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

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BlueSync Field Evaluaton Plan V3 0_FINAL
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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 3.0 
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. 
 
 
 

 
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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 hospital/clinics as needed.  
Table 1: Evaluation Sponsor Contact Information 
Evaluation Contacts 
Worldwide  Program 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 Program Leader  
 
Name, Title: Bart Wessels, PhD, Clinical Research Specialist 
Direct Phone: +31-611-347-595   
Direct Fax: +31 (0)43 356 6514 
bart.wessels@medtronic.com  
 
 
 
 

 
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1. Version History 
 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
Not Applicable, New Document 
Keith Holloman, Sr. Clinical Research 
Specialist 
2.0 
Changes to transmission intervals 
Statistical analysis of the evaluation objectives will 
be included in a separate document. Therefore, all 
statistical analysis methods have been removed 
from the evaluation plan. 
Keith Holloman, Sr. Clinical Research 
Specialist 
3.0 
Removed section referencing investigator statement 
Keith Holloman, Sr. Clinical Research 
Specialist 
 
 

 
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2. Table of Contents  
Sponsor Contact ................................................................................................................................. 2 
1. 
Version History ......................................................................................................................... 3 
2. 
Table of Contents ...................................................................................................................... 4 
3. 
Glossary ..................................................................................................................................... 6 
4. 
Synopsis .................................................................................................................................... 7 
5. 
Introduction ............................................................................................................................ 11 
5.1. 
Background ..................................................................................................................................... 11 
5.2. 
Purpose ........................................................................................................................................... 12 
6. 
Evaluation Design ................................................................................................................... 12 
6.1. 
Duration .......................................................................................................................................... 13 
6.2. 
Rationale ......................................................................................................................................... 13 
7. 
Product Description ................................................................................................................ 13 
7.1. 
Evaluation Components .................................................................................................................. 13 
7.2. 
Product Use ..................................................................................................................................... 14 
8. 
Selection of Patients ................................................................................................................ 17 
8.1. 
Evaluation Population ..................................................................................................................... 17 
8.2. 
Inclusion and Exclusion Criteria ..................................................................................................... 17 
8.3. 
Minimization of Bias ....................................................................................................................... 17 
9. 
Evaluation Procedures ............................................................................................................ 18 
9.1. 
Hospital/Clinic Personnel Requirements ....................................................................................... 18 
9.2. 
Hospital/Clinic Approval to Participate in Field Evaluation .......................................................... 18 
9.3. 
Schedule of Events .......................................................................................................................... 19 
9.4. 
Patient Screening............................................................................................................................. 20 
9.5. 
Enrollment ...................................................................................................................................... 21 
9.6. 
Twelve Month Follow-up Period ..................................................................................................... 21 
9.7. 
Evaluation Completion .................................................................................................................... 22 
9.8. 
Recording Data ............................................................................................................................... 22 
10. 
Risks and Benefits ................................................................................................................... 22 
10.1. 
Potential Risks ............................................................................................................................. 22 
10.2. 
Potential Benefits ......................................................................................................................... 22 
10.3. 
Risk-Benefit Rationale ................................................................................................................. 23 
11. 
Statistical Analysis ................................................................................................................... 23 
12. 
Evaluation Administration ...................................................................................................... 23 
12.1. 
Data Management ....................................................................................................................... 23 
12.2. 
Investigator Records .................................................................................................................... 23 
12.3. 
Sponsor Records .......................................................................................................................... 23 
13. 
References ............................................................................................................................... 23 
14. 
Appendices .............................................................................................................................. 24 

 
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Figures 
 
Figure 1 Explanation of BlueSync™ .............................................................................................................................. 15 
Figure 2 MyCareLink Heart App Operation .................................................................................................................. 16 
Figure 3 Evaluation Screening, Enrollment and Follow-up ........................................................................................... 20 
 
Tables 
Table 1: Evaluation Sponsor Contact Information ........................................................................................................... 2 
Table 2: System component information for the BlueSync™ Smart Monitoring System in Europe ................................. 8 
Table 3: System component information for the Azure™ Smart Pacemaker ................................................................. 14 
Table 4: Data collection and evaluation procedure requirements .................................................................................. 19 
 
 
 

 
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3. Glossary 
Term 
Definition 
AF 
Atrial fibrillation 
app 
Application 
Azure™  
Azure™ Smart Pacemaker 
BlueSync™ 
BlueSync™ Smart Monitoring System 
CRT-P 
Cardiac Resynchronization Therapy Pacemaker 
MCL Heart app 
MyCareLink Heart App 
Percepta™, Serena™, Solara™  
BlueSync compatible  CRT-P devices 
Smart device 
Smartphone or Tablet 
 
 

 
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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 
Patient included in 
evaluation  
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 the health care provider perception of the value of 
BlueSync™ and satisfaction with BlueSync™. The primary goal is to learn how 
many CareLink quarterly scheduled transmissions are completed within a 
prescribed time period to assess CareLink scheduled transmission compliance. 
The evaluation will also assess adoption to remote monitoring, patient 
perceived benefit of BlueSync™ (how patients interact with the smart device 
application) and health care provider perception of the value of BlueSync™ 
and satisfaction with BlueSync™ (benefits experienced by clinicians that use 
BlueSync™).  
Product Status 
The evaluation will be conducted using the components described in Table 2 
Only market released components will be used. Instructions for use of the 
devices used in this evaluation are provided in their respective manuals. 
 
 
 
 
 

 
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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 
 
MCL Heart app 
o 
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 
 
Additional system components 
 
Patient’s own smart device. 
BlueSync™ offers app-based remote monitoring via the patient’s own smart 

 
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device.  
The Azure™ Smart Pacemaker and Percepta™, Serena™, Solara™ CRT-P 
devices include 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. 
Sample Size 
Approximately 700 patients will be screened. 60% (420) of the targeted 
patient population are estimated to use smart technology, of which 60% 
(252) are estimated to meet the inclusion/exclusion criteria to be enrolled in 
the evaluation. 
Assuming that attrition from enrollment through 12-month follow-up is 7%, a 
total of 252 enrolled patients would result in approximately 234 patients 
available to evaluate the primary goal of the evaluation.  
The evaluation is expected to be conducted at approximately 30 centers, 15 in 
Europe and 15 in the United States. Up to approximately 35 patients will 
participate per hospital/clinic participating in the evaluation. Clinicians will 
sequentially screen patients who are indicated for implant with a pacemaker 
or CRT-P device. Patients who will be/have been implanted with an 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 during enrollment which is standard of care. Additionally, 
patients will complete a survey during the enrollment visit and once during 
the 12-month follow-up after enrollment 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 12 months of follow-up from 
enrollment. 
Screening Criteria 
Patient indicated for a pacemaker with or without Cardiac Resynchronization 
Therapy (CRT) 
Inclusion/Exclusion Criteria 
Inclusion criteria: 
 
Patient will be/has been implanted with an Azure™ or Percepta™, 
Serena™, Solara™ CRT-P device compatible with BlueSync™  (both 
new and replacement devices are allowed) 
 
Patient must own a smart device (Smartphone or tablet) that meets 
system requirements and be willing to use during evaluation period 
 
Patient must be able to complete the required 12-month follow-up 
after enrollment 
 
Patients must be of legal age according to local law 
Exclusion criteria: 
 
Patient unwilling to complete required surveys during 12-month 
evaluation period. 
 

 
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Evaluation Procedures and 
Assessments 
Screening: 
The clinician will meet with the patient to conduct patient screening and 
complete a screening questionnaire to determine: 
 
Whether the patient is willing to do remote monitoring 
 
Whether the patient owns a smart device  
 
Whether the operating system on the patient’s smart device is 
compatible with MCL Heart app 
 
Whether the patient is willing to participate in the evaluation 
 
Demographic information about the patient which will include: 
 
Age 
 
Education 
 
Smart device experience 
 
Smart device usage 
 
Smart device type (Apple vs Android, phone vs tablet, only one vs. 
multiple) 
 
If the patient declines participation in the evaluation, the reasons will be 
documented on the screening log. 
Enrollment: 
A subject is considered enrolled when the device pairing of the BlueSync™ 
compatible device with the CareLink network via the My CareLink Heart App is 
completed. 
 
The following procedures will be completed after implant and within two week 
of discharge from the hospital or clinic. For patients who had a BlueSync™ 
compatible device implanted previously this can be longer than two weeks 
from discharge.  
 
The process to pair the MCL Heart app and the patient’s smart device 
to the patient’s implanted device will be completed. Specific 
instruction will be provided to the clinic and patient under separate 
cover.  
 
After the patient’s implanted device is paired with the MCL Heart app, 
a transmission will be sent to confirm that the MCL 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 Enrollment: 
 
A total of six scheduled transmissions with the MCL Heart app will be 
completed during the 12-month follow-up period.  
 
Two transmissions will be scheduled to occur in the first month of 
follow up (one scheduled transmission 2 weeks after enrollment and 

 
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another four weeks after enrollment). 
 
Four quarterly scheduled transmissions must occur starting at month 
3 of follow up after enrollment (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 enrollment patients will 
complete a survey during a scheduled annual device follow-up visit to 
assess patient perceived benefit of BlueSync™ 
 
In situations where a routine device follow-up visit is not scheduled 
the survey can be completed using remote options. 
 
Clinician surveys corresponding to each patient will be completed to 
assess health care provider perception of value of BlueSync™ and 
satisfaction with BlueSync™ at 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 a technical/transmission 
issues log which will include but not be limited to: 
 
 Inefficiencies associated with transmission workflow and/or MCL 
Heart application use.  
 
Unscheduled transmissions and action taken 
 
The transmission/issues log will be maintained by the clinic until 
all enrolled patients have completed the 12 months Field 
Evaluation duration. 
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 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 

 
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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 replacing most routine office interrogations. 
Early detection of arrhythmias, lead issues and battery Recommended Replacement Time may lead to important 
clinical actions for pacemaker patients. Pacemaker patients have a high risk of atrial fibrillation (AF). AF is a 
known risk factor for stroke. For example, there is an opportunity (outside the scope of this evaluation) 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 adherence had 53% greater survival than low 
remote monitoring and 140% greater survival than no remote monitoring2 
 
26% faster diagnosis of clinical actionable events (PREFER)3 
 
66% fewer hospitalizations from atrial arrhythmias (COMPAS)4 
 
56% fewer ambulatory visits (COMPAS)4 
 
Lower health care expenditures in office visits among patients with permanent pacemakers5 
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 the health care provider perception of value of 
BlueSync™ and satisfaction with BlueSync™. Collection of this data will support development of clinical evidence 
that can be used to aid in market adoption. The primary goal is to learn how many CareLink quarterly scheduled 
transmissions are completed within a prescribed time period to assess CareLink scheduled transmission 
compliance. The field evaluation will also assess adoption to remote monitoring, patient perceived benefit of 
BlueSync™ (how patients interact with the MCL Heart application) and clinic perception of value of BlueSync™ 
and satisfaction with BlueSync™ (benefits experienced by clinicians that use BlueSync™. A description of the 
statistical analysis of the evaluation will be included in the BlueSync Statistical Analysis Plan. 
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. Evaluation Design  
The BlueSync™ Field Evaluation will be a multi-center, prospective, single-arm, post-market field evaluation. 
BlueSync™ compatible devices that will be part of this field evaluation are listed in Table 2  
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 the health care 
provider perception of value of BlueSync™ and satisfaction with BlueSync™. 

 
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Approximately 700 patients will be screened. It is estimated that 60% (420) of the screened patients will use 
smart technology and 60% (252) of these patients will meet the inclusion/exclusion criteria to be enrolled in the 
evaluation. 
Assuming attrition from enrollment through 12 month of follow-up is 7%, a total of 252 patients will 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 MCL 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 remotely. 
The evaluation will be conducted at approximately 30 hospital/clinics, 15 in Europe and 15 in the United States. 
Up to approximately 35 patients will participate from each hospital/clinic participating in the evaluation.  
6.1. 
Duration 
The expected total evaluation duration is approximately 16 months: 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 an enrollment 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 above, the sample size accounts for attrition.  
6.2. 
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 only needs the patient’s smart 
device to monitor the patient remotely. BlueSync™ connects the pacemaker or 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 as long as the smart device is kept within one meter of the 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 11 for further background on the evaluation design. 
7. Product Description 
7.1. 
Evaluation Components 
The BlueSync™ compatible devices used in the evaluation have FDA and CE mark approval and are market 
released. See Table 3 for model names and numbers.  
 
 
 
 
 
 

 
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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 
 
7.2. 
Product Use 
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 device. The patient’s smart device 
acts as a hub and transmits the data through the MCL Heart app to the remote monitoring network (see Figure 
1). In addition, the MCL Heart app provides additional information to the patient such as his/her physical activity, 
transmission status and background information (see Figure 2). 
 
 
 
 
 
 
 
 
 

 
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Figure 1 Explanation of BlueSync™ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Figure 2 MyCareLink Heart App Operation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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8. Selection of Patients 
8.1. 
Evaluation Population 
The evaluation will enroll patients who have been implanted with an Azure pacemaker or Percepta, Serena or 
Solara CRT-P devices, meet all of the inclusion criteria, and none of the exclusion criteria for the BlueSync™ field 
evaluation, and completed device pairing. 
8.2. 
Inclusion and Exclusion Criteria 
Patients indicated for a pacemaker with or without Cardiac Resynchronization Therapy (CRT), or patients already 
implanted with a BlueSync™ compatible device, will participate in the specified screening process to determine 
eligibility for participation. See section 9.4. 
In order for patients to be considered for enrollment in the evaluation, they must meet all of the inclusion criteria 
and none of the exclusion criteria, and have completed device pairing. 
Inclusion criteria: 
 
Patient will be/has been implanted with an Azure™ or Percepta™, Serena™, Solara™ CRT-P device 
compatible with BlueSync™ (both new and replacement devices are allowed) 
 
Patient must own a smart device (Smartphone or tablet) that meets system requirements and be willing 
to use during evaluation period. 
 
Patient must be able to complete the required 12-month follow-up after enrollment 
 
Patient must be legal age according to local law. 
Exclusion criteria: 
 
Patient is unwilling to complete required surveys during 12-month evaluation period. 
8.3. 
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): 
 
Hospital/clinics will not exceed approximately 35 (15%) enrollments 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 sequentially to determine their 
ability to participate in the evaluation.  
 
Data collection requirements and evaluation procedures will be standardized across all hospital/clinics  
 
 

 
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9. Evaluation Procedures  
Prior to performing evaluation related procedures, all hospital/clinics must have documentation from Medtronic of 
hospital/clinic readiness.  
Sponsor representatives may provide support as required for the evaluation under supervision of the Primary 
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 all  hospital/clinics 
9.1. 
Hospital/Clinic Personnel Requirements 
All hospital/clinic personnel involved in the evaluation must be experienced in remote monitoring.  
The role of the Primary Investigator is to implement and manage the day-to-day conduct of the field evaluation 
as well as ensure data integrity and the rights, safety and well-being of the patients involved in the field 
evaluation. 
 
The Primary Investigator shall: 
 
Be qualified by education, training, and experience to assume responsibility for the proper conduct of the 
field evaluation 
The Primary Investigator shall be able to demonstrate that the proposed evaluation hospital/clinic: 
 
Has the required number of eligible patients needed within the recruitment period 
 
Has a qualified staff and adequate facilities for the foreseen duration of the field evaluation 
 
Has adequate time and resources to conduct the evaluation throughout the duration of the evaluation 
Hospital Clinic personnel training will be completed prior to participation in this evaluation.  lists the requirements 
to be completed for evaluation personnel prior to conducting any evaluation procedure. 
9.2. 
Hospital/Clinic Approval to Participate in Field Evaluation 
During the process to prepare sites for participation in the evaluation (prior to patient enrollment), Medtronic will 
train hospital/clinic 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 shall be entered into effect by Medtronic, the participating hospital/clinic and/or the 
Primary Investigator at each evaluation hospital/clinic 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 on the 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, the following requirements shall be fulfilled:  
 
Fully executed Field Evaluation Agreement  
 
Documentation of contact list of hospital/clinic personnel  

 
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 
Documentation of evaluation hospital/clinic personnel training 
Medtronic will provide each evaluation center with field evaluation materials (i.e. patient binders, workflow 
instructions) and documentation of evaluation center/investigator readiness; this letter must be received prior to 
patient enrollment. 
9.3. 
Schedule of Events 
Field evaluation data is collected at designated time points throughout the evaluation as indicated in Table 4. At 
the end of the evaluation, the data will be frozen and retained by Medtronic. 
Table 4: Data collection and evaluation procedure requirements  
Field Evaluation Data 
Collection 
Requirements 
Screening 
Device  
Pairing 
2  
weeks 
4  
weeks 
3  
months 
6 
months 
 
9 
months 
12 
months 
Annual 
Device 
Follow-up 
Evaluation 
Completion 
(12 months) 
Evaluation eligibility 
confirmed 
X 
 
 
 
 
 
 
 
 
 
Patient Screening  
X 
 
 
 
 
 
 
 
 
 
Enrollment 
 
X 
 
 
 
 
 
 
 
 
Patient 
Demographics 
 X 
 
 
 
 
 
 
 
 
 
Patient Education 
and smart device 
usage 
 X 
 
 
 
 
 
 
 
 
 
Scheduled 
Transmissions  
Post Device Pairing 
 
 
X 
x 
x 
x 
x 
x 
 
x 
 
* A total of six scheduled transmissions with the MCL Heart app will be completed during the 12-month follow-up period. The 
first two scheduled transmissions must occur at 2 and 4 weeks after enrollment. 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).  

 
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Figure 3 Evaluation Screening, Enrollment and Follow-up 
               
  
 
9.4. 
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. It also includes patients with 
previous devices or already implanted BlueSync™ compatible devices. 
The clinician will meet with the patient to conduct patient screening and complete a screening questionnaire to 
determine: 
 
Whether the patient is willing to do remote monitoring 
 
Whether the patient owns or has access to a smart device  
 
Whether the operating system on the smart device is compatible with MCL Heart app 
 
Whether the patient is willing to participate in the evaluation 
 
Demographic Information about the patient which will include: 
 
Gender 
Patients indicated for pacemaker implant or patients already  implanted 
with a BlueSync™compatible device and receiving a  Medtronic device
Eligible for 
Evaluation
Device 
Pairing
Patient 
Enrolled
Patient  and Clinic 
Surveys Completed
12 Month Follow‐up 6 Scheduled 
transmissions, 2 in First 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 device 
follow‐up (after device implant) 
12 months ‐ Clinic personnel 
completes questionnaire  
During the 
evaluation, the 
clinic will 
 keep a log of 
 technical/ 
transmission 
related issues 
 

 
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 
Age 
 
Education 
 
Smart device experience 
 
Duration of smart device experience 
 
Type of smart device 
 
Compatibility 
 
Comfort level with technology 
 
Smart device usage 
 
Type of smart device usage: 
- 
Phone calls 
- 
Text messages 
- 
Email 
o 
Internet Use 
If the patient declines participation in the field evaluation, the reasons will be documented on the screening log. 
Patient screening must be completed prior to discharge from the hospital or clinic and before enrollment. 
9.5. 
Enrollment 
In order for patients to be considered for enrollment in the evaluation, they must meet all of the inclusion criteria 
and none of the exclusion criteria, and have completed device pairing of the BlueSync™ compatible device with 
the CareLink network via the My CareLink Heart App. 
The following procedures will be completed after implant and within two weeks of discharge from the hospital or 
clinic. For patients who had a BlueSync™ compatible device implanted previously this can be longer than two 
weeks from discharge: 
 
The MCL Heart app will be downloaded on the patient’s smart device after implant and the process for 
pairing the MCL Heart app to the Azure device will be initiated. Specific instructions will be provided to 
the clinic and patient under separate cover.  
 
After the patient’s implanted device is paired with the MCL Heart app, a transmission will be used to 
confirm that the MCL 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™.  
9.6. 
Twelve Month Follow-up Period 
Twelve Month Follow-up Period after enrollment: 
 
A total of six scheduled transmissions with the MCL Heart app will be completed during the 12-month 
follow-up period.  
 
Two scheduled transmissions must occur in the first month of follow up (one scheduled transmission at 
two weeks and the second transmission at four weeks after enrollment). 
 
Four quarterly scheduled transmissions must occur, 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 enrollment patients will complete a survey during a scheduled 
annual device follow-up visit 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. 

 
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 
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 and maintain a technical/transmission issues log which will include but not 
be limited to: 
o 
Inefficiencies associated with transmission workflow and/or MCL Heart application use.  
o 
Unscheduled transmissions and action taken 
 
The transmission/issues log will be maintained by the clinic until all enrolled patients have completed 
the 12 month  field evaluation duration. 
9.7. 
Evaluation Completion  
The participants’ involvement in the evaluation will end after 12 months from enrollment or after one of the 
following occur: 
 
Patient refuses to complete the second survey 
 
Patient decides to withdraw from the evaluation 
 
Investigator withdraws patient 
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.  
9.8. 
Recording Data 
Patient questionnaires will be entered directly into an online electronic data management system 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. Risks and Benefits 
10.1. 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 documentation of risk will be performed by 
the investigator. 
10.2. 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.  

 
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10.3. Risk-Benefit Rationale 
The risk-benefit analysis has shown that there are no major or minor additional risks associated with the 
BlueSync™ feature.  
11. Statistical Analysis 
 Medtronic employees or designees will perform all statistical analyses. A separate Statistical Analysis Plan (SAP) 
will be developed to describe statistical methods, pre-specified data handling rules, and pre-specified analyses 
that will be included in the evaluation report.  
12. Evaluation Administration 
12.1. Data Management 
Data will be collected using an electronic online based platform. Data will be stored in a secure, password-
protected database. All records and other information about patients participating in this evaluation will be 
treated as confidential.  
12.2. 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 Hospital/clinic File (i.e., the evaluation binder provided to the 
investigator) or Patient Evaluation Binder. The following records must be maintained as required by local law or 
hospital administration after the date on which the field evaluation is terminated  
 
All correspondence between sponsor and the investigator that pertains to the investigation, including 
required reports 
 
Signed and dated Field Evaluation Agreement 
 
Evaluation training records for hospital/clinic staff  
12.3. Sponsor Records 
Medtronic shall maintain the following accurate, complete, and current records: 
 
All correspondence which pertains to the evaluation 
 
Signed Field Evaluation Agreements,  
 
Names of the institutions in which the evaluation will be conducted 
 
Statistical analyses and underlying supporting data 
 
The Evaluation Plan and evaluation related reports, and revisions 
 
Evaluation training records for hospital/clinic personnel and Medtronic personnel involved in the 
evaluation 
13. References 
Refer to Appendix A 

 
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14. Appendices  
APPENDIX A: 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.