and classified. 
12.1.2. 
Complication 
Complication:  An adverse event that results in death, involves any termination of significant device 
function or requires an invasive intervention.  
Non-invasive when applied to a diagnostic device or procedure, means one that does not by design or 
intention: 
• 
Penetrate or pierce the skin mucous membranes of the body, the ocular cavity or the urethra, or 
o 
Penetrate: to pass, extend, pierce, or diffuse into or through something; to enter 
overcoming resistance; to gain entrance to 
o 
Pierce: to force a way into or through something 
• 
Enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond 
the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os.  
Blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus 
samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is 
also considered noninvasive. 
Major Complication: 
A complication which results in: 
• 
Death 

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• 
Permanent loss of device function due to mechanical or electrical dysfunction of the device (i.e. 
pacing function disabled, leaving device abandoned electrically) 
• 
System revision (explant, reposition, replacement) 
• 
Hospitalization 
• 
Prolonged Hospitalization by 48 hours or more 
NOTE: Only system or procedure related AEs will be classified as a major complication, minor 
complication or an observation 
Minor Complication: Any adverse event classified as a complication that is not a major complication (e.g. 
event classified as a complication solely based on intravenous drug administration) 
Observation: Any adverse event that is not a complication. 
12.1.3. 
Subject Death 
All subject deaths must be reported by the investigator to Medtronic as soon as possible after the 
investigator first learns of the death.  Document the adverse event that led to the subject death on an 
Adverse Event form. Further supporting evidence that is not originally provided by the site may be 
requested by Medtronic to aid in the adjudication of the death. 
In the event of a subject death, the implanted system should be explanted and returned to Medtronic for 
analysis whenever possible.  Prior to explant, the system should be interrogated and a full summary 
interrogation performed (save-to-media) when possible. If the system is not interrogated, an explanation 
must be documented.  If any system component is returned to Medtronic, internal return product 
reporting systems may be used to gather additional information about the returned device/component. 
 
A copy of the death certificate, if available and allowed by state/local law, should be sent to the 
Medtronic. When a death occurs in a hospital, a copy of the death summary report and all relevant 
hospital records should be sent to the Medtronic, if available. If an autopsy is conducted, the autopsy 
report should also be sent to the Medtronic if available and allowed by state/local law. When the death 
occurs at a remote site, it is the investigative site’s responsibility to attempt retrieval of information 
about the death. Additionally, device disposition information should be updated. In summary, the 
following data will be collected: 
 
Date of death 
• 
Detailed description of death 
• 
Cause of death 
• 
Relatedness to system and/or procedure 
• 
Device interrogation (if available) 
• 
Device disposition information (if applicable) 
• 
Death summary/hospital records (if available and allowed by local law) 
• 
Autopsy report (if available and allowed by local law) 
• 
Death certificate (if available and/or allowed by local law) 
12.1.3.1. Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. The 
Investigator shall classify each subject death per the following definitions: 

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12.3. Documentation and Reporting of Device Deficiencies 
Device Deficiency information will be collected throughout the study and reported to Medtronic.  Device 
Deficiencies that led to an AE are reported on the AE eCRF.  Device Deficiencies that did not lead to an 
AE should be reported on a Device Deficiency eCRF (one for each Device Deficiency). 
 
All Device Deficiencies, regardless if it led to an AE, must be reported.  Information reported on the 
Device Deficiency Form shall include a description of the deficiency, the date of onset, actions taken as a 
result of the deficiency, the outcome of the event, and the date the deficiency was first noticed by the 
investigator. 
 
Device deficiencies that did not lead to an adverse event but might have led to an SAE if a) a suitable 
action had not been taken, or b) an intervention had not been made, or c) circumstances had been less 
fortunate, should be reported to Medtronic as soon as possible. Initial reporting may be done by phone, 
fax, e-mail, or on the eCRF completing as much information as is available. The original fully completed 
Device Deficiency eCRF must be submitted to Medtronic as soon as possible. 
Initial reporting of AE/DD may be done by phone, fax, e-mail, or on the eCRF completing as much 
information as is available. The original fully completed AE eCRF must be submitted to Medtronic as soon 
as possible. Investigators should contact their Medtronic clinical research specialist or site monitor if they 
have any questions regarding reportable AE/DD. Medtronic will provide and maintain a listing of current 
contact details for each site.    
13. Data Review Committees  
13.1. Clinical Events Committee (CEC) Review 
As requested by the sponsor, an independent CEC will review and adjudicate at a minimum all procedure, 
system, and MRI related adverse events and deaths.   
The CEC will consist at least 3 non-Medtronic employed physicians that are not participating investigators 
for the China MicraTM Transcatheter Pacing Study, including a CEC chairperson. At least three CEC 
members must adjudicate, at a minimum, all deaths and SAEs related to any component of the system 
under investigation.  
For adverse events and deaths reviewed by the CEC, Medtronic will provide the CEC with the 
Investigator’s description and classification. The CEC is responsible for reviewing the Investigator’s 
assessment and supportive documentation (when available), reviewing applicable definitions, and 
determining final classifications for all adjudication parameters. 
If the CEC disagrees with the investigator’s classification of the event, the rationale will be provided to 
the investigator. If the investigator agrees with the CEC’s adjudication, the case report form documenting 
the AE will be updated accordingly. 
If the investigator does not agree with the CEC’s adjudication classification, both determinations will be 
provided within the final report; however the CEC’s adjudication will be used for data analysis. The 
disagreement will also be included in reporting to ethic committees and regulatory authorities, if required. 

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14. Statistical Design and Methods 
14.1. Primary Objective 
To demonstrate the MICRA TPS is safe by estimating the MICRA TPS implant procedure and/or system 
related major complications free survival probability through 6 month post implant. 
14.1.1. 
Statistical Design, Methods and Anlysis Procedures 
14.1.1.1. Hypothesis 
The primary endpoint is Micra system and/or procedure related major compliations through 6 months 
post implant. The corresponding statistical hypothsis for this study  (ultizing single arm OPC design) is: 
0
1
0
0
:
:
S
S
S
S
T
T
>
Η
≤
Η
; 
Where 
T
S  is the expected value of the probability of a subject free from Micra system and/or procedure 
related major complications through 6 months post implant; 
0
S is the OPC .The objective will be 
considered met if the lower bound of the two-sided 95% confidence interval lower bound for the estimate 
is greater thangreat then 83%.   
14.1.1.2. Statistical Analysis Method 
• 
Baseline Patient Demographics 
Summary Statistics will be obtained: frequency and percentage will be reported for categorical data; 
mean, standard deviation, minimum, maximum, median, the 1st and 3rd quartiles will be reported. 
• 
Analysis of the Primary Objective: 
All subjects who undergoes an Micra implant procedure will be included in the analysis. The 
Kaplan-Meier survival analysis will be used to estimate the probability of a subject free from Micra 
system and/or procedure related relate major complications.  The log-log transformation will be 
used to calculate calculation the confidence limits. 
Definitions: 
• 
Endpoint event for the survival analysis is Micra system and/or procedure related major 
complications (see 6.2.1) 
o 
The CEC will finally final determine if the adverse event is related to Micra system and/or 
procedure; and if the adverse  event is a major complication 
• 
Censoring occurs in subjects who does not experience any Micra system and/or procedure related 
major complications 
• 
Follow-up time: from the date of Micra implant procedure to 
o 
the onset date of a Micra system and/or procedure related major complication, or 

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o 
study termination date (e.g. subject exit, die, or study closure, etc.), or 
o 
the date of Micra deactivation due to any reason that is not related to the  Micra system 
or procedure (e.g. device system upgrade, the subject’s other comorbidities, etc) , or  
o 
the last follow-up date, if none of the above occurs. 
 
• 
Analyses of the Secondary Objectives 
The secondary objectives will be analyzed using descriptive statistics. The Statistical Analysis Plan 
will provide additional details. 
• 
Safety Evaluation 
All information associated with each adverse event, including event decription, severity, and 
relatedness to the system, etc., will be reported. In addition, event rate will be summazied. The 2-
sided 95% Confidence Intervals will be calculated using the Exact Binomial method.  
• 
The statistical analysis of the primary objective will be 2-sided, using 0.05 significance level. The 
statsitical analysis software package SAS will be used to conduct these analysis.  
14.1.1.3. Statistical Anlysis Procedures 
The statistical analysis will follow the requirements documented in the ICH E9, as well as the relevant 
requirements in the Biostatistic Guidelines for Clinical Trials issued by the Chinese Food and Drug 
Administration (CFDA). At the same time, all statistical analysis procedures will strictly comply to the 
standard operating procedures (SOP) of the Medical Reseach & Biomedtric Center, National Center for 
Cardiovascular Diseases. 
14.1.2. 
Sample Size Calculation 
14.1.2.1. Total Enrollment  Size 
The study will require a enrollment size of 82. The study size is calculated based on statistical hypothesis, 
assumed expected performance, and projected attrition.   
14.1.2.2. Rationale and Considerations for Sample Size Determination 
The study size is determined by the sample size required for the primary objective. It is reported in the 
NEngl J20157 that the Micra system and/or procedure related relate complication free survival probability 
through 6 months was 96%, (95% CI: 93.3%, 97.6%) in those who underwent Micra system implant 
                                               
 
7Dwight Reynolds, Gabor Z. Duray , etc..A Leadless Intracardiac TranscatheterPacing System. N Engl JMed 
2015;NEJMoa1511643:1-9. 

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14.1.5. 
Pass/Fail Criteria 
The study pass/fail criteria is based on statistical hypothesis and final analysis results.The analysis of 
study primary objectives will be 6-month success rate comparing to the pre-specified OPC. If the 95% 2-
sided confidence interval lower bound for the probability of free from Micra system and/or procedure 
related major complication is greater than 83%， the study will be considered yielding a positive result, 
demonstrating the success rate is higher than expected values, i.e. study objective will be met.  
14.1.6. 
Stopping Rule 
No interim analysis is planned for this study. Therefore there is no stopping rule defined. The analysis will 
be conducted after data collection is completed, verified and locked. 
14.1.7. 
Anlaysis Data Set, handling of missing data, non-compliance, error or 
non-reasonable data entry. 
Statistical analysis procedures (procedures) will strictly compy to SOP of the Medical Reseach & 
Biomedtric Center, National Center for Cardiovascular Diseases. Please refer to other relevant 
documents for additional details. 
Data entry error or non-reasonable values will be cleaned befored data analysis. In the event of subject 
exit or withdrawal of consent, the subject will still be included in the final statistical analysis. The specific 
reasons for subject exit or withdrawal will be provided in detail in the statistical report. If no data can be 
collected from a subject during post-implant follow-up, additional sensitivity analysis may be performed. 
This study will use the survival analysis method for the primary objective. Scenarios for censoring are 
previously defined. The Worst Case Scenario Analysis will only be performed if it is identified as a true 
missing (e.g. permanent missing of adverse event related data, and subsequently resulting in non-
conclusive CEC review) or if the cause of death is unknown. The sensitivity analysis may count such 
missing data as failures. 
14.1.8. 
Deviation from Pre-specified Analysis Plan 
The statistical analysis plan will be finalized by the sponsor and the primary investigator before the data is 
locked for analysis. The analysis plan may be modified to consider actual scenarios observed during the 
study phase before its being final approved.  In principle, no major analysis methods or definition of  
analysis sets should be changed. All versions will be recorded. 
14.1.9. 
Criteria and Rationale for Selection of Subjects for Analysis 
Statistical analysis sets should be clearly defined prior to the time when analysis is carried out. The 
analysis sets for this study are defined as follows: 

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Full Analysis Set (FAS): This is a dataset defined per Intention-To-Treat principle, it refers to the set of all 
subjects who participates in the study and is exposed to the investigational device. In the event when 
data can’t be collected from certain subjects, censoring or additional analysis may be applied..   
Per Protocol Set (PPS): A subset of study subjects who complies to study protocol (The subject who has 
a violation related to study inclusion/exclusion criterion will be excluded from the PPS). 
Safety Analysis Set (SS): The same definition as FAS should be used. Therefore, no additional definition 
is provided here. 
The primary objective analysis will be performed on the FAS; all baseline demographic data and 
secondary objectives  will be based on the FAS or PPS, and the safety assessment will be performed on 
the FAS. The electrical parameters will be analzyed on PPS. 
14.1.10. 
Justification for Exclusion of Special Information from the Analysis (if 
applicable) 
Not applicable. 
 
14.2. Secondary Objectives 
14.2.1. 
Secondary Objectives #1 
Objective: To demonstrate the effectiveness of MICRA Transcatheter Pacing System 
Cohort definition and analysis method 
All subjects with a successful Micra system implanted will be included in this analysis. 
Pacing capture thresholds, impedance and sensing amplitudes will be summarized for implant and 
follow-up visits.  Mean, standard deviation, and 2-sided 95% confidence interval, as well as minimum, 
median and maximum values will be presented for each measurement at each visit. 
Since Micra utilizes different battery technology, the system nominally paces at a shorter pulse 
duration (0.24ms vs 0.4ms in traditional pacemakers). It is expected that majority of the subjects will 
have pacing capture thresholds ≤ 2 Volts at all visits. 
14.2.2. 
Secondary Objectives #2 
Objective: To summarize all adverse device effect throughout the study 
Cohort definition and analysis method 
All subjects who undergo a MICRA implant procedure will include in this analysis. All reportable 
events will reviewed by the event adjudication committee for relatedness to MICRA system and/or 
implant procedure. Frequency of each event diagnosis and severity (major complication, minor 
complication vs observation) will be summarized. Event rates will be reported for this patient cohort. 
Two-sided confidence intervals will be computed using the Exact binomial method. 

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14.4. Handling of Missing Data 
Study subject disposition will be reported. Subjects visits will be tabulated, and compliance to study 
protocol required visit schedule will be summarized. Protocol deviation will be required for all missed visits 
and/or incomplete or incorrect data collection. The main analysis of the study primary objective will be 
based on available data and missing data will not be imputed. However additional sensitivity analysis will 
be done to assess the potential impact of missing data.  
14.5. Reporting of procedure deviations from the original statistical plan 
Any deviations from original statistical plan and the rationale will be described in the study report.  
15. Ethics 
15.1. Statement(s) of Compliance  
• 
This study is a pre-market clinical trial for product registration. The study will be conducted in 
accordance with the laws and regulations of China, including any future applicable laws and 
regulations in China.  
• 
To protect the rights and welfare of patients, this clinical study will be conducted in compliance with 
the latest version of the Declaration of Helsinki (2013), the Clinical Trial Agreement (CTA) and 

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Clinical Investigation Plan, the laws and regulations of China including Good Clinical Practice for 
Medical Devices (CFDA Order No. 25), Announcement of CFDA on Filing of Medical Device Clinical 
Trial (2015, No.87) and also including applicable data protection laws. Sites will also comply with any 
additional ethics committee requirements applicable. This study conforms to the Notice of 
Requirement of Examine and Approve of Clinical Trial for Medical Device Class Ⅲ from CFDA (No. 14, 
2014) and requirement for Clinical Trial Approval (CTA) will be applicable.  
• 
The principles of the Declaration of Helsinki have been implemented through the patient informed 
consent (IC) process, Ethics Committee approval, study training, clinical trial registration, preclinical 
testing, risk-benefit assessment and publication policy. 
• 
The clinical trial filing will be completed prior to conduct of this study per the requirement of the 
Announcement of CFDA on Filing of the Medical Device Clinical Trial (2015, No. 87).  
• 
Approval of the CIP or CIP amendments is required from the following groups prior to any study 
procedures at a study site: Medtronic, principal investigators and Ethics Committee. Similarly, 
approval of subsequent revisions to the CIP is required at each study center from the above 
mentioned groups prior to implementation of the revised CIP at that center. 
• 
Sponsor should be responsible for filing the study to Shanghai Municipal Food and Drug 
Administration after Ethics Committee approval of the current version of the CIP and fully executed 
Clinical Trial Agreement. 
• 
All products will be labelled as per local regulations in China and products requiring investigational 
labelling will be labelled investigational as per local regulatory requirements. 
• 
All participating study sites and investigators should make all the study data and study related 
records and including source data/records available for the monitoring, audits work from sponsor 
and inspection from EC and/or Regulatory body per their requirements to ensure the quality of the 
clinical trial.  
• 
The sponsor shall avoid improper influence on, or inducement to, the subject, monitor, any 
investigator(s) or other parties participating in, or contributing to, the China MicraTM Transcatheter 
Pacing study. 
• 
Sponsor representatives may provide support as required for the study, including technical support 
at site. Sponsor representatives may provide technical support as required for the study under 
supervision of the Principal Investigator, including: 
1) Provide study training relevant and pertinent to the involvement of personnel conducting study 
activities and investigator responsibilities. 
2) Technical support will be provided during implant and/or during follow-up visits. 
3) Technical support will be under the supervision of a study investigator, but no data entry on the 
eCRF shall be performed by Medtronic personnel or their representatives at sites. 
4) Technical support to conduct device interrogations.  

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16. Study Administration 
16.1. Monitoring  
Medtronic monitors the regulatory and reporting compliance of clinical studies to ensure the overall 
integrity and quality of the data through a combination of the following actions: 
• 
Automated data logic checks 
• 
Statistical analysis to identify data trends or anomalies 
• 
Statistical analysis to identify sites that are outliers relative to other participants 
• 
Source verification using available in-house data e.g. data transmission   
• 
Regulatory and reporting compliance trends 
• 
Interim  on-site clinical monitoring visits 
• 
Site Audits  
It is the responsibility of Medtronic to ensure proper monitoring of this study per regulations.  Trained 
Medtronic personnel or delegates appointed by Medtronic may perform study monitoring activities to 
ensure this study is conducted in accordance with the protocol, Clinical Trial Agreement, and applicable 
regulatory and local requirements.   
Medtronic (or delegates) must  be allowed access to the subjects’ case histories when conducting onsite 
interim monitoring visits (clinic and hospital records, and other source data/documentation) upon request 
as per the Informed Consent Form, Research Authorization (where applicable) and Clinical Trial 
Agreement.  
Site Monitoring Visits 
Frequency of onsite monitoring visits will be based upon subject enrollment, duration of the study, 
compliance, number of adverse events or deviations, findings from previous monitoring visits and any 
suspected inconsistency in data that requires investigation. Regulatory documents may be reviewed at 
each site. Monitoring for the study, including site qualification visits, site initiation visits, interim 
monitoring visits, and closeout visits, will be done in accordance to the study-specific monitoring plan. 
Visits may be conducted periodically to assess site study progress, the investigator’s adherence to study 
requirements regulatory compliance including but not limited to IRB approval and review of the study, 
maintenance of records and reports, and review of source documents against subject CRFs. Monitors 
review site regulatory and study compliance by identifying findings of non-compliance and 
communicating those findings along with recommendations for preventative/corrective actions to site 
personnel.  Monitors may work with study personnel to determine appropriate corrective action 
recommendations and to identify trends within the study or at a particular site. 
Further details of monitoring and a list of data which can be recorded directly in the CRF will be given in 
the study specific monitoring plan. The Monitoring Plan will be provided under a separate cover.  
16.2. Data Management 
Data will be collected using an electronic data management system.  Data reporting will be completed 
and submitted by the clinician or authorized staff.  All data will be stored in a secure, password-protected 
database.   

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Medtronic will review site reported data to monitor data quality, data discrepancies will be created as 
required and forwarded to the site for resolution. Study management reports may be generated by 
Medtronic to monitor data quality and study progress Site personnel are responsible for the timely 
submission of data and the resolution of discrepancies. 
Reported data elements should be supported in the subject’s case history.  Any time the database 
reported data are the only record, it should be appropriately documented.  In these cases, an alternate 
method of source documentation is highly recommended.   
For products capable of transmitting data, device data uploads/transmissions will be collected for 
Medtronic products only.  This data will be obtained directly from the submitted device file (i.e. 
transmission, etc.) therefore, additional source verification will not be required. 
Medtronic or regulatory authority may audit the site to evaluate the conduct of this study.  The 
Investigator(s)/institution(s) shall allow study-related monitoring, audits, EC/IRB review, and regulatory 
inspection(s) by providing direct access to study source data/documents, and regulatory documents. 
Leading site will be accountable for data management and analysis about the data from each clinical 
research institution in a centralized manner according to local regulations and study requirements. 
Medtronic will oversee all data management functions and provide support if necessary. 
16.3. Confidentiality 
All records and other information about subjects participating in this study will be treated as confidential. 
Data will be transferred and processed by Medtronic or a third party designated by Medtronic in a key 
coded form, unless it’s impossible to make it anonymous, for instance, where the patient’s name cannot 
be removed from the data carrier, such as fluoroscopy images.  
Procedures in the CIP require source documentation. Source documentation will be maintained at the site. 
Source documents, which may include worksheets, patient medical records, programmer printouts, and 
interrogation files, must be created and maintained by the investigational site team. 
Medtronic or regulatory authority may audit the site to evaluate the conduct of this study.  The 
Investigator(s)/institution(s) shall allow study-related monitoring, audits, EC/IRB review, and regulatory 
inspection(s) by providing direct access to study source data/documents, and regulatory documents. 
16.4. CIP Amendments 
Approval of the CIP or CIP amendments is required from the following groups prior to any study 
procedures at a study site: Medtronic, principal investigators, geography-specific regulatory authorities (if 
regulatory approval is required) and an independent Ethics Board. Similarly, approval of subsequent 
revisions to the CIP is required at each study center from the above mentioned groups prior to 
implementation of the revised CIP at that center.  
16.5. Record Retention 
16.5.1. 
Investigator Records 
The investigator is responsible for the preparation and retention of the records cited below. All of these 
records, with the exception of case history records and case report forms, should be kept in the 

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Clinical trial 
institution and 
Investigator 
Initiated Study 
suspension or 
termination 
CFDA 
If it is required to suspend or terminate the trial as the clinical 
trial institution and investigators found that the risk outweighs the 
possible benefits or results have been obtained that suffice the 
judgment of the safety and effectiveness of medical device, the 
investigators shall inform the subjects, and make sure 
appropriate treatment and follow-up visits for the subjects, and 
meanwhile report as required with detailed written explanation 
for the suspension and termination. Report to the food and drug 
regulatory authorities of the provinces, autonomous regions and 
municipalities directly under the central government if necessary. 
(GCP for Medical Devices, CFDA order No.25 Article 76) 
Failure to obtain 
informed consent 
Sponsor and 
Ethics 
Committee 
Informed consent shall be obtained in writing and documented 
before a subject is enrolled into the clinical investigation.  (ISO 
14155:2011) 
Safety Report 
Clinical Trial 
Institution 
Sponsor, 
Local FDA or 
Regulatory 
Authority 
For the serious adverse events occurred in clinical trials, 
investigators shall immediately adopt appropriate therapeutic 
measures for subjects, and simultaneously report to the 
management department of medical device clinical trials in 
clinical trial institutions in written form, and notify the sponsor in 
written form. Management department of medical device clinical 
trials shall report to corresponding Ethics Committee as well as 
local food and drug regulatory authority and health and family 
planning competent authority of the province, autonomous 
region and municipality directly under the central government 
where the clinical trial institution locates in written form within 24 
hours. In case of death of subjects, the investigators and clinical 
trial institutions should provide all the required additional 
information to the Ethics Committee and the sponsor. 
(GCP for Medical Devices, CFDA order No.25 Article 71) 

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Final report 
CFDA, 
Sponsor, and 
Clinical Trial 
Institution 
Upon completion of multi-center clinical trials, investigators of all 
clinical trial institutions shall issue brief summary of clinical trials, 
respectively, and submit it to coordinating investigator together 
with Case Report Form upon review as required for coordinating 
investigator to summarize and complete summary report. 
(GCP for Medical Devices, CFDA order No.25 Article 29（7）) 
Investigators should, in accordance with the design requirements 
of the clinical trial protocol, verify and validate the safety and 
effectiveness of investigational medical devices, and complete 
the Clinical Trial Report. As for multi-center clinical trials, the 
Clinical Trial Report should contain the Summaries of Clinical 
Trial of all sub-centers. 
(GCP for Medical Devices, CFDA order No.25 Article 83) 
The Clinical Trial Report should be signed and dated by the 
investigators, and submitted to the sponsor after being reviewed, 
commented, dated and sealed by medical device clinical trial 
administration department of clinical trials institutions. 
For multi-center clinical trial, the clinical trial summary of each 
center should be signed and dated by the investigators of 
respective center, and submitted to the leading site after being 
reviewed, dated and sealed by the site's clinical trial 
administration department. 
(GCP for Medical Devices, CFDA order No.25 Article 86) 
 
16.5.3. 
Medtronic Records 
Medtronic shall maintain the following (but not limited to) accurate, complete, and current records: 
 
• 
All correspondence which pertains to the studies 
• 
Investigational device tracking documentation 
• 
Signed Clinical Trial Agreements and delegation documentation as well as the signed 
agreements with third party(if applicable) and FD from PI 
• 
All electronically signed and dated case report forms submitted by investigator, including reports 
of AEs, ADEs and Device Deficiencies, Subject Deaths 
• 
All approved Informed Consent Forms, and other information provided to the subjects and 
advertisements, including translations 
• 
Copies of all EC/IRB approval letters and relevant EC/IRB correspondence and EC/IRB voting 
list/roster 
• 
Names of the institutions in which the Study will be conducted 
• 
Names/contact addresses of monitors 
• 
Statistical analyses and underlying supporting data 
• 
Study final reports 
• 
Sample eCRFs 
• 
All versions of the study protocol and IB 
• 
Training records of site personnel and Medtronic personnel involved in the study 

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Final report 
Investigators, 
CFDA 
The Clinical Trial Report should be signed and dated by 
the investigators, and submitted to the sponsor after 
being reviewed, commented, dated and sealed by 
medical device clinical trial administration department of 
clinical trials institutions. 
For multi-center clinical trial, the clinical trial summary of 
each center should be signed and dated by the 
investigators of respective center, and submitted to the 
leading site after being reviewed, dated and sealed by 
the site's clinical trial administration department. 
(GCP for Medical Devices, CFDA order No.25 Article 86) 
 
Sponsor will submit the final report to CFDA after 
obtaining it from the medical institution. 
Medtronic records and reports will be stored in secure file cabinets at Medtronic during the course of 
the study. Electronic versions of the reports will be kept on a password-protected document 
management system.  After closure of the study, all records and reports will be archived indefinitely. 
16.6. Preliminary Publication Plan 
Publications from this study will be handled according to Medtronic Standard Operating Procedures and 
as indicated in the Clinical Trial Agreement.  
Publication Committee 
The investigators of this study will serve as members of the Publication Committee, in addition to 
Medtronic representative(s). This committee will manage study publications with the goal of publishing 
findings from the data. The Publication Committee will develop the final Publication Plan as a separate 
document. 
The Publication Committee’s role is to: 
1. 
manage elements addressed in the publication plan as outlined below, 
2. 
develop the final Publication Plan under separate cover, 
3. 
execute the Publication Plan, 
4. 
oversee the publication of primary, secondary and ancillary study results, 
5. 
review and prioritize publication proposals, 
6. 
provide input on publication content, and 
7. 
determine authorship. 
In addition, the committee will apply and reinforce the authorship guidelines set forth in the Publication 
Plan. Membership in the Publication Committee does not guarantee authorship. The committee will meet 
as needed. 
Management of Publications 

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The Publication Committee reviews, prioritizes, and manages all publications for the study. The 
publications are those that address analyses of any efficacy and safety objectives, as specified in the 
Clinical Investigation Plan. 
The committee may decide that no publications, including abstracts, will be published prior to the end of 
the study or with individual site data. Requests for publications on study objectives utilizing subset data 
(e.g., single site) will be evaluated for scientific validity and the ability of Medtronic to provide resources. 
Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical Journal 
Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, www.icmje.org). 
Individual authorship criteria defined by the target journal or conference will be followed when it differs 
from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data 
• 
Drafting the article or revising it critically for important intellectual content 
• 
Final approval of the version to be published 
Decisions regarding authorship and contributor-ship will be made by the committee. The selected authors 
will be responsible for drafting the publication. All selected authors must fulfill the authorship conditions 
stated above to be listed as authors, and all contributors who fulfill the conditions must be listed as 
authors.  
All investigators not listed as co-authors will be acknowledged as the “Medtronic China Micra Study 
Investigators” and will be individually listed according to the guidelines of the applicable scientific journal 
when possible and affiliation. Any other contributors will be acknowledged by name with their specific 
contribution indicated. 
Transparency 
Transparency of study results will be maintained by the following means: 
• 
a final report, describing the results of all objectives and analysis, will be distributed to all 
investigators, Ethics Committees and Competent Authorities of China  when required by local 
law 
• 
registering and posting the study results on ClinicalTrials.gov based on the posting rules 
stipulated 
• 
submitting for publication the primary study results 
• 
disclosing conflicts of interest (e.g., financial) of the co-authors of publications 
• 
according to the policies set forth by the corresponding journals and conferences 
• 
making an individual sites study data accessible to the corresponding 
• 
investigator after the completion of the study, if requested 

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16.7. Suspension or Early Termination 
16.7.1. 
Planned Study Closure 
Study Closure is a process initiated by distribution of an initial study closure letter. Study closure is 
defined as closure of a clinical study that occurs when Medtronic and/or regulatory requirements have 
been satisfied per the protocol and/or by a decision by Medtronic or regulatory authority, whichever 
occurs first. The study closure process is complete upon distribution of the Final Report or after final 
payments, whichever occurs last. Ongoing IRB oversight is required until the overall study closure 
process is complete. 
16.7.2. 
Early Termination or Suspension 
Early Termination of the study is the closure of a clinical study that occurs prior to meeting defined 
endpoints. This is possible for the whole study or a single site. Study Suspension is a temporary 
postponement of study activities related to enrollment and distribution of the product. This is possible for 
the whole study or a single site. 
Study-Wide Termination or Suspension 
Possible reasons for considering study suspension or termination of the study include but are not limited 
to: 
• 
Adverse events associated with the system or product under investigation which might endanger 
the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic (circumstances include but are not limited to; interests of the health of the 
study subjects, continuation of the study cannot serve any scientific  purpose, insolvency) or 
regulatory body (where the study is operating under regulatory body authority) 
• 
Technical issues during the manufacturing process 
Investigator/Site Termination or Suspension 
Possible reasons for clinical investigator or site termination or suspension include but are not limited to: 
• 
Failure to obtain initial IRB approval or annual renewal of the study 
• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to eligibility criteria, 
failure to follow subjects per the scheduled follow-ups) 
• 
Lack of enrollments 
• 
Noncompliance to regulations and the terms of the Clinical Trial Agreement (e.g. failure to submit 
data in a timely manner, failure to follow-up on data discrepancies and monitoring findings in a 
timely manner, etc.) 
• 
IRB suspension 
• 
Fraud or fraudulent misconduct is discovered  
• 
Investigator request (e.g. no longer able to support the study) 

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16.7.3. 
Procedures for Suspension or Termination 
Medtronic-Initiated 
 
• 
For deciding to suspend or terminate clinical trials, sponsor shall notify the management 
department of medical device clinical trials of all clinical trial institutions within 5 days, and state 
the rationale in written form. 
• 
Management department of medical device clinical trials in clinical trial institutions shall timely 
notify corresponding investigators and Ethics Committee. 
• 
The suspended clinical trials shall not be recommenced without the approval of Ethics Committee. 
• 
Upon the completion of clinical trials, sponsor shall notify local food and drug regulatory authority 
of the province, autonomous region and municipality directly under the central government where 
he locates in written form. 
• 
Upon receipt of notification of suspending or terminating clinical trials from sponsor, investigators 
shall timely notify subjects and ensure that subjects receive appropriate treatment and follow-up.  
• 
In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic with the approval of Ethics Committee. 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare. 
 
Clinical Trial Institution and Investigator-Initiated 
• 
If it is required to suspend or terminate the trial as the clinical trial institution and investigators 
found that the risk outweighs the possible benefits or results have been obtained that suffice the 
judgment of the safety and effectiveness of medical device, the investigators shall inform the 
subjects, and make sure appropriate treatment and follow-up visits for the subjects, and 
meanwhile report as required with detailed written explanation for the suspension and 
termination. 
• 
Clinical Trial Institution and Investigator shall report to the food and drug regulatory authorities 
of the provinces, autonomous regions and municipalities directly under the central government if 
necessary. 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare. 
 
EC/IRB-Initiated 
 
• 
The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days 
• 
Subject enrollment must stop until the suspension is lifted 
• 
Subjects already enrolled should continue to be followed in accordance with Ethics 
• 
Committee policy or its determination that an overriding safety concern or ethical issue is 
involved 
• 
The investigator will inform his/her institution (where required per local requirements) 

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• 
Upon receipt of notification of suspending or terminating clinical trials from Ethics Committee, 
investigators shall timely notify subjects and ensure that subjects receive appropriate treatment 
and follow-up.  
16.8. Clinical Study Report 
The Clinical Study Report will be compliant with CFDA 2016 No. 58 Announcement Annex 5 “Template 
of Clinical Trial Report of Medical Devices” 
16.9. Insurance 
Medtronic (Shanghai) Management Co., Ltd is a wholly owned subsidiary of Medtronic, Inc., which as 
the parent company of such entity maintains appropriate clinical study liability insurance coverage as 
required under applicable laws and regulations and will comply with applicable local law and custom 
concerning specific insurance coverage. And as Ethics Committee of local clinical center may have 
special requirement on the insurance policy or other formal arrangement, it is necessary to provide a 
Clinical Study insurance statement/certificate to the Ethics Committee for review and obtain favorable 
opinion.  
16.10. Probability analysis of success 
The manufactory system of Medtronic has been tested and proven for many years. The quality of the 
investigational device has been carefully examined and verified before delivery. The investigational 
device has been commercially available globally, including the Europe and America countries, with a 
certain number of clinical application or post-marketing follow-up. The basic principles, structure 
composition and materials etc. comply with the international and domestic standards, or has been 
carefully examined and verified by Medtronic, and detected qualified by CFDA certificated medical 
device testing organization. The study design of this study complies with related CFDA instructions and 
requirements of ethical review, and all potential subjects will be strictly selected according to 
indications of the investigational device. 
16.11. Probability analysis of failure 
Although regulatory/ethical/scientific and medical requirements have been fully taken into 
consideration, the unanticipated risk in clinical application of investigational device could lead to failure 
of this study. Potential risks could be reduced to the minimum, with well-trained study staff and strict 
protocol compliance. 
16.12. Responsibilities of all parties 
Investigator responsibilities will be included in clinical trial agreement and subject responsibilties will be 
available in Informed Consent Form (ICF). Sponsor will undertake all the responsibilities of the sponsor 
as required per CFDA regulations. 
17. References 
1. 
Mallela et al, Trends in cardiac pacemaker batteries. Indian Pacing Electrophysiol J. 2004 Oct-Dec; 

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210029 
30159527 
The Second Affiliated 
Hospital of Zhejiang 
University School of 
Medicine 
Dr. Jianan Wang 
Professor
No.88, Jiefang 
Road, 
Shangcheng 
District, 
Hangzhou, 
Zhejiang 
Province, China, 
310009 
30158850 
Beijing Anzhen Hospital, 
Capital Medical 
University 
Dr. Yujie Zhou 
Professor
No.2, Anzhen 
Road, Chaoyang 
District, Beijing, 
China, 100029 
30159320 
Ruijin Hospital Shanghai 
Jiaotong University 
School of Medicine 
Dr. Liqun Wu 
Professor
No.197, Ruijin Er 
Road, Shanghai, 
China, 200005 
 
Appendix C:  
 
Comments of the Sponsor   
 
Signature (stamp)  
 
Date: MM/DD/YYYY 
 
Comments of the Investigator: 
 
Signature: 

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• 
Patient’s right groin is prepped per 
standard procedure 
• 
Diagnostic monitoring devices (EKG, O2, 
Blood pressure, etc.) are placed as 
required per standard hospital procedure
3 
Venous Access 
• 
Femoral vein is located.  (To avoid hitting 
a femoral artery, implanter can use 
ultrasound to guide access if preferred.) 
• 
Needle with syringe attached are inserted 
into vein 
• 
Guide wire is placed through needle up 
to heart  
• 
Introducer and dilator are flushed 
• 
Introducer 
is 
wetted 
to 
activate 
hydrophilic coating 
• 
Introducer/dilator are placed over the 
wire up to mid-atrium  
• 
Guide wire and dilator are removed 
• 
Introducer is aspirated and flushed 
• 
A continuous heparinized saline drip is 
attached to the introducer. 
• 
A figure-8 stitch is placed (if preferred) 
 Introducer set (needle, syringe, guide 
wire, dilator, and outer sheath) 
 Fluoroscopy 
 Suture 
 
Optional tools: 
• 
SiteRite or other ultrasound 
• 
Additional size dilators  
• 
Needle and suture  
4 
Delivery System / 
Device Prep 
• 
Delivery system is removed from package  
• 
Device is retracted into delivery system 
• 
Lumen(s) are flushed with saline  
 Delivery system loaded with 
implantable Micra device 
 Saline 
 Syringe  
5 
Transvenous 
delivery of 
catheter to heart 
• 
Delivery system is inserted into the 
introducer and advanced to the atrium. 
• 
Introducer is retracted down into IVC 
 Delivery system loaded with 
implantable Micra device 
 Fluoroscopy 
6 
Navigating to the 
RV apex 
• 
Curve is deflected on the delivery system 
to cross tricuspid valve 
• 
Delivery catheter is advanced to target 
location in the RV 
 Delivery system loaded with 
implantable Micra device 
 Fluoroscopy 
7 
Deployment/ 
fixation of device
• 
Tether is unlocked 
• 
While 
maintaining 
forward 
pressure 
against the wall of the RV, the device is 
advanced out of the delivery tool 
• 
Delivery system is pulled  back from the 
device 
 Delivery system loaded with 
implantable Micra device 
 Fluoroscopy 

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8 
Fixation 
Verification 
• 
Tug-test is performed by gently pulling 
on the tether while observing tines on 
high magnification cine  
• 
Fluoroscopy cine recording obtained per 
study protocol: during each deployment’s 
tug test to attempt visualization of each 
of the 4 tines under high magnification 
cine.  Multiple views may be required. 
Each 
recording 
10 
seconds, 
save 
recording 
of 
tug 
test 
for 
final 
deployment.  
• 
Programming head is placed in sterile 
cover (if required) and placed over the 
heart 
• 
Acute threshold, R-wave amplitude, and 
Impedance measurements are taken 
 Fluoroscopy 
 Model 2090 Programmer and 
Programmer Head 
9 
Reposition 
capsule (if 
required) 
• 
Delivery system is advanced back over 
the device  
• 
The device is re-captured back into the 
delivery system, tether is locked, and 
system is repositioned in the RV (repeat 
steps 7 and 8 as required). 
 Delivery system loaded with 
implantable Micra device 
 Fluoroscopy 
10 
 Fixation Test 
• 
Repeat Fixation Verification (step 8) 
 
 
11 
Removal of 
Delivery System 
• 
Tether is cut and gently pulled through 
delivery system while observing device 
under fluoroscopy to ensure tether 
removal doesn’t compromise fixation 
• 
Delivery system removed  
• 
Fluoroscopy cine  recorded obtained after 
delivery 
system 
removal 
per 
study 
protocol (10 second recording in AP or 
other view)  
• 
Introducer removed 
 Fluoroscopy 
12 
Closure 
• 
Pressure is applied at access location 
• 
Stitch placed at access site per physician 
discretion 
• 
If Figure of 8 stitch was placed, suture is 
 Needle and suture 
 
Optional Tools 
 
Market approved vascular closure 

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tightened  
device  
13 
Final Electrical 
Testing 
• 
Final device interrogation performed and 
saved  
 Model 2090 Programmer and 
Programmer Head 
 
Appendix E: Informed Consent Templates 
Consent form templates will be provided under a separate cover. 
 
Appendix F: Relevant qualification document(s) of the Sponsor/Local 
Sponsor(Agent) 
Relevant qualification document(s) of the Sponsor/Local Sponsor(Agent) will be provided under a 
separate cover.