Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
Phase: NA
Conditions: Heart Failure
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  
ReLINQuish (Relationship betZeen /,N4 
subcutaneous impedance and right-Vided 
Kemodynamic measurements) 
Study Product Name 
Reveal LINQTM 
Sponsor/Local Sponsor 
Medtronic , Inc. 
200 Coral Sea Street NE 
Mounds VieZ, MN 55112 
Document Version
2.0
Lead Principal Investigator(s) 
 
Coordinating Investigator 
 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. 
Any distribution, copying, or disclosure Zithout the prior Zritten authori]ation of Medtronic is strictly 
prohibited. Persons to Zhom the information is disclosed must NnoZ that it is confidential and that it 
may not be further disclosed by them. 
 
 

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TaEle oI &ontentV  
&ontentV 
Table of Contents«««««««««««««««««««««««««««««««««««««««««« 2 
1. 
Glossary«««««««««««««««««««««««««««««««««««««««««« 5 
2. 
Synopsis««««««««««««««««««««««««««««««««««««««««««  
3. 
Introduction«««««««««««««««««««««««««««««««««««««««« 10 
3.1. BacNground«««««««««««««««««««««««««««««««««««««««««« 10 
3.2. 
Purpose«««««««««««««««««««««««««««««««««««««««««««. 12 
4. 
ObMectives and Endpoints««««««««««««««««««««««««««««««««« 12 
4.1. 
ObMectives««««««««««««««««««««««««««««««««««««««««««.12 
4.1.1. 
Primary ObMective««««««««««««««««««««««««««««««««««.«..12 
4.1.2. 
Ancillary ObMective«««««««««««««««««««««««««««««««««««. 12 
4.2. 
Endpoints««««««««««««««««««««««««««««««««««««««««««. 12 
4.2.1. 
Primary Endpoint«««««««««««««««««««««««««««««««««««« 13 
5. 
Study Design«««««««««««««««««««««««««««««««««««««««. 13 
5.1. 
Duration««««««««««««««««««««««««««««««««««««««««««« 14 
5.2. 
Rationale««««««««««««««««««««««««««««««««««««««««««.. 14 
6. 
Product Description«««««««««««««««««««««««««««««««««««« 16 
6.1. 
General«««««««««««««««««««««««««««««««««««««««««««.. 16 
6.2. 
Manufacturer««««««««««««««««««««««««««««««««««««««««.. 1 
6.3. 
PacNaging««««««««««««««««««««««««««««««««««««««««««. 1 
6.4. 
Intended Population««««««««««««««««««««««««««««««««««««« 1 
6.5. 
ETuipment«««««««««««««««««««««««««««««««««««««««««« 1 
6.6. 
Product Use«««««««««««««««««««««««««««««««««««««««««. 22 
6.. 
Product Training ReTuirements««««««««««««««««««««««««««««««« 23 
6.. 
Product Receipt and TracNing«««««««««««««««««««««««««««««««« 23 
6.. 
Product Storage««««««««««««««««««««««««««««««««««««««« 23 
6.10. 
Product Return««««««««««««««««««««««««««««««««««««««. 24 
6.11. 
Product Accountability««««««««««««««««««««««««««««««««««. 24 
. 
Selection of SubMects«««««««««««««««««««««««««««««««««««. 24 
.1. 
Study Population««««««««««««««««««««««««««««««««««««««.. 24 
.2. 
SubMect Enrollment«««««««««««««««««««««««««««««««««««««.. 25 
.3. 
Inclusion Criteria««««««««««««««««««««««««««««««««««««««.. 25 
.4. 
E[clusion Criteria««««««««««««««««««««««««««««««««««««««. 25 
. 
Study Procedures««««««««««««««««««««««««««««««««««««« 25 
.1. 
Schedule of Events«««««««««««««««««««««««««««««««««««««. 25 
.1.1. 
Data Collection««««««««««««««««««««««««««««««««««««« 25 
.2. 
SubMect Screening«««««««««««««««««««««««««««««««««««««« 2 
.3. 
Prior and Concomitant Medications««««««««««««««««««««««««««««« 2 
.4. 
SubMect Consent««««««««««««««««««««««««««««««««««««««« 2 
.5. 
Study Procedures««««««««««««««««««««««««««««««««««««««. 2 
.5.1. 
Baseline««««««««««««««««««««««««««««««««««««««««« 31 
.5.2. 
Insertion««««««««««««««««««««««««««««««««««««««««. 31 

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.5.3. 
Right +eart Catheteri]ation Procedure««««««««««««««««««««««««« 32 
.5.4. 
Scheduled FolloZ-up Visits««««««««««««««««««««««««««««««« 33 
.5.5. 
Monthly CareLinN Transmissions«««««««««««««««««««««««««««« 34 
.5.6. 
+ealthcare Utili]ation«««««««««««««««««««««««««««««««««« 34 
.5.. 
Limited Posture Test««««««««««««««««««««««««««««««««««. 35 
.5.. 
Posture Test««««««««««««««««««««««««««««««««««««««..35 
.6. 
Assessment of Safety««««««««««««««««««««««««««««««««««««. 35 
.. 
Recording Data«««««««««««««««««««««««««««««««««««««««. 35 
.. 
Deviation +andling«««««««««««««««««««««««««««««««««««««.. 36 
.. 
Study E[it««««««««««««««««««««««««««««««««««««««««««. 3 
. 
RisNs and Benefits««««««««««««««««««««««««««««««««««««.. 3 
.1. 
Potential RisNs«««««««««««««««««««««««««««««««««««««««.. 3 
.2. 
Potential Benefits««««««««««««««««««««««««««««««««««««««. 41 
.3. 
RisN-Benefit Rationale«««««««««««««««««««««««««««««««««««« 41 
10. 
Adverse Event Assessments«««««««««««««««««««««««««««««««.. 42 
10.1. 
Definitions/Classifications««««««««««««««««««««««««««««««««.. 42 
10.1.1. 
Device Deficiencies«««««««««««««««««««««««««««««««««.. 42 
10.1.2. 
Event Updates and Resolution«««««««««««««««««««««««««««.. 42 
10.2. 
Definitions/Classifications««««««««««««««««««««««««««««««««« 43 
10.3. 
Reporting of Adverse Events««««««««««««««««««««««««««««««« 4 
10.3.1. 
Adverse Events and Device Deficiency Classification«««««««««««««««... 4 
10.3.2. 
Adverse Events and Device Deficiency Reporting ReTuirements«««««««««« 50 
10.4. 
SubMect Death««««««««««««««««««««««««««««««««««««««« 52 
10.4.1. 
Death Data Collection««««««««««««««««««««««««««««««««. 52 
10.4.2. 
Death Classification and Reporting«««««««««««««««««««««««««.. 53 
10.5. 
Product Complaint Reporting««««««««««««««««««««««««««««««« 53 
11. 
Data RevieZ Committees««««««««««««««««««««««««««««««««.. 54 
12. 
Statistical Design and Methods«««««««««««««««««««««««««««««.. 54 
13. 
Ethics«««««««««««««««««««««««««««««««««««««««««««. 55 
13.1. 
Statement(s) of Compliance«««««««««««««««««««««««««««««««. 55 
14. 
Study Administration«««««««««««««««««««««««««««««««««««. 56 
14.1. 
Monitoring««««««««««««««««««««««««««««««««««««««««.. 56 
14.2. 
Data Management««««««««««««««««««««««««««««««««««««.. 56 
14.3. 
Direct Access to Source Data/Documents««««««««««««««««««««««««. 5 
14.4. 
Confidentiality««««««««««««««««««««««««««««««««««««««« 5 
14.5. 
CIP Amendments«««««««««««««««««««««««««««««««««««««. 5 
14.6. 
Record Retention«««««««««««««««««««««««««««««««««««««. 5 
14.. 
Publication and Use of Information«««««««««««««««««««««««««««.. 5 
14.. 
Suspension or Early Termination««««««««««««««««««««««««««««« 5 
14..1. 
Planned study closure««««««««««««««««««««««««««««««««. 5 
14..2. 
Early termination or suspension««««««««««««««««««««««««««« 5 
14..3. 
Study-Zide termination or suspension«««««««««««««««««««««««.. 5 
14..4. 
Investigator/center termination or suspension«««««««««««««««««««. 5 
14..5. 
Procedures for termination or suspension«««««««««««««««««««««« 60 
15. 
References««««««««««««««««««««««««««««««««««««««««.. 61 

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16. 
Appendices««««««««««««««««««««««««««««««««««««««««. 62 
Appendi[ A: Patient Informed Consent Form Template««««««««««««««««««««««. 63 
Appendi[ B: Draft data collection forms««««««««««««««««««««««««««««««. 64 
Appendi[ C: ReLINQuish Study Procedure +andbooN««««««««««««««««««««««« 65 
Appendi[ D: Site Information«««««««««««««««««««««««««««««««««««.. 66 
1. 
Version +istory««««««««««««««««««««««««««««««««««««««. 6 
 
 
 

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The ReYeal /,14 deYice and the  programmer are marNetreleased Eut once the 
inYestigational /,14 +) RA0Zare is doZnloaded into the deYices they are considered 
inYestigational. 
Primary 
ObMective(s) 
The primary obMective is to characteri]e the relationship betZeen changes in 
Reveal LINQ subcutaneous impedance and cardiopulmonary hemodynamic 
measurements, resulting from:  1) short-term vasodilator and/or e[ercise 
challenges during right heart catheteri]ation procedures or 2) long-term daily 
trends of physiologic data, in patients Zith heart failure. 
Ancillary 
ObMective 
To characteri]e the relationship betZeen changes in Reveal LINQ-derived data 
and other physiologic parameters Zith any acute decompensated heart failure 
(AD+F) events.   
Study Design 
The study is a prospective, non-randomi]ed, observational clinical study to be 
conducted at up to 5 centers in the US.  Up to 30 subMects Zill be enrolled in the 
study. Study subMects Zill be folloZed for up to 1 months post-insertion or 3 
right heart catheteri]ation procedures, Zhichever comes first. The e[pected study 
duration is appro[imately 3 years representing 1 months of enrollments and 1 
months of folloZ-up. 
Sample Si]e 
Up to 30 subMects Zill be enrolled.  
Inclusion/ 
E[clusion Criteria 
Inclusion Criteria: 
x 
Patients meeting at least 1 of 3 criteria Zill be included in the study: 
R 
Patients Zith symptomatic systolic or diastolic heart failure Zho in the 
clinician¶s Mudgment have a high liNelihood of undergoing serial right 
heart catheteri]ations to aid in clinical management of their heart 
failure  
R 
Patients Zith dyspnea on e[ertion in Zhom e[ercise hemodynamics is 
indicated to diagnose diastolic dysfunction 
R 
Patients Zho have or Zill be implanted Zith a pulmonary artery 
pressure monitor 
x 
Patient is 1 years of age or older 
x 
Patient (or patient¶s legally authori]ed representative) is Zilling and able to 
provide Zritten informed consent 
x 
Patient is Zilling and able to comply Zith the protocol, including folloZ-up 
visits and CarelinN transmissions. 
E[clusion Criteria: 
x 
Patient has an e[isting Medtronic  implantable cardiac device  

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x
Patient has a left ventricular assist device (LVAD) 
x 
Patient is pregnant (all females of child-bearing potential must have a 
negative pregnancy test Zithin 1 ZeeN of enrollment)  
x 
Patient is enrolled in another study that could confound the results of this 
study, Zithout documented pre-approval from a Medtronic study manager 
Study Procedures 
and Assessments 
After enrollment, baseline data Zill be collected and a Reveal LINQTM device Zith 
LINQ-+F investigational RAMZare Zill be inserted.   
SubMects Zill be enrolled for 1 months and undergo scheduled folloZ-up visits at 
6 and 12 months.  SubMects may forego a scheduled folloZ-up visit if they have 
had a right heart catheteri]ation (R+C) procedure Zithin the folloZ-up visit 
ZindoZ. If the subMect has an implantable pressure monitor, data Zill be collected 
from the monitor at the folloZ up visits. 
For subMects undergoing clinically indicated R+Cs as determined by physician 
Mudgment, a tZo-month blanNing period post-insertion to alloZ for pocNet 
maturation Zould be preferred.  Prior to each R+C procedure, +olter mode Zill be 
enabled on the Reveal LINQTM device using a 200 programmer Zith 
investigational softZare, and a +olter monitor applied to the subMect to collect 
high-resolution impedance and ECG. After placement of the PA catheter (SZan-
Gan]), a standardi]ed procedure Zill be folloZed to ensure appropriate placement 
of the pressure reference transducer. The R+C Zill be performed according to the 
participating institution¶s procedure. ECG and hemodynamic data Zill be recorded 
on the lab recording system, a copy of Zhich Zill be provided to Medtronic.  Lab 
and +olter data Zill be synchroni]ed by introduction of noise on the ECG signal 
Zhich Zill be common to both systems (e.g., briefly disconnecting or tapping on 
an electrode). As part of the standard procedure, subMects may be administered a 
vasodilator or e[ercise challenge. +olter mode Zill be disabled at the conclusion 
of the procedure. These subMects may e[it prior to 1 months after the 
completion of three R+C procedures.   
Starting one month post-insertion, the subMect Zill utili]e the MyCareLinN +ome 
Monitor to manually transmit data on a monthly basis.  The subMects Zill be asNed 
to press the Patient Assistant Zhenever they feel increased shortness of breath 
compared to normal. +ealth Care Utili]ations (+CUs) (including hospitali]ations, 
emergency department visits, outpatient treatment involving overnight stay, 
urgent care, or clinic visits) Zill be collected and reported on a +CU Case Report 
Form. Cardiovascular-related (including hypervolemia and hypovolemia) +CU 
information should be reported upon center aZareness and assessed at all visits. 
Safety 
Assessments 
There are no defined safety endpoints in the ReLINQuish Study. Relevant Adverse 
Events (AEs), Device Deficiencies (DDs), and +ealth Care Utili]ations Zill be 

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collected throughout the study duration and Zill be assessed and reported per 
regulatory reTuirements 
 Statistics 
ReLINQuish is an observational characteri]ation study and therefore Zill not have 
poZered endpoints. Analysis Zill include descriptive comparisons betZeen LINQTM 
impedance and hemodynamic measurements.  
 ,ntroGuFtion  
 BacNground  
Filling pressures are considered to be an important diagnostic parameter in management of heart 
failure (+F) patients. +igher filling pressures are associated Zith higher risN for hospitali]ations and 
mortality.1, 2 Monitoring and adMusting therapy based on pressures may improve patient symptoms 
and has been shoZn to reduce +F events.5  The first generation implantable pressure sensor 
(Chronicle, Medtronic Inc. MN) consisted of a pressure sensor at the end of a lead that resided in 
the right ventricle.3 The measured pressures Zere used to estimate pulmonary artery diastolic 
pressure (ePAD). The pivotal human clinical trial, COMPASS-+F, using this sensor failed to achieve 
the primary outcome of reducing +F-related events compared to the standard of care arm.4 The 
neZer generation pressure sensors are leadless and are fully contained in one of the maMor right-
sided vessels in the heart.  FolloZing a successful outcome trial,5 FDA recently approved the first 
ever implantable sensor to measure filling pressures. The CardioMEMS pulmonary artery (PA) 
pressure sensor is an integral component of the FDA-approved CardioMEMS +F system (St. -ude 
Medical, MN). The sensor is implanted in a branch of the pulmonary artery and provides on-
command PA pressure Zaveforms, pressure readings, and trend data over time (e.g. over a ZeeN). 
The clinician can remotely access these data and incorporate them in patient management. For 
e[ample, a diuretic or another medication intervention may be made if the patient¶s PA pressure is 
out of the normal range. In fact such PA pressure-guided interventions Zere hallmarN of the 
successful C+AMPION trial.5 The trial shoZed that PA pressure-guided +F management Zas 
associated Zith a 2 reduction in +F hospitali]ation rate at 6 months, and 3 after an average 
folloZ-up of 15 months relative to the control arm in Zhich subMects Zere managed using clinical 
assessment alone. 
Intrathoracic impedance is another +F management tool that has been available for over a decade 
in patients Zith implantable devices (ICD and CRT-D).6  Impedance is measured across the RVcoil-
to-can vector, and a declining trend in impedance and corresponding rise in derived OptiVol inde[ 
signifies higher risN of an +F event. Intrathoracic impedance is inversely correlated Zith pulmonary 
capillary Zedge pressure (PC:P).6  Both intrathoracic impedance and OptiVol inde[ have been 
shoZn to be associated Zith higher risN of +F hospitali]ation and mortality.-   
The Reveal LINQ insertable cardiac monitor is a leadless device that is inserted in the region of the 
thora[. TZo electrodes on the body of the device continuously monitor the subMect¶s subcutaneous 
ECG and, Zith investigational softZare, impedance.  Subcutaneous impedance derived from the 
Reveal LINQ insertable cardiac monitor may be of similar utility in patients Zithout implantable 
devices.   

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The Monitoring in Dialysis (MiD) study Zas conducted in renal failure patients implanted Zith a 
Reveal LINQ insertable cardiac monitor. The results indicated subcutaneous impedance trends 
upZards Zith fluid removal during dialysis sessions and doZnZards betZeen dialysis sessions. 
Therefore, the preliminary data shoZ that continuous subcutaneous impedance monitoring has a 
direct inverse relationship to patient fluid status in both a detailed analysis and long-term trending 
analysis.10 
The LINQ +F study is utili]ing the Reveal LINQ device Zith an investigational LINQ +F RAMZare 
doZnload (version 1.1 or later). The commercially available Reveal LINQ device records and stores 
only subcutaneous ECG and activity from a single a[is accelerometer. The LINQ +F RAMZare 
enables the hardZare to record and store impedance, temperature, activity, RR interval, R-Zave 
amplitude, posture change count (based on ]-a[is accelerometer values) and [, y, and ]-a[is 
accelerometer measurements periodically.  The doZnload also has a +olter mode in Zhich 
continuous impedance and ECG signals Zill be collected acutely and recorded on a DR220 +olter 
Recorder.  The purpose of the LINQ +F study is to characteri]e Reveal LINQ derived data from 
patients Zith heart failure by assessing the relationship betZeen changes in LINQ derived data and 
other physiologic parameters Zith subseTuent acute decompensated heart failure (AD+F) events. 
The study Zill also collect information regarding +F related clinical events during the same period.    
Understanding the relationship betZeen cardiopulmonary pressure and subcutaneous tissue 
impedance is of scientific interest, and could also be of potentially clinical utility. Understanding the 
correlation betZeen the tZo parameters (or lacN thereof) Zould help to determine treatment 
strategies Zhen certain impedance values/trends are noted in patients Zith LINQ impedance data 
available (but no pressure data).   
The current proposal is to utili]e the LINQ +F RAMZare doZnload to investigate the relationship 
betZeen LINQ impedance and direct hemodynamic measurements in patients Zith heart failure.  
Additionally, the relationship betZeen changes in LINQ impedance and other physiologic parameters 
during acute decompensated +F events Zill be characteri]ed.  Monthly doZnloads Zill be performed, 
and device data from the LINQ and PA pressure monitor (Zhere applicable) Zill be collected at 
scheduled folloZ-up visits occurring 6, 12 and 1 months post-insertion of the LINQ device.  In 
subMects undergoing right heart catheteri]ation procedures, a +olter Recorder Zill be applied to 
collect continuous impedance and ECG during  the procedure .  Similar to the LINQ +F clinical study, 
information regarding +F-related clinical events Zill be collected Zhile the patient is enrolled.  The 
study Zill be conducted in three patient populations: 
1. Patients Zith symptomatic systolic or diastolic heart failure Zho in the clinician¶s Mudgment have 
a high liNelihood of undergoing serial right heart catheteri]ations (R+C) to aid in clinical 
management of their heart failure 
2. Patients Zith dyspnea on e[ertion in Zhom e[ercise hemodynamics is indicated to diagnose 
diastolic dysfunction 
3. Patients Zho have or Zill be implanted Zith a pulmonary artery pressure monitor 
 

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 PurSose
The purpose of the ReLINQuish study is to characteri]e the relationship betZeen subcutaneous 
impedance  and direct hemodynamic measurements in patients Zith heart failure to assess cardiac 
function.  Additionally, the relationship betZeen changes in subcutaneous impedance and other 
physiologic parameters during acute decompensated +F events Zill be characteri]ed.  
 2EMeFtiveV anG (nGpointV 
 OEMectiYes 
4.1.1. 
Primary ObMective 
The primary obMective is to characteri]e the relationship betZeen changes in Reveal LINQ 
subcutaneous impedance and right heart hemodynamic measurements, resulting from:  1) short-
term drug and/or e[ercise challenges during right heart catheteri]ation procedures or 2) long-term 
daily trends of physiologic data, in patients Zith heart failure.  
4.1.2. 
Ancillary ObMective 
To characteri]e the relationship betZeen changes in Reveal LINQ-derived data and other 
physiologic parameters Zith any acute decompensated heart failure (AD+F) events. 
A heart failure event is defined as any cardiovascular-related (including hypervolemia) 
+ealth Care Utili]ations (+CUs) for any one of the folloZing events. 
x 
Admission Zith primary diagnosis of +F 
x 
Intravenous +F therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at 
x 
any one of the folloZing settings: 
x 
Admission Zith secondary/tertiary diagnosis of +F 
x 
Emergency Department 
x 
Ambulance 
x 
Observation Unit 
x 
Urgent Care 
x 
+F/Cardiology Clinic 
 EndSoints 
It Zill be of interest to characteri]e the relationship betZeen changes in Reveal LINQ 
subcutaneous impedance and right heart hemodynamic measurements, resulting from:  1) short-
term drug and/or e[ercise challenges during right heart catheteri]ation procedures or 2) long-term 
daily trends of physiologic data, in patients Zith heart failure. 
It Zill also be of interest to characteri]e the relationship betZeen changes in Reveal LINQ-derived 
data and other physiologic parameters Zith any acute decompensated heart failure (AD+F) events.   

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4.2.1.
Primary Endpoint
As a feasibility study, ReLINQuish is not poZered to meet any endpoints. 
 StuG\ DeVign  
The ReLINQuish study is a prospective, non-randomi]ed, observational clinical study to be 
conducted at up to 5 centers.   Up to 30 subMects Zill be enrolled in the study. After enrollment, 
baseline data Zill be collected and a Reveal LINQTM device Zith LINQ-+F investigational RAMZare 
Zill be inserted.   
SubMects Zill be enrolled for 1 months and undergo scheduled folloZ-up visits at 6 and 12 months.  
SubMects may forego a scheduled folloZ-up visit if they have had a right heart catheteri]ation (R+C) 
procedure Zithin the folloZ-up visit ZindoZ. 
For subMects undergoing clinically indicated R+Cs as determined by physician Mudgment, a tZo-
month blanNing period post-insertion to alloZ for pocNet maturation Zould be preferred.  The 
subMect Zill remain enrolled for up to 1 months or 3 right heart catheteri]ation (R+C) procedures, 
Zhichever comes first.  The intent is to capture  up to 3 R+Cs per patient as performed as standard 
of care at the investigator¶s institution. In this observational study, physicians Zill be asNed to collect 
right heart pressures during clinically indicated R+C procedures as determined by the treating 
physician.  The R+C Zill be performed according to the participating institution¶s procedure.  There 
are no study-related reTuirements around the performance or timing of the procedures, other than 
measures to collect comprehensive data and assure Tuality.   
Prior to each R+C procedure, +olter mode Zill be enabled on the LINQ device using a 200 
programmer Zith investigational softZare, and a +olter monitor applied to the subMect to collect 
high-resolution impedance and ECG.  A standardi]ed procedure Zill be folloZed to ensure 
appropriate placement of the pressure transducer.  ECG and hemodynamic data Zill be recorded on 
the lab recording system, a copy of Zhich Zill be provided to Medtronic.  Lab and +olter data Zill be 
synchroni]ed by introduction of noise on the ECG signal Zhich Zill be common to both systems 
(e.g., briefly disconnecting or tapping on an electrode). As part of the standard procedure, subMects 
may be subMected to a drug or e[ercise challenge. +olter mode Zill be disabled at the conclusion of 
the procedure. 
Starting one month LINQ post-insertion, the subMect Zill utili]e the MyCareLinN +ome Monitor to 
manually transmit data on a monthly basis.  Site personnel Zill monitor for compliance Zith monthly 
transmissions and call the subMect as needed Zith a reminder to transmit the data monthly. The 
subMects Zill be asNed to press the Patient Assistant Zhenever they feel increased shortness of 
breath compared to normal. +ealth Care Utili]ations (+CUs) (including hospitali]ations, emergency 
department visits, outpatient treatment involving overnight stay, urgent care, or clinic visits) Zill be 
collected and reported on a +CU Case Report Form. Cardiovascular-related (including hypervolemia 
and hypovolemia) +CU information should be reported upon center aZareness and assessed at all 
contacts Zith the subMects. 

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Selection of subMects, treatment of subMects, and evaluation of study data are potential sources of 
bias.  Methods incorporated in the study design to minimi]e potential bias include (but are not 
limited to): 
x 
Patients Zill be screened to confirm elibility for enrollment in Neeping Zith the inclusion/ 
e[clusion criteria 
x 
Regular monitoring visits Zill be conducted for adherence to the CIP and to verify source 
data 
x 
All study clinicians, participating site personnel, and Medtronic personnel Zill be trained on 
their respective aspects of the study using standardi]ed training materials 
 
In summary, potential sources of bias that may be encountered in this clinical study have been 
considered and minimi]ed by careful study design. 
 Duration 
Study subMects Zill be folloZed for up to 1 months post-insertion or 3 right heart catheteri]ation 
procedures, Zhichever comes first. The e[pected study duration is appro[imately 3 years 
representing 1 months of enrollments and 1 months of folloZ-up. 
 RationaOe  
Filling pressures are considered to be an important diagnostic parameter in management of heart 
failure (+F) patients. +igher filling pressures are associated Zith higher risN for hospitali]ations and 
mortality.1, 2 Monitoring and adMusting therapy based on pressures may improve patient symptoms 
and has been shoZn to reduce +F events.5   
The Reveal LINQ insertable cardiac monitor is a minimally invasive, leadless device that is inserted 
in the region of the thora[.  Subcutaneous impedance measured betZeen tZo electrodes on the 
body of the device, in addition to other sensor data derived from the Reveal LINQ insertable 
cardiac monitor, may be of similar utility in patients Zithout implantable devices and alloZ for +F 
management Zith less invasive measurements. 
The Monitoring in Dialysis (MiD) study Zas conducted in renal failure patients implanted Zith a 
Reveal LINQ insertable cardiac monitor. The results indicated impedance trends upZards Zith fluid 
removal during dialysis sessions and doZnZards betZeen dialysis sessions. Therefore, the 
preliminary data shoZ that continuous impedance monitoring has a direct inverse relationship to 
patient thoracic fluid status in both a detailed analysis and long term trending analysis.10 
In the ReLINQuish study, the folloZ-up duration of 1 months, combined Zith selection of subMects 
Zith the liNelihood of undergoing serial R+Cs or an implanted PA pressure sensor, Zill alloZ for the 
assessment of correlation betZeen pulmonary artery pressures (as surrogates of left side cardiac 
pressures) and subcutaneous impedance over time.  Physiologic parameters captured during any 
AD+F events occurring Zhile the subMect is enrolled Zill further provide insight into correlations Zith 
LINQ impedance. 
Acute changes in subcutaneous impedance  

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x 
+ypermia:  Increased cardiac output or rela[ation of the arterioles as a result of the interventions 
may lead to generali]ed increased tissue perfusion Zhich may be sensed subcutaneously.   
 3roGuFt DeVFription 
 *eneraO 
The study is utili]ing the Reveal LINQ device Zith an investigational LINQ +F RAMZare doZnload. 
The LINQ +F RAMZare enables high-resolution impedance and ECG to be streamed to a +olter 
monitor during a right heart catheteri]ation procedure.  Surface ECG and hemodynamic data SZan-
Gan] catheter Zill be continuously  recorded on the lab system. Additionally, the RAMZare enables 
the hardZare to record and store impedance, temperature, activity, RR interval, R-Zave amplitude, 
posture change count (based on ]-a[is accelerometer values) and [, y, and ]-a[is accelerometer 
measurements periodically.  These data Zill be captured in monthly uploads via the MyCareLinN 
+ome Monitor.  The system components that Zill be used in this study are listed in the table beloZ. 
 
TaEle : Re/,N4uiVK StuG\ S\Vtem &omponentV 

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management of their heart failure, or patients Zho have or Zill be implanted Zith a pulmonary 
artery pressure monitor, Zill be included in the study. 
 ETuiSment 
Reveal LINQ Insertable Cardiac Monitor (ICM) 
The Reveal LINQ is a leadless device that is recommended to be inserted in the region of the 
thora[. A specific recommended location is provided Zithin the product manual. TZo electrodes on 
the body of the device continuously monitor the subMect¶s subcutaneous ECG. The device can store 
up to 30 min of ECG recordings from the patient-activated episodes and up to 2 min of ECG 
recordings from the automatically detected arrhythmias. 
 
)igure : Reveal /,N4 ,&M. 
Incision Tool
The Incision Tool is designed to create an incision of repeatable Zidth and depth Zith a single 
motion. It is composed of a blade, designed to maNe a repeatable incision, and handle, designed to 
ergonomically fit the clinician¶s hand. The Reveal LINQ Incision Tool is intended to maNe the 
incision simple and repeatable. 
 
)igure : Incision TooO 
 
Insertion Tool 
The Insertion Tool delivers the device through the incision and into the subcutaneous tissue. The 
tool is designed to ensure the device is delivered into a tight pocNet to ma[imi]e electrode contact 
Zith the surrounding tissue in a highly repeatable manner, and is composed of tZo parts: a handle 

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)igure : MeGtroniF  3rogrammer
 
The Medtronic 200 Programmer Zith the LINQ +F investigational RAMZare Zill be used to 
doZnload the LINQ +F investigational RAMZare onto the Reveal LINQ device. LINQ +F 
investigational RAMZare is reTuired to activate additional sensors in the Reveal LINQ ICM. The 
LINQ +F investigational RAMZare Zill be loaded onto the 200 programmers designated for clinical 
use only. The 200 programmer Zith the LINQ +F investigational RAMZare Zill alloZ the ability to 
doZnload and remove the RAMZare into and from the device. In addition, the 200 programmer Zill 
be used during the scheduled folloZ-up visits. 
 
Medtronic LINQ +F Investigational RAMZare 
The LINQ +F investigational RAMZare (ver 1.1 or later) Zill provide the ability to enable the Reveal 
LINQ hardZare for the collection and storage of Reveal LINQ sensor data. The LINQ +F 
RAMZare enables the hardZare to record and store impedance, temperature, activity, RR interval, 
R-Zave amplitude, posture change count (based on ]-a[is accelerometer values) and [, y, and ]-
a[is accelerometer measurements periodically. The device Zill collect and store this data every 60 
minutes for impedance, temperature, activity, R-Zave amplitude and every 5 minutes for RR 
intervals, posture change count, and [, y, and ]-a[is accelerometer values. In addition, impedance 
measurements are collected nightly and Zhen the Patient Assistant is used. 
Patient Assistant 
The Reveal Patient Assistant is a battery operated, hand-held telemetry device that enables the 
subMect, on e[periencing symptoms potentially indicative of a cardiac event, to manually trigger the 
Reveal LINQ ICM to collect and store an ECG record. The Reveal Patient Assistant is intended for 
unsupervised patient use aZay from a hospital or clinic. The Patient Assistant activates the data 
management feature in the Reveal LINQ ICM to initiate recording of cardiac event data in the 
implanted device memory. 
The subMects Zill be asNed to press the Patient Assistant Zhenever they feel increased shortness of 
breath compared to normal. In addition, the subMects Zill be asNed to press the Patient Assistant 
device to marN the beginning and end of their 6 Minute +all :alN test ONL< Zhen the DR220 +olter 
is not used. Additionally, the LINQ +F RAMZare enables the storage of a short segment of 
impedance signal Zhen the Reveal Patient Assistant device is used. 
 
)igure : 3atient AVViVtant 
 

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MyCareLinN +ome Monitor 
The MyCareLinN +ome Monitor is a device that enables the device diagnostic data (Zhich includes 
ECG data) to be transmitted directly from the implanted Reveal LINQ device to the Medtronic 
CareLinN NetZorN for revieZ by the physician. The additional data that is stored in the device by 
the LINQ +F RAMZare is also transmitted during a CareLinN transmission but Zill not be available for 
revieZ by the physician. 
 
)igure : M\&are/inN +ome Monitor 
 
DR220 +olter Monitor 
The NorthEast Monitoring, Inc. DR220 Digital Recorder is a +olter monitor that is commercially 
available and designed to facilitate the ambulatory cardiac monitoring of those subMects Zho may 
benefit from such monitoring on order of a physician, including but not limited to those Zith 
complaints of palpitations, syncope, chest pains, shortness of breath, or those Zho need to be 
monitored to Mudge their current cardiac function, such as subMects Zho have recently received 
pacemaNers. The DR220 Digital Recorder is intended for use Zith Medtronic System-B compatible 
implantable pulse generators, implantable cardiac defibrillators, and cardiac resynchroni]ation 
therapy devices and implantable cardiac monitors. A +olter monitor is an e[ternal bo[ used to 
record electrical heart signals from electrode patches attached to the sNin (ECG) as Zell as from the 
cardiac device (EGM). There are no contraindications for the use of a DR220 +olter monitor. The 
+olter monitor Zill be used in accordance Zith its labeling. Only trained study personnel should 
apply the monitors. 
 
The data obtained by monitoring is not analy]ed at the time of recording. After the recording is 
complete, the data must later be doZnloaded to a compatible NorthEast Monitoring, Inc. +olter 
analysis system to be analy]ed. No personal information Zill be entered and collected by DR220 
recorder. 
 
The DR220 +olter Recorder used in this study is a portable ECG device able to collect telemetry 
signals and marNer channel information from any Medtronic device for up to 4 hours. The +olter 
Recorder has application for any subMect Zith a Medtronic ICM. For the purposes of this study, the 
intended use of the +olter Recorder is to acutely uplinN continuous impedance and ECG signals that 
Zill be collected by the LINQ +F RAMZare in the +olter mode. Since only the device data uplinN 

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feature of the +olter Zill be used in this study, the device antenna Zill only be used and no ECG 
electrodes Zill be used. 
 
 
)igure : DR +olter 
 Product Use 
The Reveal LINQTM device is a programmable cardiac monitor that continuously monitors a patient¶s 
ECG and other physiological parameters. 
It Zill be implanted in all the subMects enrolled in the study and the device implant procedure Zill be 
performed as per routine practice according to the Clinician Manual. After implant, the 
investigational softZare Zill be doZnloaded onto the device maNing it interventional. In order to 
complete this installation, an ad-hoc 200 Programmer, Zith the investigational softZare on it Zill 
have to be provided to the site before study start. 
The subMect Zill be provided of: 
x 
A Patient Assistant that Zill alloZ him/her to record (marN) heart rhythm in case he/she 
e[periences any specific symptoms that could be related to his/her cardiac condition, such as 
but not limited to fainting, palpitations, di]]iness, and shortness of breath. 
x 
A CarelinN Monitor that Zill alloZ him/her to perform automatic daily transmissions and 
manual transmissions once a month. 
 
At every folloZ-up visit, a device interrogation Zill be performed in order to doZnload on a USB 
flash drive information recorded by the device on subcutaneous impedance values and standard 
LINQTM information such as ECGs and Trends (Cardiac Compass, +istograms, and Longest AF). 

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All investigational products must be controlled by Medtronic and/or trained study center personnel. 
Investigational product Zill be stored in a secure location at the study center. The method of 
storage shall prevent the use of investigational devices/products for other applications than 
mentioned in this Clinical Investigation Plan. It is the responsibility of the investigator to correctly 
handle, store, and tracN the investigational products.  
 Product Return 
Investigator agrees to use the study devices solely for the purpose of the study. Medtronic Zill 
retain all rights of possession and oZnership in the study device and Investigator Zill acTuire no 
rights of possession and oZnership in the Study Devices pursuant to the Clinical Trial Agreement or 
otherZise. Upon the termination or e[piration of this Agreement, Investigator Zill immediately 
return any unused disposable Study Devices and all non-disposable devices to Medtronic at 
Medtronic¶s cost. 
Any disposable investigational product needs to be returned to Medtronic in case of device 
deficiency during the implant procedure or during the folloZ-up visits. In that case they should be 
returned as soon as possible for investigation. 
Mailer Nits Zith prepaid US postage are available for use Zithin the United States to send CRT, ICD, 
IPG, and leads to Medtronic¶s CR+F Returned Product Analysis Lab. These mailers are si]ed to 
accommodate the devices and leads from a single patient or clinical event and are designed to meet 
US postal regulations for mailing bioha]ard materials. To receive a Nit, please contact your local field 
person or a study team member.  
 Product AccountaEiOity  
Documentation of investigational product allocation and tracNing is reTuired at each step of the 
process via the Product Accountability Log. It is the responsibility of the investigator to correctly 
handle, store, and tracN the investigational products. The investigational Product Accountability Log 
is provided to the center and Zill be used for tracNing of all investigational products. The log must 
be maintained at the center and updated Zhen the investigational product is received, used, 
disposed or returned to Medtronic. 
 SeleFtion oI SuEMeFtV 
 Study PoSuOation 
Patients Zith dyspnea on e[ertion or symptomatic systolic or diastolic heart failure Zho have a high 
liNelihood of undergoing serial right heart catheteri]ations (R+C) to aid in clinical diagnosis and/or 
management of their heart failure, or patients Zho have an implanted pulmonary artery pressure 
monitor, Zill be included in the study. 

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 SuEMect EnroOOment 
Patients must sign the patient informed consent form and meet all of the inclusion and none of the 
e[clusion criteria prior to being enrolled. 
 IncOusion Criteria 
x 
Patients meeting 1 of 3 criteria Zill be included in the study: 
1. Patients Zith symptomatic systolic or diastolic heart failure Zho have a high liNelihood of 
undergoing serial right heart catheteri]ations (R+C) to aid in clinical management of their 
heart failure 
2. Patients Zith dyspnea on e[ertion in Zhom e[ercise hemodynamics is indicated to diagnose 
diastolic dysfunction 
3. Patients Zho have or Zill be implanted Zith a pulmonary artery pressure monitor 
x 
Patient is 1 years of age or older 
x 
Patient (or patient¶s legally authori]ed representative) is Zilling and able to provide Zritten 
informed consent 
x 
Patient is Zilling and able to comply Zith the protocol, including folloZ-up visits and CareLinN 
transmissions 
 E[cOusion Criteria
x 
Patient has an e[isting Medtronic implantable cardiac device.  
x 
Patient has a left ventricular assist device (LVAD). 
x 
Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test 
Zithin 1 ZeeN of enrollment)  
x 
Patient is enrolled in another study that could confound the results of this study, Zithout 
documented pre-approval from a Medtronic study manager 
 
 StuG\ 3roFeGureV  
 ScKeduOe of EYents 
.1.1. 
Data Collection 
TaEle : Data &olleFtion 

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the 3rincipal ,nYestigator or an authori]ed designee. A suEMect may only consent after information has 
Eeen giYen to the suEMect on all aspects of the clinical inYestigation that are releYant to the suEMect¶s 
decision to participate.  
3rior to enrolling suEMects each site must haYe documented ,R% approYal of the ,nformed &onsent 
)orm ,& )orm and an Authori]ation to 8se and Disclose 3ersonal +ealth ,nformation/Research 
Authori]ation/other priYacy language as reTuired Ey laZ. Any changes to a preYiously approYed 
,nformed &onsent )orm throughout the course of the study must Ee reYieZed and approYed Ey 
0edtronic and the ,R% reYieZing the application Eefore Eeing used to oEtain consent or reconsent a 
study suEMect. The documents must Ee controlled i.e. Yersioned and/or dated to ensure it is clear 
Zhich Yersions Zere approYed Ey the,R%. 
The inYestigator must notify the suEMect of any significant neZ findings aEout the study that Eecome 
aYailaEle during the course of the study Zhich are pertinent to the safety and ZellEeing of the suEMect 
as this could impact a suEMect¶s Zillingness to participate in the study. ,f releYant approYal may Ee 
reTuested from suEMects to confirm their continuing informed consent in Zriting. 
The process of oEtaining informed consent shall: 
x 
Ensure that the Principal Investigator, or an authori]ed designee, obtains the informed consent. 
x 
Include all aspects of the clinical study that are relevant to the subMect
s decision to participate 
throughout the clinical study. 
x 
Avoid any coercion or undue improper influence on, or inducement of the subMect to participate. 
x 
Not Zaive or appear to Zaive the subMect¶s legal rights. 
x 
Ensure the Informed Consent Form and an Authori]ation to Use and Disclose Personal +ealth 
Information/Research Authori]ation/other privacy language, as reTuired by laZ, are given to the 
subMect in a non-technical language the subMect is able to read and understand. 
x 
3roYide ample time and opportunity for the suEMect to read and understand the ,nformed 
&onsent )orm to inTuire aEout details of the study and to consider participation. All Tuestions 
aEout the study should Ee ansZered to the satisfaction of the suEMect. 
x 
Include a personally dated signature of the subMect acNnoZledging that their participation in the 
study is voluntary.  
x 
Include a personally dated signature by the principal investigator or authori]ed designee 
responsible for obtaining the informed consent, as reTuired by local laZ. 
x 
Provide the subMect Zith a copy of the Informed Consent Form and an Authori]ation to Use and 
Disclose Personal +ealth Information/Research Authori]ation/other privacy language as reTuired 
by laZ. 
x 
(nsure suEMects are notified of any significant neZ findings aEout the study that Eecome 
aYailaEle during the course of the study Zhich are pertinent to the safety and ZellEeing of the 
suEMect as this could impact a suEMect¶s Zillingness to participate in the study. 
 
,f informed consent is oEtained the same day the suEMect Eegins participating in studyrelated 
procedures it must Ee documented in the suEMect¶s case history that consent Zas oEtained prior to 
participation in any studyrelated procedures. ,t is Eest practice for the informed consent process to Ee 
documented in the suEMect¶s case history regardless of circumstance. 
 
,n the eYent the suEMect cannot read and/or Zrite Zitnessed impartial third party informed consent 
Zill Ee alloZed proYided detailed documentation of the process is recorded in the suEMect¶s case 

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history and the Zitness signs and dates the ,nformed &onsent )orm. ,nformed consent shall Ee 
oEtained through a superYised oral process. An independent Zitness must Ee present throughout the 
process. The ,nformed &onsent )orm and any other information must Ee read aloud and e[plained to 
the prospectiYe suEMect if alloZed Ey local laZ. The Zitness signs and personally dates the ,nformed 
&onsent )orm attesting that the information Zas accurately e[plained and that informed consent Zas 
freely giYen. The suEMect should ³maNe his marN´ sign or otherZise physically marN the document so 
as to indicate consent on the ,nformed &onsent )orm as Zell. The ,nformed &onsent )orm should 
document the method used for communication Zith the prospectiYe suEMect and the specific means Ey 
Zhich the prospectiYe suEMect communicated agreement to participate in the study. The original of the 
signed ,nformed &onsent )orm must Ee filed in the hospital/clinical chart and/or Zith the suEMect¶s 
study documents.  
 
The ,nformed &onsent )orm and Authori]ation to 8se and Disclose 3ersonal +ealth 
,nformation/Research Authori]ation/other priYacy language as reTuired Ey laZ must Ee aYailaEle for 
monitoring auditing and regulatory inspections. Any 0edtronic )ield personnel Zho support the 
Re/,14uish study must Ee aEle to reYieZ the suEMect¶s signed and dated ,nformed &onsent )orm and 
Authori]ation to 8se and Disclose 3ersonal +ealth ,nformation/Research Authori]ation/other priYacy 
language as reTuired Ey laZ and Yerify its completeness prior to proceeding Zith any study 
procedures. ,n the eYent the 0edtronic )ield personnel identify the ,nformed &onsent )orm or 
Authori]ation to 8se and Disclose 3ersonal +ealth ,nformation/Research Authori]ation/other priYacy 
language as reTuired Ey laZ as Eeing incomplete the Re/,14uish study procedures Zill not Ee 
alloZed to occur until the informed consent of the suEMect can Ee adeTuately and appropriately 
oEtained. 
:hen a patient and the Principal Investigator or authori]ed designee, as reTuired, have personally 
signed and dated the Informed Consent Form and Authori]ation to Use and Disclose Personal +ealth 
Information/Research Authori]ation/other privacy language, as reTuired by laZ, the patient is 
considered a subMect enrolled in the study. The date the subMect signed the Informed Consent Form 
and Authori]ation to Use and Disclose Personal +ealth Information/Research Authori]ation/other 
privacy language as reTuired by laZ, must be documented in the subMect¶s medical records.  
 Study Procedures 
Data Zill be collected at the Baseline Visit, Insertion, 6 and 12-month folloZ-up visits, R+C 
procedures, and monthly CareLinN transmissions. A tZo-month blanNing period post-insertion is 
recommended but not reTuired.  SubMects may be e[ited upon completion of 3 R+Cs. 

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)igure : SFKeGule oI (ventV 
.5.1. 
Baseline 
The Baseline visit can be a standalone visit or can be performed on the same day of insertion prior 
to the insertion procedure. 
The folloZing information is reTuired to be collected in the CRF at the baseline visit prior to 
performing the device implant: 
R 
Informed consent  
R 
Inclusion/e[clusion criteria 
R 
Medical history 
R 
Demographics 
R 
Physical e[amination, including pitting edema measurement assessment 
R 
Medication assessment 
R 
Standard chemistry panel plus NT-proBNP 
R 
Symptoms and temperature (via ear is recommended) 
.5.2. 
Insertion 
FolloZing the baseline visit, a Reveal LINQ device Zill be implanted in the subMect. The implant 
procedure Zill be performed in accordance Zith the hospital¶s standard implant practice and in 
accordance Zith the Medtronic Reveal LINQ implant instructions.   
Use of the recommended implant locations is located in Figure 10 beloZ. Physicians should folloZ 
the Clinician Manual Zhen performing the Reveal LINQ implant. 
 
)igure : ReFommenGeG implant loFationV  

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After the implant procedure, the investigational softZare Zill be doZnloaded onto the implanted 
LINQ device. 
The folloZing information Zill be collected: 
R 
Final system configuration, including LINQ, Patient Assistant and CarelinN Monitor serial 
numbers 
R 
Insertion procedure information, including location of inserted device  
R 
Device interrogation (save to media) 
R 
Limited posture test 
.5.3. 
Right +eart Catheteri]ation Procedure 
A tZo-month blanNing period post-insertion to alloZ for pocNet maturation Zould be preferred prior 
to the first right heart catheteri]ation (R+C) procedure.   
Prior to each R+C procedure, +olter mode Zill be enabled on the LINQ device using a 200 
programmer Zith investigational softZare, and a DR220 +olter Recorder Zill be applied to the 
subMect to collect high-resolution impedance and ECG. See Appendi[ C for more information on 
applying the +olter.   
The R+C Zill be performed according to the participating institution¶s procedure. There are no 
study-related reTuirements around the performance or timing of the procedures, other than 
measures to collect comprehensive data and assure Tuality.  A standardi]ed procedure Zill be 
folloZed to ensure appropriate placement of the pressure transducer. The location of the pressure 
transducer Zill be measured from the substernal notch doZn and recorded at the first procedure.  
This measurement Zill be used to ensure consistent placement of the pressure transducer at 
subseTuent procedures. Both the pro[imal and distal ports of the SZan-Gan] catheter Zill be 
connected for continuous recording of right atrial and pulmonary artery pressures. Cardiac output 
and systemic blood pressure Zill be measured freTuently throughout the procedure and at least 
every 2 minutes during the drug or e[ercise challenge and recovery. ECG and hemodynamic 
Zaveform data Zill be recorded on the lab recording system, a copy of Zhich Zill be provided to 
Medtronic.  Lab and +olter data Zill be synchroni]ed by introduction of noise on the ECG signal 
Zhich Zill be common to both systems (e.g., briefly disconnecting or tapping on an electrode).  
As part of the standard procedure, subMects may be administered  an acute drug or e[ercise 
challenge. Alternatively, subMects Zith an implanted PA pressure monitor may undergo a right heart 
catheteri]ation procedure Zithout any associated drug or e[ercise challenge. The +olter Zill 
continue to record data throughout the recovery/observation period Zith the subMect remaining 
supine or Zith moderate head elevation if necessary.  The timing and description of any positional 
changes Zill be noted in the CRFs. At the conclusion of the recovery period, the posture test Zill be 
performed, the +olter recorder Zill be removed, and +olter mode Zill be disabled (see Appendi[ C 
for more information). 
The folloZing information Zill be collected prior to each right heart catheteri]ation procedure: 

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x 
Physical e[amination, including pitting edema measurement assessment 
x 
Medication assessment 
x 
Standard chemistry panel plus NT-proBNP (only if the procedure visit is substituting for the 
6- or 12-month scheduled folloZ-up visit) 
x 
Symptoms and temperature (via ear is recommended) 
x 
N<+A functional classification assessment  
 
The folloZing additional information Zill be collected at each right heart catheteri]ation procedure: 
x 
Device data  
x 
Posture test 
x 
+emodynamic measurements 
x 
+olter (DR220) data 
.5.4. 
Scheduled FolloZ-up Visits  
After receiving notice of successful LINQ insertion, Medtronic Zill provide the target dates and 
ZindoZs for each visit to the implanting center. Should a subMect miss a visit or the visit fall outside 
the pre-specified ZindoZ, a study deviation must be reported and the original folloZ-up schedule 
maintained for subseTuent visits. Data analyses include folloZ-up visits, regardless of Zhether the 
visit occurs Zithin the ZindoZ. Therefore, a late visit is preferred over a missed visit but must be 
accompanied by a deviation. FolloZ-up visit ZindoZs are listed in Table 3 and are based on days 
post-insertion.  
TaEle  3oVt,nVertion )olloZ8p 9iVit :inGoZV 
SFKeGuleG 
IolloZup viVit 
:inGoZ 
(&alFulateG Ga\V poVtinVertion) 
:indoZ Start 
Target 
:indoZ End 
6 month 
163 
13 
203 
12 month 
335 
365 
35 
E[it  
51 
54 
5 
SubMects Zill e[it at appro[imately 1 months, or after completing 3 right heart catheteri]ation procedures, 
Zhichever comes first.  It Zill not be considered a study deviation if the date of e[it of a subMect completing 
3 R+Cs occurs outside of the E[it visit ZindoZ. 
The subMect can forego a scheduled folloZ-up visit if he/she had a right heart catheteri]ation 
procedure in the same ZindoZ. 
The folloZing information is to be collected at the 6-month and 12-month folloZ-up visits: 

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x 
Physical e[amination, including pitting edema measurement assessment 
x 
Medication assessment 
x 
Standard chemistry panel plus NT-proBNP  
x 
Symptoms and temperature (via ear is recommended) 
x 
LINQ device data  
x 
Implanted PA pressure monitor data (if applicable) 
x 
N<+A functional classification assessment 
x 
Posture test  
x 
6M+: (optional) 
 
The folloZing information is to be collected at E[it: 
x 
Reason for e[it  
x 
+CU and AEs 
x 
Medication assessment 
x 
LINQ device data  
x 
Implanted PA pressure monitor data (if applicable) 
x 
LINQ +F RAMZare removal from LINQ device 
.5.5. 
Monthly CareLinN Transmissions 
Starting one month post-insertion, the subMect Zill utili]e the MyCareLinN +ome Monitor to manually 
transmit data on a monthly basis. Site personnel Zill monitor that the monthly transmissions are 
occurring and call the subMect as needed Zith a reminder to transmit the data monthly. +ealth Care 
Utili]ations (+CUs) (including hospitali]ations, emergency department visits, outpatient treatment 
involving overnight stay, urgent care, or clinic visits) Zill be collected and reported on a +CU Case 
Report Form. Cardiovascular-related (including hypervolemia and hypovolemia) +CU information 
should be reported upon center aZareness and assessed at all visits. 
 
.5.6. 
+ealthcare Utili]ation 
Cardiovascular-related +ealth Care Utili]ations (+CUs) (including hypervolemia and hypovolemia) 
Zill be collected.  This includes the folloZing: 
x 
Unscheduled clinic visit (including subMect-initiated phone calls if the subMect is e[periencing CV-
related symptoms) 
x 
Scheduled clinic visit (if the subMect is e[perienceing CV-related symptoms) 
x 
+ospital outpatient clinic visit 
x 
Urgent care visit 
x 
Other outpatient utili]ation Zith overnight stay 
x 
Emergency department visit 
x 
Inpatient hospitali]ation 
 

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+CU information should be reported upon center aZareness and assessed at all visits including the 
monthly telephone visits.  If multiple +CUs occur Zithin the same day, data from all +CUs can be 
captured on one eCRF. 
.5.. 
Limited Posture Test 
A limited posture test Zill be conducted at the Reveal LINQ insertion. SubMects Zill be reTuested to 
be put in tZo different postures: standing and supine on bacN. During each posture, the Medtronic 
200 Programmer Zith the LINQ +F investigational RAMZare Zill be used to store the [, y, and ]-
a[is accelerometer values to calibrate the posture measurements. Refer to Appendi[ C for more 
details. 
.5.. 
Posture Test 
A posture test Zill be conducted at each right heart catheteri]ation procedure, and at 6 Month and 
12 Month scheduled visits in subMects Zith implanted PAP sensors. SubMects Zill be reTuested to be 
put in four different postures: standing, supine on bacN, lying doZn on left side and lying doZn on 
right side. During each posture, the Medtronic 200 Programmer Zith the LINQ +F investigational 
RAMZare Zill be used to store the [, y, and ]-a[is accelerometer values to calibrate the posture 
measurements. Refer to Appendi[ C for more details. 
 Assessment of Safety 
There are no defined safety endpoints in the ReLINQuish Study.  Relevant Adverse Events (AEs), 
Device Deficiencies (DDs), and +ealth Care Utili]ations Zill be collected throughout the study 
duration and Zill Ee reYieZed Ey the 0edtronic Safety RepresentatiYe for reporting per regulatory 
reTuirements.  Further information on the collection of AEs and DDS is discussed in Section 11. 
 Recording Data 
Source data is all information original records of clinical findings oEserYations or other actiYities in 
a clinical trial necessary for the reconstruction and eYaluation of the trial. Source data are contained 
in source documents. ([amples of these original documents and data records include: hospital 
records clinical and office charts laEoratory notes memoranda suEMects¶ diaries or eYaluation 
checNlists pharmacy dispensing records recorded data from automated instruments such as 
hospital monitoring eTuipment and implantaEle deYices +olter 3D) reports SD cards copies or 
transcriptions certified after Yerification as Eeing accurate and complete microfiches photographic 
negatiYes microfilm or magnetic media [rays suEMect files and records Nept at the pharmacy at 
the laEoratories and at medicotechnical departments inYolYed in the clinical trial.  
The inYestigator Zill clearly marN clinical records to indicate that the suEMect is enrolled in this clinical 
study.  
Study ZorNsheets may Ee used and are considered as source documentation. 

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The data reported on the e&R)s shall Ee deriYed from source documents and Ee consistent Zith 
these source documents and any discrepancies shall Ee e[plained in Zriting. ,f applicaEle the 
e&R) may Ee considered source for the folloZing data collection elements Eut not limited to: 
 
x 
(nrollment 1otification 
R 
Site assigned patient reference 
x 
%aseline 
R 
AdministratiYe ,nformation 
R 
&ardiac Disease &lassification 
x 
DeYiations 
The site is responsiEle to record all trial related source data enaEling the sponsor to reconstruct the 
complete course of the clinical trial. Source data Zill Ee transcriEed to and reported through the &R) 
accordingly. A source data identification list Zill Ee proYided to the sponsor for approYal prior to 
commencing the clinical part of the trial. The list Zill Ee filed in the inYestigator site file. 
:here copies of the original source document as Zell as print outs of original electronic source 
documents are retained these shall Ee signed and dated Ey a memEer of the inYestigation site team 
Zith a statement that it is a true reproduction of the original source document. 
 DeYiation +andOing 
A study deviation is defined as an event Zithin a study that did not occur according to the Clinical 
Investigation Plan or the Clinical Trial Agreement. 
Prior approval by Medtronic is e[pected in situations Zhere the investigator anticipates, 
contemplates, or maNes a conscious decision to deviate. Prior approval is not reTuired Zhen a 
deviation is necessary to protect the safety, rights or Zell-being of a subMect in an emergency or in 
unforeseen situations beyond the investigator¶s control (e.g. subMect failure to attend scheduled 
folloZ-up visits, inadvertent loss of data due to computer malfunction, inability to perform reTuired 
procedures due to subMect illness). 
For medically Mustifiable conditions Zhich preempt a subMect¶s ability to complete a study-reTuired 
procedure, it may be permitted to report only one deviation Zhich Zill apply to all visits going 
forZard. This may also apply for other unforeseen situations (e.g. the subMect permanently refuses 
to complete a study reTuired procedure and the data Zill not contribute to a study end point 
analysis). +oZever, prior approval from Medtronic is reTuired for such situations.  
All study deviations must be reported on the Case Report Form regardless of Zhether medically 
Mustifiable, pre-approved by Medtronic, an inadvertent occurrence, or taNen to protect the subMect in 
an emergency. The deviation must be recorded Zith an e[planation.  Multiple deviations of the same 
type at the same visit may be reported on one case report form if they occur at the same date/visit 
and they have the same root cause.  

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In the event the deviation involves a failure to obtain a subMect¶s consent, or is made to protect the 
life or physical Zell-being of a subMect in an emergency, the deviation must be reported to the 
Institutional RevieZ Board (IRB) as Zell as Medtronic Zithin five (5) ZorNing days. Reporting of all 
other study deviations should comply Zith IRB policies and/or local laZs and must be reported to 
Medtronic as soon as possible upon the center becoming aZare of the deviation. Reporting of 
deviations must comply Zith IRB policies, local laZs, and/or regulatory agency reTuirements.  
Medtronic is responsible for analy]ing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g. amend the Clinical Investigation Plan, conduct 
additional training, and terminate the investigation). Repetitive or serious investigator compliance 
issues may result in initiation of a corrective action plan Zith the investigator and site, and in some 
cases, necessitate suspending enrollment until the problem is resolved or ultimately terminating the 
investigator
s participation in the study. Medtronic Zill provide center-specific reports to investigators 
summari]ing information on deviations that occurred at the investigational site on a periodic basis. 
 Study E[it 
At study e[it, a CRF is reTuired for all subMects e[cept in the case of death.  Prior to e[iting a subMect 
from the study, it is recommended to folloZ the subMect until all ongoing system and/or procedure 
related AEs are resolved or unresolved Zith no further actions planned.  FolloZing e[it, subMects Zill 
continue to receive standard medical care Zith their primary/enrolling physician.  Upon e[iting from 
the study, no further study data Zill be collected and no further study visits Zill occur for the 
subMect.  All data available through the time of the subMect¶s e[it Zill be used for analysis.  
SubMects Zill remain in the study until 1 months, or upon completing 3 right heart catheteri]ation 
procedures, Zhichever comes first.   
 
The subMect may also be e[ited from the study for any of the folloZing situations: 
x 
SubMect has completed folloZ-up 
x 
SubMect lost to folloZ-up 
x 
SubMect death 
x 
SubMect has an e[plant Zithout the intent to re-implant 
x 
SubMect did not meet inclusion/e[clusion criteria  
x 
SubMect did not provide consent or data use protection authori]ation 
x 
SubMect chooses to ZithdraZ (e.g., consent ZithdraZal, relocation to another geographic 
location)  
x 
Investigator deems ZithdraZal necessary (e.g., medically Mustified, inclusion/e[clusion criteria 
not met, failure of subMect to maintain adeTuate study compliance) 
x 
Lead or generator replacement 
 
If subMect is not lost to folloZ up, the folloZing information/procedure is reTuired to be 
collected/performed at e[it (Zhere available): 
x 
Reason for e[it +CU and AEs 

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x 
LINQ device data  
x 
Implanted PA pressure monitor data (if applicable) 
x 
Medication assessment 
x 
LINQ +F RAMZare removal from LINQ device 
 
In the case that the subMect is determined to be lost to folloZ-up, details of a minimum of tZo 
attempts and the method of attempt (e.g., one letter and one phone record or tZo letters) to 
contact the subMect must be recorded. In addition, folloZ the regulations set forth by the governing 
IRB.  
 RiVNV anG %eneIitV 
 PotentiaO RisNs 
 
The potential risNs associated Zith the ReLINQuish study Zere identified and have been successfully 
mitigated. Any potential risNs associated Zith this study are further minimi]ed by selecting Tualified 
investigators and training study personnel on the Clinical Investigation Plan.  
In addition, investigators Zill be actively involved in the implantation and regular folloZ-up of the 
subMects implanted Zith the Reveal LINQ Zith investigational RAMZare systems. At each office 
folloZ-up visit reTuired per protocol, the LINQ device Zill be interrogated, device data collected to 
verify appropriate device function and patient¶s health assessed for any adverse events. 
 
Medtronic has further minimi]ed the possibility of risNs by performing pre-clinical testing prior to the 
ReLINQuish clinical study, implementing Tuality control measures into softZare development 
processes, providing guidelines for subMect selection and evaluation, and providing adeTuate training 
instructions and labeling.  
There are potential risNs and side effects associated Zith a Reveal LINQ device 
implant and e[plant procedures: 
x 
Allergenic reaction or device reMection phenomena including local tissue reaction 
x 
E[cessive device migration (internal pocNet device movement as Zell as device 
e[ternali]ation) 
x 
PocNet infection 
x 
Erosion through the sNin 
x 
Tissue / vascular trauma 
 
Possible additional risNs for participating in this study include the folloZing (although others are 
possible): 
 

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E[cessive ICM migration 
folloZing implant procedure 
(internal device movement and 
e[ternali]ation) 
x 
:ound checN folloZing implant, per site¶s practice 
x 
Training and information for user on the Reveal LINQTM 
implant techniTue and incision closure techniTues 
x 
Use of the implant tools to create a small incision and 
tight pocNet. 
x 
Reveal LINQTM ICM design includes anti-migration 
features on the header 
x 
Investigator discretion to remove if deemed medically 
necessary 
Blunt tissue inMury/trauma or 
vascular trauma from 
implant/e[plant procedure 
x 
Insertion tool has a stop position the prevents insertion 
of the probe beyond the distance reTuired for implant 
x 
Training on the correct use of implant tools 
x 
Selection of e[perienced investigator 
Pain or scarring from 
implant/e[plant procedure 
x 
Use of incision tool Zill produce the smallest incision 
possible for implant 
x 
Small devices si]e minimi]es the invasiveness of the 
implant and e[plant procedures  
Undesired device interactions 
Zith the investigational 
RAMZare 
x 
Device interactions analysis to ensure there are no 
undesired interactions betZeen the LINQ +F 
investigational RAMZare and the Reveal LINQTM 
firmZare 
x 
LINQ +F investigational RAMZare is designed to be 
automatically removed by the ROM code during POR 
processing 
Premature/une[pected ICM 
e[plant 
x 
The proMected longevity of Reveal LINQTM device Zith 
investigational LINQ +F RAMZare shoZs a 5 month 
decrease in average proMected service life compared to 
a device Zithout the RAMZare. The e[act service life of 
each device Zill vary depending on each subMect¶s use. 
Electromagnetic interference 
x 
Design consideration and precautions in place for the 
Revela LINQTM system remain effective to address EMI 
risNs 

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Pain or stimulation effects from 
impedance measurements over 
duration of implant 
x 
The amount of current inMected as part of the 
impedance measurements has been minimi]ed to 
prevent subMect harm 
x 
Design controls in place to protect against fault 
conditions 
Missing/Misleading information 
causing inappropriate medical 
intervention 
x 
Data integrity checNs have been implemented 
x 
Validation testing of the system set-up Zill be 
performed 
,mproper /,14 +) 
inYestigational RA0Zare 
access and actiYation 
x 
Access code and preconditions are in place for 
appropriate activation 
x 
Data integrity checNs have been implemented 
Undesirable interaction of LINQ 
+F impedance measurement 
Zith concomitant implanted 
cardiac device (IPG/ICD/ CRT-
P/D) therapy delivery 
x 
Pre-clinical testing prior to the ReLINQuish clinical study 
Undesirable interaction of Tel-B 
Zith concomitant implanted 
devices 
x 
Pre-clinical testing prior to the ReLINQuish clinical study 
x 
E[lcusion of Medtronic IPGs, ICDs, and CRTs 
 
 PotentiaO Benefits 
The ReLINQuish study may offer no benefit to the subMect. SubMects may benefit from continuous 
arrhythmia monitoring Zith the Reveal ICM, as this monitoring could result in diagnosis of Atrial 
Fibrillation (or other arrhythmias) and comprehensive evaluation of symptoms on an earlier and 
more conclusive basis than Zhat Zould be possible Zithout an implantable cardiac monitor. 
The information gained from this study could result in the improved management of other patients 
receiving a Reveal LINQ device in the future. Additionally, information collected from this study 
may assist in the design of neZ product(s)/therapy(ies) and/or instructions for use.  
 RisNBenefit RationaOe 
Since the differences betZeen the Reveal LINQTM marNet-released device and the Reveal LINQTM 
device Zith the LINQ investigational RAMZare doZnload are minimal, both devices are used in 
accordance Zith the Reveal LINQTM implant manual and/or user manual, as applicable. The risNs 
associated Zith the device are similar as Zould be the case if the subMect received a Reveal LINQTM 
device outside the study conte[t. The risNs introduced by the LINQ +F investigational RAMZare are 
being evaluated and risN control measures being implements to reduce the risN to as loZ as possible 
to minimi]e subMect harm. 

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The study reTuirements for careful physician selection and training carry potential benefits that may 
be present if the subMect Zas not enrolled in the study. +ence, for individual subMects, participation 
in the study may have greater benefit than risN. Moreover, the value of the NnoZledge to be gained 
by conducting this clinical study could help in the diagnosis of future patients. Lastly, the prospective 
benefit to subMects of having  Reveal LINQTM cardiac monitoring, Zith the potential to diagnose life-
threatening arrhythmias, may provide the subMect Zith clinical benefit. 
 AGverVe (vent AVVeVVmentV 
 Definitions/COassifications
Reveal LINQ system and procedure-related adverse events Zill be collected throughout the study 
duration, starting at the time of signing the Patient Informed Consent Form.  In addition, all serious 
adverse events (SAEs) leading to death should be reported, regardless of relatedness. 
Reporting of these events to Medtronic Zill occur on an AE Form, including date of AE, treatment, 
resolution, assessment of both the seriousness of the AE and the relatedness to the device or procedure.  
(ach A( must Ee recorded on a separate A( e&R).  Documented pre-e[isting conditions are not 
considered AEs unless the nature or severity of the condition has Zorsened.  Unavoidable AEs, listed in 
Table 6, need not be reported unless the AE Zorsens or is present outside the stated timeframe post-
insertion.  
For AEs that reTuire immediate reporting (see Table 6), initial reporting may Ee done Ey contacting the 
study sponsor per the sponsor contact information.  The original completed AE CRF must be submitted to 
Medtronic as soon as possible.   
Any medication, Zhether cardiovascular or not, associated Zith the treatment of an AE must be reported.  
Medication changes that are not related to adverse events Zill not be collected.  
SubMect deaths are also reTuired to be reported.  Refer to Section 11.4 for SubMect Death collection and 
reporting reTuirements. 
10.1.1. Device Deficiencies 
Device deficiency (DD) information Zill be collected throughout the study and reported to Medtronic. 
Note that DDs that result in an Adverse Device Effect (ADE) to the subMect should be captured ason 
an AE CRF only. 
10.1.2. Event Updates and Resolution 
For any changes in status of a previously reported AE (i.e. change in actions taNen, change in 
outcome, change in relatedness), information needs to be updated on, or added to the original AE 

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form.  All AEs must be folloZed until the AE has been resolved, the subMect dies or e[its the study, 
or until study closure, Zhichever occurs first.  
At the time of study e[it, all collected AEs Zith an outcome of ´Unresolved´ must be revieZed and 
an update to the original AE must be reported.  At a minimum, if there are no changes to the 
description, relatedness, test and procedures or actions taNen, the outcome must be updated to 
reflect ³Unresolved at time of study e[it´. 
 DeIinitionV/&laVViIiFationV 
:here the definition indicates ³device´, it refers to any device used in the study.  This might be the 
device under investigation, or any marNet released component of the system, and includes but is not 
restricted to: the Reveal LINQTM, the programmer, and insertion tools.   
TaEle : AGverVe (vent anG DeviFe DeIiFienF\ DeIinitionV 

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Reveal LINQ System Related
(includes all implantable 
components and features, 
associated introduction tools, 
operational and installed softZare 
and programmers as defined in 
the Clinical Investigation Plan) 
An adverse event that results from the presence or 
performance of any component of the system. 
 
Device-related: An adverse event that results from the 
presence or performance (intended or otherZise) of the 
device.  
RAMZare-related: An adverse event that results from the 
presence or performance (intended or otherZise) of the 
RAMZare. 
 
Programmer Related:  An adverse event that results from 
the presence or performance (intended or otherZise) of the 
programmer 
 
Insertion Tool Related: An adverse event that results from 
the presence or performance (intended or otherZise) of the 
iinsertion tool.  
 
+olter Related: An adverse event that results from the 
presence or performance (intended or otherZise) of the 
implant tool. 
Cardiovascular Related 
An Adverse Event relating to the heart and the blood vessels 
or the circulation (e.g. Atrial Fibrillation, Myocardial 
Infarction, stroNe, perivascular disease) 

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Not Related
Relationship to the deYice or procedures can Ee e[cluded 
Zhen: 
 
The event is not a NnoZn side effect of the product 
category the device belongs to or of similar devices 
and procedures 
 
The event has no temporal relationship Zith the 
use of the device or the procedures 
 
The serious event does not folloZ a NnoZn 
response pattern to the medical device (if the 
response pattern is previously NnoZn) and is 
biologically implausible 
 
The discontinuation of medical device application or 
the reduction of the level of activation/e[posure ± 
Zhen clinically feasible ± and reintroduction of its 
use (or increase of the level of activation/e[posure) 
do not impact the serious event 
 
The event involves a body-site or an organ not 
e[pected to be affected by the device or 
procedure 
 
The serious event can be attributed to another 
cause (e.g., an underlying or concurrent 
illness/clinical condition, an effect of another 
device, drug, treatment, or other risN factors) 
 
The event does not depend on a false result given 
by the device used for diagnosis (Zhen applicable) 
 
+arms to the subMect are not clearly due to use 
error 
 
In order to establish the non-relatedness, not all 
the criteria listed above might be met at the same 
time, depending on the type of device/procedures 
and the event. 
8nliNely 
The relationship Zith the use of the deYice seems not 
releYant and/or the eYent can Ee reasonaEly e[plained Ey 
another cause Eut additional information may Ee oEtained. 
Possible 
The relationship Zith the use of the inYestigational deYice is 
ZeaN Eut cannot Ee ruled out completely. AlternatiYe causes 
are also possiEle e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another deYice drug or 
treatment. &ases Zere relatedness cannot Ee assessed or 
no information has Eeen oEtained should also Ee classified 
as possiEle.
Probable 
The relationship Zith the use of the inYestigational deYice 
seems releYant and/or the eYent cannot reasonaEly 
e[plained Ey another cause Eut additional information may 
Ee oEtained.  

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 SuEMeFt DeatK 
10.4.1. Death Data Collection 
All subMect deaths must be reported by the investigator to Medtronic on an AE form (AE Zith outcome of 
fatal) as soon as possible after the investigator first learns of the death.  In case of death, there should 
be one SAE Zith the outcome of death reported.  
In the event of a subMect¶s death, it is recommended that the implanted system be e[planted and 
returned to Medtronic for analysis Zhenever possible per local process.  Local laZs and procedures must 
be folloZed Zhere applicable. 
System Interrogation Data Recommendations: 
x 
After the subMect has died but prior to e[plant, it is strongly recommended that the system be 
interrogated and a full summary interrogation (Interrogate All) performed Zhen possible, and 
saved in a digital format.  Store one copy of the save-to-media at the site and send a copy to 
Medtronic.   
x 
MaNe the device interrogation/save-to-media file before any programming to prevent overZriting 
information in the device¶s memory and/or distinguishing betZeen events detected during versus 
before the e[plant procedure. 
x 
Recommend obtaining the e[act date and time of death as loZer temperatures after death can 
cause ERI and other ³event flags´ to be stored in the device memory. 
If the system is not interrogated, an e[planation must be entered on the AE form. If any system 
component is returned to Medtronic, internal return product reporting systems may be used to gather 
additional information about the returned device/component. 
A copy of the death certificate, if available and alloZed by state/local laZ, should be sent to the 
Medtronic ReLINQuish Study team.  :hen a death occurs in a hospital, a copy of the death summary 
report and all relevant hospital records should be sent to the Medtronic ReLINQuish Study team, if 
available.  If an autopsy is conducted, the autopsy report should also be sent to the Medtronic 
ReLINQuish Study team if available and alloZed by state/local laZ.  :hen the death occurs at a remote 
site, it is the investigative site¶s responsibility to attempt retrieval of information about the death.  
Additionally, device disposition information should be updated.  In summary, the folloZing data Zill be 
collected: 
x 
Date of death 
x 
Detailed description of death 
x 
Cause of death  
x 
Relatedness to system and/or procedure 
x 
Device interrogation and Save-to-Media (if available) 
x 
Device disposition information 

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that has been placed on the marNet. It is the responsibility of the investigator to report all product 
complaint(s) associated Zith a medical device distributed by Medtronic, regardless Zhether they are 
related to intended use, misuse or abuse of the product. Reporting must be done immediately and 
via the regular channels for marNet released-products. Medtronic Zill notify the regulatory 
authorities, as applicable for the folloZing incidents immediately upon learning of them: 
x 
Any malfunction or deterioration in the characteristics and/or performance of a 
device, as Zell as any inadeTuacy in the labeling or instructions for use Zhich led 
or might have led to the death or serious deterioration in the state of health of a 
patient, user, or other person. 
x 
Any technical or medical reason resulting in ZithdraZal of a device from the 
marNet by the manufacturer. 
x 
A serious deterioration in the state of heath includes: 
R 
Life-threatening illness or inMury, or 
R 
Permanent impairment of a body structure function or a body function, 
or 
R 
In-patient or prolonged hospitali]ation, or 
R 
Medical or surgical intervention to prevent life-threatening illness or 
inMury or permanent impairment to a body structure or a body function. 
 Data RevieZ &ommitteeV 
The purpose of the study is to characteri]e the relationship betZeen subcutaneous impedance and 
hemodynamic measurements in patients Zith heart failure.  Additionally, the relationship betZeen 
changes in subcutaneous impedance and other physiologic parameters during acute decompensated +F 
events Zill be characteri]ed.  Since this study Zill not proYide effectiYeness and/or safety data an 
independent AdYerse (Yent AdYisory &ommittee A(A& Zill not Ee utili]ed. 4ualified 0edtronic 
personnel Zill reYieZ all adYerse eYents. A Data 0onitoring &ommittee D0& Zill not Ee utili]ed to 
monitor data collected in the study since there are no safety endpoints or planned interim analysis.   
 
 
 StatiVtiFal DeVign anG MetKoGV 
This feasibility study is not poZered to formally test a hypothesis.  +oZever, it is e[pected that a 
sample of up to 30 subMects Zill be sufficient to determine Zhether this approach Zarrants further 
study.   
 

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 (tKiFV 
 Statement(s) of ComSOiance  
The ReLINQuish study Zill be conducted in compliance Zith international ethical and scientific 
Tuality standards, NnoZn as good clinical practice (GCP). GCP includes revieZ and approval by an 
independent IRB before initiating and obtaining and documenting the freely given informed consent 
of a subMect before initiating the study. 
 
The ReLINQuish study Zas designed to reflect the GCP principles outlined in ISO 14155:2011. These 
include the protection of the rights, safety and Zell-being of human subMects, controls to ensure the 
scientific conduct and credibility of the clinical investigation and the definition of responsibilities of 
the sponsor and investigators. In accordance Zith the ISO standard, the sponsor shall avoid 
improper influence on, or inducement of, the subMect, monitor, any investigator(s) or other parties 
participating in, contributing to, the clinical investigation. All investigators shall avoid improper 
influence on or inducement of the subMect, sponsor, monitor, other investigator(s) or other parties 
participating in or contributing to the clinical investigation.  
 
The study Zill be conducted according to federal, national and local laZs, regulations, standards, 
and reTuirements of the countries/geographies Zhere the study is being conducted. The principles 
of the Declaration of +elsinNi have been implemented through the patient informed consent (PIC) 
process, IRB approval, study training, clinical trial registration, preclinical testing, risN-benefit 
assessment and publication policy. 
 
All investigators are reTuired to complete financial disclosure, as outlined in 21 CFR Part 54 and all 
sites Zill need to comply Zith: 
 
x 
21 CFR Part 11 
x 
21 CFR Part 50 
x 
21 CFR Part 56 
x 
21 CFR Part 12(b) 
 
The study Zill be publicly registered on http://clinicaltrials.gov prior to first enrollment in accordance 
Zith the 200 Food and Drug Administration Amendments Act (FDAAA) (PL 110-5, Section 01(a)) 
and the Declaration of +elsinNi. 
Approval of the CIP is reTuired from the folloZing groups prior to any study procedures at a study 
center:  
 
x 
Medtronic  
x 
An Institutional RevieZ Board at each individual study center 
 
Similarly, approval of subseTuent revisions to the CIP is reTuired at each study center from the 
above mentioned groups prior to implementation of the revised CIP at that center. 

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 StuG\ AGminiVtration 
 Monitoring  
It is the responsibility of Medtronic to ensure proper monitoring of this clinical study.  Trained 
Medtronic personnel or delegates appointed by Medtronic may perform study monitoring at the 
study site in order to ensure that the study is conducted in accordance Zith the CIP, the Clinical Trial 
Agreement or :orN Order, and applicable regulatory and local reTuirements. Medtronic, or 
delegates, must therefore be alloZed access to the subMects¶ case histories (clinic and hospital 
records, and other source data/documentation) upon reTuest as per the Informed Consent Form and 
Authori]ation to Use and Disclose Personal +ealth Information/Research Authori]ation/other privacy 
language (data protection authori]ation) as reTuired by laZ and Clinical Trial Agreement or :orN 
Order.  The principal investigator should also be available during monitoring visits.  
Monitoring for the study Zill be done in accordance to the study-specific monitoring plan. 
Monitoring visits may be conducted periodically to assess site study progress, the investigator¶s 
adherence to the CIP, regulatory compliance including but not limited to IRB/EC approval and revieZ 
of the study, maintenance of records and reports, and revieZ of source documents against subMect 
eCRFs. Monitors revieZ site regulatory and study compliance by identifying findings of non-
compliance and communicating those findings along Zith recommendations for 
preventative/corrective actions to site personnel.  Monitors may ZorN Zith study personnel to 
determine appropriate corrective action recommendations and to identify trends Zithin the study or 
at a particular site. Regulatory documents may be revieZed at each study site.   
FreTuency of monitoring visits may be based upon subMect enrollment, duration of the study, study 
compliance, number of adverse events, number of deviations, findings from previous monitoring 
visits and any suspected inconsistency in data that reTuires investigation. 
 Data Management
Data Zill be collected using a data management system for clinical studies.  CRF data Zill be stored 
in a secure, passZord-protected database Zhich Zill be bacNed up nightly.  Data Zill be revieZed 
using programmed and manual data checNs.  Data Tueries Zill be made available to centers for 
resolution.  Study management reports may be generated to monitor data Tuality and study 
progress.  At the end of the study, the data Zill be fro]en and Zill be retained indefinitely by 
Medtronic. 
 
All records and other information about subMects participating in this study Zill be treated as 
confidential. Data Zill be transferred and processed by Medtronic or a third party designated by 
Medtronic in a Ney coded form, unless it is impossible to maNe it anonymous, for instance, Zhere the 
patient¶s name cannot be removed from the data carrier, such as fluoroscopy images.   

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Procedures in the CIP reTuire source documentation.  Source documentation Zill be maintained at 
the site. Source documents, Zhich may include, but not limited to, ZorNsheets, patient medical 
records, lab results, ECGs, programmer printouts, and interrogation files, must be created and 
maintained by the investigational site team. In some cases, the data reported in the CRFs may be 
considered source, as long as there is evidence of it in the subMect¶s record. The CRF may serve has 
the primary source for the folloZing data points but is not limited to the list beloZ (refer to the 
study-specific monitoring plan for complete listing). 
 
The data reported on the CRFs shall be derived from source documents and be consistent Zith these 
source documents, and any discrepancies shall be e[plained in Zriting. 
 Direct Access to Source Data/Documents  
All study investigator(s)/institution(s) Zill permit study-related monitoring, audits, IRB/IEC revieZ, 
and regulatory inspection(s), providing direct access to source data/documents as reTuired in 
accordance Zith ReLINQuish CIP and the investigator agreement.  
 ConfidentiaOity 
All records and other information about subMects participating in this study Zill be treated as 
confidential. The identity of a subMect Zill never be disclosed in the event that study data are 
published.  
SubMect confidentiality Zill be maintained throughout the clinical study in a Zay that ensures the 
information can alZays be tracNed bacN to the source data. For this purpose, a uniTue subMect 
identification code Zill be assigned and used to alloZ identification of all data reported for each 
subMect. 
Study data may be made available to third parties, e.g. in the case of an audit performed by 
regulatory authorities, provided the data are treated confidentially and that the subMect¶s privacy is 
guaranteed. Sites Zill maintain subMect privacy according to local and national regulations and 
institutional reTuirements.  
 CIP Amendments 
Amendments to this Clinical Investigation Plan shall be agreed upon betZeen Medtronic and clinical 
investigator(s) and be recorded Zith a Mustification for the amendments.  
 Record Retention 
The investigator must retain the Investigator Site File, subMect medical files and CRFs in accordance 
Zith local laZ and regulations for a minimum period of 2 year (or longer if local laZs reTuire) after 
marNet-release in his/her region. The investigator should taNe measures to prevent accidental or 
early destruction of the clinical study related materials. 

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 PuEOication and Use of Information 
Publications and presentations referring to this clinical study Zill be coordinated by Medtronic to 
alloZ the use of all available data. The folloZing publication policy Zill have to be adhered to by all 
participating investigation sites: 
Medtronic may intend to publish the results of the study in scientific Mournals and congresses. 
There are no plans to form a publication committee. Publication activities Zill be assessed after the 
study is completed and any collaboration Zith the investigator Zill be determined at that time. 
Authorship on any publication(s) resulting from this clinical study Zill be assigned according to 
substantial contributions to conception and design, acTuisition of data, or analysis and interpretation 
of data, drafting the article or revising it critically for important intellectual content and final approval 
of the version to be published. This is in accordance Zith the Vancouver principles (The Uniform 
ReTuirements for Manuscripts Submitted to Biomedical -ournals: :riting and Editing for Biomedical 
Publication, Latest ICM-E Recommendations (³Recommendations for the Conduct, Reporting, 
Editing, and Publication of Scholarly :orN in Medical -ournals´, 2013), as agreed upon by the editors 
of all maMor medical Mournals.  
The number of authors Zill be dependent on the regulations of the concerning Mournal.  
Based on the principle that Medtronic oZns the data of this clinical study, a single investigation site 
may access and use the data provided by itself for scientific publications folloZing prior approval by 
Medtronic. 
Medtronic as the oZner of the data can use the data and/or any results derived from the data or 
publications based on that data for marNeting purposes, further research and development of 
devices or educational use. 
The study sponsor Zill collect data in such Zay that no subMect can be identified, and monitor study 
records. 
Participating subMects Zill not be identified by name in any published reports about the clinical study.  
 SusSension or EarOy Termination 
14..1. Planned study closure 
Study Closure is a process initiated by distribution of a study closure letter. Study closure is defined 
as closure of a clinical study that occurs Zhen Medtronic and/or regulatory reTuirements have been 
satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory 
authority), Zhichever occurs first. The study closure process is complete upon distribution of the 
Final Report or after final payments, Zhichever occurs last. Ongoing IRB oversight is reTuired until 
the overall study closure process is complete. Refer to Section 10. for additional information 
regarding study e[it procedures. 

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14..2. Early termination or suspension
Early Termination of the Study is the closure of a clinical study that occurs prior to meeting defined 
endpoints. This is possible for the Zhole study or a single center. Study Suspension is a temporary 
postponement of study activities related to enrollment and distribution of the product. This is 
possible for the Zhole study or a single center. 
14..3. Study-Zide termination or suspension 
Possible reasons for considering study suspension or termination of the study include but are not 
limited to: 
x 
Adverse events associated Zith the system or product under investigation Zhich might 
endanger the safety or Zelfare of the subMect 
x 
Observed/suspected performance different from the product¶s design intent 
x 
Decision by Medtronic or regulatory body (Zhere the study is operating under regulatory 
body authority)  
x 
Technical issues during the manufacturing process 
14..4. Investigator/center termination or suspension 
Possible reasons for clinical investigator or center termination or suspension include but are not 
limited to: 
x 
Failure to obtain initial IRB approval or annual reneZal of the study 
x 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/e[clusion criteria, failure to folloZ subMects per scheduled folloZ-ups)  
x 
LacN of enrollment 
x 
Noncompliance to regulations and the terms of the Clinical Trial Agreement (e.g. failure to 
submit data in a timely manner, failure to folloZ-up on data Tueries and monitoring findings 
in a timely manner, etc.)  
x 
IRB suspension of the center 
x 
Fraud or fraudulent misconduct is discovered (as defined by local laZ and regulations)  
Investigator reTuest (e.g. no longer able to support the study). 

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14..5. Procedures for termination or suspension
14..5.1. 
Medtronic-initiated and regulatory authority-initiated 
x 
Medtronic Zill promptly inform the clinical investigators of the termination or suspension and 
the reasons and inform the regulatory authority(ies) Zhere reTuired 
x 
In the case of study termination or suspension for reasons other than a temporary IRB 
approval lapse, the investigator Zill promptly inform the IRB  
x 
In the case of study termination, the investigator must inform the subMects and may inform 
the personal physician of the subMects to ensure appropriate care and folloZ-up is provided 
x 
In the case of a study suspension, subMect enrollment must stop until the suspension is lifted 
by Medtronic 
x 
In the case of a study suspension, enrolled subMects should continue to be folloZed out of 
consideration of their safety, rights and Zelfare 
 
14..5.2. 
Investigator-initiated 
x 
The investigator Zill inform Medtronic and provide a detailed Zritten e[planation of the 
termination or suspension 
x 
The investigator Zill promptly inform the institution (Zhere reTuired per regulatory 
reTuirements)  
x 
The investigator Zill promptly inform the IRB 
x 
The investigator Zill promptly inform the subMects and/or the personal physician of the 
subMects to ensure appropriate care and folloZ-up is provided 
x 
In the case of a study suspension, subMects enrolled should continue to be folloZed out of 
consideration of their safety, rights and Zelfare 
14..5.3. 
IRB-initiated 
x 
The investigator Zill inform Medtronic and provide a detailed Zritten e[planation of the 
termination or suspension Zithin 5 business days 
x 
SubMect enrollment must stop until the suspension is lifted 
x 
SubMects already enrolled should continue to be folloZed in accordance Zith IRB policy or its 
determination that an overriding safety concern or ethical issue is involved 
x 
The investigator Zill inform his/her institution (Zhere reTuired per local reTuirements)  
x 
The investigator Zill promptly inform the subMects, or legally-authori]ed designees or 
guardians and/or the personal physician of the subMects, Zith the rationale for the study 
termination or suspension 
 

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 ReIerenFeV 
x 
Dra]ner M+, Rame -E, Stevenson L:, Dries DL. Prognostic importance of elevated Mugular 
venous pressure and a third heart sound in patients Zith heart failure. The NeZ England Mournal 
of medicine. 2001345:54-51 
x 
Setoguchi S, Stevenson L:, SchneeZeiss S. Repeated hospitali]ations predict mortality in the 
community population Zith heart failure. American heart Mournal. 200154:260-266 
x 
Merchant FM, Dec G:, Singh -P. Implantable sensors for heart failure. Circulation. Arrhythmia 
and electrophysiology. 20103:65-66 
x 
Bourge RC, Abraham :T, Adamson PB, Aaron MF, Aranda -M, -r., MagalsNi A, =ile MR, Smith AL, 
Smart F:, O
Shaughnessy MA, -essup ML, SparNs B, Naftel DL, Stevenson L:. Randomi]ed 
controlled trial of an implantable continuous hemodynamic monitor in patients Zith advanced 
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 AppenGiFeV  
Appendi[ A: Patient Informed Consent Form Template 
Appendi[ B: Draft data collection forms (Case Report Forms) 
Appendi[ C: ReLINQuish +andbooN 
Appendi[ D: Site Information 
 
 
 

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AppenGi[ A: 3atient ,nIormeG &onVent )orm Template 
Template informed consent form Zill Ee proYided under separate coYer. 
 

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AppenGi[ %: DraIt Gata FolleFtion IormV 
Draft data collection forms Zill be provided under separate cover. 
 

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This document is electronically controlled                                               056-F25, v3.0 Clinical Investigation Plan Template 
  
 
AppenGi[ &: Re/,N4uiVK StuG\ 3roFeGure +anGEooN 
The ReLINQuish Study Procedre +andbooN Zill be provided under separate cover.