BlueSync Field Evaluation
Conditions: Bradycardia
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

This document is electronically controlled. Printed copies are considered uncontrolled. 
Confidential 
 
 
Evaluation Plan 
Title  BlueSync™ Field Evaluation  
 Product Name BlueSync™ Smart Monitoring System  
Sponsor/Local Sponsor Medtronic, PLC. 
8200 Coral Sea Street NE 
Mounds View, MN U.S.A. 55112 
1-800-328-2518 
 
Europe, Middle East, Africa 
Medtronic, Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
Manufacturer Medtronic, Inc.  
Operational Headquarters 
710 Medtronic Parkway 
Minneapolis MN 55432 
(+1) 763-514-4000 
Document Version Version 1.0 
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. 
 
 

 
Page 2 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Sponsor Contact 
Medtronic, Inc. is sponsoring the BlueSync™ Field Evaluation. Regional contact information is provided 
below. This information may be subject to change during the course of the field evaluation. Periodic 
updates to the evaluation contact information will be sent to sites as needed.  
Table 1: Evaluation Sponsor Contact Information 
Evaluation Contacts 
Worldwide Study Leader 
 
Name, Title: Keith Holloman, Sr. Clinical 
Research Specialist 
Direct Phone: 1-763-525-1645 
Direct Fax: 1-763.526.5897 
keith.holloman@medtronic.com 
Europe Study Leader Europe 
 
Name, Title: Kevin Hermans, PhD, Clinical Research 
Specialist 
Direct Phone: +31 (0)43 356 6437 
Direct Fax: +31 (0)43 356 6514 
 kevin.hermans2@medtronic.com  
 
 
 
 

 
Page 3 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
1. Version History 
 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
Not Applicable, New Document 
Keith Holloman, Sr. Clinical 
Research Specialist 
 
 

 
Page 4 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
2. Investigator Statement 
Investigators will be provided with a separate investigator agreement to document their obligation and 
commitment with respect to field evaluation conduct.  
 
 

 
Page 5 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Table of Contents  
 
Sponsor Contact ................................................................................................................... 2 
1. 
Version History ........................................................................................................... 3 
2. 
Investigator Statement................................................................................................. 4 
Table of Contents ................................................................................................................. 5 
3. 
Glossary ....................................................................................................................... 8 
4. 
Synopsis ...................................................................................................................... 9 
5. 
Introduction .............................................................................................................. 14 
5.1. 
Background ................................................................................................................. 14 
5.2. 
Purpose ........................................................................................................................ 15 
6. 
Objectives and Endpoints ......................................................................................... 15 
6.1. 
Objectives ................................................................................................................... 15 
6.1.1. 
Primary Objective ................................................................................................................... 15 
6.1.2. 
Secondary Objective ............................................................................................................... 15 
6.1.3. 
Ancillary Objectives................................................................................................................ 16 
6.1.4. 
Additional Analysis ................................................................................................................. 16 
6.2. 
Endpoints .................................................................................................................... 16 
6.2.1. 
Primary Endpoint ................................................................................................................... 16 
7. 
Evaluation Design ..................................................................................................... 17 
7.1. 
Duration ....................................................................................................................... 17 
7.2. 
Rationale ..................................................................................................................... 17 
8. 
Product Description .................................................................................................. 18 
8.1. 
General......................................................................................................................... 18 
8.2. 
Evaluation Components ........................................................................................... 18 
8.3. 
Product Use ................................................................................................................. 19 
8.4. 
Product Training Requirements ............................................................................. 20 
9. 
Selection of Patients .................................................................................................. 20 
9.1. 
Evaluation Population .............................................................................................. 20 
9.2. 
Patient Enrollment .................................................................................................... 20 
9.3. 
Inclusion Criteria ....................................................................................................... 21 
9.4. 
Exclusion Criteria ....................................................................................................... 21 
9.5. 
Minimization of Bias.................................................................................................. 21 
10. 
Evaluation Procedures .............................................................................................. 22 
10.1. 
Evaluation Personnel Requirements ..................................................................... 22 
10.2. 
Site Approval to participate in Field Evaluation ................................................. 23 
10.3. 
Schedule of Events .................................................................................................... 23 
10.3.1. 
Patient Screening ................................................................................................................ 26 
10.4. 
Enrollment ................................................................................................................... 26 
10.5. 
Implant ........................................................................................................................ 26 

 
Page 6 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
10.6. 
Baseline Visit .............................................................................................................. 26 
10.7. 
Twelve Month Follow-up Period............................................................................. 27 
10.8. 
Evaluation Completion ............................................................................................. 27 
10.9. 
Assessment of Safety................................................................................................ 28 
10.10. 
Recording Data ....................................................................................................... 28 
10.11. 
Patient Withdrawal or Discontinuation ............................................................. 28 
10.11.1. 
Patient Does Not Meet Eligibility Criteria ........................................................................... 28 
10.11.2. 
Patient chooses not to continue participation in the evaluation ........................................... 28 
10.11.3. 
Investigator Withdraws Patient ........................................................................................... 28 
11. 
Risks and Benefits ..................................................................................................... 28 
11.1. 
Potential Risks ........................................................................................................... 28 
11.2. 
Potential Benefits ...................................................................................................... 29 
11.3. 
Risk-Benefit Rationale.............................................................................................. 29 
11.4. 
Reporting of Adverse Events ................................................................................... 29 
11.5. 
Patient Death ............................................................................................................. 29 
11.6. 
Product Complaint Reporting ................................................................................. 29 
12. 
Statistical Design and Methods ................................................................................. 29 
12.1. 
Primary Objective ...................................................................................................... 30 
12.1.1. 
Hypothesis .......................................................................................................................... 30 
12.1.2. 
Performance Requirements ................................................................................................. 30 
12.1.3. 
Endpoint Definition ........................................................................................................... 30 
12.1.4. 
Analysis Methods ................................................................................................................ 30 
12.1.5. 
Determination of Patients/Data for Analysis ...................................................................... 30 
12.1.6. 
Sample Size ......................................................................................................................... 31 
12.2. 
Secondary Objective ................................................................................................. 31 
12.2.1. 
Hypothesis .......................................................................................................................... 31 
12.2.2. 
Performance Requirements ................................................................................................. 31 
12.2.3. 
Endpoint Definition ........................................................................................................... 31 
12.2.4. 
Analysis Methods ................................................................................................................ 31 
12.2.5. 
Determination of Patients/Data for Analysis ...................................................................... 32 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
13. 
Evaluation Administration ........................................................................................ 35 
13.1. 
Data Management ..................................................................................................... 35 
13.2. 
Confidentiality ............................................................................................................ 35 
13.3. 
Record Retention ....................................................................................................... 35 
13.3.1. 
Investigator Records ........................................................................................................... 35 
13.4. 
Investigator Reports................................................................................................. 36 
13.5. 
Sponsor Records ........................................................................................................ 36 
13.6. 
Publication and Use of Information ...................................................................... 36 
13.7. 
Publication Committee ............................................................................................. 36 

 
Page 7 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
13.8. 
Management of Primary, Secondary and Ancillary Publications .................... 37 
13.9. 
Criteria for Determining Authorship ..................................................................... 37 
13.10. 
Transparency ........................................................................................................... 38 
14. 
References ................................................................................................................. 38 
15. 
Appendices ................................................................................................................ 38 
 
 
Figures 
 
Figure 1 Explanation of BlueSync™ ................................................................................................................... 19 
Figure 2 MyCareLink Heart App Operation....................................................................................................... 20 
Figure 3 Evaluation Screening, Enrollment and Follow-up ............................................................................... 25 
 
 
Tables 
Table 1: Evaluation Sponsor Contact Information ............................................................................................... 2 
Table 2: System component information for the BlueSync™ Smart Monitoring System in Europe .................. 10 
Table 3: System component information for the Azure™ Smart Pacemaker ..................................................... 18 
Table 4: Evaluation Personnel Requirements..................................................................................................... 22 
Table 5: Data collection and evaluation procedure requirements ...................................................................... 24 
Table 6: Investigator reports applicable for all geographies per Medtronic requirements ................................. 36 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Page 8 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
3. Glossary 
 
Term 
Definition 
app 
Application 
Azure™  
Azure™ Smart Pacemaker 
BlueSync™ 
BlueSync Smart Monitoring System 
CRF 
Case Report Form 
CRT-P 
Cardiac Resynchronization Therapy Pacemaker 
FEA 
Field Evaluation  Agreement 
CV 
Curriculum Vitae 
Ethics Committee 
MEC/IRB/HREB/Ethics Board 
DWAS 
Data Warehouse & Analytics Services 
GCP 
Good Clinical Practice 
IPE 
In-person evaluation 
LV 
Left Ventricular 
MCL Heart app 
MyCareLink Heart App 
RA 
Right Atrial 
ICF 
Informed Consent Form 
RRT 
Recommended Replacement Time 
RV 
Right Ventricular 
Smart device 
Smartphone or Tablet 
 
 

 
Page 9 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
4. Synopsis 
 
Title 
BlueSync™ Field Evaluation 
Type 
 
Post Market Non-interventional Field Evaluation 
Product Name 
BlueSync  
Smart Monitoring System (BlueSync) 
Sponsor  
Medtronic, Inc. 
Cardiac Rhythm and Heart Failure Clinical Research 
8200 Coral Sea Street NE 
Mounds View, MN U.S.A. 55112 
1-800-328-2518 
Regional Sponsor 
Medtronic, Bakken Research Center B.V. 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
+31-43-35-66-566 
Indication under 
investigation  
Patients indicated for pacemaker or CRT-P therapy and implanted with 
the commercial released Medtronic Azure™ Pacemaker or CRT-P 
Percepta™, Serena™, Solara™ CRT-P device within approved indications 
for use. Patients will be provided standard care after implant. 
Purpose 
The purpose of this field evaluation is to collect and evaluate information 
related to CareLink transmission compliance as well as patient perceived 
benefit of BlueSync™ and clinic perception of the value of BlueSync™ 
and satisfaction with BlueSync™. To assess the CareLink transmission 
compliance (adherence to scheduled transmission), the primary 
endpoint will characterize the proportion of the CareLink scheduled 
transmissions that are completed within a prescribed time period. The 
evaluation will also assess adoption to remote monitoring, patient 
perceived benefit of BlueSync™ (how patients interact with the smart 
device application) and clinic perception of the value of BlueSync™ and 
satisfaction with BlueSync™ (benefits experienced by clinicians that use 
BlueSync™). Interim analyses will take place after 2-months of follow up 
for all enrolled patients. Enrollment and/or follow-up will not be stopped 
due to the interim analyses. 
Product Status 
The evaluation will be conducted using the components described in 
Table 2. All components will be market released. Instructions for use of 
the devices used in this evaluation are provided in their respective 
manuals. 

 
Page 10 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Table 2: System component information for the BlueSync™ 
Smart Monitoring System in Europe 
Model Name  
Model Number  
Serial 
Number 
Prefix 
Azure™ XT DR MRI 
SureScan™ 
W2DR01 
RNF 
Azure™ S DR MRI 
SureScan™ 
W3DR01 
RNJ 
Azure™ XT SR MRI 
SureScan™ 
W2SR01 
RNE 
Azure™ S SR MRI 
SureScan™ 
W3SR01 
RNI 
Percepta™ CRT-P Quad 
MRI SureScan™ 
W4TR04 
RNV 
Percepta™ CRT-P MRI 
SureScan™ 
W1TR04 
RNU 
Serena™ CRT-P Quad 
MRI SureScan™ 
W4TR05 
RNX 
Serena™ CRT-P MRI 
SureScan™ 
W1TR05 
RNW 
Solara™ CRT-P Quad 
MRI SureScan™ 
W4TR06 
RNZ 
Solara™ CRT-P MRI 
SureScan™ 
W1TR06 
RNY 
 
System component #1 
• 
BlueSync™ Smart Monitoring System 
• 
MyCareLink Heart app 
• 
MSW002 (Android), MSW004 (IOS) 
System component #2 
• 
Azure™ Dual and Single Chambered Smart Pacemaker and 
Percepta™, Serena™, Solara™ CRT-P devices with Bluetooth 
enabled functionality, as indicated in Table 2. 
System component #3 
• 
All market-released pacing and LV leads 

 
Page 11 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Additional system components 
• 
Patient’s own smart device. 
BlueSync™ offers app-based remote monitoring via the patient’s own 
smart device.  
The Azure™ Smart Pacemaker includes a Bluetooth Low Energy chip 
that allows wireless communication between the pacemaker and the 
patient’s smart device.  
The patient’s smart device with BlueSync™ acts as a hub and transmits 
the data to the remote monitoring network. 
Primary Objective 
To assess the CareLink compliance to scheduled transmission, the 
primary objective is to characterize the proportion of the CareLink 
quarterly scheduled transmissions that are completed at specified 
intervals  during the 12-month follow-up period after the baseline visit in 
the CareLink Database via BlueSync™. 
Sample Size 
Approximately 700 patients may complete the screening questionnaire. 
It is expected that 60% (420) of the screened patients will use smart 
technology and 60% (252) of the screened patients that use smart 
technology will meet the inclusion/exclusion criteria and may be enrolled 
in the evaluation. 
 
Assuming attrition from enrollment through 12-month follow-up is 
7%, a total of 252 enrolled patients would result in approximately 
234 patients available to assess the primary endpoint.  
 
A sample size of 234 evaluable patients will produce a two-sided 95% 
confidence interval width of approximately 10%. 
 
The evaluation is expected to be conducted at approximately 20 
evaluation sites, 10 in Europe and 10 in the United States. Up to 
approximately 35 patients will participate from each evaluation site.  
Clinicians will screen sequential patients who are indicated for implant 
with a pacemaker or CRT-P device.  Patients who will be/have been 
implanted with Azure™ pacemaker or Percepta™, Serena™, Solara™ 
CRT-P device will be invited to participate in the evaluation if the 
specified selection criteria are met. Patients will complete a visit at the 
enrollment/baseline which is standard of care. Additionally patients will 
complete a survey during the enrollment/baseline visit, and once during 
the 12 month follow-up after the baseline visit which is designed to 
measure patient engagement. 
Duration  
The expected evaluation duration is approximately 16 months: Four 
months for enrollment of all patients and 12 months to complete follow-
up. The duration of individual patient participation will be at least 12 
months from enrollment to 12-months follow-up after the baseline visit. 

 
Page 12 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Screening Criteria 
• 
Patient indicated for a pacemaker with or without Cardiac 
Resynchronization Therapy (CRT) 
Inclusion/Exclusion 
Criteria 
Inclusion criteria: 
• 
Patient will be/have been implanted with an Azure™ or 
Percepta™, Serena™, Solara™ CRT-P device compatible with 
BlueSync  
• 
New or replacement devices are allowed. 
• 
Must have smart device (Smartphone or tablet) that meets 
system requirements and be willing to use during evaluation 
period 
• 
Must be able to complete the required 12 month follow-up after 
the baseline visit 
• 
Must have legal age according to local law 
Exclusion criteria: 
• 
Patient unwilling to complete required surveys during 12 month 
evaluation period. 
Evaluation Procedures and 
Assessments 
Screening: 
The clinician will meet with the patient to conduct patient screening and 
then complete a screening questionnaire that may include and not be 
limited to the following questions: 
• 
Is the patient willing to do remote monitoring? 
• 
Does the patient own a smart device?  
• 
Is the operating system on the patient’s smart device 
compatible with MCL Heart app? 
• 
Is the patient willing to participate in the evaluation? 
• 
Baseline Information about the patient 
If the patient declines participation, the reasons will be documented on 
the screening log. 
Patient screening must be completed within two weeks after implant of 
the Azure or CRT-D device.    
 
Enrollment: 
When a patient completes the device pairing of the BlueSync compatible 
device with the CareLink network via the My CareLink Heart App.   
 
Implant: 
Device implant is not being evaluated in the evaluation; is not part of 
the evaluation and will be performed according to standard of care. No 
documentation of programming of device information is required.  
 
Baseline: 
The following information will be collected at the baseline visit: 

 
Page 13 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
• 
Patient Demographics 
• 
Age 
• 
Education 
• 
Smart device Experience 
• 
Smart device usage 
The following procedures will be completed after implant and within two 
week of discharge from the hospital or clinic or when a patient with a 
previously implanted BlueSync device is converted to the BlueSync 
system.  
• 
The process to pair the MyCareLink Heart app and the patient’s 
smart device to the patient’s implanted device will be initiated. 
Specific instruction will be provided to the clinic and patient 
under separate cover.  
• 
After the patient’s implanted device is paired with the 
MyCareLink Heart app, a transmission will be used to confirm 
that the MyCareLink Heart app in the patient’s smart device is 
paired with the patient’s implanted device.  
• 
The patient will complete their first survey to assess patient 
perceived benefit of BlueSync™.  
• 
A clinician survey corresponding to each patient will be 
completed to assess clinic perception of value of BlueSync™. 
Twelve Month Follow-up Period After the Baseline Visit: 
• 
A total of six scheduled transmissions with the MyCareLink Heart 
app will be completed during the 12-month follow-up period.  
• 
Two monthly scheduled transmissions must occur in the first 2 
months of follow up (one scheduled transmission at month 1 
and the second transmission at month 2). 
• 
Four scheduled transmissions must occur quarterly 1 each 
starting at month 3 of follow up (one scheduled at month 3, 
another scheduled at month 6, the next scheduled at month 9 
and the last one scheduled at month 12).   
• 
During the 12-month follow-up period after the baseline visit 
patients will complete a survey during a scheduled device 
follow-up to assess patient perceived benefit of BlueSync™ 
• 
In those situations where a routine device follow-up visit is not 
scheduled the survey will be completed using remote options. 
• 
Clinician surveys corresponding to each patient will be 
completed to assess clinic perception of value of BlueSync™ and 
satisfaction with BlueSync™ at baseline and 12 months 
• 
At each clinic; a workflow questionnaire will be completed by 
clinic personnel after all enrolled patients have completed the 
device pairing  
• 
Clinic personnel will  complete and maintain an event log which 
will include, but not be limited to the following 
o 
Technical issues related to the BlueSync phone app 

 
Page 14 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
o 
Impact of CareLink alerts on workflow 
Evaluation completion: 
• 
The patient’s participation in the evaluation will end after 12 
months of follow-up.  
Safety Assessments 
The products used in the evaluation are market approved and used 
within the current indications for use as indicated in the product 
labeling. The collection of adverse event and patient death data is not 
required to meet the objective(s) of this evaluation. Thus, no clinical 
assessment of safety data will be performed during this field evaluation. 
5. Introduction  
5.1. 
Background  
Modern cardiac disease management seeks to integrate multiple device technologies and capabilities to 
optimize disease management and health outcomes. The BlueSync™ Smart Monitoring System utilizes a 
Bluetooth enabled smart device application to interface with the Azure™ Smart pacemaker to provide 
wireless remote monitoring for patients. 
The use of smart device technology allows for the integrated monitoring by a smart device and eliminates 
the “bedside monitor”. The informative and reassuring app allows the patient to view the status of 
CareLink transmission, physical activity and provides access to educational information which creates a 
completely new experience for the patient. 
Since Medtronic has never launched a product that relies on patients utilizing their own smart device 
instead of a home monitor, BlueSync™ will be evaluated for compliance, patient perceived benefit, and 
value to the clinic using the technology as well as for identifying workflow issues in this new paradigm. 
 
Value of Remote Monitoring for pacemaker patients  
The 2015 HRS Expert Consensus Statement on Remote Interrogation states that remote monitoring 
represents the new standard of care with alert-driven in-person evaluation (IPE) replacing most routine 
office interrogations. 
Early detection of arrhythmias, lead issues and battery Recommended Replacement Time (RRT) may lead 
to important clinical actions for pacemaker patients. Pacemaker patients have a high risk of AF. AF is a 
known risk factor for stroke. There is an opportunity to better manage AF leveraging the pacemaker 
capabilities1.  
In large studies, remote monitoring of pacemaker patients is associated with: 
• 
Increased survival: Patients with high Remote Monitoring (RM) adherence had 53% greater 
survival than low RM and 140% greater survival than no RM2 
• 
26% faster diagnosis of clinical actionable events (PREFER)3 
• 
66% fewer hospitalizations from atrial arrhythmias (COMPAS)4 
• 
56% fewer ambulatory visits (COMPAS)4 

 
Page 15 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
• 
Lower health care expenditures in office visits among patients with permanent pacemakers          
( PPMs)5 
5.2. 
Purpose 
The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission 
compliance as well as patient perceived benefit of BlueSync™ and clinical perception of value of 
BlueSync™ and satisfaction with BlueSync™. Collection of this data will provide data to support 
development of clinical evidence that will be used to aid in market adoption. To assess the CareLink 
transmission compliance (adherence to scheduled transmission), the primary endpoint will measure the 
proportion of the CareLink quarterly scheduled transmissions that are completed within a prescribed time 
period. The field evaluation will also assess adoption to remote monitoring, patient perceived benefit of 
BlueSync™ (how patients interact with the MyCareLink Heart application) and clinic perception of value of 
BlueSync™ and satisfaction with BlueSync™ (benefits experienced by clinicians that use BlueSync™). 
Interim analyses will take place after 2-months of follow up for all enrolled patients. Enrollment and/or 
follow-up will not be stopped due to the interim analyses. 
The expected evaluation duration is 16 months; four months for enrollment and twelve months to 
complete follow-up. The duration of individual patient participation will be 12 months from enrollment 
date.  
6. Objectives and Endpoints 
6.1. 
Objectives 
6.1.1. 
Primary Objective 
To assess chronic CareLink transmission compliance (adherence to scheduled transmission), the primary 
objective is to characterize the proportion of the CareLink quarterly scheduled transmissions that are 
completed within the prescribed window during the 12-month follow-up after the baseline visit in the 
CareLink Database via the MyCareLink Heart™ app 
• 
Four scheduled transmissions must occur quarterly 1 each starting at month 3 of follow up (one 
scheduled at month 3, another scheduled at month 6, the next scheduled at month 9 and the last 
one scheduled at month 12). 
6.1.2. 
Secondary Objective 
To assess acute (1st two months) CareLink transmission compliance (adherence to scheduled 
transmission), the secondary objective is to characterize the proportion of the CareLink monthly 
scheduled transmissions that are completed within the prescribed window during the2-month follow-up 
after the baseline visit in the CareLink Database via the MyCareLink Heart™ app 
• 
Two monthly scheduled transmissions must occur in the first 2 months of follow up (one 
scheduled transmission at month 1 and the second transmission at month 2). 
 

 
Page 16 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
6.1.4. 
Additional Analysis 
Analytics data will be evaluated by the BlueSync™ Systems Engineer and will not be part of the 
objectives for the evaluation. 
6.2. 
Endpoints 
6.2.1. 
Primary Endpoint 
Proportion of CareLink quarterly scheduled transmissions that are completed within prescribed window 
during the 12-month follow-up after the baseline visit in the Carelink Database using BlueSync™.  
Rationale for endpoint selection: The primary endpoint will use the proportion of CareLink quarterly 
scheduled transmissions that are completed within prescribed window during the 12-month follow-up 
after the baseline visit in the CareLink Database via BlueSync™ to assess compliance with scheduled 
transmissions. 
Remote monitoring of cardiac implantable electronic devices (CIEDs) has been shown to be cost effective, 
convenient and associated with reduced mortality2. Patient compliance with monitoring is another 
important criterion which is important to clinicians. By demonstrating improved compliance with 
monitoring over time, the evaluation will support the primary benefits of BlueSync™ which are: 
• 
Seamless remote monitoring via a patient’s smart device, even outside the home, leads to 
increased adherence/compliance with monitoring 
• 
Patient access to select information and automatic transmissions reduce workload and calls to the 
clinic 
 

 
Page 17 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
7. Evaluation Design  
The BlueSync™ Field Evaluation will be a multi-center, prospective, single-arm, post-market field 
evaluation. All patients will be implanted with any Medtronic market-released pacemaker or CRT-P device 
that is compatible with BlueSync (Table 2). It is recommended to use Medtronic RA, RV and LV leads that 
are compatible with the pacemaker and CRT-P devices used in the evaluation.  
The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission 
compliance as well as adoption of remote monitoring, patient perceived benefit of BlueSync™ and clinical 
perception of value of BlueSync™ and satisfaction with BlueSync™. 
Approximately 700 patients may be screened and complete the screening questionnaire. It is expected 
that 60% (420) of the screened patients will use smart technology and 60% (252) of the screened 
patients that use smart technology will meet the inclusion/exclusion criteria and may be enrolled in the 
evaluation. 
Assuming attrition from enrollment through 12 month of follow-up is 7%, a total of 252 patients may 
be enrolled in this evaluation to allow approximately 234 patients to have Azure™, or Percepta™, 
Serena™, Solara™ CRT-P device implanted and compatible with BlueSync and MyCareLink Heart app 
downloaded onto the patient’s smart device and patients been followed for 12-month with a total of 
six scheduled transmissions to occur from outside of the clinic. 
The evaluation is expected to be conducted at approximately 20 evaluation sites, 10 sites in Europe and 
10 sites in the United States. Up to approximately 35 patients will participate from each evaluation site.  
7.1. 
Duration 
The expected total evaluation duration is approximately 16 months. This represents 4 months for patient 
enrollment and at least twelve months for the patient follow-up. Patients are anticipated to be in the 
evaluation for approximately 12 months. Patients will complete a baseline visit and then complete 
participation in the evaluation after the 12 months follow-up period. Patients will not be replaced with 
newly enrolled patients upon completion of participation in the evaluation. As described in Section 12.1.6, 
the sample size accounts for attrition.  
7.2. 
Rationale  
Medtronic has developed the BlueSync™ feature which is a cardiac monitoring system that is secure, 
reliable, provides select information to patients about their pacemaker or CRT-P device and uses only the 
patient’s smart device to monitor the patient remotely. BlueSync™ connects the Azure™ Pacemaker or 
Percepta™, Serena™, Solara™ CRT-P device via low energy to the patient’s smart device and the 
CareLink network. BlueSync™ allows for automatic transmission of device data through the use of 
Bluetooth technology. The patient only needs to keep their smart device within one meter of their 
implanted device.  
This evaluation provides an opportunity to confirm that BlueSync™ will improve patient compliance to 
scheduled transmission as recorded in the CareLink Network. See Section 5.2 for further background 
information and evaluation of collected data. See Section 12 for further background on the evaluation 
design. 

 
Page 18 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
8. Product Description 
8.1. 
General 
The evaluation will be conducted using the components described in Table 3. All components will be 
market released. Instructions for use of the devices used in this evaluation are provided in their 
respective manuals. Device is intended to be used for patients diagnosed with bradycardia or heart failure 
who are indicated for implant of a pacemaker or CRT-P device.  
8.2. 
Evaluation Components 
All devices used in the evaluation have FDA and CE mark approval.  All devices will be used inside the 
intended use and for approved indications. 
 
Table 3: System component information for the Azure™ Smart Pacemaker  
Model Name  
Model 
Number  
Serial Number 
Prefix 
Azure™ XT DR MRI SureScan™ 
W2DR01 
RNF 
Azure™ S DR MRI SureScan™ 
W3DR01 
RNJ 
Azure™ XT SR MRI SureScan™ 
W2SR01 
RNE 
Azure™ S SR MRI SureScan™ 
W3SR01 
RNI 
Percepta™ CRT-P Quad MRI SureScan™ 
W4TR04 
RNV 
Percepta™ CRT-P MRI SureScan™ 
W1TR04 
RNU 
Serena™ CRT-P Quad MRI SureScan™ 
W4TR05 
RNX 
Serena™ CRT-P MRI SureScan™ 
W1TR05 
RNW 
Solara™ CRT-P Quad MRI SureScan™ 
W4TR06 
RNZ 
Solara™ CRT-P MRI SureScan™ 
W1TR06 
RNY 
 
Any market-released, commercially available RA, RV, and LV leads that are compatible with the 
pacemaker and CRT-P devices (see Table 3) may be used in this field evaluation. It is recommended to 
use Medtronic RA, RV and LV leads that are compatible with the pacemaker and CRT-P devices used in 
the evaluation. 
BlueSync™ offers app-based remote monitoring via the patient’s own smart device: The Azure™ 
pacemaker and Percepta™, Serena™, Solara™ CRT-P devices. Azure™ pacemakers include a Bluetooth 
Low Energy chip that allows wireless communication between the pacemaker and the patient smart 

 
Page 19 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
device. The patient’s smart device acts as a hub and transmits the data to the remote monitoring 
network. 
8.3. 
Product Use 
Figure 1 Explanation of BlueSync™ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Additional alerts 
are available for 
CRT-P devices 

 
Page 20 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Figure 2 MyCareLink Heart App Operation 
 
8.4. 
Product Training Requirements 
Details of required training can be found in section 10.1. 
9. Selection of Patients 
9.1. 
Evaluation Population 
The evaluation will enroll patients who will be or have been implanted with an Azure pacemaker or CRT-P 
device and who meet all of the specific evaluation inclusion criteria, and none of the exclusion criteria for 
the BlueSync™ field evaluation. 
9.2. 
Patient Enrollment 
In order for patients to be considered for enrollment, they must meet all of the inclusion criteria and 
none of the exclusion criteria.  If necessary  approval from the MEC/IRB/HREB/Ethics Board (Ethics 
Committee) of the BlueSync™ Evaluation Plan, and any other applicable documents must be obtained 
prior to enrolling patients in the evaluation.  
 

 
Page 21 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
9.3. 
Inclusion Criteria 
Patient indicated for a pacemaker with our without Cardiac Resynchronization Therapy (CRT) will 
participate in the specified screening process to determine eligibility for participation.  See section 10.3.1 
Patient Screening. 
 
Patients must meet all of the following inclusion criteria to be eligible to participate in the evaluation: 
Inclusion criteria: 
• 
Patient will be/have been implanted with an Azure™ or Percepta™, Serena™, Solara™ CRT-P 
device compatible with BlueSync  
• 
New or replacement devices are allowed. 
• 
Must have smart device (Smartphone or tablet) that meets system requirements and be willing to 
use during evaluation period 
• 
Must be able to complete the required 12 month follow-up after the baseline visit 
• 
Must have legal age according to local law 
 
9.4. 
Exclusion Criteria 
• 
Patient is unwilling to complete required surveys during 12-month evaluation period after the 
baseline visit. 
9.5. 
Minimization of Bias 
In summary, potential sources of bias that may be encountered in this evaluation have been considered 
and minimized by careful evaluation design. 
 
Selection of patients, treatment of patients, and evaluation of evaluation data are potential sources of 
bias. Methods incorporated in the evaluation design to minimize potential bias include (but are not limited 
to): 
• 
Each site will enroll no more than approximately 35 (15%) patients to ensure a diverse patient 
population experience across multiple geographies and types of hospitals. 
• 
All center personnel will be trained in evaluation transmissions workflow and other procedures to 
ensure consistency across all geographies and evaluation centers. 
All patients indicated for a pacemaker or CRT-P device will be screened to determine their ability to 
participate in the evaluation.  
• 
Patient demographics will be collected at baseline and differences that may affect primary 
endpoints will be identified 
• 
Data collection requirements and evaluation procedures will be standardized across all sites  
• 
A separate Statistical Analysis Plan (SAP) will be developed to further describe statistical 
methods, pre-specified data handling rules, and pre-specified analyses that will be included in the 
clinical evaluation report prior to analysis of the data. 
 

 
Page 22 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
10. Evaluation Procedures  
Prior to performing evaluation related procedures, all sites must have documentation from Medtronic of 
site readiness.  Additionally any clinic requirements for Ethics Committee/Institutional Review Board 
should be documented.   
Sponsor representatives may provide support as required for the evaluation under supervision of the 
Principal Investigator, including: 
• 
Provide evaluation training relevant and pertinent to the involvement of personnel conducting 
evaluation activities and investigator responsibilities 
• 
Technical support under the supervision of an evaluation investigator, but no data entry, shall be 
performed by Medtronic personnel or their representatives at sites 
10.1. Evaluation Personnel Requirements 
All clinical investigators managing the patient’s bradycardia must be qualified practitioners and 
experienced in the diagnosis and treatment of patients with bradycardia. All implanting physicians must 
be experienced and/or trained in the handling of pacemakers and CRT-P devices. 
The role of the principal investigator is to implement and manage the day-to-day conduct of the field 
investigation as well as ensure data integrity and the rights, safety and well-being of the patients 
involved in the field evaluation. 
The principal investigator shall: 
• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the field evaluation 
The principal investigator shall be able to demonstrate that the proposed investigational site: 
• 
Has the required number of eligible patients needed within the recruitment period 
• 
Has one or more qualified investigators, a qualified investigational site team and adequate 
facilities for the foreseen duration of the field evaluation 
• 
adequate time and resources to conduct the evaluation throughout the duration of the evaluation 
• 
Ability to comply with applicable Institutional Review Board (IRB)/Ethics Committee (EC) and 
regulatory requirements 
• 
Documentation that investigator is not debarred, disqualified, or working under 
sanctions in applicable regions 
Site personnel training and delegation will be completed prior to participation in this evaluation. Table 4 
lists the requirements for evaluation personnel prior to conducting any evaluation procedure. 
 
Table 4: Evaluation Personnel Requirements 
Evaluation Personnel 
Documented 
Evaluation 
Training 
Activated by 
Medtronic 
Primary Investigators 
X 
X 
Co-Investigators 
X 
X 

 
Page 23 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Evaluation Personnel 
Documented 
Evaluation 
Training 
Activated by 
Medtronic 
General Evaluation 
Personnel (Coordinators, 
technicians, etc.) 
X 
X* 
   *Coordinators only 
10.2. Site Approval to participate in Field Evaluation 
During the process to prepare  sites for participation in the evaluation (prior to patient enrollment), 
Medtronic will train site personnel on the  Field Evaluation Plan data collection and reporting tools. If new 
members join the evaluation center team, they will receive training on the applicable field evaluation 
requirements relevant to their role before contributing to the field evaluation. 
A Field Evaluation  Agreement (FEA) shall be entered into effect by Medtronic, the participating 
investigation site and/or the principal clinical investigator at each investigational site as per local legal 
requirements, and returned, fully executed, to Medtronic prior to the commencement of any evaluation 
activities. Financial aspects of conducting and reporting an evaluation will be specified in the agreement. 
By signing and dating the agreement the investigator indicates approval of the field evaluation. 
Prior to performing evaluation related activities, all local regulatory the following requirements shall be 
fulfilled:  
 
• 
Fully executed Field Evaluation Agreement  
• 
Documentation of delegated tasks 
• 
Documentation of evaluation site personnel training 
Additional requirements imposed by the Ethics Committee and regulatory authority shall be followed, if 
applicable.  
Medtronic will provide each evaluation center with field evaluation materials (i.e. patient binders, case 
report forms) and documentation of evaluation center/investigator readiness; this letter must be received 
prior to patient enrollment. 
10.3. Schedule of Events 
• 
Field evaluation data is collected at designated time points throughout the evaluation as indicated 
in Table 5. See Section 16 for more information. At baseline; demographics of the patient are 
collected.  Additionally at baseline and at the end of the 12 month follow-up period after the 
baseline visit clinic surveys will be completed. A total of six scheduled transmissions with the MCL 
Heart app will be completed during the 12 month follow-up period. Two monthly scheduled 
transmissions must occur in the first 2 months of follow up (one scheduled transmission at month 
1 and the second transmission at month 2). Four scheduled transmissions must occur quarterly 1 
each starting at month 3 of follow up (one scheduled at month 3, another scheduled at month 6, 
the next scheduled at month 9 and the last one scheduled at month 12).   
At the end of the evaluation, the data will be frozen and retained by Medtronic 
 
 

 
Page 24 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Table 5: Data collection and evaluation procedure requirements  
Field Evaluation Data 
Collection Requirements 
Screening 
log 
Enrollment Baseline 
Device 
Pairing 
After enrollment 
During annual 
pacemaker visit  
Evaluation 
Completion 
(12 months) 
Patient Screening  
X 
 
 
 
 
 
Enrollment 
 
 
X 
 
 
 
Evaluation eligibility 
confirmed 
X 
X 
 
 
 
 
Patient  Demographics 
 X 
  
X 
 
 
 
Patient Education and 
smart device usage 
  
  
X 
 
 
 
2 scheduled transmissions 
in the 1st two months 
4  Scheduled Transmissions 
1 at 3, 6, 9 and 12 months* 
  
  
 
 
X 
 
Evaluation Completion 
Form 
 
 
 
 
 
X 
* A total of six scheduled transmissions with the MyCareLink Heart app will be completed during the 12-month 
follow-up period. Two monthly scheduled transmissions must occur in the first 2 months of follow up (one 
scheduled transmission at month 1 and the second transmission at month 2). Four scheduled transmissions 
must occur quarterly 1 each starting at month 3 of follow up (one scheduled at month 3, another scheduled 
at month 6, the next scheduled at month 9 and the last one scheduled at month 12).  
 
 

 
Page 25 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
Figure 3 Evaluation Screening, Enrollment and Follow-up 
  
 
 
 
 
 
Patients indicated for 
pacemaker implant 
Eligible for Evaluation 
Patient Enrolled 
Baseline 
Device Pairing 
Patient  and Clinic 
Surveys Completed 
12 Month Follow-up 6 Scheduled 
transmissions, 2 in 1st month and 
then 1 every 3 months 
Patient Surveys Post Device 
Pairing 
Evaluation Complete 
Not Eligible for 
Evaluation 
Screening Log 
Completed 
A) After device pairing Patient completes questionnaire 
(within two weeks after device implant or as scheduled 
for previous implants) 
 B) Clinic completes questionnaire after each patient 
completes download 
C) Clinic completes workflow questionnaire after all 
patients enrolled have completed device pairing 
During standard of care annual clinic  visit 
(after device implant) 
12 months- Clinic personnel completes 
enters questionnaire  
During the 
evaluation, the 
clinic will keep 
a log of 
transmission 
related events 
 

 
Page 26 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
10.3.1. 
Patient Screening 
Screening will occur prior to enrollment. All patients indicated for a pacemaker or CRT-P device that are 
identified sequentially by the clinics will be invited to participate in the screening process. 
The clinician will meet with the patient to conduct patient screening and then complete a screening 
questionnaire that may include and not be limited to the following questions:  
• 
Is the patient willing to do remote monitoring? 
• 
Does the patient own a smart device? 
• 
Is the operating system on the smart device compatible with MCL Heart app? 
• 
Is the patient willing to participate in the evaluation? 
• 
Patient Demographics 
If the patient declines participation, the reasons will be identified on the screening log. Patient screening 
must be completed prior to discharge from the hospital or clinic and before enrollment. 
10.4. Enrollment 
Enrollment occurs when a patient completes the device pairing of the BlueSync compatible device with 
the CareLink network via the My CareLink Heart App.   
  
10.5. Implant 
Device implant/Replacement is not being evaluated as part of the evaluation and will be performed 
according to standard of care procedures 
 
10.6. Baseline Visit 
The following information is required to be collected at the baseline visit: 
• 
Patient Demographics 
• 
Gender 
• 
Age 
• 
Education 
• 
Smart device Experience 
• 
Duration of smart device ownership 
• 
Type of smart device 
• 
Compatibility 
• 
Comfort level with technology 
• 
Smart device usage 
• 
Type of use 
- 
Phone calls 
- 
Text messages 
- 
Email 
- 
Internet Use 
 

 
Page 27 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
 
The following procedures will be completed after implant and within two weeks of discharge from the 
hospital or clinic except for patients who had a BlueSync compatible device implanted previously: 
• 
The MyCareLink Heart app will be downloaded on the patient’s smart device after implant and 
the process for pairing the MyCareLink Heart app to the Azure device will be initiated. Specific 
instruction will be provided to the clinic and patient under separate cover.  
• 
After the patient’s implanted device is paired with the MyCareLink Heart app, a transmission will 
be used to confirm that the MyCareLink Heart app in the patient’s smart device is paired with the 
patient’s implanted device. The patient will complete their first survey to assess patient perceived 
benefit of BlueSync™. 
• 
A clinician survey corresponding to each patient will be completed to assess clinic perception of 
value of BlueSync™ and satisfaction with BlueSync™.  
10.7. Twelve Month Follow-up Period 
Twelve Month Follow-up Period after the Baseline Visit: 
• 
A total of six scheduled transmissions with the MyCareLink Heart app will be completed during 
the 12-month follow-up period.  
• 
Two monthly scheduled transmissions must occur in the first 2 months of follow up (one 
scheduled transmission at month 1 and the second transmission at month 2). 
• 
Four scheduled transmissions must occur quarterly 1 each starting at month 3 of follow up (one 
scheduled at month 3, another scheduled at month 6, the next scheduled at month 9 and the last 
one scheduled at month 12).   
• 
During the 12-month follow-up period after the baseline visit patients will complete a survey 
during a scheduled device follow-up to assess patient perceived benefit of BlueSync™ 
• 
Clinician surveys corresponding to each patient survey will be completed to assess clinic 
perception of value of BlueSync™ and satisfaction with BlueSync™ at baseline and 12 months 
• 
A workflow questionnaire will be completed by clinic personnel after all enrolled patients have 
completed the device pairing 
• 
Clinic personnel will  complete an event log which will include but not be limited to the following 
o 
Technical issues related to the BlueSync phone app 
o 
Impact of CareLink alerts on workflow 
• 
 The event  log will be maintained by the clinic until all enrolled patients have completed the 12 
months Field Evaluation duration. 
10.8. Evaluation Completion  
The participants involvement in the evaluation will end after 12 months or after one of the following 
occur: 
• 
Patient refuses to complete the second survey 
• 
Patient decides to withdraw from the evaluation 
• 
Patient Death (should include cause of death if available) 
Following completion of the evaluation, patients will continue to receive standard medical care. There will 
be no further evaluation-related activities after evaluation is complete.  

 
Page 28 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
10.9. Assessment of Safety 
This evaluation will not be assessing safety as part of any endpoints. User (Investigator) reporting of 
events to regulatory authorities related to market approved products may be required. 
10.10. Recording Data 
The evaluation will collect data using a phone based electronic data management system.   Patient 
questionnaires will be entered directly into a Smart Device or collected via paper and entered into the 
electronic data management system. The option used by the patient to complete the questionnaire will 
be based upon what is most appropriate.  
10.11. Patient Withdrawal or Discontinuation 
10.11.1. Patient Does Not Meet Eligibility Criteria 
If a patient is enrolled and later it is determined that evaluation eligibility criteria have not been met the 
patient must be removed from participation in the evaluation.  
10.11.2. Patient chooses not to continue participation in the evaluation  
A patient can withdraw from the evaluation at any time. If the patient wishes not to participate in  the 
evaluation (i.e. the patient revokes consent), the site is required to document the reason for ending 
participation  on the evaluation completion form. In addition, evaluation sites shall follow the regulations 
set forth by the governing Ethics Committee. If possible, the following data should be collected prior to 
patient withdrawal: 
• Report the reason for patient withdrawal 
• Patient survey (if possible) 
10.11.3. Investigator Withdraws Patient 
No patients should be withdrawn by investigators unless compelling medical justification is present. It is 
recommended investigators discuss any withdrawals with the evaluation team prior to withdrawing  
patients. If an Investigator withdrawal is necessary, the following data should be collected prior to patient 
withdrawal if possible: 
• Report the reason for patient withdrawal 
• Patient survey (if possible) 
11. Risks and Benefits 
11.1. Potential Risks 
There are no incremental risks introduced to the patient as a result of participation in this evaluation. 
The safety and clinical performance of the market released systems in this evaluation have been 
demonstrated through previous pre-clinical testing and clinical studies in similar populations, but not 
necessarily the same population as this evaluation. Continuous monitoring, assessment and 

 
Page 29 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
documentation of risk will be performed by the investigator. 
11.2. Potential Benefits 
BlueSync™ may offer no benefit. The information gained from this evaluation could result in the 
improved management of other patients with bradycardia and heart failure conditions. Additionally, 
information collected from this evaluation may assist in the design of new product(s)/therapy (ies) and/or 
instructions for use.  
11.3. Risk-Benefit Rationale 
The risk-benefit analysis has shown that there are no major or minor additional risks associated with the 
BlueSync™ feature.  
11.4. Reporting of Adverse Events 
The collection of adverse event and patient death data is not required to meet the objective(s) of this 
evaluation. The products used in the evaluation are market approved and used within the current 
indications for use as indicated in the product labeling; however, it is the responsibility of the Investigator 
to abide by any adverse event reporting requirements stipulated by the site’s IRB. User (Investigator) 
reporting of events to regulatory authorities related to market approved product may be required. Refer 
to local regulations for reporting requirements. 
11.5. Patient Death 
Evaluation of patient death data is not required to meet the objective(s) of this evaluation. Patient death 
information may only be reported as a reason for ending participation in the evaluation if it were to 
occur.  Investigator reporting of events to regulatory authorities related to market approved product may 
be required. Refer to local regulations for reporting requirements. 
11.6. Product Complaint Reporting 
It is the responsibility of the investigator to report all product complaint(s) associated with a medical 
device distributed by Medtronic, regardless whether they are related to intended use, misuse or abuse of 
the product. Reporting must be done immediately and via the regular channels for market-released 
products. 
12. Statistical Design and Methods 
 Medtronic employees or designees will perform all statistical analyses. Additionally, a separate Statistical 
Analysis Plan (SAP) will be developed to further describe statistical methods, pre-specified data handling 
rules, and pre-specified analyses that will be included in the clinical evaluation report. Any change to the 
data analysis methods described in the field evaluation plan will require an amendment only if it changes 
a principal feature of the field evaluation plan. Any other change to the data analysis methods described 
in the field evaluation plan, and the justification for making the change, will be described in the 
evaluation report. Additional exploratory analyses of the data may be conducted as deemed appropriate. 
Missing data will not contribute to the objectives unless specified otherwise within the analysis methods. 

 
Page 30 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
The primary and ancillary objective data will be analyzed after all patients have enrolled and completed 
their 12-month follow-up. Interim analyses of the secondary as well as applicable ancillary objectives will 
take place after 252 patients have been enrolled and at the time their 2 month follow up is reached. 
Enrollment and/or follow-up will not be stopped due to the interim analyses. 
12.1. Primary Objective  
To assess chronic CareLink transmission compliance (adherence to scheduled transmission), the primary 
objective is to characterize the proportion of the CareLink quarterly scheduled transmissions that are 
completed within prescribed window during the 12-month follow-up in the CareLink Database via the 
MyCareLink Heart™ app. 
12.1.1. Hypothesis  
There are no pre-specified hypotheses for this objective.  
12.1.2. Performance Requirements  
There are no pre-specified performance criteria for the analysis.  
12.1.3. Endpoint Definition  
Scheduled transmissions are transmissions scheduled by a physician and documented in the CareLink 
Database.  
Four quarterly transmissions will be scheduled by the clinic. Four scheduled transmissions must occur 
quarterly 1 each starting at month 3 of follow up (one scheduled at month 3, another scheduled at 
month 6, the next scheduled at month 9 and the last one scheduled at month 12).   
Scheduled transmissions are expected to be completed within prescribed window in the CareLink 
Database via the CareLink Heart™ app during the 12-month follow-up. The proportion of the CareLink 
scheduled transmissions that are completed within prescribed window during the 12-month follow-up in 
the CareLink Database via the BlueSync™ is the endpoint of interest. 
12.1.4. Analysis Methods  
For the calculation of the proportion of scheduled transmissions completed,  
• 
Completed scheduled transmission will be included in this calculation.  
• 
For scheduled transmissions that were not completed, only patients who died on or before the 
schedule date of their scheduled transmission will be excluded in this calculation. 
A two-sided 95% confidence interval based on generalized estimating equations (GEE) for binomial 
distribution will be calculated for this proportion. 
12.1.5. Determination of Patients/Data for Analysis  
Quarterly scheduled transmission will be used for analysis. For scheduled transmissions that were not 
completed, only patients who died on or before the schedule date of their scheduled transmission will be 
excluded from the analysis. 

 
Page 31 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
12.1.6. Sample Size  
Approximately 700 patients may consent to be screened and complete the screening questionnaire. It is 
expected that 60% (420) of the screened patients will use smart technology and 60% (252) of the 
screened patients that use smart technology will meet the inclusion/exclusion criteria and may be 
enrolled in the evaluation. 
 
Assuming attrition from enrollment through 12-month follow-up is 7%, a total of 252 enrolled 
patients would result in approximately 234 patients available to assess the primary endpoint.  
 
A sample size of 234 evaluable patients will produce a two-sided 95% confidence interval width of 
approximately 10%. 
12.2. Secondary Objective  
To assess acute CareLink transmission compliance (adherence to scheduled transmission), the secondary 
objective is to characterize the proportion of the CareLink monthly scheduled transmissions that are 
completed within prescribed window during the first 2-month of follow-up in the CareLink Database via 
the My CareLink Heart App™ . 
12.2.1. Hypothesis  
There are no pre-specified hypotheses for this objective.  
12.2.2. Performance Requirements  
There are no pre-specified performance criteria for the analysis.  
12.2.3. Endpoint Definition  
Scheduled transmissions are transmissions scheduled by a physician and documented in the CareLink 
Database.  
Two monthly scheduled transmissions must occur in the first 2 months of follow up (one scheduled 
transmission at month 1 and the second transmission at month 2).   
Scheduled transmissions are expected to be completed within prescribed window in the CareLink 
Database via the CareLink Heart™ app during the first 2-month follow-up. The proportion of the CareLink 
monthly scheduled transmissions that are completed within prescribed window during the 2-month 
follow-up in the CareLink Database via the BlueSync™ is the endpoint of interest. 
12.2.4. Analysis Methods  
For the calculation of the proportion of scheduled transmissions completed,  
• 
Completed scheduled transmission will be included in this calculation.  
• 
For scheduled transmissions that were not completed, only patients who died on or before the 
schedule date of their scheduled transmission will be excluded in this calculation. 
A two-sided 95% confidence interval based on generalized estimating equations (GEE) for binomial 
distribution will be calculated for this proportion. 

 
Page 32 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
12.2.5. Determination of Patients/Data for Analysis  
Scheduled transmission will be used for analysis. For scheduled transmissions that were not completed, 
only patients who died on or before the schedule date of their scheduled transmission will be excluded 
from the analysis. 
 
 
 
  
 
 
  
 
  
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 

 
Page 33 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
 
 
 
 
 
 
 
   
 
 
  
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 

 
Page 34 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Page 35 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
 
 
 
 
 
 
13. Evaluation Administration 
13.1. Data Management 
Data will be collected using an electronic smart device based platform. Data will be stored in a secure, 
password-protected database. Evaluation management reports may be available to monitor data quality 
and evaluation progress. Procedures for verification, validation and securing of electronic clinical of the 
clinical data system will be developed. At the end of the evaluation, the data will be frozen and will be 
retained indefinitely by Medtronic. 
All records and other information about patients participating in this evaluation will be treated as 
confidential.  
13.2. Confidentiality 
All records and other information about patients participating in this evaluation will be treated as 
confidential. See Section 13.1 for further information.  
13.3. Record Retention 
13.3.1. 
Investigator Records 
The investigator is responsible for the preparation and retention of the records cited below. All of the 
below records should be kept in the Investigator Site File (i.e., the evaluation binder provided to the 
investigator) or Patient Evaluation Binder. The following records are patient 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  
• 
All correspondence between the IRB/MEC, sponsor, monitor, regulatory authority and the 
investigator that pertains to the investigation, including required reports 
• 
Any additional documents as  
• 
Signed and dated Field Evaluation Agreement 
• 
IRB/MEC approval documentation. Written information that the investigator or other evaluation 
staff, when member of the IRB/MEC, did not participate in the approval process. Approval 
documentation must include the Ethics Board composition (if applicable) 
• 
Regulatory authority notification, correspondence and approval, where required per local law. 
• 
Evaluation training records for site staff  
• 
Final Evaluation Report including the statistical analysis 

 
Page 36 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
13.4. Investigator Reports 
If any action is taken by an IRB/MEC with respect to this evaluation, 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.  
 
Table 6: Investigator reports applicable for all geographies per Medtronic requirements 
Report  
Submit to 
Description/Constraints 
Withdrawal of 
IRB/MEC approval 
 (if applicable) 
Sponsor and 
Relevant 
Authorities 
The investigator must report a withdrawal of approval by 
the reviewing IRB/MEC of the investigator’s part of the 
investigation within 5 working days. 
Final Report 
IRBs/MECs and  
Relevant 
Authorities 
This report must be submitted within 3 months of 
evaluation completion or termination. 
13.5. Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records: 
• 
All correspondence which pertains to the evaluation 
• 
Signed Field Evaluation  Agreements,  
• 
All approved informed consent templates (if required), and other information provided to the 
patients and advertisements, including translations 
• 
Copies of all IRB/MEC approval letters and relevant IRB/MEC correspondence and IRB/MEC 
voting list/roster/letter of assurance if applicable 
• 
Names of the institutions in which the  evaluation will be conducted 
• 
Statistical analyses and underlying supporting data 
• 
Final report of the evaluation 
• 
The Evaluation Plan and evaluation related reports, and revisions 
• 
Evaluation training records for site personnel and Medtronic personnel involved in the evaluation 
• 
Any other records that local regulatory agencies require to be maintained. 
 
13.6. Publication and Use of Information 
Publications from the BlueSync™ Targeted Launch Clinical Evaluation will be handled according to 
Medtronic Policies and Standard Operating Procedures and as indicated in the Clinical Trial Agreement. 
13.7. Publication Committee 
Medtronic may form the BlueSync™ Targeted Launch Evaluation Publication Committee from evaluation 
investigators. Medtronic personnel may serve as members of the committee. This committee will manage 
evaluation 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: 
• 
manage elements addressed in the publication plan as outlined in this appendix  

 
Page 37 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
• 
develop the final Publication Plan under separate cover 
• 
execute the Publication Plan 
• 
oversee the publication of primary, secondary and ancillary evaluation results 
• 
review and prioritize publication proposals provide input on publication content 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 least yearly, as needed. 
13.8. Management of Primary, Secondary and Ancillary Publications 
The 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 Field Evaluation Plan.  
An ancillary publication is any publication that does not address the evaluation objectives identified in the 
Field Evaluation Plan. They include publications proposed and developed by other Medtronic departments 
or entities, clinicians participating in this clinical evaluation, and clinicians not participating in this clinical 
evaluation. 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 evaluation or with individual center data. Requests for publications on evaluation objectives utilizing 
subset data (e.g., regional) will be evaluated for scientific validity and the ability of Medtronic to provide 
resources.  
13.9. Criteria for Determining Authorship 
Publications will adhere to authorship criteria defined by the International Committee of Medical Journal 
Editors (ICMJE, Uniform requirements for manuscripts submitted to biomedical journals, www.icmje.org). 
Individual authorship criteria defined by the target journal or conference will be followed when it differs 
from ICMJE criteria. 
Authors, including Medtronic personnel, must at a minimum meet all of the conditions below: 
• 
Substantial contribution to conception and design, or acquisition of data, or analysis and 
interpretation of data 
• 
Drafting the article or revising it critically for important intellectual content 
• 
Final approval of the version to be published 
• 
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 BlueSync™ Field 
Evaluation Investigators” and will be individually listed according to the guidelines of the applicable 

 
Page 38 of 38 
 
BlueSync™ Field  
VERSON 1.0 
Evaluation Plan 
 
04 APRIL 2017 
Medtronic Confidential 
 
scientific journal when possible and affiliation. Any other contributors will be acknowledged by name with 
their specific contribution indicated. 
13.10. Transparency 
Transparency of evaluation 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. 
• 
Registering and posting the evaluation results on ClinicalTrials.gov based on the posting rules 
stipulated  
• 
Submitting for publication the primary evaluation results after the evaluation 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 evaluation data accessible to the corresponding investigator after 
the completion of the evaluation, if requested 
 
14. References 
Refer to Appendix c 
15. Appendices  
APPENDIX A: DRAFT DATA COLLECTION ELEMENTS (CASE REPORT FORMS) 
Draft Case Report Forms for the BlueSync™ Field Evaluation will be provided under separate cover. Final 
CRFs will be provided to sites via the electronic data management system after the site has fulfilled all 
requirements for database access. 
 
APPENDIX B: PARTICIPATING INVESTIGATORS AND INSTITUTIONS 
At the time of the BlueSync™ Evaluation Plan Version 1 completion, a list of clinics that had agreed to 
participated  was not finalized. A complete list of participating investigators and institutions where 
evaluation activities will be conducted will be distributed under a separate cover when available. 
 
APPENDIX C: BIBLIOGRAPHY 
1 Chen KP et al. Reduction of atrial fibrillation in remotely monitored pacemaker patients: results from a Chinese multicenter 
registry. Chin Med J (Engl). 2013 Nov;126(22):4216-21 
2. Mittal S, et al. Increased Adherence to Remote Monitoring is Associated with Reduced Mortality in Both Pacemaker and 
Defibrillator Patients. Presented at HRS 2014 (LB01-05) 
3.Crossley G, et al. Clinical Benefits of Remote Versus Transtelephonic Monitoring of Implanted Pacemakers (PREFER). J Am Coll 
Cardiol. 2009;54:2012-2019. 
4. Mabo P, et al. A Randomized Trial of Long-Term Remote Monitoring of Pacemaker Recipients (COMPAS). Eur Heart J. 
2012;9:1105-1111. 
5. Ladapo J, et al. Remote Monitoring of Implantable Cardiovascular Devices is Associated with Reductions in Healthcare Utilization. 
Presented at HRS 2014.