Accelerometer Sensing for Micra AV Study
Phase: NA
Conditions: AV Block, AV Block Complete, 3rd Degree Heart Block, Complete Heart Block
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

 
 
AccelAV Study (Accelerometer Sensing for Micra AV) 
NCT04245345 
Clinical Investigation Plan, 24-JAN-2020 

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Clinical Study Document Approval Form
Study Name/Identifier 
AccelAV Study (Accelerometer Sensing for Micra 
AV) 
Document Version and Date
2.0 – 24JAN2020
Document Name
AccelAV Study
Document Reference Number
MDT19018
Author Name: Nicole Wood
Role or Title: Prin. Clinical Research Specialist,
Clinical Study Manager
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Author Name: Kurt Stromberg
Role or Title: Sr. Prin. Statistician, Medical Writer
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Author Name: Francesca Lemme
Role or Title: Senior Statistician, Medical Writer
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Approver Name: Andrea Schminke
Role or Title: Sr. Clinical Research Specialist, 
Medical Writer
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Approver Name: Jeff Cerkvenik
Role or Title: Distinguished Biostatistician
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Approver Name: Jennifer Tinsley
Role or Title: Clinical Leadership (BU)
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Approver Name: Sheila Emmans 
Role or Title: Clinical Quality/Compliance
Electronic Signature
Electronic Date

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Signature
Signature Date (DD-MMM-YYYY)
Approver Name: Taryn Randall
Role or Title: Clinical Monitoring
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Approver Name: David Brooke
Role or Title: Regulatory 
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Approver Name: Ellen Iseminger
Role or Title: Safety
Electronic Signature
Electronic Date
Signature
Signature Date (DD-MMM-YYYY)
Author Name: Vincent Splett
Role or Title: Therapy SME
Electronic Signature
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Signature
Signature Date (DD-MMM-YYYY)
Approver Name: Todd Sheldon
Role or Title: Therapy SME
Electronic Signature
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Signature
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Approver Name: Trent Fischer
Role or Title: Medical Advisor
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Clinical Investigation Plan
Clinical Investigation Plan/Study Title Accelerometer Sensing for Micra AV 
Abbreviated Name: AccelAV study
Study Product Name
Micra AV Transcatheter Pacing System
Sponsor
Medtronic, Inc.
Name: Nicole Wood, Principal Clinical Research 
Specialist, Global Study Lead
Medtronic, Inc. 
8200 Coral Sea Street NE
Mounds View, MN U.S.A. 55112
Phone: +1-800-328-2518
Local Sponsor/United States
Name: Andrea Schminke, Sr. Clinical Research 
Specialist
Medtronic, Inc. 
8200 Coral Sea Street NE
Mounds View, MN U.S.A. 55112
Phone: +1-800-328-2518
Local Sponsor/Hong Kong
Name: Tina Ling, Clinical Research Specialist
Medtronic Hong Kong Medical Ltd. 1104-11, 
11/F, Tower 1, 
The Gateway, 
Harbour City, Kowloon, 
Hong Kong SAR, China
Phone: +852-2919-1300
Sponsor’s Medical Advisor
Name: Trent Fischer, MD, Principal Scientist
Medtronic, Inc. 
8200 Coral Sea Street NE
Mounds View, MN U.S.A. 55112
Phone: +1-800-328-2518
Document Version
2.0 – 24JAN2020
Document Reference Number
MDT19018
Principal Investigator(s) and Study Steering 
Committee
United States:
Larry A. Chinitz, MD FACC FHRS (Chair)
New York University School of Medicine
550 1st Avenue
New York, NY 10016-6402

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Phone: +1-212-263-7149
Fax: +1-212-263-8685
Larry.Chinitz@nyumc.org
Mikhael El-Chami
Emory University Hospital
1364 Clifton Rd NE
Atlanta, GA 30322-1059
Phone: +1-404-693-2578
melcham@emory.edu
Hong Kong:
Dr. Joseph Yat Sun Chan
Prince of Wales Hospital
30-32 Ngan Shing Street Sha Tin
Hong Kong, Hong Kong
Phone: +852 26322211
Fax: +852 26373852
jyschan@cuhk.edu.hk
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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Table of Contents 
Table of Contents ...................................................................................................................... 3
Table of Tables .......................................................................................................................... 9
1.
Glossary............................................................................................................................ 10
2.
Synopsis ........................................................................................................................... 13
3.
Introduction ..................................................................................................................... 17
3.1. Background ...........................................................................................................................17
3.2. Purpose.................................................................................................................................18
4.
Objectives and Endpoints................................................................................................. 19
4.1. Objectives .............................................................................................................................19
4.1.1.
Primary Objective..................................................................................................................19
4.1.2.
Secondary Objectives............................................................................................................19
4.1.2.1.
Secondary Objective #1.....................................................................................................19
4.1.2.2.
Secondary Objective #2.....................................................................................................19
4.1.2.3.
Secondary Objective #3.....................................................................................................19
...............................................................................................................19
4.2. Endpoints ..............................................................................................................................20
5.
Study Design .................................................................................................................... 21
5.1. Duration................................................................................................................................22
5.2. Rationale...............................................................................................................................23
5.3. Minimization of Bias ...............................................................................................................23
6.
Product Description.......................................................................................................... 24
6.1. General .................................................................................................................................24
6.1.1.
Micra AV Transcatheter Pacing System ................................................................................26
6.1.1.1.
Implantable device ............................................................................................................26
6.1.1.2.
Device Delivery Catheter System ......................................................................................27

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6.1.1.3.
Programmer and Software................................................................................................27
6.1.2.
Extended Range Holter Monitor System...............................................................................27
6.2. Dosage Form and Route of Administration...............................................................................27
6.3. Manufacturer .........................................................................................................................28
6.4. Packaging..............................................................................................................................28
6.5. Intended Population...............................................................................................................28
6.6. Equipment.............................................................................................................................28
6.7. Product Use...........................................................................................................................28
6.8. Product Training Requirements...............................................................................................28
6.9. Product Receipt and Tracking .................................................................................................29
6.10.
Product Storage ...............................................................................................................29
6.11.
Product Return.................................................................................................................29
6.12.
Product Accountability ......................................................................................................29
7.
Selection of Subjects........................................................................................................ 30
7.1. Study Population....................................................................................................................30
7.2. Subject Enrollment.................................................................................................................30
7.3. Inclusion Criteria....................................................................................................................30
7.4. Exclusion Criteria ...................................................................................................................31
7.5. Enrollment Strategy ...............................................................................................................31
8.
Study Procedures ............................................................................................................. 31
8.1. Schedule of Events.................................................................................................................31
8.2. Subject Screening ..................................................................................................................33
8.3. Prior and Concomitant Medications .........................................................................................34
8.4. Subject Consent.....................................................................................................................34
8.5. Randomization and Treatment Assignment ..............................................................................35
8.6. Baseline Visit .........................................................................................................................36
8.6.1.
Demographic and Pacing Indication...................................................................................36
8.6.2.
Medical History.................................................................................................................36
8.6.3.
Cardiovascular Medications ...............................................................................................36
8.6.4.
Height, Weight, and Blood Pressure ..................................................................................36
8.6.5.
12-Lead Electrocardiogram ...............................................................................................36

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8.6.6.
Patient Symptom Checklist................................................................................................36
8.6.7.
Quality of Life Questionnaire.............................................................................................36
8.7. Micra AV Implant ...................................................................................................................37
8.7.1.
ECG Setup .......................................................................................................................37
8.7.2.
Accelerometer Waveform Data Collection...........................................................................37
8.7.3.
X-rays of Micra AV Implant Location ..................................................................................37
8.7.4.
Holter Monitoring Post-Implant .........................................................................................37
8.7.5.
Final Device Interrogation.................................................................................................38
8.7.6.
Holter Removal ................................................................................................................38
8.8. Echocardiogram Assessment...................................................................................................38
8.8.1.
ECG Setup .......................................................................................................................38
8.8.2.
Initial Device Interrogation ...............................................................................................38
8.8.3.
Atrial Sensing Optimization ...............................................................................................39
8.8.4.
Echocardiogram ...............................................................................................................39
8.8.5.
Final Device Interrogation.................................................................................................39
8.9. Follow-up (1- and 3-Month) Visits ...........................................................................................39
8.9.1.
Visit Windows ..................................................................................................................39
8.9.2.
Patient Symptom Checklist................................................................................................40
8.9.3.
Quality of Life Assessment ................................................................................................40
8.9.4.
ECG Setup / Place Holter Monitor ......................................................................................40
8.9.5.
Initial Device Interrogation ...............................................................................................40
8.9.6.
Data Collection with Initial Micra Parameters......................................................................40
8.9.7.
Atrial Sensing Optimization ...............................................................................................40
8.9.8.
Resting Evaluation............................................................................................................41
8.9.9.
Final Device Interrogation.................................................................................................41
8.9.10.
Ambulatory Holter Monitoring (1-Month Visit Only) .........................................................41
8.9.11.
Study Completion (3-Month Visit Only)...........................................................................41
8.10.
Unscheduled Follow-up Visits ............................................................................................41
8.11.
System Modification .........................................................................................................42
8.12.
Medication Compliance .....................................................................................................42
8.13.
Assessment of Efficacy .....................................................................................................42
8.14.
Assessment of Safety .......................................................................................................43

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8.15.
Recording Data ................................................................................................................43
8.16.
Deviation Handling ...........................................................................................................43
8.17.
Subject Withdrawal or Discontinuation...............................................................................44
9.
Risks and Benefits............................................................................................................ 45
9.1. Potential Risks .......................................................................................................................45
9.2. Potential Benefits...................................................................................................................46
9.3. Risk-Benefit Rationale ............................................................................................................47
10.
Adverse Events and Device Deficiencies ....................................................................... 47
10.1.
Adverse Events ................................................................................................................48
10.2.
Device Deficiencies...........................................................................................................48
10.3.
Event Updates and Resolution...........................................................................................48
10.4.
Definitions/Classifications..................................................................................................48
10.5.
Reporting of Adverse Events .............................................................................................54
10.6.
Adverse Events and Device Deficiency Reporting Requirements...........................................55
10.7.
Subject Death ..................................................................................................................56
11.
Data Review Committees .............................................................................................. 57
11.1.
CRO/Core Labs.................................................................................................................57
11.2.
Clinical Events Committee (CEC) .......................................................................................57
11.3.
Data Monitoring Committee (DMC)....................................................................................58
11.4.
Steering Committee..........................................................................................................58
12.
Statistical Design and Methods ..................................................................................... 58
12.1.
General Considerations .....................................................................................................58
12.1.1.
Standard Baseline Variables...........................................................................................59
12.2.
Usable Holters..................................................................................................................59
12.3.
Classification of Predominant Heart Rhythm During Echo....................................................59
12.4.
Classification of Predominant Heart Rhythm During Holter Monitoring .................................59
12.5.
Primary Objective.............................................................................................................60
12.5.1.
Endpoint Definition........................................................................................................60
12.5.2.
Performance Requirement .............................................................................................60
12.5.3.
Analysis Methods ..........................................................................................................60
12.5.4.
Sample Size..................................................................................................................61
12.5.5.
Determination of Subjects and Data for Analysis .............................................................62

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12.5.6.
Missing Data.................................................................................................................62
12.5.7.
Other Planned Analyses.................................................................................................63
12.6.
Secondary Objective #1....................................................................................................63
12.6.1.
Endpoint Definition........................................................................................................63
12.6.2.
Performance Requirement .............................................................................................63
12.6.3.
Analysis Methods ..........................................................................................................63
12.6.4.
Determination of Subjects and Data for Analysis .............................................................64
12.6.5.
Missing Data.................................................................................................................64
12.7.
Secondary Objective #2....................................................................................................64
12.7.1.
Endpoint Definition........................................................................................................64
12.7.2.
Performance Requirement .............................................................................................64
12.7.3.
Analysis Methods ..........................................................................................................64
12.7.4.
Determination of Subjects/Data for Analysis ...................................................................65
12.7.5.
Missing Data.................................................................................................................65
12.7.6.
Other Planned Analyses.................................................................................................65
12.8.
Secondary Objective #3....................................................................................................65
12.8.1.
Endpoint Definition........................................................................................................65
12.8.2.
Performance Requirement .............................................................................................66
12.8.3.
Analysis Methods ..........................................................................................................66
12.8.4.
Determination of Subjects/Data for Analysis ...................................................................66
12.8.5.
Missing Data.................................................................................................................66
12.8.6.
Other Planned Analyses.................................................................................................66
..........................................................................................................67
...................................................................................................67
...................................................................................................67
...................................................................................................68
...................................................................................................69
...................................................................................................70
...................................................................................................71
...................................................................................................71
13.
Ethics ............................................................................................................................. 72
13.1.
Statement(s) of Compliance..............................................................................................72

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14.
Study Administration..................................................................................................... 74
14.1.
Monitoring .......................................................................................................................74
14.2.
Data Management............................................................................................................75
14.3.
Direct Access to Source Data/Documents...........................................................................75
14.4.
Confidentiality..................................................................................................................76
14.5.
Liability............................................................................................................................76
14.6.
Insurance (US).................................................................................................................76
14.7.
Insurance (Hong Kong) ....................................................................................................77
14.8.
CIP Amendments .............................................................................................................77
14.9.
Record Retention .............................................................................................................77
14.10.
Investigator Records ........................................................................................................77
14.11.
Investigator Reports.........................................................................................................78
14.12.
Sponsor records ...............................................................................................................79
14.13.
Sponsors reports ..............................................................................................................80
14.14.
Publication and Use of Information....................................................................................80
14.14.1.
Publication Committee...................................................................................................81
14.14.2.
Management of Publications ..........................................................................................81
14.14.3.
Criteria for Determining Authorship ................................................................................81
14.14.4.
Transparency................................................................................................................82
14.15.
Suspension or Early Termination .......................................................................................82
14.15.1.
Early Termination or Suspension....................................................................................83
14.15.2.
Procedures for Termination or Suspension......................................................................84
14.15.3.
Planned Study Closure...................................................................................................85
15.
References..................................................................................................................... 85
16.
Appendices .................................................................................................................... 86
17.
Version History .............................................................................................................. 90

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Table of Tables
Table 1: System component information ...................................................................................................24
Table 2: AccelAV Data Collection Summary................................................................................................33
Table 3: Follow-up Visit Windows...............................................................................................................39
Table 4: Adverse Event and Device Deficiency Definitions.........................................................................49
Table 5: Adverse Event Classification Responsibilities ...............................................................................55
Table 6: Reporting Requirements...............................................................................................................56
Table 7: CRO and Core Laboratory Information .........................................................................................57
Table 8: Relationship Between Sample Size and Confidence Interval Width.............................................62
Table 9: Investigator reports applicable for all geographies per Medtronic requirements.......................79
Table 10: Summary of System Related AEs by Severity and MedDRA Term (Micra IDE Clinical Study).....88
Table 11: Summary of Procedure Related AEs by Severity and MedDRA Term (Micra IDE Clinical Study)88

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1. Glossary
Term
Definition
A4
Accelerometer signal associated with active
ventricular filling (associated with A-wave on echo)
ACC
American College of Cardiology
ACE
Atrial Contraction Excursion
AE
Adverse Event
AF
Atrial Fibrillation
ADE
Adverse Device Effect
ADL
Activities of Daily Living
AP
Anterior-Posterior
AV
Atrioventricular
AVB
Atrioventricular Block
CEC
Clinical Event Committee
CIP
Clinical Investigation Plan
CRF
Case Report Form
CRO
Contract Research Organization
.csv
Comma-Separated Values file
CTA
Clinical Trial Agreement
CV
Curriculum Vitae
DD
Device Deficiency
DMC
Data Monitoring Committee
EC
EthicsCommittee
e-CRF
Electronic Case Report Form

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Term
Definition
ECG
Electrocardiogram
EDC
Electronic Data Capture
Ethics Board
Term that will be used collectively to reference an 
Institutional Review Board (IRB), Medical Ethics 
Committee (MEC), Human Research Ethics Committee 
(HREC), Research Ethics Board (REB), or Ethics 
Committee (EC) unless otherwise stated
FAL
Foreseeable Adverse Event List
GCP
Good Clinical Practice
HIPPA
Health Insurance Portability and Accountability Act of 
1996
HRS
Heart Rhythm Society
IC
InformedConsent
ICF
Informed Consent Form
ICMJE
International Committee of Medical Journal Editors
IDE
investigational Device Exemption
IFU
Instructions For Use
IRB
Institutional Review Board
ISF
Investigator Site File
LVEF
Left Ventricular Ejection Fraction
MATLAB
A multi-paradigm numerical computing environment 
and proprietary programming language developed by 
MathWorks, Natick, MA
MEC
Medical Ethics Committee
MedDRA
Medical Dictionary for Regulatory Activities
MR
Magnetic Resonance 
LVOT
Left Ventricular Outflow Tract
PHI
Protected Health Information

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Term
Definition
RDC
Remote Data Capture
RV
Right Ventricular
SAE
Serious Adverse Event
SADE
Serious Adverse Device Effect
SAP
Statistical Analysis Plan
SID
Subject Identification Number
TAPSE
Tricuspid Annular Plane Systolic Excursion
TPS
Transcatheter Pacing System
US
United States
USB
Universal Serial Bus
VDD pacing mode
Sensing occurs in the atrium and in the ventricle, while 
pacing is limited to the ventricle. In VDD, pacing is 
synchronized to atrial sensing. In the absence of atrial 
activity, VVI pacing behavior is seen. The ventricle is 
paced synchronously to the atrium up to the 
programmed maximum tracking rate.
VDI pacing mode
Sensing occurs in the atrium and in the ventricle, while 
pacing is limited to the ventricle. In VDI, pacing is not 
synchronized to atrial sensing. The pacing behavior is 
the same as VVI pacing behavior. The ventricle is 
asynchronously paced to the atrium at the 
programmed lower rate.
VTI
Velocity Time Integral
VVI pacing mode
Sensing and pacing occur only in the ventricle.
VVIR pacing mode
Rate adaptive VVI pacing

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2. Synopsis
Title
Accelerometer Sensing for Micra AV
Abbreviated Name: AccelAV study 
Clinical Study Type
Interventional Study
Product Name
Medtronic MicraTM AV Transcatheter Pacing System (Model 
MC1AVR1)
Sponsor 
Medtronic
8200 Coral Sea Street
Mounds view, MN 55112
1-800-633-8766
Investigation Purpose
Medtronic is sponsoring the AccelAV Study to characterize chronic AV 
synchrony in subjects implanted with MicraTM AV device.  This study 
will be conducted upon market approval of the MicraTM AV 
Transcatheter Pacing System.
Product Status
Model Number
Component 
(Manufacturer)
System or 
Accessory 
Component
Commercially
Available* or 
Investigational
System Components
MC1AVR1
MicraTM Implantable 
Device and 
Transfemoral Catheter 
Delivery System
System
Commercially
available in 
applicable 
geographies
SW044
MicraTM Software 
Version 1.1 or most 
current Version
System
Commercially
available in 
applicable 
geographies
Accessory Components
MI2355+A
Micra Introducer 
Sheath (Medtronic)
Accessory
Commercially
available in 
applicable 
geographies
29901 Series
Standard Medtronic 
Carelink Programmer
Accessory
Commercially
available in 
applicable 
geographies
2090 Series
Standard Medtronic 
Carelink Programmer
Accessory
Commercially
available in 
applicable 
geographies
9986
2090 Programmer 
Baseline Operating 
System Software
Accessory
Commercially
available in 
applicable 
geographies
SW028
29901 Programmer 
Baseline Operating 
System Software
Accessory
Commercially
available in 
applicable 
geographies

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Model ER220 
Extended Range 
Holter Monitor**
ERX10 Extended Range 
Tel-B Antenna 
(Medtronic)
Accessory
Investigational
DR220 Holter 
(NorthEast 
Monitoring, Inc)
Accessory
Commercially
available in 
applicable 
geographies
* Either currently commercially available or will be approved for use in the geographies where 
the AccelAV study will be conducted prior to subject enrollment.
**When permanently attached together, the commercial DR220 Holter and ERX10 Extended 
Range Tel-B Antenna become ER220 Extended Range Holter Monitor and will be considered 
investigational.  
Primary Objective(s)
Characterize AV synchrony during rest at 1-month post-implant in 
subjects with persistent 3rd degree atrioventricular block (AVB) and 
normal sinus node function.
Secondary Objective(s)
1.
Characterize the stability of AV synchrony during rest between 1-
month and 3-months post-implant in subjects with persistent 3rd
degree AVB and normal sinus node function.
2.
Characterize the ambulatory AV synchrony at 1-month in subjects 
with persistent 3rd degree AVB and normal sinus node function.
3.
Characterize the change in stroke volume, as measured by left 
ventricular outflow tract velocity time integral, during Micra AV 
mediated VDD pacing and VVI pacing in subjects with persistent
3rd degree AVB and normal sinus node function.
 
 
 
Study Design
The Accel AV study is a prospective, single-arm, global, multi-center 
clinical study to characterize the chronic AV synchrony in subjects 
implanted with the market released Micra AV (Model MC1AVR1) 
system.  The study is planned to be conducted in the US and Hong 
Kong.  Overall, the study is expected to be conducted at 
approximately 20 centers and will enroll up to 175 subjects to obtain 

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approximately 150 subjects with usable Holter datasets at the 1-
month visit to meet the sample size required to evaluate the primary 
objective of the study.  Within 48 hours of implantation of a Micra AV, 
an echocardiogram will be performed. Subsequently, there are 
required study visits at 1-month and 3-months post-implant.  
The expected total study duration (from first subject enrollment to 
the exit of the last subject) is approximately 12-15 months,
representing the time necessary to enroll the target sample size and 
to complete the 3-month follow-up visit.
Sample Size
A sample size of approximately 150 subjects with usable Holter 
recordings is required to evaluate the study’s objectives.  Based on 
the predicate MARVEL and MARVEL 2 studies it is expected that 
approximately half, or 75, of these subjects will have a predominant 
rhythm of persistent 3rd degree AVB and normal sinus node function 
during the 1-month visit.  A sample size of 75 subjects with persistent 
3rd degree AVB and normal sinus node function will allow the 
percentage of AV synchrony during rest to be measured with a 
precision (distance from point estimate to lower 2-sided 95% CI) of 
approximately ≤3.5%. 
Since not all subjects may have usable Holter datasets, up to 175 
subjects may be enrolled.  
Enrollment Strategy
The intent is to ensure that an adequate number of subjects 
(approximately 75) contribute to the primary and secondary 
objectives, specifically subjects with persistent 3rd degree AVB and 
normal sinus node function.  Thus, Medtronic personnel will monitor 
the number of subjects with a predominant heart rhythm (based on 
the 1-month Holter monitor) of persistent 3rd degree AVB and 
communicate this number periodically to study site staff to ensure 
that an adequate number of subjects with this predominant rhythm 
are included in the study.
Inclusion Criteria
Inclusion Criteria

Subject will be implanted with a MicraTM (Model MC1AVR1)
for an approved indication for use

Subject has history of AV block*

Subject is ≥ 18 years old and as per required local law.

Subject (and/or witness as applicable per local regulations) 
provides signed and dated authorization and/or consent per 
institution and local requirements.

Subject is willing and able to comply with the protocol.
*This includes subjects with normal sinus node function and persistent 3rd degree AV 
block and subjects with other forms of AV block.
Exclusion Criteria
Exclusion Criteria

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
Subject currently enrolled or planning to participate in a 
potentially confounding drug or device trial during the study.  
Co-enrollment in concurrent trials is only allowed when 
documented pre-approval is obtained from the Medtronic 
Clinical Research Specialist 

Subject implanted with a MicraTM (Model MC1AVR1) on a 
non-permanent basis (e.g. CIED infection)

Subject is pregnant (if required by local law, women of child-
bearing potential must undergo a pregnancy test within 
seven days prior to MicraTM Model MC1AVR1 implant 
procedures)

Subject meets any exclusion criteria required by local law 
(age or other).
Study Procedures and 
Assessments
After consent and enrollment, the subject will be implanted with a 
MicraTM (Model MC1AVR1).  During implant, data will be collected to 
characterize the implant procedure.  Immediately following implant, a 
Holter will be placed for approximately 1 hour to record data related 
to the device’s Atrial Sensing Setup process.  Within 48 hours of 
implant, an echocardiogram will be performed in both VDD and VVI 
modes.  At the 1-month and 3-month visits, data, including any 
reportable adverse events, will be collected, an initial MicraTM Model 
MC1AVR1 device interrogation will be performed, and a customized 
Holter monitor will be placed on the subject. The Holter will record 
surface ECG, EGM, accelerometer signals, and device markers.  
Following Holter placement at the 1-month and 3-month visit, the 
subject will rest quietly for approximately 20-minutes to assess AV 
synchrony during rest.  Additionally, at the 1-month visit, the subject 
will wear the Holter for approximately 24-hours to assess ambulatory 
AV synchrony performance.  The study participation is expected to 
last 3 months.
Safety Assessments
All Micra AV system (including the Micra AV device, delivery system 
and software) or procedure related adverse events (AEs) and all 
cardiovascular related AEs regardless of their severity that occur from 
the time of enrollment through study exit will be collected and 
reported to Medtronic starting from the time the Informed Consent 
Form is signed.  Additionally, all deaths will be reported on an AE CRF.   
Additionally, any device deficiencies related to the MicraTM Model 
MC1AVR1 transcatheter pacing system will be collected.  
Statistics
The primary objective of the study is to characterize the percentage 
of AV synchrony in subjects with a predominant rhythm of persistent 
3rd degree AVB and normal sinus node function during rest at the 1-
month study visit.  For each ECG detected P-wave, the primary 
endpoint will be considered met if the Micra AV system delivers a 

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pacing spike or senses an intrinsic R-wave within 300 ms of the 
confirmed P-wave.  A logistic regression model utilizing generalized 
estimating equations to account for within subject correlation in AV 
synchrony status will be used to estimate the average percentage of 
AV synchrony in the study population during rest and its two-sided 
95% confidence interval. 
In addition, AV synchrony percentage will also be computed using the 
methods described above for subjects not included in the primary 
objective cohort including those with intact AV conduction or other 
predominant rhythms.
3. Introduction 
3.1.
Background
The MicraTM Transcatheter Pacing System (TPS), Model MC1VR01, hereafter referred to as Micra VR, was 
developed to provide pacing entirely within the right ventricle to minimize or eliminate the acute and 
chronic complications related to the leads and pocket-based generator of traditional transvenous 
systems.1  In a cohort of 726 implants with a median follow-up of 16.9 months, Micra VR had a system 
or procedure major complication rate that was nearly half that observed in studies of traditional 
transvenous pacing systems2 and these results have been maintained in real-world settings.3
The MicraTM Model MC1AVR1, hereafter referred to as Micra AV, is expected to be approved for use in 
all the geographies where the AccelAV study will be conducted, specifically:  US and Hong Kong.  The 
Micra AV system provides all the functionality of the Micra VR system including VVI(R) pacing.  
Additionally, the Micra AV system provides a form of VDD pacing that is based on mechanical atrial 
sensing utilizing the device’s 3-axis accelerometer, which provides rate response in the Micra VR.4 This 
allows the potential benefits of leadless pacemakers for patients where there is a need to preserve 
atrioventricular synchrony, such as those with AV block.5
The MASS/MASS2 studies collected the intracardiac accelerometer signal from 39 subjects with an 
implanted Micra VR and intrinsic AV conduction during the study period.  These studies showed that 
four distinct signals, including a signal associated with atrial contraction (designated A4) could be 
observed.6  Accelerometer signals from these subjects were used to develop an algorithm to provide AV 
synchronous pacing.  That algorithm was evaluated in the MARVEL study.  The MARVEL study 
demonstrated improved atrioventricular synchronous pacing in humans using Micra VR’s intracardiac 
accelerometer to mechanically detect atrial contraction.6  Specifically, a total of 64 subjects completed 
the MARVEL study procedure at 12 centers in 9 countries.  The MARVEL study showed that the average 
AV synchronous pacing percentage was 87.0% (95% CI: 81.8% - 90.9%) across all subjects and 80.0% in 

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subjects with high-grade AV block.  In subjects with high-grade AV block, the AV synchrony was greater 
than the 37.5% observed during VVI pacing (p<0.001). The MARVEL study also demonstrated that VDD 
pacing based on mechanical atrial sensing was safe.  A sub-study of the MARVEL study, MARVEL-Evolve, 
re-tested the MARVEL algorithm in patients from one center to compare the accelerometer signals and 
AV synchrony at two time-points.7 The mean time between visits was 7.1±0.6 months. MARVEL-Evolve 
study showed no evidence of a difference in the percentage of AV synchrony during rest between study 
visits (p=0.740).  There was no difference in the A4 amplitude during rest between visit 1 (205.7 mG, 
95% CI: 97.9 – 313.6 mG) and visit 2 (207.1 mG, 95% CI: 91.9 – 322.4 mG, p=0.933).
The accelerometer signal is complex and currently is not well understood by clinicians. Therefore, it is 
desirable to reduce the clinical burden and expertise required to accurately set up the accelerometer 
detection algorithm.   To accomplish this, Medtronic enhanced the MARVEL algorithm to automatically 
adjust the most often programmed detection parameters.  In addition, two mode-switching algorithms 
were incorporated: 1) a mode-switch to VVI-40 for patients with paroxysmal AV block who often have 
intact AV conduction and 2) a mode-switch algorithm that switches to VVIR (rate adaptive pacing) if the 
sensor rate is significantly faster than the VDD pacing rate.  The performance of the enhanced algorithm 
was the focus of the MARVEL 2 study, which showed the safety and ability of mechanical sensing of the 
atrium to provide atrioventricular synchronous pacing during rest leading to improved cardiac function 
in subjects with persistent 3rd degree AV block and normal sinus node function.8  Specifically, among 40 
subjects with a predominant rhythm of persistent 3rd degree AV block and normal sinus node function, 
38 (95.0%) had >70% AV synchrony during rest compared to 0% during VVI pacing (P<0.001) with 
average AV synchrony percentage improving from 26.8% during VVI pacing to 89.2% during mechanical 
sensing based VDD pacing.  In these same subjects, stroke volume, as measured by LVOT VTI, increased 
from 22.7 cm during VVI pacing to 24.5 cm (P=0.002) during VDD pacing as measured by blinded 
echocardiogram assessment. The MARVEL 2 clinical study was used as pivotal evidence to support 
market approval of the Micra AV system for expanding the use of transcatheter pacing systems into 
patients with AV block and normal sinus node function.  
The focus of Accelerometer Sensing for Micra AV Study (AccelAV) is to characterize chronic AV 
synchrony in subjects implanted with the market released Micra AV.  
3.2.
Purpose
The purpose of the Accelerometer Sensing for Micra AV Study is to characterize chronic AV synchrony in 
subjects implanted with the market released Micra AV (Model MC1AVR1).

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4. Objectives and Endpoints
4.1.
Objectives
4.1.1.
Primary Objective
Characterize AV synchrony during rest at 1-month post-implant in subjects with persistent 3rd degree 
AVB and normal sinus node function.
4.1.2.
Secondary Objectives
4.1.2.1. Secondary Objective #1
Characterize the stability of AV synchrony during rest between 1-month and 3-months post-implant in 
subjects with persistent 3rd degree AVB and normal sinus node function. 
4.1.2.2. Secondary Objective #2
Characterize the ambulatory AV synchrony at 1-month post-implant in subjects with persistent 3rd
degree AVB and normal sinus node function.
4.1.2.3. Secondary Objective #3
Characterize the change in stroke volume, as measured by left ventricular outflow tract velocity time 
integral, during Micra AV mediated VDD pacing and VVI pacing in subjects with persistent 3rd degree 
AVB and normal sinus node function.
 
  
 

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4.2.
Endpoints
AV Synchrony:  AV synchrony will be computed on an individual heartbeat basis and is defined as met for 
paced or sensed ventricular beats that are within 300 ms following an ECG confirmed P-wave. This 
endpoint will be used for the primary objective (AV synchrony during rest at 1-month post-implant), for 
the secondary objective #1 (stability of AV synchrony during rest between 1-month and 3-months post-
implant) and for the secondary objective #2 (ambulatory AV synchrony at 1-month post-implant).
 
 
 
 
Micra AV system revision: A Micra AV system revision is defined as an invasive modification (i.e., explant 
attempt or repositioning attempt) or programming the device off (i.e., programming pacing mode to 
OOO or Device Off mode) on a permanent basis after an initial successful implant.
LVOT VTI: This endpoint is the left ventricular outflow tract (LVOT) velocity time integral (VTI) as 
obtained from echocardiogram while the Micra AV is programmed to VDD and VVI pacing. This will be 
measured by the Echo Core Lab.
 
 
 
 
 
 

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5. Study Design 
The Accel AV study is a prospective, global, multi-center clinical study to characterize the chronic AV 
synchrony in subjects implanted with the market released Micra AV.  The study is planned to be 
conducted in the US and Hong Kong.  Overall, the study is expected to be conducted at approximately 20 
centers and will enroll up to 175 subjects to obtain approximately 150 usable Holter datasets at the 1-
month follow-up visit to meet the sample size required to evaluate the primary objective of the study.  
Holter datasets will be considered usable if there are readable telemetry signals as determined by 
Medtronic personnel experienced in the review of Holter recordings.  
There is no minimum number of subjects required to be enrolled at a center.  However, to ensure a 
widespread distribution of data and minimize center bias in study results, the maximum number of 
enrolled subjects at a single site is 30 (or approximately 20% of the target sample size).  Figure 1 displays 
the AccelAV study flow for all study subjects.

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Figure 1. AccelAV Study Flow
5.1.
Duration
The expected total study duration (from first subject enrollment to the exit of the last subject) is 
approximately 12-15 months.  This represents the time necessary to enroll the target sample size of at 
least 150 subjects and to complete a 3-month follow-up.
Subject study visits will include baseline, Micra AV implant, an echocardiogram, 1-month post-implant 
and 3-months post-implant.  
Verify inclusion/exclusion criteria
Patient informed consent
Implant Micra AV
Collect and save frozen strips
Holter monitor setup
1-month study visit-Day 1
Device interrogations
Place Holter monitor 
Collect data in VDD and VDI-50
Optimize settings, if necessary
Collect data during rest
Monitor performance during 
activities of daily living 
(up to 24 hours) 
3-month study visit
Device interrogations
Place Holter monitor 
Collect data in VDD and VDI-50
Optimize settings, if necessary
Collect data during rest
Remove Holter monitor
Exit subject
1-month study visit-Day 2
Return/remove Holter monitor 
Echocardiogram
Device interrogations
Optimize settings, if necessary
Echocardiogram (in VVI and VDD 
modes)

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Overall, individual subject study participation is approximately 26-28 hours across all study visits 
including the overnight hours of the Holter monitor recording at the 1-month study visit.  These study 
visits include:

Baseline: At baseline, a subject’s height, weight, and blood pressure will be measured.  In 
addition, quality of life and patient symptoms questionnaires will be completed.  This visit will 
take approximately 10-15 minutes.

Implant: At implant, study procedures will consist of confirming programming of the subject’s 
Micra AV device and will take approximately 15-20 minutes in total to collect accelerometer and 
EGM waveform data, device interrogations, placement of a Holter monitor, and additional 
programming per physician’s discretion. 

Echocardiogram: Within 48 hours of the Micra AV implant, the subject will have an 
echocardiogram. This will take approximately 30-45 minutes. Prior to the echocardiogram, atrial 
sensing of the Micra will be assessed and sensing parameters may be optimized. The expected 
time for this assessment is approximately 30 minutes.

1-month follow-up: Approximately 1 hour of in-clinic testing will be performed at the 1-month 
follow-up. Subsequent to this testing, the subject will wear a Holter monitor for 24 hours to 
record Micra AV performance during the subject’s activities of daily living.  The subject will 
receive an activity log to document activities of daily living described in Ambulatory Holter 
Monitoring (1-Month Visit Only)

3-month follow-up: Approximately 1 hour of in-clinic testing will be performed at the 3-month 
follow-up. Once this is completed, the subject will be exited from the study.
5.2.
Rationale 
The acute nature of the MARVEL 2 study was meant to optimize the length of data collected with the 
limitation that the mechanical sensing algorithm in its downloadable implementation, combined with 
the study’s Holter telemetry requirements, consumed battery energy at an unacceptable rate for longer-
term testing.  Thus, data collection to assess AV synchrony in MARVEL 2 was limited to less than 5 hours.  
Therefore, the main focus of the AccelAV study is to characterize chronic AV synchrony in subjects 
implanted with the market released Micra AV system.  The objectives of this study are to characterize, at 
rest, the percentage and stability of AV synchrony respectively at the subject’s 1- and 3-month study 
visits.  
5.3.
Minimization of Bias
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias. 
Methods incorporated in the study design to minimize potential bias include (but are not limited to):

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1.
Subjects will undergo screening to confirm eligibility for enrollment with defined inclusion/exclusion 
criteria prior to enrollment.
2.
All centers will use the same version of the clinical investigation plan and standardized case report 
forms.
3.
All investigational center personnel, echocardiogram core lab personnel, and Medtronic personnel 
will be trained using standardized training materials.
4.
An independent echocardiogram core lab will make all echocardiogram measurements.  The Echo 
Core Lab will also be blinded to the study center, subject, and pacing mode (VDD or VVI) when 
making LVOT VTI measurements.
5.
To ensure widespread distribution of the data between study centers, a maximum of 30 subjects 
may enroll at any single study center.
6.
Regular monitoring visits will be conducted for adherence to the CIP and to verify source data.
7.
A statistical analysis plan will be developed prior to analyzing data.  The plan will further document 
all pre-specified analyses and analysis methods.
8.
An independent CEC will regularly review and adjudicate reported adverse events.
6. Product Description
6.1.
General
The study will be conducted using the components described in Table 1 below. Products are listed as 
Commercially Available or Investigational in applicable geographies.  Instructions for use are provided in 
the respective device manuals; each of the system and accessory components are manufactured by 
Medtronic with the exception of the DR220 Holter Monitor. Figure 2 depicts the Micra AV System.  
Refer to the respective manuals for any possible interaction with concurrent medical interventions.
Table 1: System component information
Model Number
Component
(Manufacturer)
System or Accessory 
Component
Commercially Available*
or Investigational
System Components
MC1AVR1
MicraImplantable 
Device and 
Transfemoral Catheter 
Delivery System
(Medtronic)
System
Commercially available in 
applicable geographies

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Model Number
Component
(Manufacturer)
System or Accessory 
Component
Commercially Available*
or Investigational
SW044
MicraSoftware Version 
1.1 or most current 
Version (Medtronic)
System
Commercially available in 
applicable geographies
Accessory Components
Ml2355+A
Micra Introducer 
Sheath (Medtronic)
Accessory
Commercially available in 
applicable geographies
29901 Series
Carelink Encore 
Programmer
(Medtronic)
Accessory
Commercially available in 
applicable geographies
2090 Series
Carelink Programmer
(Medtronic)
Accessory
Commercially available in 
applicable geographies
9986 
2090 Programmer 
Baseline Operating 
System Software
(Medtronic)
Accessory
Commercially available in 
applicable geographies
SW028
29901 Programmer 
Encore Baseline 
Operating System 
Software (Medtronic)
Accessory
Commercially available in 
applicable geographies
Model ER220 Extended 
Range Holter Monitor 
System ER220**
Model ERX10 Extended 
Range Tel-B Antenna
(Medtronic)
Accessory
Investigational in all 
geographies
DR220 Holter 
(NorthEast Monitoring, 
Inc.)
Accessory
Commercially available in 
applicable geographies
* Either currently commercially available or will be approved for use in the geographies where the AccelAV study will be 
conducted prior to subject enrollment.
**When permanently attached together, the DR220 Holter and ERX10 Extended Range Tel-B Antenna become ER220 Extended 
Range Holter Monitor and will be considered investigational.  

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Figure 2 : Micra AV Transcatheter Pacing System
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 AV device are similar to those for the commercially available Micra VR 
transcatheter pacing system.  Detailed descriptions of the system and accessory components are listed 
in the sections below.
6.1.1.
Micra AV Transcatheter Pacing System 
The Medtronic Micra AV Model MC1AVR1 MR Conditional dual chamber, transcatheter pacing system 
with SureScan technology is a programmable cardiac device that monitors and regulates the patient’s 
heart rate by providing rate-responsive bradycardia pacing to the right ventricle and AV synchrony 
based on the mechanical sensing of atrial activity.
6.1.1.1. Implantable device
The Micra AV Model MC1AVR1 is a dual chamber transcatheter pacing system that provides AV 
synchronous pacing and bipolar sensing and pacing in the right ventricle. The device has an active 

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fixation mechanism consisting of 4 electrically inactive tines designed to anchor the device in the cardiac 
tissue at the implant location in the right ventricle.
6.1.1.2. Device Delivery Catheter System
The Micra AV delivery catheter system consists of the following parts:  
A delivery catheter designed to carry, deliver, and position the device for implant in the right ventricle
by accessing this chamber through the femoral vein. The delivery catheter has a steerable, flexible shaft 
with a rigid distal end that contains a device cup to hold the device and a recapture cone to retrieve it. 
The delivery catheter is compatible with a 7.8 mm (23 Fr) introducer sheath that is 56 cm (22 in) long or 
longer, such as the Medtronic Micra Introducer.
A handle with controls to navigate the delivery catheter and deploy the device. The handle also provides 
a tether designed as an aid to test the device fixation and to recapture and reposition the device for 
proper fixation during the implant procedure.
6.1.1.3. Programmer and Software
The Medtronic programmer and software are used to program the device for implant testing and 
patient follow-up sessions. The use of a Medtronic programming head is required for communication 
between the device and the programmer. Programmers from other manufacturers are not compatible 
with Medtronic devices but will not damage Medtronic devices.
6.1.2.
Extended Range Holter Monitor System
A customized investigational Extended Range Holter Monitor System (ER220) will be used to collect data 
from the Micra AV in all study subjects. The ER220 system uses a market-released Model DR220 Holter 
Monitor (NorthEast Monitoring, Inc, Maynard, MA) and an investigational accessory cable (Model 
ERX10) created by Medtronic, Inc.  The accessory cable is based on a market-released cable that 
communicates with the implanted devices via telemetry; it has been modified to extend its range and 
increase noise rejection to communicate with the Micra device inside the heart.  
Each study site will receive Medtronic Extended Range Holter Monitor Systems (ER220, each system 
consists of a DR220 Holter and ERX10 Extended range Tel-B antenna cable), in order to perform the 
study procedure on the enrolled subjects. Based on estimated AccelAV enrollment rates for participating 
sites, it is expected that approximately 2-3 Holter monitors per site need to be provided. The 
participating site and sponsor will use a Holter disposition log to track this item.
6.2.
Dosage Form and Route of Administration
This section is not applicable.

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6.3.
Manufacturer
The Micra AV system and ancillary components are manufactured by Medtronic except for the 
commercial DR220 Holter Monitor manufactured by NorthEast Monitoring Inc, Maynard, MA.
6.4.
Packaging
Labeling for the commercially available Micra AV systems and ancillary components can be found with 
each package insert and is provided in English language. Labeling is also found on 
http://manuals.medtronic.com.  
The investigational Holter monitor will be labeled according to the local regulatory requirements.  
Outside the United States it will state “Exclusively for Clinical Investigations” and in the US it will state 
“CAUTION: Investigational Device, limited by Federal law (USA) to investigational use.”
6.5.
Intended Population
Micra Model MC1AVR1 will be used as intended per the MicraTM AV MC1AVR1 Device Manual and 
inclusion/exclusion criteria as described in section 7.
6.6.
Equipment
The maintenance and calibration of the Medtronic Carelink Programmers used for this study will be 
conducted using standard Medtronic processes and is not part of this clinical study.  Sites are 
responsible for maintaining and calibrating equipment (such as an echo machine and Medtronic Carelink 
Programmer) used during this study in accordance with established site practice or local regulation.  
Maintenance and calibration records should be kept and able to be provided upon request by the 
Sponsor or Regulatory Agency.
6.7.
Product Use
Micra Model MC1AVR1 will be used within its approved labeling and inclusion/exclusion criteria as 
described in section 7.
6.8.
Product Training Requirements
Product training on the Micra AV system and ancillary components is required prior to the clinical site’s 
first study procedure. Training on the implantation and ongoing system management must be 
performed by individuals trained in the operation and handling of the system and be in compliance with 
procedures described in the appropriate technical instructions.  Principles of operation of the ER220 
Holter Monitor will be provided in the Digital Holter ER220 Instructions.  

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6.9.
Product Receipt and Tracking
Commercially available product will be tracked in a manner consistent with other market-released 
products.  The date when the study participating site receives the investigational ER220 Holter Monitors 
will be maintained during the clinical investigation. Each received Holter monitor will be traced by the 
Holter serial number.
6.10. Product Storage
Commercially available product will be stored in a manner consistent with other market-released 
products.  The storage area of ER220 Holter Monitors should be locked and secure with access limited 
only to approved study trained personnel.  The Medtronic Carelink Programmers can be used for 
commercial use and there are no special storage requirements.
6.11. Product Return
ER220 Holter Monitors will be shipped back to Medtronic Operational Support at 8200 Coral Sea St. NE, 
RM S1221, Mounds View, MN 55112, USA, at the end of the AccelAV clinical study.  Commercially 
available product related to device explant and return products/procedure will be managed in a manner 
consistent with other market-released products, as applicable.  
6.12. Product Accountability 
All products used in the AccelAV study, with exception of the ER220 Holter Monitor, will become
commercially available to study participating geographies prior to each site’s first enrollment in the 
study.  Product accountability may be required per local laws and regulations. Product accountability 
will be documented in the electronic Case Report Forms (e-CRFs) which will be maintained in the 
Electronic Data Capture (EDC) system. The e-CRF will track at a minimum: date of receipt, serial number 
of the investigational components, location of the investigational components, and date and reason for 
return.
Device information of the Micra AV system will be collected at implant (e.g., model number, serial 
number).  If there are additional local requirements related to implanted information beyond what is
collected by Medtronic on the e-CRF, it is the investigator’s responsibility and should be recorded in the 
subject’s medical records, but will not be collected by Medtronic (e.g., national registration card 
number, identification code linked to names and contact information, log of all subjects enrolled in the 
clinical study, lot or batch number).
Commercially available product supply will be managed in a manner consistent with other market-
released products.  

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7. Selection of Subjects
7.1.
Study Population
The target population will consist of subjects ≥18 years in age, who are being implanted with a Micra AV
per approved indications for use.  
7.2.
Subject Enrollment
Ethics Board and Medtronic approval of this clinical investigation plan, the Informed Consent Form, and 
any other applicable documents must be obtained prior to enrolling subjects in the study. Medtronic will 
provide each study center with documentation of study center and investigator readiness; this letter 
must be received prior to subject enrollment. 
When a patient and the principal investigator or authorized designee, as required, have personally 
signed and dated the Informed Consent Form, the patient is considered a subject enrolled in the study. 
Subjects must provide informed consent before any study related procedures. The date the subject 
signed the Informed Consent Form and data protection authorization, as required by local law, must be 
documented in the subject’s medical records.
Subjects will be screened to ensure they meet all inclusion criteria and none of the exclusion criteria 
prior to study enrollment.
7.3.
Inclusion Criteria

Subject will be implanted with a MicraTM (Model MC1AVR1) for an approved indication for use

Subject has history of AV block*

Subject is ≥ 18 years old and as per required local law

Subject (and/or witness as applicable per local regulations) provides signed and dated 
authorization and/or consent per institution and local requirements

Subject is willing and able to comply with the protocol
*This includes subjects with normal sinus node function and persistent 3rd degree AV block and subjects with other 
forms of AV block.

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7.4.
Exclusion Criteria

Subject currently enrolled or planning to participate in a potentially confounding drug or device 
trial during the study.  Co-enrollment in concurrent trials is only allowed when documented pre-
approval is obtained from the Medtronic Clinical Research Specialist 

Subject implanted with a MicraTM (Model MC1AVR01) on a non-permanent basis (e.g. CIED 
infection)

Subject is pregnant (if required by local law, women of child-bearing potential must undergo a 
pregnancy test within seven days prior to MicraTM Model MC1AVR01 implant procedures)

Subject meets any exclusion criteria required by local law (age or other)
7.5.
Enrollment Strategy
The intent is to ensure that an adequate number of subjects (approximately 75) contribute to the 
primary and secondary objectives, specifically subjects with persistent 3rd degree AVB and normal sinus 
node function.  Thus, Medtronic personnel will monitor the number of subjects with a predominant
heart rhythm (based on the 1-month Holter monitor) of persistent 3rd degree AVB and communicate this 
number periodically to study site staff to ensure that an adequate number of subjects with this 
predominant rhythm are included in the study.
8. Study Procedures 
8.1.
Schedule of Events
After subject enrollment, study procedures will consist of collecting subject’s medical history, physical 
exam, cardiovascular medications, and device implant information. During the Micra AV implant, 
additional study-specific data will be collected including: accelerometer and EGM waveforms (either
paper strips or electronic form) and device interrogations. Immediately following implant, a Holter will 
be placed for approximately 1 hour to record data related to the device’s Atrial Sensing Setup process.  
Within 48 hours of the Micra AV implant, an echocardiogram will be performed.  Prior to the 
echocardiogram, the atrial sensing will be reviewed and optimized, if necessary. 
One month after the Micra AV implant, the subject will come into an in-clinic setting for the 1-month 
post-implant visit. See Table 3: Follow-up Visit Windows.  A Holter monitor will be placed on the subject
to record accelerometer, EGM, and ECG waveforms and device-specific markers. The atrial sensing will 
be reviewed and optimized, if necessary. Overall, approximately 30 minutes of data will be collected 
during the in-clinic visit with approximately 20 minutes collected at rest. The subject will then be given 
an activity log to be filled out and will wear the Holter monitor for approximately 24 hours. The Holter 
can be returned in-person or sent back in a pre-addressed package.

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Three months after the Micra AV implant, the subject will come back for the final in-clinic 3-month post-
implant study visit. See Table 3: Follow-up Visit Windows.  A Holter monitor will again be placed on the 
subject to record accelerometer, EGM, and ECG waveforms and device-specific markers. The atrial 
sensing will be reviewed and optimized, if necessary. Overall, approximately 30 minutes of data will be 
collected during the in-clinic visit with approximately 20 minutes collected at rest.  Following the in-clinic
data collection, the Holter monitor will be removed, and the subject will be exited from the study.
Overall, individual subject study participation is approximately 26-28 hours across all study visits 
including the overnight Holter monitoring at the 1-month study visit.  A summary of the data collected 
for this study is displayed below in Table 2.  

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Table 2: AccelAV Data Collection Summary
AccelAV Study 
Data Collection
Baseline
Micra AV 
Implant
Echocardiogram
1-month 
visit
3-month 
visit
Inclusion/exclusion assessment 
X
Patient informed consent
X
Demographics and pacing indication
X
Medical history
X
Height and weight
X
12-lead ECG
X
Blood pressure
X
Cardiovascular medications
X
X
X
X
Patient symptom checklist
X
X
X
Quality of life questionnaire
X
X
X
Micra AV implant procedure data collection
X
Accelerometer waveform data collection
X
Holter monitoring post-implant
X
X-rays of Micra AV implant location
X
Echocardiogram
X
Initial device interrogation
X
X
X
Confirm atrial sensing parameters
X
X
X
In-clinic Holter monitoring
X
X
Ambulatory Holter monitoring
X
Subject activity log
X
Final device interrogation
X
X
X
X
Study exit
X
Adverse events
If Occur
Study deviations
Device deficiencies
System modification*
Unsuccessful implant
Unscheduled visit
* If the primary reason for the system modification is pacemaker syndrome then collect the subject’s blood pressure and 12-
lead ECG prior to the system modification procedure.
8.2.
Subject Screening 
Pre-screening of potential subjects may be over the telephone or in person (e.g. during a routine clinical 
care visit) to determine their initial eligibility and interest in the study.

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Final screening of potential subjects needs to be performed in person on the day of the baseline visit to 
confirm the subject meets the inclusion/exclusion criteria.
8.3.
Prior and Concomitant Medications
There are no restrictions regarding prior or concomitant medications.  All cardiovascular medications 
prescribed to the subjects at baseline and any changes throughout their participation in the study are to 
be documented on the case report forms (e-CRFs).
8.4.
Subject Consent
Informed Consent (IC) is defined as a legally effective documented confirmation of a subject’s voluntary 
agreement to participate in a particular clinical study after information has been given to the subject on 
all aspects of the clinical study that are relevant to the subject’s decision to participate. This process 
includes obtaining an IC and other privacy language, as required by law, that has been approved by 
Medtronic and the study center’s Ethics Board and signed and personally dated by the subject and by 
the person who conducted the informed consent discussion, as applicable to local requirements. A 
subject may only consent after information has been given to the subject on all aspects of the clinical 
investigation that are relevant to the subject’s decision to participate.
Prior to enrolling subjects, each center’s Ethics Board will be required to approve the Informed Consent 
Form (ICF) and other privacy language, as required by law. The document(s) must be controlled (i.e.,
versioned and dated) to ensure it is clear which version(s) was approved by the Ethics Board. Any 
adaptation of the sample ICF must be reviewed and approved by Medtronic and the Ethics Board
reviewing the application prior to enrolling subjects.  
The investigator must notify the subject of any significant new findings about the study that become 
available during the study which are pertinent to the safety and well-being of the subject, as this could 
impact a subject’s willingness to participate in the study. If relevant, approval may be requested from 
subjects to confirm their continued participation. ICF templates will be provided under a separate cover.
Prior to initiation of any study-specific procedures, IC must be obtained from the subject (or legally 
authorized representative). Likewise, privacy or health information protection regulation may require 
subjects to sign additional forms to authorize centers to submit subject information to the study 
sponsor. The IC process must be conducted by the principal investigator or an authorized designee, and 
the ICF and other privacy language, as required by law, must be given to the subject in a language he or 
she is able to read and understand. The process of IC must be conducted without using coercion or 
undue improper influence on or inducement of the subject to participate by the investigator or other 
center personnel. The IC process shall not waive or appear to waive subject’s legal rights. The language 

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used shall be as non-technical as possible and must be understandable to the subject and the impartial 
witness, where applicable.
The subject must have ample time and opportunity to read and understand the ICF, to inquire about 
details of the study, and to decide whether to participate in the clinical study. All questions about the 
study should be answered to the satisfaction of the subject.
When the subject decides to participate in the clinical study, the ICF must be signed and personally 
dated by the subject and investigator or authorized designee, as required by the ICF.
If the IC is obtained the same day the subject begins participating in study-related procedures, it must 
be documented in the subject’s case history that consent was obtained prior to participation in any 
study-related procedures. It is best practice for the IC process to be documented in the subject’s case 
history, regardless of circumstance.
In the event the subject cannot read and/or write and if allowed by local law the IC process shall be 
obtained through a supervised oral process. An independent witness (if applicable as per local 
regulation) must be present during this process. The ICF and any other information must be read aloud 
and explained to the prospective subject, and whenever possible, either shall sign and personally date 
the ICF attesting that the information was accurately explained and that ICF was freely given. The source
documentation should provide the method used for communication with the prospective subject and 
the specific means by which the prospective subject communicated agreement to participate in the 
study.
The original of the signed ICF must be filed in the hospital/clinical chart and/or with the subject’s study 
documents.
A copy of the ICF and other privacy language as required by law, signed and dated if required by local 
law, must be provided to the subject.
The ICF and other privacy language as required by law must be available for monitoring and auditing. 
Any Medtronic field personnel who support the study procedure must be able to review the subject’s 
signed and dated ICF and verify its completeness prior to proceeding with the study procedure. In the 
event the Medtronic Field personnel identify ICF as being incomplete, the study procedure will not be 
allowed to occur until the consent of the subject can be adequately and appropriately obtained.
8.5.
Randomization and Treatment Assignment
The Accel AV study is not a randomized study.  However, to blind the echocardiography (echo) core 
laboratory to study site, study subject, and pacing mode, a random 5-digit number (echo ID) will be

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assigned to label the echo recording medium. This echo ID will allow linking the Echo Core Lab results to 
an individual study subject and pacing mode.  
Additionally, study sites will be randomized to perform the echo while the pacing mode is programmed 
to VDD mode first followed by VVI mode second or VVI mode first followed by VDD mode. Note that 
these strategies will blind the Echo Core Lab personnel to study site, subject, and pacing mode. The 
study worksheets will indicate the programming mode sequence in which the echo images should be 
acquired.
8.6.
Baseline Visit
8.6.1.
Demographic and Pacing Indication
The subjects’ demographics and pacing indication will be obtained and recorded in an e-CRF.
8.6.2.
Medical History
The subjects’ medical history will be obtained and recorded in an e-CRF.
8.6.3.
Cardiovascular Medications
The cardiovascular medications prescribed to the subjects at baseline and any changes throughout their 
participation in the study will be recorded in an e-CRF.
8.6.4.
Height, Weight, and Blood Pressure
Each subject’s height and weight (if not in the subject’s medical chart) and blood pressure will be 
measured and recorded in an e-CRF.
8.6.5.
12-Lead Electrocardiogram
A 12-lead electrocardiogram will be recorded and sent to Medtronic. The recording of this 
electrocardiogram should be within seven days prior to implant of the Micra.
8.6.6.
Patient Symptom Checklist 
The subjects will be asked about presence of cardiac-related symptoms from a list of questions with the 
responses collected and recorded in an e-CRF.
8.6.7.
Quality of Life Questionnaire
The subjects’ response to the EQ-5D-3L patient questionnaire will be collected and recorded in an e-CRF.

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8.7.
Micra AV Implant
8.7.1.
ECG Setup
Prior to implant, an ECG from the subject will be connected to the Medtronic Carelink Programmer.  The 
ECG may be obtained from an external source (e.g., external defibrillator). If P-waves are not visible on 
the Medtronic Carelink Programmer, ECG electrodes should be placed or the ECG connections should be 
repositioned until P-waves are visible.
8.7.2.
Accelerometer Waveform Data Collection
At each deployment location and prior to the tether being cut and removed, frozen waveform strips on 
the Medtronic Carelink Programmer will be collected for up to four (4) accelerometer vectors.  Each of 
the frozen strips will be saved to a PDF file on a USB drive inserted into the Medtronic Carelink
Programmer.
After the tether is cut and removed, frozen waveform strips on the Medtronic Carelink Programmer will 
be collected for up to four (4) accelerometer vectors.  Each of the frozen strips will be saved to a PDF file 
on a USB drive inserted into the Medtronic Carelink Programmer.
The PDF file containing the frozen strips, along with the device interrogation data, should be sent to 
Medtronic using a secure, electronic transfer.
8.7.3.
X-rays of Micra AV Implant Location
After implantation of the Micra AV, an X-ray will be collected so that the implant location of the Micra 
AV can be determined.  At a minimum, the X-rays will be collected in lateral and anterior-posterior (AP) 
views.  A copy of the X-rays will be sent to Medtronic.  
8.7.4.
Holter Monitoring Post-Implant
The running of the Atrial Sensing Setup in the Micra AV will be postponed until the ER220 Holter 
Monitor is placed on the study subject. Following the implant, the ER220 Holter Monitor will be placed 
on the subject per the instructions for use. The ECG electrodes, if previously placed on the subject for 
connection to the Medtronic Carelink Programmer, may be used for connection to the Holter monitor.
Holter telemetry in the Micra AV will be turned on for one hour. Once good Holter telemetry between 
the Holter monitor and implanted Micra AV device is established, the Atrial Sensing Setup process will 
be initiated.
Placement of the Holter monitor and initiation of the Atrial Sensing Setup should be performed in the
Micra implant room, prior to being transferred to a recovery room, if possible.

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8.7.5.
Final Device Interrogation
An interrogation of the Micra AV will be performed after the Holter monitoring is completed (final 
device interrogation) and saved on a USB drive or on a diskette. Device interrogation data (.pdd file) 
should be sent to Medtronic using a secure, electronic transfer. Missed device interrogations are 
considered a protocol deviation and must be documented in the protocol deviation e-CRF.  
8.7.6.
Holter Removal
After approximately one hour, the Holter monitor will be removed from the subject. The data recorded 
on the SD card in the Holter monitor should be sent (physically or electronically) to Medtronic for 
evaluation.  
8.8.
Echocardiogram Assessment
An echocardiogram (echo) will be performed within 48 hours of the Micra AV implant.  Prior to the 
echocardiogram, atrial sensing of the Micra will be assessed and sensing parameters may be optimized.
 
 
 
 
 
.
8.8.1.
ECG Setup
To support optimization of Micra AV programming, ECG cables from the Medtronic Carelink 
Programmer will be connected to the subject. If P-waves are not visible on the Medtronic Carelink 
Programmer, the ECG connections should be repositioned until P-waves are visible.
8.8.2.
Initial Device Interrogation
An interrogation of the Micra will be performed prior to device programming (initial device 
interrogation) and saved on a USB drive or on a diskette. Device interrogation data (.pdd file) should be 
sent to Medtronic using a secure, electronic transfer. Missed device interrogations are considered a 
protocol deviation and must be documented in the protocol deviation e-CRF.

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8.8.3.
Atrial Sensing Optimization
The atrial sensing and AV synchrony will be evaluated on the Medtronic Carelink Programmer. If 
necessary, to improve atrial sensing and AV synchrony, the Micra AV parameters will be updated. 
Changes from the initial device programming will be documented on the e-CRFs.  
8.8.4.
Echocardiogram
The echocardiogram (echo) should be performed in accordance with the echo views specified by the e-
CRF and the AccelAV Study Reference Guide for Cardiac Echocardiogram Data Acquisition (Appendices
I). The echo views and measurements that will be collected include, but are not limited to, apical 4-
chamber, left atrial volume, LVOT VTI, and mitral flow including E and A wave measurements. A copy of 
the recording will be sent to the Echo Core Lab for analysis either by mailing the electronic storage 
medium or through electronic transfer. A copy must be maintained at the center with the subject’s 
records. It is recommended that echo recordings are sent to the Echo Core Lab as soon as possible after 
obtaining the echocardiogram. The Echo Core Lab will conduct a quality review of all echoes and provide 
feedback to study centers as needed.
Randomly generated numbers will be assigned to label the echo recording medium and link the Echo 
Core Lab results to an individual study center and subject as described in section 8.5.
8.8.5.
Final Device Interrogation
An interrogation of the Micra AV will be performed after the echo and device programming is completed 
(final device interrogation) and saved on a USB drive or on a diskette. Device interrogation data (.pdd 
file) should be sent to Medtronic using a secure, electronic transfer. Missed device interrogations are 
considered a protocol deviation and must be documented in the protocol deviation e-CRF.  
8.9.
Follow-up (1- and 3-Month) Visits
8.9.1.
Visit Windows
The study subjects will be studied at 1- and 3-months following their Micra AV implant. At this study
timepoint, the follow-up study procedures will be performed. The visit windows for the follow-up visits 
are shown in Table 3.  Visits outside the windows are considered a protocol deviation and must be 
documented in the protocol deviation e-CRF.
Table 3: Follow-up Visit Windows
Visit
Window Start
Target
Window End
1-month
21 days
28 days
42 days

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3-month
90 days
90 days
111 days
Note: Day of implant is considered day zero
8.9.2.
Patient Symptom Checklist 
The subjects will be asked about presence of cardiac-related symptoms from a list of questions with the 
responses collected and recorded on an e-CRF.  
8.9.3.
Quality of Life Assessment
The subjects’ response to the EQ-5D-3L patient questionnaire will be collected and recorded on an e-
CRF.
8.9.4.
ECG Setup / Place Holter Monitor
The ER220 Holter Monitor will be placed on the subject per the instructions for use.
In addition to the ECG cables for the Holter monitor, ECG cables from the Medtronic Carelink
Programmer will be connected to the subject. If P-waves are not visible on the Medtronic Carelink 
Programmer, the ECG connections should be repositioned until P-waves are visible.  
8.9.5.
Initial Device Interrogation
An interrogation of the Micra AV will be performed prior to device programming (initial device 
interrogation) and saved on a USB drive or on a diskette. Device interrogation data (.pdd file) should be 
sent to Medtronic using a secure, electronic transfer. Missed device interrogations are considered a 
protocol deviation and must be documented in the protocol deviation e-CRF.
8.9.6.
Data Collection with Initial Micra Parameters
Approximately 5 minutes of data will be collected on the Holter monitor with the initial Micra AV 
programmed settings. Subsequently, the Micra AV will be programmed to VDI mode and an additional 
approximately 5 minutes of data will be collected. During this data collection, the subject should remain 
in a consistent supine or sitting position.
8.9.7.
Atrial Sensing Optimization
The atrial sensing and AV synchrony will be evaluated on the Medtronic Carelink Programmer. If 
necessary, to improve atrial sensing and AV synchrony, the Micra AV parameters will be updated. 
Changes from the initial device programming will be recorded as source documentation on an e-CRF.  

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8.9.8.
Resting Evaluation
Subsequent to the atrial sensing optimization approximately 20 minutes of Holter data will be collected 
while the Micra AV is in VDD mode at rest. During this resting period, the subject should remain in a 
consistent supine or sitting position.
8.9.9.
Final Device Interrogation
An interrogation of the Micra AV will be performed after device programming is completed (final device 
interrogation) and saved on a USB drive or on a diskette. Device interrogation data (.pdd file) should be 
sent to Medtronic using a secure, electronic transfer. Missed device interrogations are considered a 
protocol deviation and must be documented in the protocol deviation e-CRF.  
8.9.10.
Ambulatory Holter Monitoring (1-Month Visit Only)
At the 1-month visit, subjects leave the in-clinic visit and continue Holter monitor recording.  During the 
ambulatory Holter monitoring the subject may leave the study site (e.g., return home) and should go 
about their activities of daily living (ADL).  Each subject will receive a subject activity log and be 
instructed to document the time of day and a variety of pre-populated ADLs including, but not limited 
to, “transportation” or “sleep.”  
The following day, the subject may return to the study site to return the Holter monitor and subject 
activity log or send the monitor and log back in a pre-addressed mailing package. The data recorded on 
the SD card in the Holter monitor should be sent (physically or electronically) to Medtronic for 
evaluation.  
8.9.11.
Study Completion (3-Month Visit Only)
At completion of the 3-month visit, the Holter telemetry will be turned off in the Micra AV and the 
Holter monitor will be removed from the subject. The data recorded on the SD card in the Holter 
monitor should be sent (physically or electronically) to Medtronic for evaluation. Following study 
completion, the subject will be exited.
8.10. Unscheduled Follow-up Visits
An unscheduled follow-up visit is defined as any unplanned visit by the subject to the investigational 
study site due to the Micra AV system between protocol required visits.  Routine visits such as wound 
checks or other planned visits are not considered unscheduled visits and are not collected.  Emergency 
department visits are not considered unscheduled visits, however if the emergency department visit is 
associated with an adverse event, the adverse event should be recorded on the e-CRFs.
If an unscheduled visit occurs:

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1.
Document any adverse events and device deficiencies on their associated e-CRFs
2.
Where possible complete an initial and final device interrogation and save on a USB drive or 
diskette.  Device interrogation data (.pdd file) should be sent to Medtronic using a secure, electronic 
transfer.
8.11. System Modification
A system modification will be reported in the event the Micra AV requires an invasive modification (e.g. 
explant, replacement, repositioning, device) or is programmed off (OOO or Device Off) on a permanent 
basis after an initial successful implant.
For each system modification, the investigator should indicate whether the primary reason for the 
system revision was due to pacemaker syndrome.  The 2012 HRS/ACC Expert consensus statement on 
pacemaker device and mode selection defines pacemaker syndrome as the occurrence of overt 
symptoms, such as fatigue, chest discomfort, dyspnea, cough, confusion, presyncope, or syncope due to 
adverse hemodynamics that result from loss of AV synchrony and occurrence of ventriculoatrial 
conduction or atrial contraction against closed AV valves in patients with an implanted pacemaker.5 If 
the primary reason for the system modification is pacemaker syndrome then collect the subject’s blood 
pressure and 12-lead ECG prior to the system modification procedure.
Where possible complete an initial and final (if applicable) device interrogation and save on a USB drive 
or diskette.  Device interrogation data (.pdd file) should be sent to Medtronic using a secure, electronic 
transfer.
If a new Micra AV device is implanted during the system modification, repeat the implant visit 
procedures as described in section 8.7 and complete a new implant e-CRF.  However, the follow-up 
schedule for the subject will remain unchanged, with day 0 being the day of the initial implant.
Following a system modification where the Micra AV is no longer active the subject may be exited
following the resolution of any system or procedure related AEs.
8.12. Medication Compliance
This section is not applicable.  
8.13. Assessment of Efficacy
The study’s primary and secondary objectives (see sections 4.1.1 and 4.1.2) will be the primary means by 
which the efficacy of the Micra AV system are evaluated.

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8.14. Assessment of Safety
 
  Additionally, any device deficiencies 
and any unsuccessful Micra AV implants that occur during the study will be collected and summarized.
8.15. Recording Data
Subject data and product accountability data will be collected on the e-CRFs and will be reported to 
Medtronic via the RDC System, Oracle Clinical.
Non-CRF data including device interrogation data, 12 lead ECG, and X-ray images will be saved on 
supported media and will be delivered to Medtronic electronically via a secure web-based application, 
e.g. Medtronic Box.  
Data saved on the Holter monitor SD card(s) will be delivered to Medtronic either electronically via a 
secure web-based application, e.g. Medtronic BOX.
Echo data will be saved on supported media and will be delivered to the Echo Core Lab either 
electronically via a secure web-based application, e.g. Medtronic BOX, or via mail.  The Echo Core Lab 
will also enter data onto e-CRFs within the Oracle Clinical database.
Procedures in the CIP require source documentation. Source documentation will be maintained at the 
site. Source documents may include but are not limited to, subject medical records, electronic device 
data, subject activity logs, study-guided worksheets, quality of life questionnaires, and subject symptom 
checklists.  For the purposes of the AccelAV study, study-guided worksheets may be created and used to 
aid in compliance of protocol related data collection and to document real-time source data, e.g. blood 
pressure measurements, subject symptom checklists, and quality of life questionnaires.  These will be
signed and dated by personnel who record data on the study-guided worksheets.  If someone other than 
the site team member records data on the worksheet, a site team member will review, sign, and date 
worksheets upon completion.  The data will be transferred and reported onto the e-CRFs in a secure, 
password-protected database, and shall be derived from source documents and be consistent with 
these source documents, and any discrepancies between the two shall be explained in writing.
8.16. Deviation Handling
A study deviation is defined as an event within a study that did not occur according to the CIP or the 
Clinical Trial Agreement.
Prior approval by Medtronic is expected in situations where the investigator anticipates, contemplates, 
or makes a conscious decision to deviate. Prior approval is not required when a deviation is necessary to 
protect the safety, rights or well-being of a subject in an emergency or in unforeseen situations beyond 
the investigator’s control (e.g. inadvertent loss of data due to computer malfunction, inability to 
perform required procedures due to subject inability or illness).

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For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward. 
This may also apply for other unforeseen situations (e.g. the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary endpoint analysis). However, 
prior approval from Medtronic is required for such situations.
All study deviations must be reported on the e-CRF regardless of whether medically justifiable, pre-
approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
Multiple deviations of the same type at the same visit may be reported on one e-CRF.
In the event the deviation involves a failure to obtain a subject’s consent or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the Ethics Board as 
well as Medtronic within five (5) working days. Reporting of all other study deviations should comply 
with Ethics Board policies and/or local laws and must be reported to Medtronic as soon as possible upon 
the center becoming aware of the deviation.
Reporting of deviations must comply with Ethic Board policies, local laws, and/or regulatory agency 
requirements. Refer to Investigator Reports (Table 9), for geography-specific deviation reporting 
requirements and timeframes for reporting to Medtronic and/or regulatory bodies.
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the CIP, conduct additional training, and 
terminate the investigation). Repetitive or serious investigator compliance issues may result in initiation 
of 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.
Examples of study deviations include but are not limited to:

Failure to obtain proper patient informed consent

Failure to collect required study data (e.g. required echocardiogram)

Inclusion/exclusion criteria not met

Missing required device interrogation files

Missing Holter data

Missed visit
8.17. Subject Withdrawal or Discontinuation 
A subject can withdraw from the study at any time.  If a subject is withdrawn from the clinical study, the 
reason for withdrawal will be recorded in the e-CRF and in the subject’s hospital record.  In addition, 

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centers should follow their procedures for subject withdrawals or discontinuations as set forth by their 
Ethics Board.  It is recommended that that subjects be followed until all Micra AV or study procedure 
related adverse events are resolved. 
Subjects that exit the study prior to completing the study procedures will not be replaced since a sample 
size of up to 175 enrolled subjects accounts for the possibility that not all subjects may contribute usable 
Holter data as the target sample size requires approximately 150 usable Holter datasets.  
Possible reasons for premature withdrawal from the study are:

Subject chooses to withdraw (e.g. consent withdrawal)

Subject did not meet inclusion/exclusion criteria after consent, but prior to Micra AV implant

Subject lost to follow-up (not expected to occur due to the short study duration for individual 
subjects)

Investigator withdrew subject from the study for technical reasons (e.g. Holter telemetry)

Investigator withdrew subject from the study for medical reasons (e.g. inability to complete 
resting period and/or Holter recording)

Unsuccessful Micra AV implant attempt.  An unsuccessful implant attempt is defined as an 
implant attempt where an operating Micra AV device does not remain in the right ventricle 
following groin access site closure.  If the Micra AV implant is unsuccessful, the subject should 
be exited from the study: 1) following the resolution of any collectable adverse events or 2) if 
the collectable adverse event is not resolved and no further Micra AV implant attempts are 
planned.  An unsuccessful implant is not an adverse event, however, any adverse events 
occurring during an unsuccessful implant should be reported.

System modification where a Micra AV device is no longer active following the system 
modification procedure.

The sponsor decides the study will be closed or a particular center will be closed.
In the case that the subject is determined to be lost to follow-up at least two attempts to contact the 
subject are required.  The method of attempt (e.g. one letter and one phone record or two letters) 
should be documented in the subject’s medical record. 
9. Risks and Benefits
9.1.
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.  

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All devices used in the AccelAV study with exception of the ER220 Holter Monitor, will be commercially 
released and used in accordance with their approved labeling. The safety and clinical performance of the
algorithm used in the Micra AV system has been demonstrated through previous clinical studies.  The 
potential risks and side effects associated with the Micra AV Transcatheter Pacing System can be found 
in the Instructions For Use (IFU) labeling (Appendices F) and the foreseeable adverse event list 
(Appendices E) consistent with market-released Micra Transcatheter pacing system.  Subjects who are
pregnant may be at increased risk (e.g., radiation exposure, and other unforeseen risk to the fetus), and 
are excluded from participation in the study. If a subject becomes pregnant during the study, she must 
notify the physician immediately.  The subject will remain in the study, but the investigator will avoid 
any procedures that may be determined harmful.  The risks must be continuously monitored, assessed 
and documented by the investigator.    
The telemetry uplink mode during the Holter monitoring portion required by the study protocol is 
expected to reduce Micra AV battery longevity by a maximum of 2.7%, meaning approximately 3 to 6 
months, depending upon the amount of pacing.  The telemetry uplink time is a programmable
parameter, which allows the user to choose the allotted telemetry uplink time required per the Accel AV 
protocol.  Telemetry uplink will shut off automatically after the programmed time to reduce further 
battery drain of the device.  This information will be disclosed in the patient informed consent.
There is potential risk of a skin and/or allergic reaction to adhesive when applying the ER220 Holter 
monitor per instructions for use, or when removing adhesive tape.  To minimize this risk, information 
will be disclosed in the patient informed consent, and study sites will be trained by Medtronic on 
applying the ER220 Holter monitor per instructions for use. Participating sites will be provided standard 
electrode patches used within its labeling that have been provided by a Medtronic approved supplier for 
Holter monitor application.
The study requires the additional radiation associated with two chest X-rays of the Micra AV implant 
location. The amount used in a chest X-ray is small and considered low risk. The amount of radiation 
exposure for a chest X-ray is approximately 0.02% of the maximum lifetime diagnostic radiation 
exposure recommended by the American College of Radiology. In addition, subjects will undergo an 
echocardiogram examination with an echocardiography machine available on site at the hospital or 
clinic.  The echocardiogram procedure poses negligible or no risk to the subjects and will be disclosed in 
the patient informed consent.  
Lastly, during the study, risks will be continuously monitored, assessed and documented by the study 
investigators.
9.2.
Potential Benefits
The potential benefits of having the Micra AV Transcatheter Pacing System is to provide VDD pacing in 
subjects who have adequate sinus rates and who may benefit from maintenance of AV synchrony.  The 

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decision to implant the Micra AV should consider the benefits of leadless pacing versus the subject’s 
need for continuous AV synchrony.  In addition, subjects enrolled in the study may have additional 
contact with their physicians or other medical care staff beyond their normal standard of care visits,
which may provide benefit from a patient care perspective. 
The information gained from this study could result in improved management of subjects with the Micra 
AV Transcatheter Pacing System. Additionally, information collected from this study may assist in the 
design of new product(s)/therapy(ies) and/or instructions for use.
Participation in the AccelAV study may offer no benefit to the subject.
9.3.
Risk-Benefit Rationale
The potential risks associated with the commercially available Micra AV Transcatheter Pacing System 
were identified and have been successfully mitigated. Any potential risks associated with this study are 
further minimized by selecting qualified investigators and training study personnel on the Clinical 
Investigation Plan. In addition, investigators will be actively involved in the implantation and follow-up 
of the subjects. Risks will be minimized by careful assessment of each subject prior to, during, and after 
implant. Medtronic has further minimized the possibility of risks by product testing applicable to all 
commercially available devices prior to their use in this clinical study, implementing quality control 
measures into production processes, providing guidelines for subject selection and evaluation, and 
providing adequate instructions and labeling.  Lastly, a summary of the risk-benefit analysis for the 
Micra AV Transcatheter Pacing System is documented in the Micra AV Risk Management Report 
(D00054473, or current approved version).
After implantation, subjects in this clinical study will be followed at regular intervals to monitor the 
condition of the implanted system. At each study-required follow-up, in all subjects, the investigator 
must interrogate the Micra AV device to verify appropriate device function and to assess any adverse 
events.  Taking the risk mitigation and risk minimization into account, the potential benefits outweigh 
the potential risks for patients participating in this study.
10. Adverse Events and Device Deficiencies
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are 
crucial for the protection of subjects.  Reporting and analysis of safety data are mandated by regulatory 
authorities worldwide. Medtronic has established procedures in conformity with worldwide regulatory 
requirements to ensure appropriate reporting of safety information.  The study is conducted in 
accordance with these procedures and regulations.

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Since the safety reporting requirements and classification systems vary for each regulatory agency, 
requirements from all geographies are taken into account for the collection and reporting of safety 
information.  
10.1. Adverse Events
All Micra AV system or procedure related adverse events (AEs) and all cardiovascular related AEs 
regardless of their severity that occur from the time of enrollment (i.e., the time the informed consent is 
signed) through study exit will be collected and reported to Medtronic.  Additionally, all deaths will be 
reported on an AE e-CRF with a fatal outcome. Reporting of these events to Medtronic will occur on an 
AE e-CRF, including date of AE onset, AE term, AE description, AE treatment and actions taken, AE
outcome and resolution, and assessment of both the seriousness of the AE and the relatedness to the 
procedure and system components.  Each AE must be recorded on a separate AE e-CRF.  Documented 
pre-existing conditions are not considered AEs unless the nature or severity of the condition has 
worsened. 
10.2. Device Deficiencies
Device deficiency (DD) information will be collected throughout the study and reported to Medtronic. 
Note that DDs that result in an Adverse Device Effect (ADE) to the subject should be captured as an AE 
only.  Device Deficiencies that did not lead to an AE but could have led to a Serious Adverse Device 
Effect (SADE) (i.e., if suitable action had not been taken, if intervention had not been made, or if the 
circumstances had been less fortunate) require immediate reporting.  For DDs that require immediate 
reporting, initial reporting may be done by contacting the study sponsor per the sponsor contact 
information.
10.3. Event Updates and Resolution
For any changes in status of a previously reported AE (e.g. change in actions taken, change in outcome, 
change in relatedness), information needs to be updated on, or added to the original AE form.  All 
efforts should be made to continue following the subject until all unresolved system related adverse 
events, as classified by the investigator, are resolved.
10.4. Definitions/Classifications
For the purposes of the clinical report, Medtronic will classify each adverse event according to ISO 
14155:2011 definitions.  The study will follow the definitions, however is not claiming full compliance to 
ISO 14155:2011.
Where the definition indicates “device”, it refers to any device used in the study. This may be the device 
under investigation, or any market released component of the system.

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Table 4: Adverse Event and Device Deficiency Definitions
General
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device
NOTE 1: This definition includes events related to the investigational 
medical device or the comparator.
NOTE 2: This definition includes events related to the procedures 
involved.
NOTE 3: For users or other persons, this definition is restricted to 
events related to investigational medical devices.
(ISO 14155:2011, 3.2)
Adverse Device Effect (ADE)
Adverse event related to the use of an investigational medical device
NOTE 1: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
investigational medical device.
NOTE 2: This definition includes any event resulting from an error use 
or from intentional misuse of the investigational medical device. (ISO 
14155:2011, 3.1)
Device Deficiency (DD)
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. 
NOTE: Device deficiencies include malfunctions, use errors and 
inadequate labeling (ISO 14155:2011, 3.15)
Relatedness
Cardiovascular Related
An adverse event relating to the heart and the blood vessels or the 
circulation. (e.g., atrial fibrillation, myocardial infarction, stroke, 
peripheral vascular disease, heart failure).
Pacemaker Syndrome Related
The 2012 HRS/ACC Expert consensus statement on pacemaker device 
and mode selection defines pacemaker syndrome as the occurrence 
of overt symptoms, such as fatigue, chest discomfort, dyspnea, cough, 
confusion, presyncope, or syncope due to adverse hemodynamics that 
result from loss of AV synchrony and occurrence of ventriculoatrial

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conduction or atrial contraction against closed AV valves in patients 
with an implanted pacemaker.5
Procedure Related
An adverse event related to the Micra AV implantation or 
modification, or to the AccelAV study procedures.
Micra Procedure related: an adverse event that occurs that is 
directly related to the implantation or modification of the Micra 
system
AccelAV Procedure related: an adverse event that is related to the 
protocol required procedures
System Related
An adverse event that results from the presence or performance of 
any component of the system.
Micra AV Device Related: An adverse event that results from the 
presence or performance (intended or otherwise) of the 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 presence 
or performance (intended or otherwise) of the Micra AV software.
Programmer Related:  An adverse event that results from the 
presence or performance (intended or otherwise) of the 
programmer.
Holter Related: An adverse event that results from the presence or 
performance (intended or otherwise) of the Holter.
Not Related
Relationship to the device or procedures can be excluded when:

The event is not a known side effect of the product category 
the device belongs to or of similar devices and procedures.

The event has no temporal relationship with the use of the 
device or the procedures.

The serious event does not follow a known response pattern 
to the medical device (if the response pattern is previously 
known) and is biologically implausible.

The discontinuation of medical device application or the 
reduction of the level of activation/exposure – when clinically 
feasible – and reintroduction of its use (or increase of the 
level of activation/exposure) do not impact the serious event.

The event involves a body-site or an organ not expected to be 
affected by the device or procedure.

The serious event can be attributed to another cause (e.g., an 
underlying or concurrent illness/clinical condition, an effect of 
another device, drug, treatment, or other risk factors).

The event does not depend on a false result given by the 

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device used for diagnosis (when applicable).

Harms to the subject are not clearly due to use error.
In order to establish the non-relatedness, not all the criteria listed 
above might be met at the same time, depending on the type of 
device/procedures and the event.
Unlikely
The relationship with the use of the device seems not relevant and/or 
the event can be reasonably explained by another cause, but 
additional information may be obtained.
Possible
The relationship with the use of the investigational device is weak but 
cannot be ruled out completely. Alternative causes are also possible 
(e.g. an underlying or concurrent illness/clinical condition or/and an 
effect of another device, drug or treatment). Cases where relatedness 
cannot be assessed or no information has been obtained should also 
be classified as possible.
Probable
The relationship with the use of the investigational device seems 
relevant and/or the event cannot be reasonably explained by another 
cause, but additional information may be obtained. 
Causal Relationship
The event is associated with the device or study procedures beyond 
reasonable doubt when:

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
The event is a known side effect of the product category the 
device belongs to or of similar devices and procedures.

The event has a temporal relationship with device 
use/application or procedures.

The event involves a body-site or organ that the device or 
procedures are applied to or the device or procedures have an 
effect on.

The serious event follows a known response pattern to the 
medical device (if the response pattern is previously known).

The discontinuation of medical device application (or 
reduction of the level of activation/exposure) and 
reintroduction of its use (or increase of the level of 
activation/exposure) impact on the serious event (when 
clinically feasible).

Other possible causes (e.g., an underlying or concurrent 
illness/clinical condition or/and an effect of another device, 
drug, or treatment) have been adequately ruled out.

Harm to the subject is due to error in use.

The event depends on a false result given by the device used 
for diagnosis (when applicable).

In order to establish the relatedness, not all the criteria listed 
above might be met at the same time, depending on the type 
of device/procedures and the serious event.
Seriousness
Serious Adverse Event (SAE)
Adverse event that did one of the following:
a) led to death,
b) led to serious deterioration in the health of the subject, that 
either resulted in
1) a life-threatening illness or injury, or
2) a permanent impairment of a body structure or a body 
function, or
3) in-patient or prolonged hospitalization, or
4) medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure 
or a body function.
c) led to fetal distress, fetal death or a congenital abnormality or 
birth defect

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NOTE 1: Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not considered 
a serious adverse event.
(ISO 14155:2011, 3.37)
Serious Adverse Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event.
(ISO 14155:2011, 3.36)
Complication
An adverse event that includes the following is considered a 
complication:
a) Results in death,
b) Involves any termination of significant device function, or
c) Requires an invasive intervention
NOTE: Only system or procedure related AEs will be classified as 
complications or observations
Major Complication
A complication that results in any of the following:
1) Death
2) Permanent loss of device function due to mechanical or 
electrical dysfunction of the device (i.e., pacing function 
disabled, leaving device abandoned electrically)
3) Hospitalization
4) Prolonged hospitalization 
5) System revision (explant, reposition, replacement)
NOTE: Only system or procedure related AEs will be classified as 
complications or observations.
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).
NOTE: Only system or procedure related AEs will be classified as 
complications or observations.
Observation
An adverse event that is not a complication. 
NOTE: Only system or procedure related AEs will be classified as 
complications or observations
Timing

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Pre-Implant AE
An adverse event that occurs after the consent form has been signed 
but before the skin incision during implant
During Implant AE
An adverse event that occurs during implant, after skin incision and 
prior to completion of skin closure
Post-Implant AE
An adverse event that occurs after the completion of skin closure for 
the implant
Other
Unavoidable AE
An adverse event inherent to a surgical procedure that is expected to 
occur in all subjects for a projected duration.  Unavoidable AEs are not 
considered reportable unless the AE worsens or is present outside the 
stated timeframe.
Description
Timeframe (hours) 
from the Surgical 
Procedure
Anesthesia related nausea / vomiting
24
Low-grade fever (<100⁰F or <37.8⁰C)
48
Pain at the access site
72
Mild to moderate bruising / ecchymosis
168
Sleep problems (insomnia)
72
Back pain related to lying on table
72
10.5. Reporting of Adverse Events
All reported AEs and DDs will be reviewed by a Medtronic representative.  Adverse events will be
classified according to the definitions provided.  Upon receipt of an AE or DD at Medtronic, a Medtronic
representative will review the AE/DD for completeness and accuracy and when necessary will request 
clarification and/or additional information from the investigator.  Medtronic will use the Medical 
Dictionary for Regulatory Activities (MedDRA), to assign a MedDRA term for each AE based on the 
information provided by the investigator. 
Regulatory reporting of AEs and DDs that could have led to a SADE will be completed according to local 
regulatory requirements.  Refer to Table 6 for a list of required investigator and Medtronic reporting 
requirements and timeframes.  It is the responsibility of the investigator to abide by any additional AE 
reporting requirements stipulated by the Ethics Board responsible for oversight of the study.
Appendix E contains the Foreseeable Adverse Event List (FAL), which is a list of adverse events related to 
the Micra system that have been observed in previous studies and may be experienced by subjects.  

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For emergency contact regarding a SAE and/or SADE, contact a Medtronic study representative 
immediately (refer to the study contact list provided in the site’s study documents binder, Investigator 
Site File or refer to the Sponsor Contact Information section provided in the CIP).
Adverse Events will be classified according to the standard definitions as outlined below in Table 5 .
Table 5: Adverse Event Classification Responsibilities
What is 
classified? 
Who classifies? Classification Parameters
Relatedness
Investigator
MicraImplantable Device and Transfemoral 
Catheter Delivery System, Micra Software, 
Programmer and Programmer Software, ER220 
Holter, Accel AV study procedures, Micra implant
or modification procedure
Sponsor
MicraImplantable Device and Transfemoral 
Catheter Delivery System, Micra Software, 
Programmer and Programmer Software, ER220 
Holter, Accel AV study procedures, Micra implant 
or modification procedure
Seriousness
Investigator
SAE, Device Deficiency with SADE potential
Sponsor
SAE, Complication/Observation (including major 
complication), Device Deficiency with SADE 
potential 
Diagnosis
Investigator
Based on presenting signs and symptoms and other 
supporting data
Sponsor
MedDRA term assigned based on the data provided 
by investigator
10.6. Adverse Events and Device Deficiency Reporting Requirements
Regulatory reporting of AEs and DDs 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 site’s Ethics Board.  If an Adverse event is related to a 
market-released device used during the study, post market surveillance is also applicable, and the 
investigator is responsible for immediate reporting of the product complaint via the regulatory channels 
for market-released products.  Adverse events and Device Deficiencies reporting requirements are 
outlined below in Table 6.

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Table 6: Reporting Requirements
Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs)
Investigator submit to:
Medtronic
All geographies: Report to the sponsor, without unjustified delay, all serious adverse events. 
Ethics Committee
All geographies:  Submit to Ethics Committee per local reporting requirement.
Sponsor submit to:
Regulatory authorities
All geographies: Submit to Regulatory authorities per local reporting requirement.
All Device Deficiencies with SADE potential or without
Investigator submit to:
Medtronic
All other geographies: Submit or report as required per local reporting requirements.
Ethics Committee
All geographies: Submit to Ethics Committee per local reporting requirement.
Sponsor submit to:
Regulatory authorities
All geographies: Submit to Regulatory authorities per local reporting requirement.
10.7. Subject Death
All subject deaths must be reported by the investigator to Medtronic on an Adverse Event form (AE with 
a fatal outcome) as soon as possible after the investigator first learns of the death.  In case of death, 
there should be one AE with a fatal outcome.
In the event of a subject’s death, it is recommended that the implanted system be explanted and 
returned to Medtronic for analysis whenever possible per local process. Local laws and procedures must 
be followed where applicable. If any system component is returned to Medtronic, return product 
reporting systems may be used to gather additional information about the returned device or 
component.
A copy of the death certificate, if available and allowed by national and local law, should be sent to the 
Medtronic clinical study team. When a death occurs in a hospital, a copy of the death summary report 
and all relevant hospital records should be sent to the Medtronic clinical study team, if available. If an 
autopsy is conducted, the autopsy report should also be sent to the Medtronic clinical study team, if 
available and allowed by national and local law. When the death occurs at a remote site, it is the 
investigational 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 and Save-to-Media (if available)

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• Device disposition information
• Death summary/hospital records (if available and allowed by national and local law)
• Autopsy report (if available and allowed by national and local law)
• Death certificate (if available and allowed by national and local law)
11. Data Review Committees 
11.1. CRO/Core Labs
This information in Table 7 may be subject to change during the clinical study. Periodic updates to study 
contact information will be sent to sites as needed.
Table 7: CRO and Core Laboratory Information
Contact Information
Role
Cognizant Technology Solutions
500 Frank W. Burr Blvd.
Teaneck, NJ 07666
United States
Direct Phone: (201) 801-0233
Direct Fax: (201) 801-0243
Development of the study database, review of 
electronic case report forms, and management of 
discrepancies
Echocardiography Core Laboratory
TBD (Information will be provided under 
separate cover)
Review and analysis of study echocardiograms
11.2. Clinical Events Committee (CEC) 
An independent Clinical Events Committee (CEC) will conduct a medical review of AEs for subjects 
participating in the study. 
The CEC will consist of a minimum of three (3) non-Medtronic employed physicians that are not 
participating investigators for the study, including a CEC chairperson. At a minimum, the CEC will 
adjudicate all Micra AV system or procedure-related AEs, and all AEs with a fatal outcome (deaths). 
Medtronic personnel may facilitate and participate in a CEC meeting but will be non-voting members.
For AEs 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. For adverse events, classification includes Micra AV procedure and 
system relatedness, pacemaker syndrome relatedness (only for AEs resulting in a Micra AV system 
revision) and the additional adjudication of a cardiac death classification will be provided for all reported 

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deaths. Source documents to support adjudication will be requested for all AEs with an outcome of 
‘fatal’ and may be requested for other events of interest on an as needed basis.
If the CEC disagrees with the investigator’s classification of the event, the study site will be notified. If 
the investigator agrees with the CEC’s adjudication, the case report form documenting the AE will be 
updated accordingly. CEC classifications will be used for analysis.
11.3. Data Monitoring Committee (DMC)
A Data Monitoring Committee (DMC) is not needed for this study.  This decision was made based on the 
following criteria: 
1.
Limited duration of subject participation in study
2.
Short overall study duration (approximately 15 months)
3.
Little safety risk to subjects participating in study
11.4. Steering Committee
A Steering Committee will serve to oversee and guide the conduct of the study as well as develop 
publications and presentations. The Steering Committee is independent from Medtronic.  The Steering
Committee will also serve as a publication committee and will be primarily responsible for the creation, 
review, and submission of publications and presentations related to the study. A publication plan will be 
developed in conjunction with the Sponsor prior to the start of the trial. This publication plan may need 
to be adjusted, as appropriate, based on the progress of the study.
12. Statistical Design and Methods
12.1. General Considerations
Medtronic employees or their designated representatives will perform all statistical analyses.
A Statistical Analysis Plan (SAP) will be created prior to analysis of the primary objective.  The SAP will 
elaborate on the statistical methods described below and include a comprehensive description of the 
pre-specified statistical methods to be included in study report(s).  Any change to the data analysis 
methods described in the CIP will require an amendment only if it changes a principal feature of the CIP.  
Any other change to the data analysis methods described in the CIP will be described in the SAP and in 
the clinical study report.  
Note that the goal of the AccelAV study is to estimate the rate of AV synchrony in the real-world 
population rather than test a specific hypothesis with specific type I error control.

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12.1.1.
Standard Baseline Variables
Standard baseline and relevant medical history will be collected on the e-CRFs for all enrolled subjects.  
Baseline variables to be summarized include, but are not limited to: age, sex, physical exam findings, 
pacing indication, arrhythmia history, medical and surgical history, and cardiovascular medications.  
Baseline variables will be summarized for all enrolled subjects, all subjects with a successful Micra AV 
implant, and all subjects contributing to the primary objective (i.e., those subjects with a predominant 
rhythm of 3rd degree AV block and normal sinus node function during the 1-month visit).
For continuous variables, mean, standard deviation, median, and range will be reported.  For categorical 
variables, frequency and percentage will be reported.
12.2. Usable Holters
A Holter dataset (i.e., device data and surface ECG recordings telemetered to the Holter memory) will be 
considered usable if there is readable telemetry signal as determined by the presence of visible device 
marker channel.  Additionally, to be included in the analysis of the primary efficacy objective
 
, visible P-waves must be present on the surface ECG 
recordings.
12.3. Classification of Predominant Heart Rhythm During Echo
Atrial and ventricular heart rates, along with the PR interval will be used to determine each subject’s 
predominant heart rhythm at the time of the echo.  Specifically, both the sinus function and AV block 
status will be assessed.   The AV conduction status will be categorized as 3rd degree AV block, intact AV 
conduction, or other (e.g. 1st or 2nd degree AV block).   The sinus node function will be categorized as 
normal sinus node function, sinus node dysfunction (sinus bradycardia, sinus tachycardia, or other) or 
atrial arrhythmia.
12.4. Classification of Predominant Heart Rhythm During Holter Monitoring
Holter data from the VDI data collection period and resting period will be used to determine each 
subject’s predominant heart rhythm.  Specifically, both the sinus function and AV block status will be 
assessed.   The AV conduction status will be categorized as persistent 3rd degree AV block, intact AV 
conduction, or other (e.g. 1st or 2nd degree AV block).   The sinus node function will be categorized as 
normal sinus node function, sinus node dysfunction (sinus bradycardia, sinus tachycardia, or other) or 
atrial arrhythmia. 
A subject’s 1-month and 3-month visit Holter will be assessed individually for predominant rhythm 
classification.  Thus, a subject may have different predominant rhythms at each study visit (e.g., 3rd

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degree persistent AV block with normal sinus node function at the 1-month visit, but intact AV 
conduction at the 3-month visit).  
12.5. Primary Objective
Characterize AV synchrony during rest at 1-month post-implant in subjects with persistent 3rd degree 
AVB with normal sinus node function.
12.5.1.
Endpoint Definition
For each ECG confirmed P-wave that occurs during the 20-minute resting period at the 1-month visit, 
the endpoint will be considered met if a ventricular beat (ventricular pace or sensed event) is within 300 
ms following an ECG confirmed P-wave.
12.5.2.
Performance Requirement
There is no pre-specified performance requirement for this study.
12.5.3.
Analysis Methods
At the 1-month study visit, a Holter monitor will be placed on the subject. Each subject’s Holter monitor 
will record surface ECG and Micra AV markers.  Specifically, the Holter will record whether the Micra AV
senses an atrial contraction (A4 signal representing active ventricular filling detected by the 
accelerometer), delivers a pacing spike, or inhibits a pacing spike based on a sensed intrinsic R-wave.  
Similar to the MARVEL and MARVEL 2 studies, Holter files will be processed and reviewed by Medtronic 
personnel experienced in the review of Holter recordings using Holter and MATLAB utilities.  A human 
overread will also be used to truth each P-wave.  Device markers will not be used by the MATLAB scripts 
or human overread to identify P-waves.  Finally, a MATLAB script will collate the identified P-waves, 
times corresponding to distinct study procedures, and Micra AV markers in a .csv format file.  This .csv 
file will indicate the time after each P-wave a ventricular pace or intrinsic sensed R-wave occurred.  
Comparison of this P-R interval to 300 ms will determine whether a beat was synchronous.
A logistic regression model using generalized estimating equations, to account for the fact that the 
Micra AV’s performance may be correlated within a study subject, will be used to construct a single 
estimate of the rate of AV synchrony and its 95% two-sided confidence interval across all subjects.  
Specifically, the model outcome will be each successful/unsuccessful synchronous beat during the 
approximately 20 minutes resting period at the 1-month visit and the model will contain an intercept 
term and consider observations repeated across subjects with an exchangeable working correlation 
structure.  

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Additionally, point estimates for the percentage of synchronous beats at the 1-month visit will also be 
calculated for each individual subject by dividing the number of synchronous beats by the total number 
of evaluable cardiac cycles.
12.5.4.
Sample Size
The MARVEL 2 study reported an average AV synchrony rate during rest of 89.2% (95% CI: 84.8% -
92.5%) with a median of 94.3% across the 40 subjects with a predominant heart rhythm of 3rd degree AV 
block and normal sinus node function and P-waves visible on their Holter ECG channel.  The remaining 
subjects included 17 subjects with intact AV conduction, and 7 subjects with other predominant 
rhythms.  Based on the distribution of predominant rhythms in the MARVEL 2 study together with the 
enrollment strategy described in section 7.5 it is expected that approximately half of the subjects with 
usable Holters will have a predominant rhythm of 3rd degree AV block and normal sinus node function at 
their 1-month visit.
A simulation based on resampling with replacement from the MARVEL 2 subjects suggests that a sample 
size of 75 subjects with Holter recordings and with a predominant rhythm of 3rd degree persistent AV 
block and normal sinus node function at the 1-month visit will enable the percentage of AV synchrony to 
be measured with a precision (distance from point estimate to lower 2-sided 95% confidence interval) of 
<3.5% with 89.7% probability.  Since it is expected that approximately half of the subjects with usable 
Holter data at the 1-month visit will have a predominant rhythm of persistent 3rd degree AV block and 
normal sinus node function, approximately 150 subjects with usable Holter files will be required to 
evaluate the primary objective.  To account for the possibility of unusable Holters, unsuccessful Micra 
AV implant attempts, and study attrition, approximately 175 subjects may be enrolled.
Since the number of subjects that will have a predominant rhythm of 3rd degree AV block at the 1-month 
visit is somewhat unknown, Table 8 displays the relationship between the number of subjects that will 
contribute to the primary efficacy analysis and the distance between the point estimate and lower 95% 
confidence interval for sample sizes ranging from 40 to 90 subjects.

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Table 8: Relationship Between Sample Size and Confidence Interval Width
n1
Median Point 
Estimate (%)2
Median Lower 
95% CI
Median Distance 
from Point 
Estimate to 
Lower CI
Probability 
Distance <3.5%
40
88.76%
84.83%
4.1%
37.7%
50
88.73%
85.19%
3.5%
45.2%
60
88.79%
85.58%
3.2%
63.0%
70
88.82%
85.90%
2.9%
81.9%
75
88.76%
85.87%
2.9%
89.7%
80
88.73%
85.96%
2.8%
92.9%
90
88.76%
86.13%
2.6%
98.6%
1n is the number of subjects with usable Holter files with a predominant rhythm of persistent 3rd AV block and normal sinus 
node function at the 1-month visit.
2Based on 1000 bootstrap samples from 40 subjects in the MARVEL 2 study with a predominant rhythm of persistent 3rd AV 
block and normal sinus node function during Holter monitoring.
Program Name: V:\AccelAV\Sample_Size
12.5.5.
Determination of Subjects and Data for Analysis
All enrolled subjects with usable Holter data, a predominant rhythm of persistent 3rd degree AV block 
and normal sinus node function at the 1-month visit, and at least 500 evaluable beats during resting 
period at the 1-month visit will be included.  Specifically, data from the approximately 20 minute resting
period at the 1-month visit will be included in the analysis of the primary objective.
12.5.6.
Missing Data
Given the relatively short duration of the study, missing data is not expected to be a serious issue.  
However, missing data may occur if the Holter telemetry signal is lost or the Holter data file is otherwise 
corrupted (i.e., Holter file is not considered usable).  
Since telemetry dropout may influence the number of evaluable beats, the total number of heart beats 
and total number of evaluable beats will be summarized. 
If any subjects do not have usable Holter data during the study, the reason the Holter data was not 
usable will be discussed.  
Additionally, a sensitivity analysis will be performed to assess the sensitivity of the observed AV 
synchrony percentage estimate with respect to the missing data. The analysis will consist of including in 
the statistical model all subjects that had some usable Holter data during the 20-minutes resting period 

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at the 1-month visit regardless of the number of evaluable beats.  Other stochastic based methods to 
investigate the sensitivity of the results to the number of unevaluable beats due to telemetry lost may 
be utilized if necessary.
12.5.7.
Other Planned Analyses
As described in section 12.3 subjects may have different predominant heart rhythms at their 1-month 
and 3-month visits.  For example, a subject may have intact AV conduction at their 1-month visit but
have persistent 3rd degree AV block and normal sinus node function at their 3-month visit.  Thus, an 
estimate of percent AV synchrony will also be computed using the methods described in section 12.5.3
using each subject’s 3-month visit Holter recording where they have at least 500 evaluable beats and 
have a predominant rhythm of persistent 3rd degree AV block and normal sinus node function.  
The AV synchrony percentage will also be computed using the methods described in section 12.5.3 for 
subjects not included in the primary objective analysis cohort including those subjects with intact AV 
conduction and other predominant rhythms.
12.6. Secondary Objective #1
Characterize the stability of AV synchrony during rest between 1-month and 3-months post implant in 
subjects with persistent 3rd degree AVB and normal sinus node function.
12.6.1.
Endpoint Definition
The endpoint for secondary objective #1 will be the same as for the primary objective (see section 
12.5.1) with the exception that ECG confirmed P-waves that occur during the 20-minute resting period 
at both the 1-month and 3-month visits will be included in the analysis.
12.6.2.
Performance Requirement
There is no pre-specified performance requirement for this study.
12.6.3.
Analysis Methods
A Holter monitor will be placed on each subject at the 1-month and 3-month visits.  Each Holter file will 
be processed as described in section 12.5.3 and the AV synchrony during the 20-minutes resting periods 
at the 1-month and  3-months visits will be compared using a generalized linear model incorporating 
generalized estimating equations.  The response for this model on an individual heart beat basis will be 
AV synchrony endpoint met as defined in section 12.5.1 (i.e., 1= yes, 0=no).  The model will also 
incorporate an intercept term and indicator for visit (1-month or 3-month visits) and utilize an 
exchangeable working correlation structure to account for the fact that the atrioventricular synchrony 

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may be correlated within subject.  The difference in the least squared means between visits on the 
linear scale (i.e., when utilizing the identity link function with the binomial distribution) and its related 
95% confidence interval will be used to assess the stability of the AV synchronous pacing rate between 
study visits.
12.6.4.
Determination of Subjects and Data for Analysis
All subjects with persistent 3rd degree AVB and normal sinus node function and at least 500 evaluable 
beats during the approximately 20 minute period where the subject is resting quietly at both the 1-
month and 3-month visits will be included in the analysis of this objective.
12.6.5.
Missing Data
Similar to the primary objective, beats with no ventricular sense or pace markers and indication of 
telemetry dropout in the first 300 ms following a P-wave will be excluded (i.e., they are not evaluable 
beats).  The total number of heart beats and total number of evaluable beats will be summarized for 
each subject and visit combination.
Additionally, a sensitivity analysis will be performed to assess the sensitivity of the estimated difference 
in AV synchrony percentage with respect to the missing data. Specifically, the analysis will include in the 
statistical model all subjects with persistent 3rd degree AV block and normal sinus node function and at 
least one evaluable cardiac cycle at the 1-month and 3-month visits respectively.
12.7. Secondary Objective #2
Characterize the percentage of ambulatory AV synchrony at 1-month in subjects with persistent 3rd
degree AVB and normal sinus node function.
12.7.1.
Endpoint Definition
The endpoint for secondary objective #2 will be the same as for the primary objective (see section 
12.5.1) with the exception that ECG confirmed P-waves that occur during the ambulatory period during 
the 1-month Holter recording will be used in the analysis.
12.7.2.
Performance Requirement
There is no pre-specified performance requirement for this objective.
12.7.3.
Analysis Methods
At the 1-month visit, a Holter monitor will be placed on the subject and following the in-clinic study 
procedures the subject will wear the Holter monitor for approximately 24 hours as they go about their 

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activities of daily living.  The Holter files will be processed as described in section 12.5.3 and a logistic 
regression model using generalized estimating equations will be used to construct a single estimate and 
95% confidence interval for algorithm performance across all subjects using the methods described in 
section 12.5.3.  For analysis purposes, the ambulatory period will be defined as starting at the end of the 
20-minute resting period.
12.7.4.
Determination of Subjects/Data for Analysis
All subjects with a predominant rhythm of persistent 3rd degree AVB and normal sinus node function
and at least 500 usable beats during the ambulatory Holter monitoring period will be included in the 
analysis of this objective.
12.7.5.
Missing Data
Similar to the primary objective, beats with no ventricular sense or pace markers and indication of 
telemetry dropout in the first 300 ms following a P-wave will be discarded (i.e., they are not evaluable 
beats). The total number of heart beats and total number of evaluable beats will be summarized for 
each subject.
Additionally, a sensitivity analysis will be performed to assess the sensitivity of the AV synchrony 
percentage estimate with respect to the missing data. Specifically, the analysis will include in the 
statistical model all subjects with persistent 3rd degree AV block and normal sinus node function and at 
least one evaluable cardiac cycle during the ambulatory period at the 1-month will be included.
12.7.6.
Other Planned Analyses
The AV synchrony percentage will also be computed during the 1-month ambulatory period for subjects 
with predominant rhythms other than persistent 3rd degree AV block and normal sinus node function 
including those with intact AV conduction and other predominant rhythms.
12.8. Secondary Objective #3
Characterize the change in stroke volume, as measured by left ventricular outflow tract velocity time 
integral, during Micra AV mediated VDD pacing and VVI pacing in subjects with persistent 3rd degree 
AVB and normal sinus node function.
12.8.1.
Endpoint Definition
The endpoint is LVOT VTI as obtained from echocardiogram and measured by the Echo Core Lab while 
the Micra AV is programmed to VDD and VVI pacing.  

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12.8.2.
Performance Requirement
There is no pre-specified performance requirement for this objective.
12.8.3.
Analysis Methods
Echocardiograms will be collected for each subject during VDD pacing and during VVI pacing within 48 
hours of the Micra AV implant. To ensure that the Echo Core Lab is blinded to subject and programmed 
pacing mode, randomly generated numbers will be used to label the echo recording. Specifically, a 
random 5-digit number (“echo id”) will be assigned to label the echo recording and link the Echo Core 
Lab results to an individual study subject and pacing mode.  Additionally, study sites will be randomized 
to perform the echo while the Micra AV system is programmed to VDD pacing first followed by VVI 
pacing or to VVI pacing first followed by VDD pacing.  This strategy will blind the Echo Core Lab 
personnel to study site, subject, and pacing mode and allow the “echo id” to link to the appropriate 
center, subject, and pacing mode.
Since subject is the experimental unit, the difference in LVOT VTI during the VDD and VVI pacing will be 
computed within each subject and a 95% confidence interval for the mean difference will be 
constructed based on the t-distribution.
12.8.4.
Determination of Subjects/Data for Analysis
All subjects with persistent 3rd degree AV block and normal sinus node function at the time of their 
echocardiogram with paired LVOT VTI measurements during VDD and VVI pacing will be included in the 
analysis.
12.8.5.
Missing Data
Since the echocardiogram is expected to be performed prior within 48 hours of the Micra AV implant, 
missing data is not expected to be a serious issue.  However, missing data may arise if a subject does not 
perform the echocardiogram or the echocardiogram is uninterpretable by the Echo Core Lab. Note that 
both reasons for missing data may plausibly be considered independent to change in LVOT VTI.
12.8.6.
Other Planned Analyses
Point estimates for the mean difference in LVOT VTI between VDD and VVI pacing and its corresponding 
95% confidence interval will also be constructed for subjects not included in the analysis cohort for this 
objective including those with intact AV conduction or with other predominant rhythms.

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13. Ethics
13.1. Statement(s) of Compliance 
The study will be conducted according to the Declaration of Helsinki, Clinical Investigation Plan, Good 
Clinical Practice (GCP) and in accordance to the national and local laws, regulations, standards, and 
requirements of the countries/geographies in which the study is conducted. The principles of the 
Declaration of Helsinki have been implemented through the patient informed consent (IC) process, 
Ethics Board/IRB/MEC approval, study training, clinical trial registration, risk-benefit assessment and 
publication policy.
The clinical investigation shall not begin until all required approvals and documents from the Ethics 
Board and regulatory authorities, if needed, have been received. Any additional requirements imposed 
by the Ethics Board or regulatory authority shall be followed, if appropriate.
This study will be conducted in compliance with international ethical and scientific quality standards, 
known as good clinical practice (GCP). GCP includes review and approval by an independent Ethics 
Board/IRB/MEC before initiating a study, continuing review of an ongoing study by an Ethics Boards and 
obtaining and documenting the freely given informed consent of a subject before initiating the study.
All devices used in the AccelAV study, with exception of the ER220 Holter Monitor, will be commercially 
released and used within scope of approved labeling, indications, and patient population. The ER220 
Holter is an investigational device but will be used as a noninvasive diagnostic/data collection only and 
introduces no increased risks to subjects as compared to standard of care.  The study is considered 
exempt per 21 CFR 812.2(c)(3):
812.2(c)(3)
Noninvasive diagnostic device
(3) A diagnostic device, if the sponsor complies 
with applicable requirements in Sec. 809.109(c) 
and if the testing:
(i) Is noninvasive,

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(ii) Does not require an invasive sampling 
procedure that presents significant risk
(iii) Does not by design or intention 
introduce energy into a subject, and 
(iv) Is not used as a diagnostic procedure 
without confirmation of the diagnosis by 
another, medically established diagnostic 
product or procedure
In addition, the study does not meet the FDA definition of a significant risk device as defined by 21 CFR 
812.3 (m).  This study is not designed to determine safety and effectiveness and does not introduce new 
or increased risks to study subjects.  For further information of study risks, please go to section 9.1.  
Ultimately, all sites in all geographies will and comply with:

Principles of Declaration of Helsinki

21 CFR Part 11 (Electronic Records, Electronic Signatures)

The Clinical Trial Agreement

The procedures described within this CIP

Local Ethics Board Requirements

809.10(c) Labeling
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national and local laws, regulations, standards, and requirements of the countries/geographies 
where the study is being conducted. These include but are not limited to the following: 
In the United States, the study is in compliance with 21 CFR Parts:

50: Protection of Human Subjects

56: Institutional Review Boards

809.10(c) Labeling

21 CFR Part 11: (Electronic Records, Electronic Signatures)

21 CFR Part 803: Medical Device Reporting
The study will be publicly registered prior to first enrollment in accordance with the 2007 Food and Drug 
Administration Amendments Act FDAAA and Declaration of Helsinki on http://clinicaltrials.gov (PL 110-
85, section 810(a)). In addition, the study may be registered in local regulatory databases where 

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required by local law. Approval of the CIP and CIP amendments is required from the following groups 
prior to any study procedures at a study site:

Medtronic

Principal Investigators 

An independent medical ethics committee or institutional review board
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above-
mentioned groups prior to implementation of the revised CIP at the site.
14. Study Administration
14.1. Monitoring 
It is the responsibility of Medtronic to ensure proper monitoring of this clinical study per regulations. 
Trained Medtronic personnel may perform study monitoring at the study site in order to ensure that the 
study is conducted in accordance with the CIP, the Clinical Trial Agreement, and applicable regulatory 
and local requirements. Medtronic, or delegates, must therefore be allowed direct access to the 
subjects’ case histories (clinic and hospital records, and other source data/documentation) upon request 
as per the Patient Informed Consent, and Clinical Trial Agreement. The consent form or other privacy 
language where required by law must be available for monitoring and auditing. The principal 
investigator should also be available during monitoring visits.
Monitoring for the study, including site initiation visits, interim monitoring visits, and closeout visits, will 
be done in accordance to the study-specific monitoring plan.
Monitoring visits may be conducted periodically to assess site study progress, the investigator’s 
adherence to the CIP, regulatory compliance including but not limited to Ethics Board approval and 
review of the study, maintenance of records and reports, and review of source documents including 
source data verification in accordance to the study-specific monitoring plan. Monitors review site 
regulatory and study compliance by identifying findings (non-compliances) 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 center.
Frequency of monitoring visits may be based upon subject enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, observations from previous monitoring 

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visits and any suspected inconsistency in data that requires investigation. Regulatory documents may be 
reviewed at each study center.
14.2. Data Management
The e-CRF data reported to Medtronic will be stored in a secure, password-protected database. Data will 
be reviewed using programmed and manual data checks. Data queries will be made available to centers 
for resolution. Study management reports may be generated to monitor data quality and study 
progress. At the end of the study, the data will be frozen and will be retained indefinitely by Medtronic. 
The investigator must ensure accuracy, completeness and timeliness of the data reported in the e-CRFs. 
Only authorized persons can complete and sign e-CRFs, as specified on the Delegated Tasks List included 
in the Investigator Site File.
The Device interrogation data, Holter data, X-ray, ECG, and Echo data delivered to Medtronic will be 
downloaded or saved to a secure network drive prior to being processed.
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 X-ray images.  
The data reported on the e-CRFs shall be derived from source documents and be consistent with these 
source documents, and any discrepancies shall be explained in writing. 
Device data from transmissions will be uploaded to secure servers.  Save-to-disk data collected at clinic
visits will be sent to Medtronic.  Upon receipt, device data will be maintained with databases and 
retrieved for analysis and reporting.
14.3. Direct Access to Source Data/Documents 
Procedures in the CIP require source documentation.  Source documentation will be maintained at the 
site.  Source documents, which may include worksheets, X-rays, ECGs, patient medical records, echo 
data, Holter data, programmer printouts, and interrogation files, must be created and maintained by the 
investigational site team. 
Where copies of the original source document as well as print outs of original electronic source 
documents are retained, these shall be signed and dated by a member of the investigational site team 
with a statement that it is a true reproduction of the original source document. 

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The sponsor or a regulatory authority may audit or inspect the study site to evaluate the conduct of the 
study. The clinical investigator(s)/institution(s) shall allow study related monitoring, audits, Ethics Board 
review and regulatory inspection by providing direct access to source data/documents.
Study sites should inform Medtronic upon notification of an inspection by a regulatory body 
immediately.  A list of acceptable source documents is described in data management, section 14.2.
14.4. Confidentiality
All records and other information about subjects participating in this study will be treated as 
confidential. All information and data sent to parties involved in study conduct concerning subjects or 
their participation in this study will be considered confidential. A unique subject identification number 
(SID) will be assigned to each subject. Records of the subject/SID relationship will be maintained by the 
study site. The SID number is to be recorded on all subject related study documents to link them to the 
subject’s medical records at the site. Confidentiality of data will be observed by all parties involved at all 
times throughout the clinical study. All data shall be secured against unauthorized access. The privacy of 
each subject and confidentiality of his/her information shall be preserved in reports and when 
publishing any data.  In the US, “Protected Health Information” (PHI) will be maintained in compliance 
with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). To maintain 
confidentiality, the subject’s name or any other PHI should not be recorded on any study document 
other than the Informed Consent Form. This scenario will be covered in the Informed Consent Form. In 
the event a subject’s name/PHI is included for any reason, it will be blinded as applicable. In the event of 
inability to blind the identification (e.g. digital media), it will be handled in a confidential manner by the 
authorized personnel.  Data relating to the study might be made available to third parties (for example 
in case of an audit performed by regulatory authorities), provided the data are treated as confidential 
and that the subject’s privacy is guaranteed. No identifiable subject information will be published.
14.5. Liability
Warranty information is provided in the product packaging for the commercially released transcatheter 
pacing system and additional copies are available upon request.
14.6. Insurance (US)
Medtronic, plc maintains appropriate clinical trial liability insurance coverage as required under 
applicable laws and regulations and will comply with applicable local law and custom concerning specific 
insurance coverage. If required, a clinical trial insurance statement or certificate will be provided to the 
Ethics Board.

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14.7. Insurance (Hong Kong)
Medtronic Hong Kong Medical Ltd is a wholly owned subsidiary of Medtronic, which as the parent 
company of such entities 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. If required, a Clinical Trial insurance statement or certificate will be 
provided to the Ethics Committee.
14.8. CIP Amendments
Medtronic will submit any significant amendment to the CIP, including a justification for this
amendment, to the appropriate regulatory authorities and to the investigators to obtain approval from 
their Ethics Board, if applicable. Administrative amendments to the Clinical Investigation Plan will be 
submitted to the Institution Review/Ethics Board and appropriate regulatory authorities for notification, 
if applicable. Any revisions or amendments to the CIP or Informed Consent Form, along with a 
statement of justification for the changes, will be submitted to all affected governing Ethics Boards, 
according to applicable regulations. All amendments to the CIP shall be agreed upon between Medtronic 
and the principal investigator(s).  Approval by Institution Review/Ethics Board (where applicable) must 
be obtained prior to implementing a CIP revision at the site.
In case the investigator will propose any appropriate modification(s) of the CIP, Medtronic will review 
this proposal and decide whether the modification(s) will be implemented.
14.9. Record Retention
All study-related documents must be retained for a period of at least 2 years after study closure (or 
longer if required by local law/regulation hospital administration requirements). Medtronic will inform 
the investigator/site when these documents are no longer required to be retained.
No study document or image will be destroyed without prior written agreement between Medtronic 
and the investigator. The investigator should take measures to prevent accidental or premature 
destruction of documents. Should the investigator wish to assign the study records to another party or 
move them to another location, advance written notice must be given to Medtronic.
Medtronic will retain the study records according to Medtronic policy.
14.10.
Investigator Records
The investigator is responsible for the preparation and retention of the records including, but not limited 
to, those cited below.  All of the below records, with the exception of case report forms, should be kept 
in the ISF (i.e., the study binder provided to the investigator) or Subject Study Binder. E-CRFs must be 
maintained and signed electronically within the electronic data capture system during the study. The 

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following records are subject to inspection and must be retained for a period of two years (or longer as 
local law or hospital administration requires) after the date on which the investigation is terminated.

Correspondence between the IRB/EC, sponsor, monitor, and/or the investigator that pertains to 
the investigation, including required reports. 

Subject’s case history records, including: 
o
Signed and dated Informed Consent Form, in accordance with local requirements 
o
Observations of adverse events/adverse device effects/device deficiencies
o
Medical history
o
Baseline, study procedure, and follow-up data (if applicable)
o
Documentation of the dates and rationale for any deviation from the protocol

Electronically signed and dated e-CRFs and a blank set of CRFs where required by local law

All approved versions of the CIP and ICF 

Fully executed Clinical Trial Agreement

Ethics Committee approval documentation.  Written information that the investigator or other 
study staff, when member of the Ethics Committee, did not participate in the approval process. 
Approval documentation must include the Ethics Board composition, where required per local 
law.  

List of investigational sites: This list is not yet final at the time of CIP development.  The list will 
be provided under a separate cover and will be maintained by the sponsor.

Subject Identification and enrollment log

Device traceability logs and internal tracking of investigational product

Current curriculum vitae (signed and dated) of principal investigators (US and Hong Kong)

Documentation of delegated tasks

Study training records for investigational site team

Insurance certificates

Final Study Report including the statistical analysis
14.11.
Investigator Reports
The investigator is responsible for the preparation (review and signature) and submission to the sponsor 
of all case report forms, adverse events and adverse device effects (reported per the country-specific 
collection requirements), device deficiencies, deaths, and any deviations from the clinical investigation 
plan.  If any action is taken by an Institution Review/Ethics Board with respect to this clinical study, 
copies of all pertinent documentation must be forwarded to Medtronic in a timely manner. Reports are 
subject to inspection and to the retention requirements as described above for investigator records. 

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Safety data investigator reporting requirements are listed in Section 10.6 of the Adverse Event section. 
The investigator shall prepare and submit in a complete, accurate and timely manner the reports listed 
in this section.
Table 9: Investigator reports applicable for all geographies per Medtronic requirements
Report 
Submit to
Description/Constraints
Withdrawal of 
Ethics Board 
approval
Sponsor and Relevant 
Authorities
The investigator must report a withdrawal of 
approval by the reviewing Ethics Board of the 
investigator’s part of the investigation within 5 
working days.
Study Deviations 
Sponsor and Ethics 
Board
Any deviation from the clinical investigational plan 
shall be recorded together with the explanation of 
the deviation.
Notice of deviations from the CIP to protect the life 
or physical well-being of a subject in an emergency 
shall be given as soon as possible, but no later than 5 
working days after the emergency occurred.  Except 
in such emergency, prior approval is required for 
changes in the plan or deviations. 
Final Report
Ethics Board and 
Relevant Authorities
This report must be submitted within 3 months of 
study completion or termination.
14.12.
Sponsor records
Medtronic shall maintain the following accurate, complete, and current records that includes, but is not 
limited to:

Correspondence that pertains to the AccelAV Study

Executed Clinical Trial Agreement

Current curriculum vitae of investigators 

Device accountability logs and internal tracking of investigational products 

Electronically signed and dated e-CRFs

All approved informed consent templates, and other information provided to the subjects and 
advertisements, including translations

Copies of all Ethics Committee approval letters and relevant Ethics Committee correspondence 

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and Ethics Committee voting list/roster/letter of assurance

Names and addresses of the institutions in which the AccelAV study will be conducted: This list 
is not yet final at the time of CIP development. The list will be provided under a separate cover 
and will be maintained by the sponsor

Regulatory authority correspondence, notification and approval as required by national 
legislation

Insurance certificates 

Names and contact addresses of monitors

Monitoring reports (interim monitoring visit reports, follow-up letters and close-out visit 
reports)

Statistical analyses and underlying supporting data

Final report of the AccelAV study

The approved Clinical Investigation Plan, and study related reports, and revisions

Documentation of delegated tasks

Site qualification reports and/or waivers

Study training records for site personnel and Medtronic personnel involved in the study

Any other records that local regulatory agencies require to be maintained
14.13.
Sponsors reports
Medtronic shall prepare and submit the complete, accurate, clinical study reports to participating 
investigators and Institutional Review/Ethics Board.  Additionally, upon request, Medtronic will provide 
accurate, complete, and current information about any aspect of the investigation.  Safety data 
Medtronic reporting requirements are listed in the Adverse Event section.  
Medtronic records and reports will be maintained in a password-protected document management 
system, and paper documents (where applicable) will be stored in stored in secured file cabinets at 
Medtronic during the course of this study. 
14.14.
Publication and Use of Information
Results may be submitted for publication. If results from the Accel AV study will be published, they will 
be handled according to Medtronic Standard Operating Procedures and as indicated in the Clinical Trial 
Agreement.

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14.14.1. Publication Committee
Medtronic may form an Accel AV Publication Committee from study investigators.  Medtronic personnel 
may serve as members of the committee.  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 in Appendices H, 2) develop the final Publication Plan as outlined in Appendix H, 3) execute the 
Publication Plan, 4) oversee the publication of primary, secondary 
 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 at 
a regular interval, as needed.
14.14.2. Management of Publications
A Publication Committee reviews, prioritizes, and manages all publications including primary, secondary 
and ancillary publications.  Primary and secondary publications are those that address analyses of any or 
all primary objectives or secondary objectives, respectively, as specified in the Clinical Investigation Plan. 
An ancillary publication is any publication that does not address the study objectives identified in the 
Clinical Investigation Plan.  They include publications proposed and developed by other Medtronic 
departments or entities, clinicians participating in this clinical study, and clinicians not participating in 
this clinical study.  The committee will work with Medtronic to ensure that requests do not present 
conflicts with other proposals, are not duplicative, and to determine which ancillary publication 
proposals, if any, will be supported.  
The committee may decide that no publications, including abstracts, will be published prior to the end of 
the study or with individual center data.  Requests for publications on study objectives utilizing subset 
data (e.g. regional) will be evaluated for scientific validity and the ability of Medtronic to provide 
resources.
14.14.3. 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.

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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

Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved.
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 Accel AV Clinical 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.
14.14.4. 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 Board and Competent Authorities of participating countries 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 after the study ends 

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 centers study data accessible to the corresponding investigator after the 
completion of the study, if requested
14.15.
Suspension or Early Termination
Medtronic or a Regulatory Authority may decide to suspend or prematurely terminate the clinical study 
(e.g., if information becomes available that the risk to study subject is higher than initially indicated). If 
the clinical study is terminated prematurely or suspended, Medtronic shall promptly inform the clinical 

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investigators of the termination or suspension and the reason(s) for this. The investigator shall then 
promptly inform the reviewing Ethics Board, the study subjects, and the general practitioner.
Medtronic, Ethics Board or Regulatory Authority may decide to suspend or prematurely terminate an 
investigational site (e.g., in case of expiring approval of the reviewing Ethics Board, non-compliance to 
the Clinical Investigation Plan or lack of enrollment). If an investigational site is suspended or 
prematurely terminated, Medtronic shall promptly inform the investigator(s) of the termination or 
suspension and the reason(s) for this. The investigator shall then promptly inform the reviewing Ethics 
Board, if required, the study subjects and general practitioner.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of 
definite outcomes, investigators must assess whether to continue, modify or immediately stop the 
clinical study in the respective investigational site and immediately inform the sponsor and Ethics Board, 
if applicable. Risks will be continuously monitored, assessed and documented by the investigators.
In case of early investigational site suspension or termination subjects will be followed-up as per 
standard of care.
14.15.1. Early Termination or Suspension
Early termination is the closure of a clinical study that occurs prior to meeting defined endpoints. This is 
possible for the whole study or a single center. 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 center.
Study 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 or suspected performance different from the product’s design intent

Decision by Medtronic or regulatory body (where the study is operating under regulatory body               
authority) 

Technical issues during the manufacturing process
Investigator/center termination or suspension
Possible reasons for clinical investigator or center termination or suspension include but are not limited 
to:

Failure to obtain initial Ethics Board approval or annual renewal of the study

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
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria) 

Lack of enrollment

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 queries and monitoring findings in a
timely manner, etc.) 

Ethics Board suspension of the center

Fraud or fraudulent misconduct is discovered (as defined by local law and regulations)

Investigator request (e.g. no longer able to support the study)
14.15.2. Procedures for Termination or Suspension
Medtronic-initiated and regulatory authority-initiated

Medtronic will promptly inform the clinical investigators of the termination or suspension and 
the reasons and inform the regulatory authority(ies) where required

In the case of study termination or suspension for reasons other than a temporary Ethics 
Committee approval lapse, the investigator will promptly inform the Ethics Committee along 
with the reason(s) for termination or suspension 

In the case of study termination, the investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided

In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic

In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare.
Investigator-initiated 

The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension

The investigator will promptly inform the institution (where required per regulatory 
requirements) 

The investigator will promptly inform the Ethics Committee and provide detailed explanation of 
termination/suspension

The investigator will promptly inform the subjects and/or the personal physician of the subjects 
to ensure appropriate care and follow-up is provided

In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare
Ethics Board-initiated 

The investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days

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
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) 

The investigator will promptly inform the subjects and the personal physician of the subjects, 
with the rationale for the study termination or suspension
14.15.3. Planned Study Closure
Study closure is a process initiated by distribution of a study closure letter. Study closure is defined as 
closure of a clinical study that occurs when Medtronic and/or regulatory requirements have been 
satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, 
whichever occurs first. The study closure process is complete upon distribution of the Final Report or 
after final payments, whichever occurs last. Ongoing Ethics Board oversight is required until the overall 
study closure process is complete. Upon study closure, subjects should be managed and followed per 
physician discretion.
15. References
1 Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, Narasimhan C, Steinwender C, Brugada J,
Lloyd M, Roberts PR, Sagi V, Hummel J, Bongiorni MG, Knops RE, Ellis CR, Gornick CC, Bernabei MA,
Laager V, Stromberg K, Williams ER, Hudnall JH, Ritter P; Micra Transcatheter Pacing Study Group. A
Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Feb 11;374(6):533-41. Doi:
10.1056/NEJMoa1511643. Epub 2015 Nov 9.
2 Duray GZ, Ritter P, El-Chami M, Narasimhan C, Omar R, Tolosana JM, Zhang S, Soejima K, Steinwender
C, Rapallini L, Cicic A, Fagan DH, Liu S, Reynolds D; Micra Transcatheter Pacing Study Group. Long-term
performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing
Study. Heart Rhythm. 2017 May;14(5):702-709. Doi: 10.1016/j.hrthm.2017.01.035. Epub 2017 Feb 10.
3 Roberts PR, Clementy N, Al Samadi F, Garweg C, Martinez-Sande JL, Iacopino S, Johansen JB, Vinolas
Prat X, Kowal RC, Klug D, Mont L, Steffel J, Li S, Van Osch D, El-Chami MF. A leadless pacemaker in the
real-world setting: The Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. 2017
Sep;14(9):1375-1379. Doi: 10.1016/j.hrthm.2017.05.017. Epub 2017 May 11.
4 Lloyd M, Reynolds D, Sheldon T, Stromberg K, Hudnall JH, Demmer WM, Omar R, Ritter P, Hummel J,
Mont L, Steinwender C, Duray GZ. Rate adaptive pacing in an intracardiac pacemaker. Heart Rhythm.
2017 Feb;14(2):200-205. Doi: 10.1016/j.hrthm.2016.11.016. Epic 2016 Nov 15.
5 Gillis AM, Russo AM, Ellenbogen KA, Swerdlow CD, Olshansky B, Al-Khatib SM, Beshai JF, McComb JM,
Nielsen JC, Philpott JM, Shen WK. HRS/ACCF expert consensus statement on pacemaker device and
mode selection. J Am Coll Cardiol. 2012 Aug 14;60(7):682-703. Doi: 10.1016/j.jacc.2012.06.011. Epub
2012 Jul 30.

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6 Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L,
Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C.
Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results
from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 May 11. Pii: S1547-
5271(18)30470-3. Doi: 10.1016/j.hrthm.2018.05.004.
7 Garweg C, Splett V, Sheldon TJ, Chinitz L, Ritter P, Steinwender C, Lemme F, Willems R. Behavior of 
leadless AV synchronous pacing during atrial arrhythmias and stability of the atrial signals over time-
Results of the MARVEL Evolve subanalysis. Pacing Clin Electrophysiol. 2019 Mar;42(3):381-387.
8 Steinwender et al.  Atrioventricular synchronous pacing using a leadless ventricular pacemaker:  
Results from the MARVEL 2 study.  JACC Clin Electrophysiol. 2019 Nov 2. pii: S2405-500X(19)30843-6. 
doi: 10.1016/j.jacep.2019.10.017. [Epub ahead of print]
16. Appendices 
APPENDIX A: DATA COLLECTION ELEMENTS (ELECTRONIC CASE 
REPORT FORMS)
Electronic Case Report Forms for the AccelAV clinical study will be provided under separate cover. Final 
e-CRFs will be provided to sites via the electronic data management system after the site has fulfilled all 
requirements for database access.
APPENDIX B: INFORMED CONSENT TEMPLATE(S)
Geography-specific Informed Consent templates will be provided under separate cover.
APPENDIX C: PARTICIPATING INVESTIGATORS AND 
INSTITUTIONS
At the time of AccelAV CIP Version 1.0 completion, site confirmation was not finalized. A complete list of 
participating investigators and institutions (including names, titles/professional positions, address(es), 
and telephone numbers) where study activities will be conducted will be distributed under a separate 
cover when available.
APPENDIX D: ETHICS COMMITTEE
At the time of AccelAV CIP Version 1.0 completion, site confirmation was not yet finalized. Therefore, a 
complete list of participating Ethics Committee and the Chairperson(s) will be distributed under 
separate cover when available upon request.

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APPENDIX E: FORESEEABLE ADVERSE EVENT LIST
The information provided in this section pertains to foreseeable adverse events that may be observed in 
the AccelAV Study and may assist in identifying those events that are unexpected in nature. Potential 
risks and associated adverse events related to the patient’s implanted Micra device are in alignment 
with the product labeling. 
Potential risks associated with the AccelAV study as well as risk minimization are discussed within 
Section 9. Treatment required for AccelAV study related adverse events may include device 
reprogramming, medications, or other surgical and medical remedies.  Evaluation of potentially 
anticipated events may involve data in this Clinical Investigation Plan as well as a thorough review of all 
available information (e.g. labeling, current event reporting, published data, etc.).  
Potential adverse events related to the presence or performance of Micra AV include: 

Inadequate rate adaptive pacing during study participation 

Unintended loss of capture

Loss of pacing

Skin rash/irritation, or allergic reaction

Reduced device longevity resulting in early replacement procedure could result in complications 
from replacement procedure

Dizziness

Palpitations

Angina

Swelling in Feet

Pulsation in neck

Fatigue

Shortness of breath

Difficulty sleeping

Syncope

Decreased heart rate

Arrhythmia

Asystole

Syncope/fainting

Death

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Table 10 provides examples of adverse events associated with the presence or performance of the Micra 
Transcatheter Pacing System that reported in the Micra IDE Clinical Study.
Table 10: Summary of System Related AEs by Severity and MedDRA Term (Micra IDE Clinical 
Study)
Number of Events (Number, % Subjects)
(Denominator = 726 Subjects with Implant Attempt)
Adverse Event Keyterm
Event
Serious Event
Complication
Total Adverse Events
65 (60, 8.3%)
38 (37, 5.1%)
32 (30, 4.1%)
Cardiac arrhythmias
17 (16, 2.2%)
7 (7, 1.0%)
6 (6, 0.8%)
  Atrioventricular block complete
8 (8, 1.1%)
5 (5, 0.7%)
5 (5, 0.7%)
  Bundle branch block right
4 (4, 0.6%)
1 (1, 0.1%)
0 (0, 0.0%)
  Sinus node dysfunction
1 (1, 0.1%)
0 (0, 0.0%)
0 (0, 0.0%)
  Ventricular fibrillation
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
  Ventricular tachycardia
3 (3, 0.4%)
0 (0, 0.0%)
0 (0, 0.0%)
Traumatic Cardiac Injury
13 (13, 1.8%)
12 (12, 1.7%)
12 (12, 1.7%)
  Cardiac perforation
3 (3, 0.4%)
3 (3, 0.4%)
3 (3, 0.4%)
  Pericardial effusion
10 (10, 1.4%)
9 (9, 1.2%)
9 (9, 1.2%)
Pacing Issues
9 (9, 1.2%)
4 (4, 0.6%)
2 (2, 0.3%)
  Device dislocation
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
  Device pacing issue
8 (8, 1.1%)
3 (3, 0.4%)
1 (1, 0.1%)
Other
26 (25, 3.4%)
15 (15, 2.1%)
12 (12, 1.7%)
  Angina pectoris
3 (3, 0.4%)
0 (0, 0.0%)
0 (0, 0.0%)
  Cardiac failure
7 (7, 1.0%)
7 (7, 1.0%)
6 (6, 0.8%)
  Chest pain
1 (1, 0.1%)
0 (0, 0.0%)
0 (0, 0.0%)
  Non-cardiac chest pain
5 (5, 0.7%)
1 (1, 0.1%)
1 (1, 0.1%)
  Pacemaker syndrome
5 (5, 0.7%)
3 (3, 0.4%)
2 (2, 0.3%)
  Pericarditis
2 (2, 0.3%)
1 (1, 0.1%)
1 (1, 0.1%)
  Presyncope
2 (2, 0.3%)
2 (2, 0.3%)
1 (1, 0.1%)
  Syncope
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
Table 11 provides a summary of procedure related adverse events by MedDRA keyterm that occurred 
during the Micra IDE clinical study.
Table 11: Summary of Procedure Related AEs by Severity and MedDRA Term (Micra IDE 
Clinical Study)
Number of Events (Number, % Subjects)
(Denominator = 726 Subjects with Implant Attempt)
Adverse Event Keyterm
Event
Serious Event
Complication
Total Adverse Events
117 (100, 13.8%)
48 (44, 6.1%)
50 (45, 6.2%)
Cardiac arrhythmias
17 (16, 2.2%)
8 (8, 1.1%)
7 (7, 1.0%)
  Atrioventricular block complete
8 (8, 1.1%)
5 (5, 0.7%)
5 (5, 0.7%)
  Bundle branch block right
4 (4, 0.6%)
1 (1, 0.1%)
0 (0, 0.0%)

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Number of Events (Number, % Subjects)
(Denominator = 726 Subjects with Implant Attempt)
Adverse Event Keyterm
Event
Serious Event
Complication
  Ventricular fibrillation
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
  Ventricular tachycardia
4 (4, 0.6%)
1 (1, 0.1%)
1 (1, 0.1%)
Embolism and thrombosis
5 (5, 0.7%)
3 (3, 0.4%)
3 (3, 0.4%)
  Deep vein thrombosis
4 (4, 0.6%)
2 (2, 0.3%)
2 (2, 0.3%)
  Pulmonary embolism
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
Events at Groin Puncture Site
51 (49, 6.7%)
11 (11, 1.5%)
11 (11, 1.5%)
  Arterial injury
5 (5, 0.7%)
0 (0, 0.0%)
1 (1, 0.1%)
  Arteriovenous fistula
5 (5, 0.7%)
4 (4, 0.6%)
4 (4, 0.6%)
  Impaired healing
1 (1, 0.1%)
0 (0, 0.0%)
0 (0, 0.0%)
  Incision site complication
1 (1, 0.1%)
0 (0, 0.0%)
0 (0, 0.0%)
  Incision site haematoma
8 (8, 1.1%)
0 (0, 0.0%)
1 (1, 0.1%)
  Incision site haemorrhage
18 (17, 2.3%)
3 (3, 0.4%)
2 (2, 0.3%)
  Incision site infection
2 (2, 0.3%)
0 (0, 0.0%)
0 (0, 0.0%)
  Incision site pain
3 (3, 0.4%)
0 (0, 0.0%)
0 (0, 0.0%)
  Incisional drainage
6 (6, 0.8%)
2 (2, 0.3%)
2 (2, 0.3%)
  Vascular pseudoaneurysm
2 (2, 0.3%)
2 (2, 0.3%)
1 (1, 0.1%)
Traumatic Cardiac Injury
13 (13, 1.8%)
12 (12, 1.7%)
12 (12, 1.7%)
  Cardiac perforation
3 (3, 0.4%)
3 (3, 0.4%)
3 (3, 0.4%)
  Pericardial effusion
10 (10, 1.4%)
9 (9, 1.2%)
9 (9, 1.2%)
Pacing Issues
2 (2, 0.3%)
2 (2, 0.3%)
2 (2, 0.3%)
  Device dislocation
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
  Device pacing issue
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
Other
29 (28, 3.9%)
12 (12, 1.7%)
15 (15, 2.1%)
  Acute myocardial infarction
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
  Angina pectoris
3 (3, 0.4%)
0 (0, 0.0%)
0 (0, 0.0%)
  Back pain
1 (1, 0.1%)
0 (0, 0.0%)
0 (0, 0.0%)
  Chest pain
1 (1, 0.1%)
0 (0, 0.0%)
0 (0, 0.0%)
  Dysuria
1 (1, 0.1%)
0 (0, 0.0%)
0 (0, 0.0%)
  Hypotension
3 (3, 0.4%)
1 (1, 0.1%)
3 (3, 0.4%)
  Medication error
2 (2, 0.3%)
1 (1, 0.1%)
2 (2, 0.3%)
  Metabolic acidosis
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
  Non-cardiac chest pain1
6 (6, 0.8%)
1 (1, 0.1%)
1 (1, 0.1%)
  Osteoarthritis
1 (1, 0.1%)
0 (0, 0.0%)
1 (1, 0.1%)
  Pericarditis
2 (2, 0.3%)
1 (1, 0.1%)
1 (1, 0.1%)
  Presyncope
5 (5, 0.7%)
5 (5, 0.7%)
3 (3, 0.4%)
  Syncope
1 (1, 0.1%)
1 (1, 0.1%)
1 (1, 0.1%)
  Urinary retention
1 (1, 0.1%)
0 (0, 0.0%)
1 (1, 0.1%)
1One event of non-cardiac chest pain was considered to have an unknown relationship to the Micra procedure.
APPENDIX F: LABELING
Labeling and packaging for all products used in this study will follow the local regulatory requirements. 
Labeling for all system components market released at study start in the respective geographies can be 
found with each package insert and/or will be available on http://manuals.medtronic.com. 

AccelAV Clinical Investigation Plan 
MDT19018
Version 2.0
Page 90 of 90
Medtronic Controlled Information
056-F275, v A Clinical Investigation Plan Template
The Model ER220 Extended Range Holter Monitor is investigational in certain geographies and will be 
labelled according to local requirements with the statements “For Medtronic Clinical Use Only.  Not 
intended for commercial distribution."
APPENDIX G: INVESTIGATOR STATEMENT
The investigator Statement will be provided under a separate cover.
APPENDIX H: PUBLICATION PLAN
The Publication Plan will be provided under a separate cover.
APPENDIX I: ACCELAV Study Reference Guide for Cardiac 
Echocardiogram Data Acquisition
The AccelAV Study Reference Guide for Cardiac Echo Data Acquisition will be provided under a separate 
cover.
17. Version History
Version
Summary of Changes
Author(s)/Title
1.0 06JAN2020
Not Applicable, New Document
Nicole Wood, Pr CRS
Kurt Stromberg, Sr Pr Statistician
Francesca Lemme, Sr Statistician
Vincent Splett, Pr Scientist
2.0 24JAN2020
Changed Version number & date of CIP.
Pg. 13, 2. Synopsis: removed ‘this study will be 
conducted upon market approval of the Micra 
AVTMTranscatheter Pacing System’
Pg. 87, Appendix E-Foreseeable Adverse 
Events: ‘changed AccelAV software to AccelAV 
study’. 
Revised ‘Potential adverse events related to 
participation in the AccelAV study include:’  to 
‘Potential adverse events related to the 
presence or performance of the Micra AV 
would include:’
Removed bullet ‘discomfort during exercise 
manuvers’.
Page 90: retitled Echo Acquistion Manual to 
AccelAV Study Reference Guide for Cardiac 
Echocardiogram Data Acquistion
Nicole Wood, Pr CRS
Kurt Stromberg, Sr Pr Statistician
Francesca Lemme, Sr Statistician
Vincent Splett, Pr Scientist