Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure
Conditions: Heart Failure
Sponsor: Abbott Medical Devices

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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INTELLECT 2-HF 
INvesTigation to OptimizE Hemodynamic Management of HeartMate II™ Left VentricuLar Assist 
DEvice Patients using the CardioMEMS™ Pulmonary ArTery Pressure Sensor in Advanced Heart 
Failure 
(INTELLECT 2-HF) 
CRD_892 
Study Document No: CIP-10178 
Version B 
Date: 06-18-18 
Clinical Investigation Plan (CIP) 
 
 
Sponsor : 
Abbott 
        
 
23 Fourth Avenue 
      
  
Burlington, MA 01803 
        
 
U.S.A. 
 
 
 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 2 of 44 
 
TABLE OF CONTENTS 
Table of Appendices ................................................................................................................ 4 
List of Tables .......................................................................................................................... 4 
List of Figures......................................................................................................................... 4 
1 
Introduction ...................................................................................................................... 5 
2 
Background and Justification for Clinical Investigation ............................................................. 5 
3 
Device(s) Under Investigation.............................................................................................. 6 
3.1 
Identification and Description of the Devices under Study ................................................ 6 
3.1.1 
Identification.................................................................................................. 6 
3.1.1.1 
The CardioMEMS™ Heart Failure (HF) System.................................... 6 
3.1.1.2 
The HeartMate™ Left Ventricular Assist System (LVAS)........................ 6 
3.1.2 
Device Description and Intended Purpose ......................................................... 7 
3.1.3 
Intended Purpose within the Clinical Investigation ............................................... 7 
4 
Clinical Investigation Design................................................................................................ 7 
4.1 
Clinical Investigation Design ....................................................................................... 7 
4.2 
Objectives ................................................................................................................ 7 
4.3 
Endpoints ................................................................................................................ 8 
4.3.1 
Descriptive Endpoints ..................................................................................... 8 
4.3.2 
Additional Descriptive Data Analyses ................................................................ 8 
4.4 
Study Population....................................................................................................... 8 
4.4.1 
Inclusion Criteria ............................................................................................ 8 
4.4.2 
Exclusion Criteria ........................................................................................... 9 
5 
Procedures....................................................................................................................... 9 
5.1 
Patient Recruitment ................................................................................................... 9 
5.2 
Informed Consent Process ......................................................................................... 9 
5.3 
Screening .............................................................................................................. 10 
5.4 
Point of Enrollment .................................................................................................. 10 
5.5 
Scheduled Procedures ............................................................................................. 10 
5.5.1 
Baseline ..................................................................................................... 11 
5.5.2 
Scheduled Follow-ups .................................................................................. 11 
5.6 
Hemodynamically Guided Clinical Management........................................................... 11 
5.6.1 
Merlin.net ................................................................................................... 12 
5.7 
Patient Reported Outcome (PRO) Measures ............................................................... 12 
5.7.1 
EQ-5D-5L Questionnaire............................................................................... 12 
5.8 
Unscheduled Visits .................................................................................................. 13 
5.8.1 
Unscheduled Office Visits.............................................................................. 13 
5.8.2 
Emergency Room Visits or Outpatient Short Stays ............................................ 13 
5.8.3 
Hospitalizations ........................................................................................... 13 
5.8.4 
Right Heart Catheterization ........................................................................... 13 
5.8.5 
Subject Home PA Pressure Readings ............................................................. 13 
5.8.6 
PA Pressure Readings in the Hospital ............................................................. 13 
5.9 
Ramp Studies......................................................................................................... 13 
5.10 Study Flow Chart .................................................................................................... 14 
5.11 Description of Activities Performed by Sponsor Representatives .................................... 16 
5.12 Subject Study Completion ........................................................................................ 16 
5.13 Subject Withdrawal.................................................................................................. 16 
5.14 Study Committees ................................................................................................... 16 
5.14.1 Steering Committee (SC) .............................................................................. 16 
5.14.2 Publication Committee (PC)........................................................................... 16 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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TABLE OF CONTENTS 
6 
Data analysis Considerations ............................................................................................ 17 
6.1 
Analysis of Endpoints .............................................................................................. 18 
6.1.1 
Descriptive Endpoints ................................................................................... 18 
6.1.2 
Additional Descriptive Data Analyses .............................................................. 18 
6.1.3 
Adverse Events ........................................................................................... 19 
6.2 
Overall Sample Size ................................................................................................ 19 
6.3 
Timing of Analysis ................................................................................................... 19 
6.4 
Success Criteria...................................................................................................... 19 
6.5 
Interim Analysis ...................................................................................................... 19 
6.6 
Statistical Criteria for Termination .............................................................................. 19 
7 
Risks and Benefits........................................................................................................... 19 
7.1 
Risks Associated with Clinical Investigation Assessments ............................................. 19 
7.2 
Risk Control Measures ............................................................................................. 19 
7.3 
Anticipated Benefits ................................................................................................. 20 
7.4 
Risk-to-Benefit Rationale .......................................................................................... 20 
8 
Requirements for Investigator Records and Reports ............................................................. 20 
8.1 
Deviations from CIP................................................................................................. 20 
8.2 
Safety Reporting ..................................................................................................... 20 
8.2.1 
Subject Death ............................................................................................. 21 
8.2.2 
Complaint ................................................................................................... 22 
8.3 
Source records ....................................................................................................... 22 
8.4 
Records Retention .................................................................................................. 22 
9 
Clinical Data Handling ...................................................................................................... 22 
9.1 
Protection of Personally Identifiable Information ........................................................... 23 
9.2 
Data Management Plan............................................................................................ 23 
9.3 
Document and Data Control...................................................................................... 23 
9.3.1 
Traceability of Documents and Data ............................................................... 23 
9.3.2 
Recording Data ........................................................................................... 23 
10 Data Monitoring............................................................................................................... 23 
11 Compliance Statement ..................................................................................................... 23 
11.1 Statement of Compliance ......................................................................................... 23 
11.2 Quality Assurance Audits and Regulatory Inspections................................................... 24 
11.3 Repeated and Serious Non-Compliance ..................................................................... 24 
12 Suspension or Premature Termination of the Clinical Investigation .......................................... 24 
13 Clinical Investigation Conclusion ........................................................................................ 25 
14 Publication Policy ............................................................................................................ 25 
15 Reporting Results on ClincalTrials.gov Website ................................................................... 25 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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Table of Appendices 
Appendix A: CIP Revisions ..................................................................................................... 26 
Appendix B: Definitions .......................................................................................................... 27 
Appendix C: NYHA Classification............................................................................................. 30 
Appendix D: 6 Minute Hall Walk With CardioMEMS Readings Pre and Post Test Protocol................ 31 
Appendix E: Modified Rankin Score ......................................................................................... 34 
Appendix F: Management of Hemodynamic Parameters ............................................................. 35 
Appendix G: Bibliography ....................................................................................................... 36 
Appendix H: Informed Consent Form ....................................................................................... 37 
 
 
 
 
 
 
List of Tables 
Table 1 – Identification of Devices under Investigation .................................................................. 6 
Table 2 – List of All Clinical Investigation Specific Tests and Procedures ....................................... 15 
Table 3 – CIP Revision History ................................................................................................ 26 
Table 4 – NYHA Classification................................................................................................. 30 
Table 5 – Modified Rankin Score ............................................................................................. 34 
Table 6 – Recommended Frequency of CardioMEMS HF System Review ..................................... 35 
 
 
 
 
 
 
List of Figures 
Figure 1 – Study Flow Chart ................................................................................................... 14 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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1 
INTRODUCTION 
This document is a clinical investigation plan (CIP) for the  INvesTigation to OptimizE 
Hemodynamic Management of HeartMate II™ Left VentricuLar Assist DEvice Patients using the 
CardioMEMS™ Pulmonary ArTery Pressure Sensor in Advanced Heart Failure (INTELLECT 2-
HF) study. This observational post market study is intended to characterize hemodynamic-guided 
management of patients with an existing left ventricular assist device (LVAD) to protocol specified 
target ranges and its impact on functional status, quality of life, and readmissions. Data will be 
collected in patients with a HeartMate™ Left Ventricular Assist System (LVAS) and CardioMEMS 
HF system.  Both devices are FDA approved and will be utilized on label. This clinical 
investigation is sponsored by Abbott. All parties involved in the conduct of the clinical 
investigation will be qualified by education, training, and experience to perform their tasks and 
this training will be documented appropriately. 
2 
BACKGROUND AND JUSTIFICATION FOR CLINICAL INVESTIGATION 
Heart failure (HF) is a progressive condition which affects the heart’s ability to pump blood to the 
body’s tissues and organs.  Symptoms of HF include fluid retention, dyspnea, and exercise 
intolerance. When patients advance to NYHA class IIIA and are hospitalized, the CardioMEMS™ 
HF system is indicated for wireless PA pressure monitoring to guide HF management1. As the 
disease progresses to NYHA class IIIB, the HeartMate LVAD becomes an important treatment 
option for patients ineligible for cardiac transplant or those awaiting transplant. The pump is 
implanted in parallel with the native heart and is intended to provide long-term hemodynamic 
support2, 3. HeartMate use in advanced HF patients results in increased survival, quality of life, 
and functional status2-4. 
 
The majority of patients respond well clinically to LVAD support and improve to NYHA class I or 
II.  However, approximately 20% of LVAD patients continue to experience poor functional status 
with NYHA class III or IV symptoms4.  LVAD patients with worsening HF or impaired pump 
performance due to suboptimal hemodynamics are often re-hospitalized. In the ROADMAP study, 
about 80% of LVAD patients were re-hospitalized within a year after implant, and 10% of 
readmissions were due to pressure/volume management or worsening HF5.  
 
Improved hemodynamic monitoring of LVAD patients may reduce the readmission burden due to 
HF and volume management.  CardioMEMS is an implantable wireless pressure sensor proven 
to reduce hospital admissions in NYHA class III patients. In the CHAMPION trial, CardioMEMS 
provided daily monitoring of PA pressure to optimize drug therapy in HF patients, resulting in a 
37% reduction of HF related hospitalizations1. In addition to reduced readmission rates, HF 
management with CardioMEMS leads to improved quality of life, NYHA class, and six-minute 
walk distance1, 6. In LVAD patients, remote monitoring with CardioMEMS should allow physicians 
to intervene earlier when hemodynamic deterioration occurs. Appropriate medication or pump 
speed changes can be made to optimize pulmonary artery pressure and indirectly left ventricular 
filling pressure which may reduce HF hospital readmissions7. Frequent hemodynamic 
optimization may lead to improved functional status and quality of life, especially for patients who 
are failing to respond well to LVAD therapy. 
 
Currently, there is limited data from patients with both a CardioMEMS device and LVAD.  The 
purpose of this post market study is to characterize and evaluate hemodynamic-guided 
management in patients that have per indications received a HeartMate LVAD and a 
CardioMEMS HF System. Patients will be managed with the goal of achieving a PA diastolic 
pressure in a target range of 8 to 15 mmHg.  This range is slightly higher than the PA diastolic 
pressure range found in healthy subjects (4 to 12 mmHg)8 and allows for volume and pressure 
changes during the course of the day and avoid hypovolemia. The learnings from this feasibility 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 6 of 44 
 
study will be used to develop CardioMEMS-guided treatment strategies to improve clinical 
outcomes of HeartMate patients with poor functional status and provide meaningful evidence for 
designing future studies. 
3 
DEVICE(S) UNDER INVESTIGATION 
3.1 
IDENTIFICATION AND DESCRIPTION OF THE DEVICES UNDER STUDY 
3.1.1 
Identification 
3.1.1.1 
The CardioMEMS™ Heart Failure (HF) System 
The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for 
the monitoring and management of heart failure (HF) patients. The system measures PA 
pressure which physicians use to initiate or modify heart failure treatment. 
 
The CardioMEMS HF System received CE Mark in 2011 and the current certificate was 
issued by British Standard Institute (BSI) on May 1, 2014.  The system received Food and 
Drug Administration (FDA) approval on May 28, 2014 for commercial use in the United 
States. The CardioMEMS HF System is currently indicated for wirelessly measuring and 
monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association 
(NYHA) Class III heart failure patients who have been hospitalized for heart failure in the 
previous year. The hemodynamic data are used by physicians for heart failure management 
with the goal of reducing heart failure hospitalizations. 
3.1.1.2 
The HeartMate™ Left Ventricular Assist System (LVAS) 
The HeartMate II LVAS is a set of equipment and materials that together comprise a medical 
device designed to provide therapeutic benefit to those afflicted with advanced heart failure.  
In service, the LVAS assumes some or all of the workload of the left ventricle, thereby 
restoring the patient's systemic perfusion while palliating the underlying pathology.  The 
HeartMate II LVAS received FDA approval on January 20, 2010 and CE Mark approval in 
November, 2005. The FDA approved HeartMate II™ to provide hemodynamic support in 
patients with advanced refractory left ventricular heart failure; either for bridge to cardiac 
transplantation (BTT) or destination therapy (DT).   
 
Table 1 – Identification of Devices under Investigation 
Device name 
Model/ 
Part Number 
Manufacturer 
Region/ Country 
Investigational or Market 
Released 
CardioMEMS™ PA Sensor 
and Delivery Catheter 
CM2000 
Abbott (formerly St. 
Jude Medical) 
United States 
Market Released  
CardioMEMS™ Patient 
Electronics System 
CMEMS1000, 
1010 or 1100 
Abbott 
United States 
Market Released 
CardioMEMS™ Hospital 
Electronics System 
CM3000 
Abbott 
United States 
Market Released 
HeartMate II™ LVAS  
106015  
Abbott 
United States. 
Market Released 
HeartMate 3™ LVAS  
106524 
Abbott 
United States 
Upon Market Release 
indication 
 
HeartMate 3™ is a next generation LVAS currently under investigation in the United States in 
the MOMENTUM 3 Investigational Device Exemption (IDE) clinical trial and Continued 
Access Protocol (CAP). The HeartMate 3™ LVAS is intended to provide hemodynamic 
support in patients with advanced refractory left ventricular heart failure; either for short term 
support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 7 of 44 
 
term support, such as destination therapy (DT). FDA approval for short term support was 
received in August 2017. Patients with a HeartMate 3 implant can be considered for 
enrollment into INTELLECT 2 if they meet one of the following criteria: 
• Patients with a commercial HeartMate 3 implant 
• Short-term support patients such as BTT patients participating in the MOMENTUM 3 CAP 
• BTT patients who have completed two year follow-up in the MOMENTUM 3 IDE trial 
• Once FDA approval is granted for long-term support, long-term support patients such as 
DT patients from MOMENTUM 3 CAP or DT patients with complete two year follow-up 
from MOMENTUM 3 IDE are allowed to be enrolled 
 
3.1.2 
Device Description and Intended Purpose 
The market approved devices to be used in this study are listed in the Table 1 above. All devices 
are commercially approved and market released and will be used per the approved labeling, 
Instructions for Use and Indications. For details regarding the instructions for use, training, 
storage and handling, preparation for use, precautions, intended populations, and indications for 
each product, please see the specific user’s manual. For CardioMEMS™, the manuals are 
located at http://manuals.sjm.com and for HeartMate™, manuals can be found at 
http://www.thoratec.com/medical-professionals/resource-library/index.aspx.  
3.1.3 
Intended Purpose within the Clinical Investigation 
This clinical investigation is an observational study intended to characterize the use of the 
CardioMEMS HF hemodynamic monitoring system in patients with an existing HeartMate LVAS. 
This study will help develop clinical strategies for managing LVAD patients with the use of a 
hemodynamic monitor and will inform the design of more definitive studies in this patient 
population. 
4 
CLINICAL INVESTIGATION DESIGN 
4.1 
CLINICAL INVESTIGATION DESIGN 
The INTELLECT 2-HF Study is a prospective, non-randomized multicenter, single-arm 
observational study, which will be conducted at up to 25 U.S. centers, and will enroll up to 100 
subjects.  
 
The expected duration of enrollment is approximately 18 months with a six month follow-up 
period. Patients will exit the study when they complete their six month follow-up visit. The total 
duration of the clinical investigation is expected to be approximately two years. 
 
Patients will be managed with the goal of achieving a PA diastolic pressure in a target range 
between 8 and 15 mmHg. Clinician discretion is allowed on how to reach this target range by 
remotely adjusting diuretic/ vasodilator therapy, or by changing pump speeds at clinic visits. The 
change implemented, and reason for the change, must be documented in the CRF. If no change 
is made when the patient is outside the target range, the clinician must document the clinical 
rationale for not making a change. It is recommended that adjustments to diuretic medications be 
the first approach unless an alternate approach is clinically more appropriate. Pump speed 
changes in these patients are expected to be infrequent. 
4.2 
OBJECTIVES 
INTELLECT 2 will gather data from patients with both the CardioMEMS™ HF System and 
HeartMate™ LVAD. Both devices are commercially approved and will be used, as indicated, per 
the labeling. The objective of this clinical investigation is to understand the role of hemodynamic 
monitoring in LVAD patients and: 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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• 
Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients 
under different clinical and physiologic conditions  
• 
Characterize the effects of PA pressure on functional status, quality of life, and hospital 
readmissions of LVAD patients 
• 
Evaluate target ranges for PA pressure and assess the impact of medication and pump 
speed changes on PA pressures 
 
The results from this study will facilitate the design of future studies in this patient population, 
leading to the development of clinical strategies for managing LVAD patients using information 
from an implantable hemodynamic monitor. 
4.3 
ENDPOINTS 
There are ten descriptive endpoints in this clinical investigation. 
4.3.1 
Descriptive Endpoints 
1. Change in Six Minute Hall Walk (6MHW) distance from enrollment to six months 
2. Changes in CardioMEMS PA pressure over time 
3. Percentage of days PA pressure is in the pre-specified target range 
4. Changes in PA pressure before 6MHW test to after 6MHW test  
5. Device malfunction (e.g. loss of performance in either device) 
6. NYHA classification at baseline and each scheduled follow-up visit 
7. Health related quality of life (EQ-5D-5L) 
8. All-cause hospitalization rate 
9. Heart failure hospitalization rate including emergency department visits, or 
unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular 
medication management  
10. Change in 6MHWD, NYHA class, health related quality of life, or unscheduled 
hospitalizations by PA pressure 
4.3.2 
Additional Descriptive Data Analyses 
1. CardioMEMS PA pressure data during LVAD speed ramp test, when done as standard 
of care 
2. CardioMEMS PA pressure data during collection of right heart catheterization (RHC) 
data, when done as standard of care  
3. LVAD speed, power, and estimated flow parameters 
4. Heart Failure medications (counts and Total Daily Dosage (TDD)) 
 
4.4 
STUDY POPULATION 
The intended population for this clinical investigation is comprised of advanced heart failure 
patients over the age of 18 years who have a CardioMEMS device and a HeartMate LVAD. 
4.4.1 
Inclusion Criteria 
To participate in this clinical investigation, the subject must meet all of the following inclusion 
criteria: 
 
1. Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD 
(Group A) 
OR 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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Subject has commercially-approved HeartMate LVAD is experiencing NYHA class III 
symptoms, and has had a previous HF hospitalization and meets FDA indications for 
CardioMEMS. The CardioMEMS sensor must be implanted within 72 hours of consent 
(Group B)  
2. Signed an informed consent form and agreed to provide access to patient and device data 
(including CardioMEMS Merlin.net data) 
3. No connectivity or transmission problems with CardioMEMS 
4. On HeartMate LVAD support for at least 3 months 
5. Age ≥ 18 years 
4.4.2 
Exclusion Criteria 
Subjects who meet any of the following exclusion criteria must be excluded from the clinical 
investigation: 
 
1. Current participation in an investigation that is likely to confound study results or affect study 
outcome 
2. Current participation in the MOMENTUM3 IDE clinical trial and has not completed the two 
year follow-up for that trial 
3. Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, 
orthopedic issues, amputation etc.) 
5 
PROCEDURES 
This clinical investigation will be conducted in accordance with this CIP. All parties involved in the 
conduct of this clinical investigation will be qualified by education, training, or experience to 
perform their tasks and this training will be documented appropriately. 
 
This clinical investigation will not commence until the Sponsor receives written approval from the 
Institutional Review Board (IRB) and all required documents have been collected from the 
investigational site(s). All study staff will be required to undergo training prior to performing any 
study related activities. Approval from the Sponsor must be received and patients must sign 
written informed consent prior to initiating study procedures. 
 
The following sections provide a detailed description of procedures required by this CIP. 
5.1 
PATIENT RECRUITMENT 
Patients will be recruited for the study by reviewing the device database for HeartMate LVAS 
patients with CardioMEMS devices for appropriateness for inclusion. Due to the narrow inclusion 
criteria requiring two specific devices, no additional steps will be taken to recruit under 
represented populations. 
5.2 
INFORMED CONSENT PROCESS 
The Principal Investigator or his/her authorized designee will conduct the Informed Consent 
Process, as required by applicable regulations and the center’s IRB. Patients from Group A will 
provide consent for the sponsor to access CardioMEMS historical data collected prior to study 
enrollment as well as current data from the Merlin.net website.  Group B will provide consent to 
review all data collected in the study. The CardioMEMS sensor must be implanted within 72 
hours of consent. 
 
This informed consent process will include a verbal discussion with the subject on all aspects of 
the clinical investigation that are relevant to the subject’s decision to participate, such as details of 
clinical investigation procedures, anticipated benefits, and potential risks of clinical investigation 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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participation. During the discussion, the Principal Investigator or his/her authorized designee will 
avoid any improper influence on the subject and will respect the subject’s legal rights. The subject 
shall be provided with the informed consent form written in a language that is understandable to 
the subject and has been approved by the center’s IRB. The subject shall have adequate time to 
review, ask questions and consider participation. 
 
If the subject agrees to participate, the Informed Consent form must be signed and dated by the 
subject and by the person obtaining the consent. The signed original will be filed in the subject’s 
hospital or research charts, and a copy will be provided to the subject. 
 
Failure to obtain informed consent from a subject prior to clinical investigation enrollment should 
be reported to Sponsor within 5 working days and to the reviewing center’s IRB according to the 
IRB’s reporting requirements. 
 
During the clinical investigation, when new information becomes available that can significantly 
affect a subject's future health and medical care, the Principal Investigator or his/her authorized 
designee, will provide this information to the subject. If relevant, the subject will be asked to 
confirm their continuing informed consent in writing. 
5.3 
SCREENING 
If it is institutional practice to allow pre-screening of charts for consideration in clinical trials, sites 
will follow institutional policies. Ideally identification of potential patients should be done during the 
startup process. After IRB approval and activation, potential patients presenting at the 
investigational sites will be fully informed about the clinical investigation, following the established 
Informed Consent Process (described in section 5.2). Once a duly dated and signed ICF is 
obtained, the screening procedures may begin.  
 
If a subject does not meet all inclusion criteria or meets any of the exclusion criteria, or if a 
subject is not implanted with both the CardioMEMS HF System or the HeartMate LVAS, the 
subject will not be included in the study.  
5.4 
POINT OF ENROLLMENT 
For Group A, the subject is considered enrolled (and will count toward the analysis,) when the 
subject has provided written Informed Consent, has been confirmed to meet all inclusion criteria 
and none of the exclusion criteria. For Group B, the subject is considered enrolled (and will count 
toward the analysis,) when the subject has provided written Informed Consent, has been 
confirmed to meet all inclusion criteria and none of the exclusion criteria and has been 
successfully implanted with CardioMEMS. Patients who do not have a successful CardioMEMS 
implant after consent, will not be considered enrolled.  
 
The Principal Investigator or delegated study personnel will record enrollment information (name 
of the clinical investigation, date of consent and Inclusion/exclusion information) in the patient 
records and complete and submit applicable case report forms (CRF) in a timely manner, but not 
greater than 10 days from the study visit. 
 
Notification of enrollment to the Sponsor is considered to have occurred when the Sponsor has 
received the applicable CRF. For Group B, the component information CRF will be completed 
upon successful implant and submitted to the sponsor.  
5.5 
SCHEDULED PROCEDURES 
The Principal Investigator is responsible for ensuring all clinical investigation data is collected as 
required per CIP scheduled procedures.  

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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5.5.1 
Baseline 
The following baseline assessments and information will be collected after informed consent is 
obtained at the baseline visit. For Group A patients, these assessments will be done after 
consent. For Group B patients, assessments will be performed after consent and within 3 days 
prior to the CardioMEMS™ HF System implant. 
 
• 
Medical history, physical and documentation of Inclusion/ exclusion information, 
• 
Heart failure visit assessment including assessing and recording NYHA class, height, weight 
and vital signs 
• 
Documentation of demographic information 
• 
Documentation of HeartMate device model and CardioMEMS™ study device sensor serial 
number information (for group B this CRF will be completed after successful CardioMEMS 
implant) 
• 
Current Medications: anticoagulation/anti platelet, and cardiovascular medications including 
ACE inhibitors, ARBs, beta blockers, nitrates, hydralazine, aldosterone antagonists, digoxin 
and diuretics. Other medications do not need to be tracked.  
• 
Documentation of current pump parameters 
• 
Administer Six Minute Hall Walk test (6MHWT). For Group A, CardioMEMS PA reading taken 
before 6MHW test (at rest) and immediately following 6MHW test (see Appendix D), ideally 
within one minute of test 
• 
Administer EQ-5D-5L survey 
5.5.2 
Scheduled Follow-ups 
Follow-up schedules are calculated from the time of baseline. Follow-up visits are scheduled at 
Months 1, 3, and 6 post study enrollment (two devices implanted). Sponsor Representatives will 
be involved in providing technical support during the Follow-up procedures. 
 
At each visit, the following procedures must be completed: 
 
• 
Document all changes in cardiovascular medications: ACE inhibitors, ARBs, beta blockers, 
nitrates, aldosterone antagonists, digoxin and diuretics  
• 
Record vital signs 
• 
NYHA Classification  
• 
Administer EQ 5D 5L survey  
• 
Review and document changes in pump parameters 
• 
Administer 6MHW test per Appendix D 
• 
CardioMEMS PA readings taken before (at rest) 6MHW test and immediately following 
6MHW test, ideally within one minute of test completion (Group A and Group B) 
• 
Emergency room visits, hospitalizations and cause for hospitalization documented 
• 
Occurrence of protocol defined AEs (date of adverse event, determination of the seriousness 
and/or relation to the device, resolution of the adverse event)  
• 
Reoperations/operative procedures pertaining to the two devices under study (HeartMate 
and, CardioMEMS) 
• 
Pump Replacements/Explants/Device Exchanges (note patients are required to be withdrawn 
from the study at the time either device is removed) 
5.6 
HEMODYNAMICALLY GUIDED CLINICAL MANAGEMENT 
The CardioMEMS HF System allows intermittent assessment of pulmonary artery systolic, 
diastolic and mean pulmonary artery pressures. Pulmonary artery pressure data from the 
CMEMS system, in conjunction with symptoms, weight and physical exam will be used to guide 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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clinical management of subjects following the initial CardioMEMS implant and throughout the 6-
month follow-up period after enrollment.  
 
Pulmonary artery diastolic pressure will be targeted and maintained between 8 and 15 mmHg 
through heart failure medical management (primarily with diuretics, nitrates, titration of HF 
medications), blood pressure control or LVAD speed adjustments. It is anticipated that 
medications can be adjusted remotely based on PA pressures observed on Merlin.net. LVAD 
speed adjustments are expected to be infrequent and must be done in the clinical setting. 
Pressure data from the CardioMEMS system will be reviewed and monitored by the clinician as 
frequently as is clinically indicated, but at a minimum weekly. LVAD speed changes and 
adjustments to HF medications will be logged throughout the follow-up period, along with the 
reason for the adjustment. Additionally, failure to maintain the patient in the targeted range of 
between 8-15 mmHg will be documented along with the reason for nonconformance. 
5.6.1 
Merlin.net 
The Investigator or designee will review the PA pressure measurements transmitted from the 
home monitoring unit to Merlin.net via the Merlin.net portal. Pressure thresholds will be set to 
between 8 and 15 mmHg, and notifications can be set to alert the physician if pressures fall out of 
these ranges. These threshold notifications are intended to guide the Investigator to review the 
Merlin.net website and, if clinically appropriate, make a change. The Investigator or designee will 
review the PA pressure measurements on a weekly basis at a minimum and appropriately utilize 
the information to assist in the clinical management of subjects. Logins to the database will be 
monitored by the sponsor. Reminders will be sent to the clinical sites if no appropriate logins are 
observed. Clinical and technical support from the sponsor will be available to the Investigator as 
needed. Patients from Group A will provide consent for the sponsor to access CardioMEMS 
historical data collected prior to study enrollment as well as current data from the Merlin.net 
website.   Group B will provide consent to review all Merlin.net data collected in the study. 
5.7 
PATIENT REPORTED OUTCOME (PRO) MEASURES 
The Study Coordinator or designee will administer patient-reported outcome questionnaires. It is 
important the subject understands the meaning of all words and instructions in the 
questionnaires. The subject should be instructed to ask any questions about the questionnaires if 
further explanation is needed. The subject should be provided with the questionnaire as the first 
activity upon arrival and prior to any clinical interviewing.  Once the questionnaires are completed, 
the Study Coordinator or designee will review for completeness to verify that all questions have 
been answered according to the directions provided. 
 
The following PRO measures will be collected according to the study requirements. 
5.7.1 
EQ-5D-5L Questionnaire 
The EQ-5D-5L Questionnaire is a standardized measure of health status developed by the 
EuroQol Group in order to provide a simple, generic measure of health for clinical and economic 
appraisal. The self-administered/electronic questionnaire consists of questions relating to 
mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 
5 levels: no problems, slight problems, moderate problems, severe problems, and extreme 
problems. The subject is asked to indicate his/her health state by ticking (or placing a cross) in a 
box next to the most appropriate statement in each of the 5 dimensions and the visual analogue 
score. The data collected will be transferred into the Remote Data Capture (RDC) application by 
the coordinator and the original questionnaire kept as source. The questionnaire takes 
approximately five minutes to complete.  

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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5.8 
UNSCHEDULED VISITS 
5.8.1 
Unscheduled Office Visits 
The site is required to report any associated reportable adverse events as detailed in section 8.2, 
as well as documentation of any medication or pump changes, and the reason for such changes, 
on the Heart Failure Medication Log and Pump Parameter Log CRF. 
5.8.2 
Emergency Room Visits or Outpatient Short Stays 
All emergency room or short stays (<24 hours) visits related to heart failure will be documented 
and reported. Visit details must be reported to the Sponsor through the Hospitalization CRF and 
AE CRF through the electronic data capture system upon discovery of the event.  
5.8.3 
Hospitalizations 
All hospitalizations with the associated reasons will be captured as sites become aware and will 
be reviewed during the follow-up visit. While hospitalized, the follow-up visit assessments will 
continue to be performed according to the follow-up schedule. Hospitalizations must be reported 
to the Sponsor through the EDC system upon discovery of the event or, at the latest, if the 
hospitalization is unknown to the implanting site (i.e. at another facility), during the next follow-up 
visit.  
5.8.4 
Right Heart Catheterization 
CardioMEMS readings will be taken along with standard hemodynamic measurements collected 
any time a right heart catheterization (RHC) procedure is done as standard of care.  See RHC 
data collection instruction on RHC CRF. Following sensor implant, subsequent RHC procedures 
or pulmonary artery catheter insertions must be performed under fluoroscopic guidance to avoid 
sensor dislodgement.   
 
Resetting of the sensor baseline will be performed as deemed necessary by the investigator or 
the Sponsor. Baseline resetting may require an echocardiogram or a RHC procedure. Following 
the sensor implant, should a RHC procedure or PA catheter evaluation be clinically warranted, 
comparative pulmonary artery pressures utilizing the CardioMEMS HF System should also be 
obtained utilizing the hospital electronics unit. 
5.8.5 
Subject Home PA Pressure Readings 
Following the sensor implant procedure, the Patient System Guide will be followed and subjects 
will be instructed on how to take their own pulmonary artery pressure measurements, utilizing the 
CardioMEMS HF System per standard of care. Patients can refer to the Patient System Guide for 
detailed information. 
5.8.6 
PA Pressure Readings in the Hospital  
If a subject is hospitalized, seen in the emergency room (ER) or has a clinic visit, the 
CardioMEMSTM HF System may be used to obtain pulmonary artery pressure measurements at 
the investigator’s discretion.  
5.9 
RAMP STUDIES 
When any ramp studies are performed per institutional protocol, PA pressure data will also be 
collected with the CardioMEMSTM system with each change in pump speed.

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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5.10 
STUDY FLOW CHART 
A Study Flow Chart (Figure 1) and list of tests performed and assessments at each follow-up visit (Table 
2) summarizes the requirements of this clinical investigation. 
 
Figure 1 – Study Flow Chart 
Group - A
Have both CMEMS and HM implanted
Group – B
Have existing HM/scheduled for 
CMEMS Implant scheduled within 72 
hours of baseline
End of Study
Baseline
•  Enrollment (Informed consent)
•  Demographics
•  Medical History
•  Vital Signs
•  NYHA Class
•  EQ-5D-5L Survey
•  Current CV medications including dosage
•  Current pump parameters
•  6MHWT- CMEMS PA reading at rest, 
  before and after
•  CMEMS device information
Baseline
•  Informed consent
•  Demographics
•  Medical History
•  Vital Signs
•  NYHA Class
•  EQ-5D-5L Survey
•  Current CV medications, including dosages
•  Current pump parameters
•  6 MHWT 
•  CMEMS device information
Month 1
•  NYHA Class
•  EQ-5D-5L Survey
•  Changes in CV medications
•  Changes in pump parameters
•  6MHWT with CMEMS PA reading at 
  rest, before and after walking (Group 
  A and Group B)
Month 3-  Same as Month 1
Month 6  - Same as Month 1
Study Cohort

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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Table 2 – List of All Clinical Investigation Specific Tests and Procedures 
 
Visit 
Study Activity 
Enrollment & 
Baseline 
+ 3 days 
1 Month 
(30 ±7 days 
window) 
3 Month 
(90 ±7 days 
window) 
6 Month 
(180 ±30 days 
window) 
As occurs 
Informed Consent 
Process, 
cardiovascular history 
and inclusion review 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Heart failure exam 
including vital signs 
X 
X 
X 
X 
 
Medical history 
X 
 
 
 
 
Review cardiovascular 
medications, including 
dosages 
X 
X 
X 
X 
X 
LVAD pump 
parameters 
X 
X 
X 
X 
X 
CardioMEMS and 
LVAD device 
information 
X 
 
 
 
 
CardioMEMS reading 
pre and post six 
minute walk test  
X* 
X 
X 
X 
 
EQ-5D-5L 
X 
X 
X 
X 
 
NYHA Class 
X 
X 
X 
X 
 
6 minute walk test 
X 
X 
X 
X 
 
Changes in CV 
medications 
 
 
 
 
(X) 
Adverse event, 
hospitalization and 
device malfunction  
 
 
 
 
(X) 
Deviation or 
withdrawal 
 
 
 
 
(X) 
CardioMEMS 
measurements during 
RHC 
 
 
 
 
(X) 
CardioMEMS 
measurements during 
RAMP testing 
 
 
 
 
(X) 
(as indicated) 
* For Group A Only 
Note: Medications logs and pump changes are to be updated when changes occur 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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5.11 
DESCRIPTION OF ACTIVITIES PERFORMED BY SPONSOR REPRESENTATIVES 
Trained Sponsor personnel may provide technical expertise and technical guidance on the use of 
the CardioMEMS™ HF System and HeartMate™ LVAS, including study training, technical 
training and will be available to respond to queries. 
 
While Sponsor representatives may assist with these activities, the Principal Investigator remains 
responsible for ensuring all clinical investigation data is collected as required per CIP. 
5.12 
SUBJECT STUDY COMPLETION 
Subject participation in the clinical investigation will conclude upon completion of the 6-month 
visit.  
5.13 
SUBJECT WITHDRAWAL 
Subjects must be informed about their right to withdraw from the clinical investigation at any time 
and for any reason without sanction, penalty or loss of benefits to which the subject is otherwise 
entitled. Withdrawal from the clinical investigation will not jeopardize their future medical care or 
relationship with the investigator. Subjects will be requested to specify the reason for the request 
to withdraw. The investigator must make all reasonable efforts to retain the subject in the clinical 
investigation until completion of the clinical investigation. 
 
If a subject at any time prior to the six month visit, has either the CardioMEMS™ or HeartMate™ 
device explanted, once the AE is captured, the patient should be withdrawn since they can no 
longer contribute meaningful study data. The reason for explant will be documented.  
 
A subject will be considered ‘Lost to Follow-up’ after two missed visits and a minimum of two 
unsuccessful phone calls from investigational site personnel to the subject or contact to schedule 
the next follow-up visit. These two phone calls must be documented in the subject’s hospital 
records. If the subject is deemed lost to follow-up a letter should be sent to the subject’s last 
known address or to the subject’s general practitioner (GP) and a copy of the letter must be 
maintained in the subject’s hospital records. 
 
When subject withdrawal from the clinical investigation is due to an adverse event, the subject will 
be followed until resolution of that adverse event or determination that the subject’s condition is 
stable. The status of the subject’s condition should be documented at the time of withdrawal. 
 
In case of subject withdrawal, the site should make attempts to schedule the subject for a final 
study visit. At this final study visit, the subject will undergo assessments scheduled for the follow 
up visit subject is closest to. 
5.14 
STUDY COMMITTEES 
5.14.1 Steering Committee (SC) 
A Steering Committee has been formed and has advised the Sponsor on key aspects related to 
the development, execution, analysis and reporting, and overall conduct of the clinical 
investigation. 
5.14.2 Publication Committee (PC) 
A Publication Committee shall be established to oversee study publications. Publication 
Committee membership may include members of the Steering Committee, a representative of 
Abbott and a statistician. The Publication Committee will be responsible for identifying, selecting 
and approving publication proposals and determining authorship according to a Publication Plan.  

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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86357_CIP Template_Rev_B 
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A Publication Committee charter will define membership of the committee and outline the roles 
and responsibilities of the committee, as well as rules to define authorship. 
6 
DATA ANALYSIS CONSIDERATIONS 
This is a feasibility study evaluating commerciallyapproved devices and has only descriptive 
endpoints.  These endpoints will be evaluated via descriptive summary statistics without formal 
tests of hypothesis.  The goal of this study is to gather data from subjects with both the 
CardioMEMS™ HF System and an FDA-approved HeartMate II™ (and HeartMate 3™ upon FDA 
approval) Left Ventricular Assist Device (LVAD). Both devices are commercially approved and will 
be used, as indicated, per the labeling.  The underlying belief is that maintaining pulmonary artery 
pressure within a target range using CardioMEMS hemodynamic monitoring will improve 
outcomes in HeartMate LVAD patients.   
 
Statistical analyses will be conducted to understand the role of hemodynamic monitoring in LVAD 
patients in order to: 
 
• 
Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients 
under different clinical and physiologic conditions  
 
To characterize PA pressure in LVAD patients, descriptive statistics will be used to quantify 
pressure at baseline, throughout the study and at 6 months using available data throughout 
the study. Raw PA pressures will be analyzed similarly at 1, 3, and 6 months.  To 
characterize the impact of physical activity on PA pressure, descriptive statistics will be used 
to quantify the change in PA pressure before and after the 6MHW test. 
 
• 
Characterize the effects of PA pressure on functional status, quality of life, and hospital 
readmissions of LVAD patients 
 
To characterize the effects of PA pressure on clinical outcomes, patients will also be divided 
into subgroups based on time spent in the target PA pressure range and overall change in 
PA pressure during the follow-up period. Hospital readmissions and changes in functional 
status and quality of life will be quantified in these subgroups. The results can be used to find 
potential pressure ranges that are achievable in LVAD patients and have good clinical 
outcomes. 
 
• 
Evaluate target ranges for PA pressure and assess the impact of medication and pump 
speed changes on PA pressures 
 
The percentage of days that PA pressure is in the target range at different points in the study 
will be used to assess the impact of medication and pump speed changes on PA pressures.  
 
The results of this study will be used to design future clinical trials. Any statistical significance 
levels (p-values) obtained from the statistical tests will be used to help identify endpoints that are 
sensitive to the potential benefits achieved from utilizing the CardioMEMS HF System to monitor 
and treat LVAD patients. Note that Group A and B patients will be analyzed together as one 
group and also as separate groups. 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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6.1 
ANALYSIS OF ENDPOINTS  
6.1.1 
Descriptive Endpoints 
The following endpoints will be analyzed using descriptive statistics. Continuous variables will be 
summarized using numbers of subjects, mean, standard deviation, median, minimum, and 
maximum.  Categorical variables will be summarized using frequency and percentages. Rate 
data will be summarized using events per patient-time.   
 
1. Change in Six Minute Hall Walk (6MHW) distance will be summarized as change from 
baseline and using raw values, at 1, 3, and 6 months. 
2. Changes in CardioMEMS™ PA pressure over time will include PA systolic, diastolic 
and mean pressures; heart rate; and cardiac output (calculated using latest algorithm 
for CardioMEMs) and will be summarized at baseline, throughout the study, and at 6 
months. 
 
3. Percentage of days over 6 months that PA diastolic pressure is between 8 and 15 
mmHg will be summarized using the total number of days that pressures were 
measured as the denominator. The percentage will also be calculated at different 
points during the study. This endpoint will be used to assess the impact of medication 
and pump speed changes on PA pressures.   
 
4. Changes in PA pressure before the 6MHW test to after the 6MHW test will be 
summarized at baseline (Group A only) and at 1, 3, and 6 months for both groups.  
 
5. Device malfunction will include all instances of loss of performance of either device and 
will be summarized separately by device and type of loss of performance at 1, 3, and 6 
months. 
 
6. NYHA classification will be analyzed as a categorical variable and as a continuous 
variable at baseline, 1, 3, and 6 months.  Change from baseline in NYHA will be 
analyzed similarly. 
 
7. Health related quality of life (EQ-5D-5L) total score and visual analogue scale will be 
scored using the recommended scoring algorithms and analyzed at baseline, 1, 3, and 
6 months. The change from baseline in EQ5D-5L will be analyzed similarly. 
 
8. All-cause hospitalization rate will be summarized over 6 months in units of events per 
patient-time. 
 
9. Heart failure hospitalization rate including emergency department visits, or 
unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular 
medication management will be summarized over 6 months in units of events per 
patient-time. 
 
10. Change in 6MHWD, NYHA class, EQ-5D-5L, or unscheduled hospitalizations will be 
analyzed descriptively according to subgroups based on PA diastolic pressure. 
6.1.2 
Additional Descriptive Data Analyses 
1. CardioMEMS™ PA pressure data during LVAD speed ramp test, when done as 
standard of care, will be summarized over 6 months. 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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86357_CIP Template_Rev_B 
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2. CardioMEMS PA pressure data during collection of right heart catheterization (RHC) 
data, when done as standard of care, will be summarized over 6 months. 
 
3. LVAD speed, power, and estimated flow parameters will be summarized over 6 
months. 
 
4. Heart Failure medications will be summarized as both counts and total daily dosage 
according to class of medication at baseline 1, 3, and 6 months.   
6.1.3 
Adverse Events 
All protocol-required adverse events (AE) will be summarized by type of AE (non-serious AE, 
serious AE, non-serious device-related AE and serious device-related AE) at 1, 3, and 6 months.  
6.2 
OVERALL SAMPLE SIZE 
The sample size of 100 subjects is expected to provide enough data to address each of 
objectives stated above. This study will inform the design of future clinical studies.  
6.3 
TIMING OF ANALYSIS 
Analyses will be performed when the last patient enrolled completes 6 months of follow-up in the 
study. 
6.4 
SUCCESS CRITERIA 
As a feasibility study, there are no pre-specified statistical criteria for success. 
6.5 
INTERIM ANALYSIS 
Interim analyses will be conducted as data accumulates in this study. As there are no hypotheses 
to be tested, type I error control is not applicable.  
6.6 
STATISTICAL CRITERIA FOR TERMINATION 
There are no statistical criteria for termination of this trial.   
7 
RISKS AND BENEFITS 
It is not anticipated that patients would experience any new risks not identified in the User Manual 
for either the CardioMEMS sensor and the HeartMate LVAS. There are some minor possible risks 
to the protocol and are listed below. The additional tests and assessments required by the clinical 
investigation were analyzed for additional risks and are incorporated in the sections below. 
7.1 
RISKS ASSOCIATED WITH CLINICAL INVESTIGATION ASSESSMENTS 
The risks for the CardioMEMSTM device are known and are detailed in the user manuals. No 
additional risks are known that involve participation in the clinical investigation. If new risks are 
learned during the course of the study, sites will be notified. 
7.2 
RISK CONTROL MEASURES 
Every possible effort will be taken to minimize the risks, including: 
• 
Careful selection of experienced Investigators for the clinical investigation  
• 
Adequate monitoring for each clinical investigation site 
• 
Conducting the clinical investigation in accordance with the CIP, all applicable laws and 
regulations and any conditions of approval imposed by the appropriate IRB/EC or applicable 
regulatory authorities where the clinical investigation is performed 
• 
Use of the HeartMate and CardioMEMS devices and performance will be in accordance with 
the device IFUs 
• 
Training of Investigators on the CIP  

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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7.3 
ANTICIPATED BENEFITS 
The combined use of HeartMate with CardioMEMS has the potential benefit of improving 
management of HeartMate patients, improving functional status and reducing adverse events and 
hospitalizations.  
7.4 
RISK-TO-BENEFIT RATIONALE 
The patients enrolled in this study will already have market approved devices implanted on 
indication for the management of heart failure. Clinicians will be expected to manage the patients 
per standard of care while data is collected. While no benefit may be found, it is possible that 
patients will experience reduction in symptoms leading to reduction in frequency of hospitalization 
for heart failure.  This feasibility study is intended to provide data that will be used to inform the 
design of future clinical studies to answer the question of combined benefit. As such, the benefit 
outweighs risks supporting the feasibility study.  
8 
REQUIREMENTS FOR INVESTIGATOR RECORDS AND REPORTS 
8.1 
DEVIATIONS FROM CIP 
A deviation is defined as an instance(s) of failure to follow, intentionally or unintentionally, the 
requirements of the CIP. The investigator should not deviate from the CIP. 
 
In some cases, failure to comply with the CIP may be considered failure to protect the rights, 
safety and well-being of subjects; such non-compliance exposes subjects to unreasonable risks. 
Examples: failure to adhere to the inclusion/exclusion criteria, failure to perform safety 
assessments intended to detect adverse events. Investigators should seek to minimize such risks 
by adhering to the CIP. 
 
The PI must maintain accurate, complete, and current records, including documents showing the 
date of and reason for each deviation from the CIP. Relevant information for each deviation will 
be documented as soon as possible on the applicable CRF. The site will submit the CRF to the 
Sponsor. 
 
The PI is required to adhere to local regulatory requirements for reporting deviations to IRB. 
 
An investigator shall notify the Sponsor and the reviewing IRB of any deviation from the 
investigational plan to protect the life or physical well-being of a subject in an emergency. Such 
notice shall be given as soon as possible, but in no event later than 5 working days after the 
emergency occurred. Except in such an emergency, prior approval by the Sponsor is required for 
changes in or deviations from a plan, and if these changes or deviations may affect the scientific 
soundness of the plan or the rights, safety, or welfare of human subjects, FDA and IRB is also 
required. 
 
8.2 
SAFETY REPORTING 
Safety surveillance within this study and the safety reporting performed both by the investigator 
and Sponsor for these market release devices starts after the indicated devices have been 
implanted and as soon as the subject is enrolled in this clinical investigation (refer to section 5.4 
for enrollment timing). Procedure related adverse events, prior to both devices being successfully 
implanted, do not require reporting within this study.  
 
The safety surveillance and the safety reporting will continue until the last investigational visit (six 
months) has been performed, the subject is deceased, the subject/investigator concludes his 
participation into the clinical investigation or the subject withdrawal from the clinical investigation. 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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86357_CIP Template_Rev_B 
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For purposes of this study, any adverse event that is possibly or likely related to either device,  
will be collected throughout the clinical investigation. Refer to device specific user manuals. 
Additionally, adverse events that are possibly or likely related to treating to target ranges (detailed 
below) will be reported to the Sponsor on a CRF.  
 
Adverse events will be monitored until they are adequately resolved or the subject has ended 
his/her participation in the trial, whichever comes first. The status of the subject’s condition should 
be documented at each visit. 
 
For the purposes of this clinical investigation, the following events that could be potentially 
caused by using the CardioMEMS™ device to manage PA pressures to target ranges in patients 
with HeartMateTM Left Assist devices require reporting. The following adverse events will be 
required to be reported within the study if they are possibly or likely related to the study 
procedures or to either of the study devices(see Appendix B for definitions): 
 
• 
Cardiac Arrhythmias 
o Ventricular Arrhythmia 
o Supraventricular Arrhythmia 
o Both (Ventricular and Supraventricular Arrhythmia) 
• 
Strokes regardless of their types and etiology 
o Hemorrhagic Stroke 
o Ischemic Stroke 
o Debilitating Stroke 
• 
Other Neurological Events felt to be related to managing PA pressures 
• 
Renal Dysfunction secondary to heart failure 
• 
Respiratory Failure secondary to cardiovascular cause 
• 
Right Heart Failure 
• 
Syncope/presyncope/dizziness and hypovolemia 
• 
Worsening Heart Failure 
• 
Other Adverse Event that in the opinion of the investigator are suspected to be related to 
using the CardioMEMS device to manage PA pressures to target ranges. 
 
All above study defined reportable events will be reported to the Sponsor, as soon as possible, 
but no later than 3 calendar days of first learning of the event. The Sponsor will ensure that all 
applicable events are reported to the relevant authorities as per regulations. The sites should 
notify the Sponsor of reportable adverse events by creating and saving the appropriate adverse 
event CRF within the electronic data capture (EDC) system. Additional information may be 
requested by the Sponsor in order to support the reporting of AEs to regulatory authorities. 
Device issues unrelated to this study, which do not meet the AE requirements by this CIP but fall 
under complaint definition, will be reported by investigators to Sponsor as complaints through the 
regular complaint reporting procedure. The investigator must notify the IRB, if appropriate, in 
accordance with national and local laws and regulations, of the AEs reported to the Sponsor.  
8.2.1 
Subject Death 
All deaths that occur during the investigation, regardless of cause are to be reported to the 
sponsor. Subject deaths will be documented and reported to the Sponsor as soon as possible, 
but no later than 3 calendar days after becoming aware of the event via the applicable CRF. 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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86357_CIP Template_Rev_B 
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8.2.2 
Complaint 
A complaint is defined as an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. Complaints may be submitted from the time of 
consent through the end of the study.  
 
If a complaint involves an adverse event category or death as described in the protocol (section 
8.2), then the investigator shall notify the Sponsor by completing the adverse event or death case 
report form as applicable and must provide the Sponsor with all necessary documentation 
needed.  
 
If the complaint does not involve a reportable adverse event per protocol the investigator should 
notify the Abbott Product Surveillance Department through one of the methods listed below as 
soon as possible after becoming aware of a complaint.  
 
CardioMEMS™ related complaints: 
Email address: SYcomplaints@sjm.com 
Toll Free: 800-722-3774 
Direct: 818-364-1506 
FAX: 800-756-7223 
 
HeartMate™ pump related complaints: 
Email address: MCSProductSurveillance@sjm.com 
Toll Free: 800-456-1477 
 
Complaints will be collected and reported by Abbott according to our product reporting process 
8.3 
SOURCE RECORDS 
Source documents will be created and maintained by the investigational site team throughout the 
clinical investigation. The data reported on the CRFs will be derived from, and be consistent with, 
these source documents, and any discrepancies will be explained in writing. Additionally, sites 
are required to provide all relevant medical records for adverse events, ER visits, short stays or 
hospital admissions as requested by the sponsor.  
8.4 
RECORDS RETENTION 
The Sponsor and the Principal Investigators will maintain the clinical investigation documents as 
required. Measures will be taken to prevent accidental or premature destruction of these 
documents. The Principal Investigator or the Sponsor may transfer custody of records to another 
person/party and document the transfer at the investigational site or the Sponsor’s facility, as 
appropriate. 
 
These documents must be retained by the investigational site for a period of 2 years after the 
conclusion of the clinical investigation and made available for monitoring or auditing by the 
Sponsor’s representative or representatives of the applicable regulatory agencies. 
 
All original source documents must be stored for the maximum time required by the regulations at 
the hospital, research institute, or practice in question. If original source documents can no longer 
be maintained at the site, the investigator will notify the Sponsor.  
9 
CLINICAL DATA HANDLING 
The Sponsor will be responsible for the data handling. The Sponsor and/or its affiliates will be 
responsible for compiling and submitting all required reports to governmental agencies. Data will 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
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86357_CIP Template_Rev_B 
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be analyzed by the Sponsor and may be transferred to the Sponsor’s locations worldwide and/or 
any other worldwide regulatory authority in support of a market-approval application. 
9.1 
PROTECTION OF PERSONALLY IDENTIFIABLE INFORMATION 
Abbott respects and protects personally identifiable information collected or maintained for this 
clinical investigation. The privacy of each subject and confidentiality of his/her information will be 
preserved in reports and when publishing any data. Confidentiality of data will be observed by all 
parties involved at all times throughout the clinical investigation. All data will be secured against 
unauthorized access. It is the responsibility of the investigational site to ensure the removal of 
subject identifiers and to add the substitution of the patients ID number 
9.2 
DATA MANAGEMENT PLAN 
A Data Management Plan (DMP) will describe procedures used for data review, database 
cleaning, and issuing and resolving data queries. If appropriate, the DMP may be updated 
throughout the clinical investigation duration. All revisions will be tracked and document 
controlled. 
 
Subject data will be captured in a validated electronic data capture (EDC) system hosted by the 
Sponsor. 
 
Only authorized site personnel will be permitted to enter the CRF data through the EDC system 
deployed by Abbott. An electronic audit trail will be used to track any subsequent changes of the 
entered data. 
9.3 
DOCUMENT AND DATA CONTROL 
9.3.1 
Traceability of Documents and Data 
The investigator will ensure accuracy, completeness legibility and timeliness of the data reported 
to the Sponsor on the CRFs and in all required reports. 
9.3.2 
Recording Data 
The CRF will be reviewed by the authorized site personnel. An appropriate comment will be 
provided to explain changes to data reported on the CRF. 
10 
DATA MONITORING 
It is the responsibility of the Sponsor to ensure the clinical investigation is conducted, recorded 
and reported according to the approved CIP, subsequent amendment(s), applicable regulations 
and guidance documents. 
 
Prior to beginning the clinical investigation, the Sponsor will contact the investigator or designee 
to train on the clinical investigational plan and the data collection requirements. Abbott personnel 
will remotely review the subject data and appropriate associated source documents and issue 
queries as appropriate. 
11 
COMPLIANCE STATEMENT 
11.1 
STATEMENT OF COMPLIANCE 
In addition to applicable regional or local laws and regulations, this clinical investigation will be 
conducted in compliance with the most current version of the World Medical Association (WMA) 
Declaration of Helsinki and 21 CFR Parts 50, 54, 56 and 812. In the event of any conflicts, local 
laws and regulations will have precedence and in such cases, good faith efforts will be made to 
adhere to the intent of the other documents. 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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The investigator will sign a Clinical Trial Agreement and agrees to be compliant with it. The 
investigator will not start enrolling subjects or requesting informed consent from any subject prior 
to obtaining IRB/EC approval and relevant Regulatory Authority approval, if applicable, and 
authorization from the Sponsor in writing for the clinical investigation. If additional requirements 
are imposed by the IRB, those requirements will be followed. If any action is taken by an IRB with 
respect to the clinical investigation, that information will be forwarded to the Sponsor. 
11.2 
QUALITY ASSURANCE AUDITS AND REGULATORY INSPECTIONS 
The investigator and/or delegate should contact the Sponsor immediately upon notification of a 
regulatory authority inspection at the site. A monitor or designee will assist the investigator and/or 
delegate in preparing for the audit. The Sponsor may perform quality assurance audits, as 
required. 
 
The Principal Investigator or institution will provide direct access to source data during and after 
the clinical investigation for monitoring, audits, IRB/ review and regulatory authority inspections, 
as required. The Principal Investigator or institution will obtain permission for direct access to 
source documents from the subject, hospital administration and national regulatory authorities 
before starting the clinical investigation. 
11.3 
REPEATED AND SERIOUS NON-COMPLIANCE 
In the event of repeated non-compliance or a one-time serious non-compliance, as determined by 
the Sponsor, a monitor or designee will attempt to secure compliance by one or more of the 
following actions: 
• 
Visiting the investigator, 
• 
Contacting the investigator by telephone, 
• 
Contacting the investigator in writing, 
• 
Retraining of the investigator. 
 
If an investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or 
any other conditions of the clinical investigation, the Sponsor will either secure compliance or, at 
its sole discretion, terminate the investigator’s participation in the clinical investigation. In case of 
termination, the Sponsor will inform the responsible regulatory authority, as required, and ensure 
that the IRB is notified, either by the Principal Investigator or by the Sponsor. 
12 
SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION 
The Sponsor reserves the right to terminate the clinical investigation at any stage, with 
appropriate written notice to the investigators, and IRB, if required.  
 
A Principal Investigator, IRB or regulatory authority may suspend or prematurely terminate 
participation in a clinical investigation at the investigational sites for which they are responsible. 
The investigators will follow the requirements specified in the Clinical Trial Agreement.  
 
If suspicion of an unacceptable risk to subjects arises during the clinical investigation or when so 
instructed by the IRB or regulatory authority, the Sponsor may suspend the clinical investigation 
while the risk is assessed. The Sponsor will terminate the clinical investigation if an unacceptable 
risk is confirmed. If the Sponsor completes an analysis of the reasons for the suspension, 
implements the necessary corrective actions, and decides to lift the temporary suspension, the 
Sponsor will inform the Principal Investigators, IRB, or regulatory authority, where appropriate, of 
the rationale, providing them with the relevant data supporting this decision. Approval from the 
IRB/EC or regulatory authority, where appropriate, will be obtained before the clinical 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
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86357_CIP Template_Rev_B 
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investigation resumes. If subjects have been informed of the suspension,  the Principal 
Investigator, or authorized designee will inform them of the reasons for resumption. 
 
If the Sponsor suspends or prematurely terminates the clinical investigation at an individual 
investigational site in the interest of safety, the Sponsor will inform all other Principal 
Investigators. 
 
If suspension or premature termination occurs, the Sponsor will remain responsible for providing 
resources to fulfill the obligations from the CIP and existing agreements for following up the 
subjects enrolled in the clinical investigation, and the Principal Investigator or authorized 
designee will promptly inform the enrolled subjects at his/her investigational site, if appropriate. 
13 
CLINICAL INVESTIGATION CONCLUSION 
The clinical investigation will be concluded when: 
• 
All sites are closed AND 
• 
The study is closed with the approving IRB. 
14 
PUBLICATION POLICY 
Publications or presentations of clinical investigation methods or results will adhere to Abbott’s 
publication policy, which is based on Good Publication Practices and International Committee of 
Medical Journal Editors (ICMJE) guidelines. A copy of the policy will be provided upon request of 
the investigator. Publication planning and authorship determinations will be overseen by the 
Steering Committee (see section 5.14), and investigators will be notified via email about the 
dissemination of study data and opportunities for involvement as authors on 
publications/presentations.  
15 
REPORTING RESULTS ON CLINCALTRIALS.GOV WEBSITE 
This feasibility clinical investigation will be registered on ClinicalTrials.gov. as pre the 
requirements. 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
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86357_CIP Template_Rev_B 
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Appendix A: CIP Revisions 
 
Procedure for CIP Amendments 
 
This CIP may be amended as appropriate by the Sponsor. Rationale will be included with each amended 
version in the revision history table below. The version number and date of amendments will be 
documented. 
 
CIP Amendments will be acknowledged by the Principal Investigators will be collected on the signature 
pages. 
 
IRB/EC and relevant Regulatory Authorities, if applicable, will be notified of amendments to the CIP. 
 
 
Table 3 – CIP Revision History 
Amendment 
Number 
Version 
Date 
Rationale 
Details 
Not Applicable 
A 
4/28/2017 First release of CIP 
NA 
1 
B 
6/15/2018 
Changes to exclusion 
criteria and clarification of 
safety and death reporting 
timeframe 
Changed exclusion criteria 
to allow for enrollment of 
MOMENTUM 3 CAP 
patients. Changed safety 
and death reporting 
timeframe to 3 calendar 
days. 
 
 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 27 of 44 
 
Appendix B: Definitions 
 
Non-study Specific Definitions 
 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the study 
medical device under clinical investigation. 
 
Serious Adverse Event (SAE) 
An SAE is any untoward medical occurrence which resulted in serious injury to a subject or other person. 
A serious adverse event is one that led to: 
 
• 
Death 
• 
A serious deterioration in the health of the subject, that either resulted in: 
o A life-threatening illness or injury OR 
o A permanent impairment to a body structure or a body function OR 
o An in-patient or prolonged hospitalization OR 
o A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function OR 
• 
Fetal distress, fetal death or a congenital abnormality or birth defect 
 
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is not 
considered a serious adverse event. 
 
Adverse Device Effect (ADE) 
An adverse event related to the use of the study device when the occurrence does not meet the definition 
of serious. 
 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. 
 
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational medical device. 
 
Serious Adverse Device Effect (SADE) An adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
 
 
 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
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86357_CIP Template_Rev_B 
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Study Specific Definitions 
 
Cardiac Arrhythmias 
Any documented arrhythmia that results in clinical compromise (e.g., diminished VAD flow, oliguria, pre-
syncope or syncope) that requires hospitalization or occurs during a hospital stay.  Cardiac arrhythmias 
are classified as 1 of 2 types: 
1) Sustained ventricular arrhythmia requiring defibrillation or cardioversion. 
2) Sustained supraventricular arrhythmia requiring drug treatment or cardioversion. 
 
 
Hospitalization  
Defined as an admission to the hospital for greater than or equal to 24 hours.  
 
Heart Failure (HF) Hospitalization 
HF hospitalization meets the definition of hospitalization and is further determined to be related to heart 
failure when the diagnosis of heart failure is listed on the discharge diagnosis.  
 
Neurologic Dysfunction 
Any new, temporary or permanent, focal or global neurological deficit, ascertained by a standard 
neurological history and examination administered by a neurologist or other qualified physician and 
documented with appropriate diagnostic tests and consultation note; or an abnormality identified by 
surveillance neuroimaging. The examining physician will classify the event as defined below:  
 
a. Transient ischemic attack*, defined as an acute transient neurological deficit conforming 
anatomically to arterial distribution cerebral ischemia, which resolves in < 24 hours and is 
associated with no infarction on brain imaging (head CT performed >24 hours after symptom 
onset; or MRI) 
b. Ischemic Stroke*: a new acute neurologic deficit of any duration associated with acute infarction 
on imaging corresponding anatomically to the clinical deficit, or a clinically covert ischemic stroke 
seen by surveillance imaging, without clinical findings of stroke or at the time of event recognition. 
c. Hemorrhagic Stroke*: a new acute neurologic deficit attributable to intracranial hemorrhage (ICH), 
or a clinically covert ICH seen by surveillance imaging, without clinical findings of ICH at the time 
of event recognition. 
d. Encephalopathy: Acute new encephalopathy** due to hypoxic-ischemic injury (HIE), or other 
causes, manifest as clinically evident signs or symptoms, or subclinical electrographic seizures 
found by complete neurological diagnostic evaluation to be attributable to acute global or focal 
hypoxic, or ischemic brain injury not meeting one of ischemic stroke or ICH events as defined 
above. 
e. Seizure of any kind 
f. 
 Other neurological event (non-CNS event): examples include neuro muscular dysfunction or 
critical care neuropathy 
 
*Modified Rankin Score will be used to classify the severity of all strokes (See Appendix E: Modified 
Rankin Score) 
**Acute encephalopathy is a sign or symptom of some underlying cerebral disorder, and is manifest as 
depressed consciousness with or without any associated new global or multifocal neurologic deficits in 
cranial nerve, motor, sensory, reflexes and cerebellar function. 
 
Renal Dysfunction  
Two categories of renal dysfunction will be identified: 
 
Acute Renal Dysfunction 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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86357_CIP Template_Rev_B 
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Abnormal kidney function requiring dialysis (including hemofiltration) in Subjects who did not 
require this procedure prior to implant, or a rise in serum creatinine of greater than 3 times 
baseline or greater than 5 mg/dl sustained for over 48 hours. 
 
Chronic Renal Dysfunction 
An increase in serum creatinine of 2 mg/dl or greater above baseline, or requirement for 
hemodialysis sustained for at least 90 days. 
 
Right Heart Failure 
Symptoms and signs of persistent right ventricular dysfunction requiring RVAD implantation, or requiring 
inhaled nitric oxide or inotropic therapy for a duration of more than 1 week at any time after LVAD 
implantation. 
 
Syncope/Presyncope/dizziness or hypovolemia 
Transient sensation that may lead to inability to maintain an upright posture. Can be felt as 
lightheadedness, muscular weakness, blurred vision, feeling faint and. In extreme cases could leave to 
fainting (syncope).  
 
 
 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
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Appendix C: NYHA Classification 
 
NYHA Classification must be performed by an advanced practice physician, or by an experienced 
clinician designated by the principal investigator in writing. 
 
 
Table 4 – NYHA Classification 
Classification 
Definition 
I 
Cardiac disease without resulting limitations of physical activity. Ordinary 
physical activity does not cause undue fatigue, palpitations, dyspnea or chest 
pain. 
II 
Cardiac disease resulting in slight limitation of physical activity. Subjects are 
comfortable at rest. Ordinary physical activity results in fatigue, palpitation, 
dyspnea, or chest pain. 
IIIA 
Cardiac disease resulting in marked limitations of physical activity. Subjects 
are comfortable at rest. Less than ordinary physical activity causes fatigue, 
palpitation, dyspnea, or chest pain. 
IIIB 
Cardiac disease resulting in marked limitations of physical activity. Subjects 
are comfortable at rest. Mild physical activity causes fatigue, palpitation, 
dyspnea, or chest pain. 
IV* 
Cardiac disease resulting in inability to carry on any physical activity without 
discomfort. Symptoms of cardiac insufficiency or of the chest syndrome may 
be present even at rest. If any physical activity is undertaken, discomfort is 
increased. 
*For all post-enrollment NYHA assessments, any patient who is inotrope dependent will be considered 
NYHA Class IV.

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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86357_CIP Template_Rev_B 
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Appendix D: 6 Minute Hall Walk With CardioMEMS Readings Pre and Post Test 
Protocol 
 
Purpose 
The purpose of the 6-Minute Hallway Walk test (6MHWT) is to walk as far as possible for 6-minutes, 
without running or jogging, as a way of measuring functional status. The subject should be encouraged to 
walk any distance that they can, no matter how small. 
 
Procedure 
A CardioMEMS PA pressure reading will be taken two times: once before the 6 Minute Hall Walk test and 
immediately after the test is over. Be sure to keep the CardioMEMS hospital unit plugged in and running 
for the post exercise reading. At baseline, Group B will not have a CardioMEMS PA sensor implanted and 
thus, will not provide a reading before or immediately following the 6MHWT.  
 
Preparing for the Test 
 
1. Establish a 30-meter (or 100 foot) walking course in an enclosed corridor, preferably free of 
distractions/debris and close to a wall so that if needed, the Subject may rest against it during the 
test (note: a treadmill is not an acceptable alternate method for this study).  You must use a 
measuring wheel or measuring tape to mark and establish the course. 
2. Mark the course at 3-meter (ten foot) intervals using a method unnoticeable to the Subject.   
3. Place noticeable markers at either end of the course to indicate the turnaround points. It is 
advisable to have chairs at either end in case the subject needs to rest. 
4. The distance covered during the preceding walk test will not be revealed to the Subject during the 
study.  
5. A warm up prior to the test should NOT be performed. It is suggested that for accuracy the patient 
be brought to the starting point in a wheel chair so as not to cause undue fatigue prior to the test. 
6. Staff should not walk with or pace the patient during the test. 
7. If the patient is significantly symptomatic, please encourage the patient to take as many steps as 
are possible and measure this distance. 
 
Explaining the Test Procedure to the Subject 
1. Clearly explain to the Subject what is required of him/her using the following instructions 
verbatim: 
 
THE PURPOSE OF THIS TEST IS TO WALK AS FAR AS POSSIBLE FOR SIX-MINUTES.  YOU 
WILL START FROM THIS POINT AND FOLLOW THE HALLWAY TO THE MARKER AT THE 
END, THEN TURN AROUND AND WALK BACK.  WHEN YOU ARRIVE BACK AT THE 
STARTING POINT, YOU WILL GO BACK AND FORTH AGAIN.  YOU WILL GO BACK AND 
FORTH AS MANY TIMES AS YOU CAN IN THE SIX-MINUTE PERIOD.  IF YOU NEED TO, 
YOU ARE PERMITTED TO SLOW DOWN, TO STOP, AND TO REST AS NECESSARY.  YOU 
MAY LEAN AGAINST THE WALL WHILE RESTING, BUT RESUME WALKING AS SOON AS 
YOU ARE ABLE.  HOWEVER, THE MOST IMPORTANT THING ABOUT THE TEST IS THAT 
YOU COVER AS MUCH GROUND AS YOU POSSIBLY CAN DURING THE SIX MINUTES.  I 
WILL KEEP TRACK OF THE NUMBER OF LAPS YOU COMPLETE AND I WILL LET YOU 
KNOW WHEN THE SIX MINUTES ARE UP.  WHEN I SAY STOP, PLEASE STAND RIGHT 
WHERE YOU ARE. YOU MAY LEAN AGAINST THE WALL IF YOU NEED TO DURING THE 
TEST. 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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86357_CIP Template_Rev_B 
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DO YOU HAVE ANY QUESTIONS ABOUT THE TEST? 
 
PLEASE EXPLAIN TO ME WHAT YOU ARE GOING TO DO. 
 
2. The Subject will re-state the instructions.  If the Subject does not seem to understand, repeat the 
entire instructions until the patient can re-state them and verbalize them. 
 
Conducting the Test 
1. Position the Subject at the starting line.   
2. Repeat the sentence: 
THE MOST IMPORTANT THING ABOUT THE TEST IS THAT YOU COVER AS MUCH 
GROUND AS YOU POSSIBLY CAN DURING THE SIX MINUTES. 
 
ARE YOU READY? 
 
START NOW, OR WHENEVER YOU ARE READY. 
Start the timer as soon as the Subject takes the first step.   
3. During the test, the walking pace of the Subject should not be influenced.  The test supervisor 
must walk behind the Subject – do not walk with, rush up behind, or rush past the Subject. 
4. Each time the Subject returns to the starting line, record the lap. 
5. While walking, encourage the Subject at one minute intervals with the following phrases: 
 
1 minute: YOU ARE DOING WELL.  YOU HAVE 5 MINUTES TO GO.  
2 minutes: KEEP UP THE GOOD WORK.  YOU HAVE 4 MINUTES TO GO. 
3 minutes: YOU ARE DOING WELL.  YOU ARE HALFWAY DONE. 
4 minutes: KEEP UP THE GOOD WORK.  YOU HAVE ONLY 2 MINUTES LEFT. 
5 minutes: YOU ARE DOING WELL.  YOU HAVE ONLY ONE MINUTE TO GO. 
 
6. The Subject should only be spoken to only during the 1-minute encouragements; no response 
should be made to the Subject’s questions about the time and distance elapsed.   
 
a. If the Subject is not concentrating on the walking, the Subject can be reminded at a 1-
minute mark: 
 
THIS IS A WALKING TEST, TALKING WILL UTILIZE YOUR ENERGY RESERVE AND 
INTERFERE WITH YOUR PERFORMANCE. 
 
7. When only 15 seconds remain, state: 
 
IN A MOMENT I AM GOING TO TELL YOU TO STOP.  WHEN I DO, STOP RIGHT WHERE 
YOU ARE AND I WILL COME TO YOU.   
 
8. When the timer reads 6-minutes (or zero if counting down), instruct the Subject to STOP and walk 
over to him/her. Bring the wheel chair to the place where the subject stopped.  Mark the spot 
where the Subject stopped.   
 
9. If the Subject wishes to stop walking during the test or; 
10. If the Subject is slowing down and expresses that he/she wants to pause, keep the timer running 
and state: 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
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86357_CIP Template_Rev_B 
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REMEMBER, IF YOU NEED TO, YOU MAY LEAN AGAINST THE WALL UNTIL YOU CAN 
CONTINUE WALKING AGAIN. 
 
11. If the Subject wishes to stop before the 6-minutes are complete and refuses to continue (or you 
decide that he/she should not continue), provide a chair/ wheelchair for the Subject to sit on and 
discontinue the test.  Record the distance completed, the time the test was stopped and the 
reason for pre-maturely stopping.   
 
Immediately Following the Test 
1. Write the number of completed laps and add the additional distance covered in the final partial 
lap.  Immediately take the patient back to the CardioMEMS hospital unit and record the post 
exercise CardioMEMS reading. After the patient leaves, use the work sheet to calculate laps and 
record the distance walked to the nearest foot or meter. 
2. Observe the Subject for at least 10 minutes after the test is completed to ensure adequate 
recovery. Observation can be accomplished while taking the post effort CardioMEMS PA reading.

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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Appendix E: Modified Rankin Score 
 
 
 
Table 5 – Modified Rankin Score 
Score 
Definition1  
0 
No observed neurological symptoms 
1 
No significant neurological disability despite symptoms; able to carry 
out all usual duties and activities 
2 
Slight neurological disability; unable to carry out all previous activities, 
but able to look after own affairs without assistance 
3 
Moderate neurological disability; requiring some help, but able to walk 
without assistance 
4 
Moderate severe neurological disability; unable to walk without 
assistance and unable to attend to own bodily needs without 
assistance 
5 
Severe neurological disability; bedridden, incontinent and requiring 
constant nursing care and attention as a result of a neurological deficit 
6 
Dead 
 
1 van Swieten J, Koudstaal P, Visser M, Schouten H, et al (1988). “Interobserver agreement for the 
assessment of handicap in stroke Subjects”. Stroke 19 (5): 604-607 

 
Study Document No:  SJM-CIP-10178 
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Clinical Investigation Plan (CIP) 
 
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Appendix F: Management of Hemodynamic Parameters 
 
The CardioMEMS HF System allows intermittent assessment of pulmonary artery systolic, diastolic and 
mean pulmonary artery pressures.  Hemodynamic information obtained by the system should be used for 
clinical decision making in addition to symptoms, weights or physical examination (traditional markers of 
volume). 
Target Pulmonary Artery Diastolic Pressure Range:  8 - 15 mmHg 
Initially, thresholds will be set automatically at the CardioMEMS commercially acceptable range.  The 
physician will then adjust the thresholds to the specified range above, specifically for each patient.  These 
threshold notifications are intended to guide the physician to review the Merlin.net website.  Every attempt 
should be made to keep the pulmonary artery pressures within the specified pulmonary artery pressure 
ranges utilizing the guidelines.  In order to clinically manage patient’s PA pressures, the physician must 
review the PA pressure measurements on a frequent basis, for example, some patients may require a 
daily review of their PA pressure measurements, while some patients may need a weekly review.  The 
physician or designee has unlimited access to the Merlin.net website.   
An elevation of pressures beyond the patient’s pressure ranges should be considered a volume 
overloaded status and should be managed using one of the recommended treatment options listed below.  
A decrease in the pulmonary pressures below the patient’s pressure ranges should be considered a 
volume depletion event and managed using one of the recommended treatment options listed below.    
Diuretics and vasodilators should be adjusted based on the patient’s baseline diuretic requirement, 
knowledge of the patient’s prior response to these agents, and clinician judgment to accomplish the 
pressure goals set forth in this guideline.  
 
The PA pressure readings should be used in addition to weights, signs and symptoms, laboratory values 
and other traditional markers of volume in the management of heart failure. It is important to review the 
trend of PA pressures. As with all other diagnostic information, physicians should consider the entire 
medical history of each patient when initiating or modifying therapies. 
Recommended Treatment Options: 
 
• 
Diuretic Management  
• 
Vasodilators such as nitrates and hydralzine 
• 
Titration of HF medications 
• 
LVAD Speed Changes 
 
 
Table 6 – Recommended Frequency of CardioMEMS HF System Review 
Subject Status 
Weekly 
At least  2– 3 times per week until 
optivolemic 
Acceptable PA Pressure (Opti-volemic) 
X 
 
Elevated PA Pressure (Hyper-volemic) 
 
X 
Low PA Pressure(Hypo-volemic) 
 
X 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
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Appendix G: Bibliography 
1. 
Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, Strickland W, 
Neelagaru S, Raval N, Krueger S, Weiner S, Shavelle D, Jeffries B, Yadav JS and Grp CTS. Wireless 
pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 
2011;377:658-666. 
2. 
Park SJ, Milano CA, Tatooles AJ, Rogers JG, Adamson RM, Steidley DE, Ewald GA, 
Sundareswaran KS, Farrar DJ and Slaughter MS. Outcomes in advanced heart failure patients with left 
ventricular assist devices for destination therapy. Circ Heart Fail. 2012;5:241-8. 
3. 
Pagani FD, Miller LW, Russell SD, Aaronson KD, John R, Boyle AJ, Conte JV, Bogaev RC, 
MacGillivray TE, Naka Y, Mancini D, Massey HT, Chen L, Klodell CT, Aranda JM, Moazami N, Ewald GA, 
Farrar DJ, Frazier OH and HeartMate III. Extended mechanical circulatory support with a continuous-flow 
rotary left ventricular assist device. J Am Coll Cardiol. 2009;54:312-21. 
4. 
Rogers JG, Aaronson KD, Boyle AJ, Russell SD, Milano CA, Pagani FD, Edwards BS, Park S, 
John R, Conte JV, Farrar DJ, Slaughter MS and HeartMate III. Continuous flow left ventricular assist 
device improves functional capacity and quality of life of advanced heart failure patients. Journal of the 
American College of Cardiology. 2010;55:1826-34. 
5. 
Estep JD, Starling RC, Horstmanshof DA, Milano CA, Selzman CH, Shah KB, Loebe M, Moazami 
N, Long JW, Stehlik J, Kasirajan V, Haas DC, O'Connell JB, Boyle AJ, Farrar DJ, Rogers JG and 
Investigators RS. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and 
Medical Management in Ambulatory Heart Failure Patients: Results From the ROADMAP Study. J Am 
Coll Cardiol. 2015;66:1747-61. 
6. 
Jermyn R, Alam A, Kvasic J, Saeed O and Jorde U. Hemodynamic-guided heart-failure 
management using a wireless implantable sensor: Infrastructure, methods, and results in a community 
heart failure disease-management program. Clinical cardiology. 2016. 
7. 
Lampert BC and Emani S. Remote hemodynamic monitoring for ambulatory left ventricular assist 
device patients. Journal of thoracic disease. 2015;7:2165-71. 
8. 
Rosenkranz S and Preston IR. Right heart catheterisation: best practice and pitfalls in pulmonary 
hypertension. European respiratory review : an official journal of the European Respiratory Society. 
2015;24:642-52. 
 
 
 
 
 
 
 
 
 
 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 37 of 44 
 
Appendix H: Informed Consent Form 
A sample informed consent will be provided under separate cover. 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 38 of 44 
 
 
STUDY TITLE AND NUMBER  
INTELLECT 2 Study 
SPONSOR 
Abbott 
PRINCIPAL INVESTIGATOR 
 
Name of principal investigator 
Address 
SITE NAME 
 
Institution/Site Name 
Address 
 
 
Introduction 
You are being asked to take part in a research study. The study will evaluate how your doctor can 
most effectively use the CardioMEMSTM HF Monitoring system and with your HeartMateTM Left 
Ventricular Assist Device (LVAD) to manage your heart failure (HF). You were asked because 
you have heart failure. You also have or will shortly have two medical devices known to treat HF. 
In heart failure, the heart has reduced efficiency. Heart failure is treated with medications. In some 
instances, it is also treated with implanted medical devices.  
 
Your doctor previously determined that you would benefit from the HeartMate device. You may 
have also have previously been implanted or will soon be implanted with the CardioMEMS HF 
monitoring system. The CardioMEMS system detects changes in pressures, which can serve as 
an early warning that your HF is worsening. If you already have this device implanted, it is 
currently providing information to your doctor. However, very little information can be found on 
how to use these two devices together to give you the greatest benefit.  
 
This study is an early learning study. It will try to better understand how when using these two 
devices together, a doctor might improve your symptoms and possibly your rate of 
rehospitalization. 
 
This form explains why this research study is being done and what your role will be if you decide 
to participate. This form also talks about the possible risks that may happen if you take part in 
this study. The study is sponsored by Abbott.  This company manufactures medical devices. 
 
Please read this form carefully. Ask your study doctor any questions you may have about the 
research study. Make sure your questions are answered before you decide if you want to take 
part in this study. Please take your time and talk about this information with your family, friends, 
or family doctor.   
 
This consent form may contain some words that you do not understand.  It is important that you 
understand what is in this form.  It will explain the different activities you will be asked to do or 
participate if you take part in the research study and what the risks might be; whether or not you 
do take part is entirely your choice. Please ask the study doctor or the study staff to explain any 
words or information that you do not understand. 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 39 of 44 
 
If you decide you want to take part in the research study, you will be asked to sign the consent 
section before any study-related activities are performed. By signing it you are telling us that 
you: 
• 
Understand what you have read 
• 
Consent to take part in the research study  
• 
Consent to have the tests and treatments that are described  
• 
Consent to the use of your personal and health information as described. 
 
Taking part in this research study is entirely voluntary.  If you don’t wish to take part, you don’t 
have to.  You will receive the best possible care whether or not you take part in the study.  
Refusing participation will not involve any penalty or loss of benefit.  If you decide to take part in 
this study, you must sign your name at the end of this form. No research study activity can be 
performed until you sign this form. 
 
What is the purpose of this study? 
The purpose of this research study is to determine if patients with Heart Failure who have a 
HeartMate LVAD and also a CardioMEMS HF Monitoring system when doctors apply 
management strategies will improve how they feel and what they can to do. The purpose of this 
small study is to better understand how these two devices can be used together to help heart 
failure patients. About one hundred patients will participate in this study at approximately twenty 
sites in the United States.  Some of these tests are part of your normal care and would be done 
even if you were not in the study. The study team at this hospital will let you know which tests 
are not considered to be part of your normal care. 
 
There are no experimental procedures in this study. The devices and procedure used in this 
study are FDA approved and part of standard of care. You are already using both devices 
independently from one another. No devices will be implanted outside of standard approved 
indication for this study. We hope to learn how to best use the information gained from the two 
devices to the maximum benefit in Heart Failure treatment.  
 
What will be requested from you if you take part in this research study? 
Your doctor will decide if you qualify to take part in the INTELLECT 2 HF study. If you are a 
candidate, you will be asked to provide informed consent by signing and dating the study 
consent form after all of your questions have been asked and answered. In order to qualify, both 
of your devices need to be working properly. If your device or devices are not working properly, 
you will not be able to participate in the study and will be withdrawn.   
 
If your doctor determines that you qualify, and you decide to take part in this research study, 
you will come for four study visits over six months. The following tests will be performed at the 
visits: 
 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 40 of 44 
 
 
Study Visit 
Study Procedures and Data Collection 
Baseline (first visit) 
1. Questions about your medical history 
2. Checking of your vital signs 
3. Assessment of your functional capacity 
4. Assessment of your quality of life 
5. Recording of your current heart medications 
6. Recording of your current LVAD pump information 
7. Review of your data from your CardioMEMS device 
including reviewing online measurements taken since 
your implant and prior to your study participation 
8. Walking for six minutes and recording the distance  and 
taking a CardioMEMS PA reading at rest before 
walking and again immediately after the walk 
One month after first visit  
or CardioMEMS implant 
1. Checking of your vital Signs 
2. Assessment of your functional capacity 
3. Assessment of your quality of life 
4. Recording of your current cardiovascular medications 
5. Recording of your current LVAD pump information 
6. Seeing how far you can walk in six minutes and 
recording CardioMEMS PA reading at rest before the 
walk and immediately following the walk 
Three months after first 
visit or CMEMS implant  
1. Same assessments as Month 1 
Six months after first visit  
or CMEMS implant 
1. Same assessment as Month 1 
2. End of your study participation 
3. Review of your online CardioMEMS readings 
As it happens 
1. Documentation of all hospitalization and all 
unscheduled clinic visits for worsening Heart Failure, 
cardiovascular medication and/or volume management 
2. Measuring of CardioMEMS data when performing a 
Right Heart Catheterization if doing the procedure for 
another reason 
3. Measuring of CardioMEMS data if testing your LVAD is 
indicated 
4. Reviewing of your CardioMEMS data on the Merlin.net 
website including old data from before your 
participation in this study to better understand your 
condition 
 
 
There may be a representative of the sponsor at your study visits and the representative may 
carry out some of the study procedures. The sponsor might help your doctor to take readings 
from your CardioMEMS during your six minute walk tests. 
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 41 of 44 
 
How long will the study last? 
If you agree to take part in the research study, your involvement will last approximately six 
months unless you no longer have two devices, in which case, your participation would end. 
Each visit will take approximately thirty minutes.  
 
About 100 people will take part in this research study at about 25 sites in the United States. 
 
What are the possible risks and discomforts? 
There are no known risks to participating in this study, but there may be some discomforts or 
inconveniences associated with the study tests and procedures which are listed below. 
 
Six Minute Walk Test: 
• 
You many become tired from walking 
• 
You might trip or fall while walking 
 
It is not expected that this risk is any greater than what occurs in your own daily life. The walking 
test will be done at your own pace. You will be asked to cover as much distance as is possible. 
Study personnel will be there to assist you if you get tired.  
 
There may be other risks or discomforts to you (or to an embryo, unborn child or nursing infant if 
you become pregnant) that are not known at this time. If important information is learned during 
the course of this research study, your doctor will be notified by Abbott.  Your doctor will discuss 
with you important new information that is learned during the course of this study that may affect 
your condition or willingness to continue to take part in this research study. 
 
What are the risks for women of childbearing age? 
If you are pregnant or plan to become pregnant in the next six months, you should discuss your 
participation with your study doctor.  Patients who become pregnant while taking part in the 
study should contact the study doctor right away.    
 
What are the possible benefits to you or others? 
There may be no direct benefit to you should you decide to participate in this study. However, the 
information gathered from this research study might help your doctor to understand ways to better 
manage your heart failure using your two devices. It is hoped that the overall study results may 
benefit heart failure patients with Left Ventricular Assist Devices. The information could be 
published in medical journals to help other physicians or it could be used to design future larger 
studies. 
 
If you decide to take part in this research study, you may feel better, but there is no guarantee 
that this will happen. While there is no guarantee that anything will be learned, our hope is to help 
advance our understanding of heart failure. 
 
If you do not want to take part in this research study, what other options are available to 
you? 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 42 of 44 
 
Your participation in this study is voluntary. You can choose not to participate in the study. If you 
decide not to participate in the study, you will still be able to continue receiving your current 
treatment(s) for heart failure. Your study doctor will discuss other treatment options available to 
you.  
 
If you decide to participate in the research study, but decide to withdraw your participation at a 
later time, you are welcome to do so without any penalty or loss of benefit. 
 
If you choose to take part in this study, what are the costs?  
There will be no cost to you for participating in this study. The study sponsor will pay your doctor for 
his time at his standard rate when conducting study visits. Your insurance will not be billed for any 
study related tests or study required visits. However, any costs related to your care or routine 
management of your heart failure or devices that are outside of the study will be your responsibility.  
 
What if you are injured because of this study?  
If you suffer any injuries, illnesses, or complications as a direct result of participation in this study, 
medical treatment will be available to you.  You or your insurance company will be responsible for 
all costs resulting from such treatment.  No other arrangement has been made for other 
compensation (such as lost wages, lost time or discomfort) with respect to such injuries. However, 
signing this consent form in no way limits your legal rights against the Sponsor, investigators, or 
anyone else, and you do not release the study doctors or participating institutions from their legal 
and professional responsibilities.   
 
During the study, if you experience any injuries, illnesses, or complications from taking part in this 
research study, please contact Dr. ______________ at ___-___-_____. 
 
What are your rights if you decide to take part in this research study? 
Your signature on this consent form means that you have received information about this 
research study and that you agree to be a part of the research study.  
 
You may stop taking part in the research study at any time without penalty or loss of benefits to 
which you are otherwise entitled. If you wish to stop taking part in this research study for any 
reason, you should contact Dr. ______________ at ___-___-_____.   
 
If you do withdraw your consent during the study, the study doctor and relevant study staff will 
not collect additional personal information from you, although personal information already 
collected will be retained to ensure that the results of the research study project can be 
measured properly and to comply with the law.  You should be aware that data collected by the 
sponsor up to the time you withdraw will be part of the study results.  New findings during the 
course of the study that may affect your continued participation shall be provided to you.  
 
Your study doctor or designee will discuss with you what follow-up is required if you decide to 
withdraw, or are withdrawn from the research study before the study is finished. Your doctor or 
the sponsor of the study (Abbott) may also stop your participation in the research study at any 
time, without your consent, for any reason.   
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 43 of 44 
 
How will your information be kept confidential? 
If you decide to take part in this research study, your medical records and personal information will 
be kept confidential to the extent allowed by Federal, State, and local law.  However, information 
from the study may be exported to countries where different data protection laws apply.  The data 
protection laws in other countries may be less strict than those of your country.  
 
If you decide to participate in the research study, the study sponsor and others who work with the 
study, such as the study staff and Institutional Review Board (IRB) will see health information about 
you. The IRB is a group of people who perform independent review of research study as required 
by laws governing this type of research study.  
 
The information collected about you may be used in several ways. Information about you and your 
health that might identify you may be given to others to carry out the research study. Your study 
doctor may use some of the information in making decisions about your care.  
 
The sponsor may use the information in any of the following ways:  
• 
To analyze and make conclusions about the results of the study, 
• 
For reporting undesirable events to the FDA and other government health agencies, 
• 
To provide overall study results to other study doctors, including in publications, 
• 
To conduct new medical research study, to reanalyze the study results in the future or to 
combine your information with information from other studies, 
• 
To develop new medical products and procedures, and other product-development related 
activities. 
• 
To assist with submitting insurance claims and processing reimbursement requests, 
• 
To provide business and research partners, affiliates, organizations, or companies who 
perform services on behalf of the sponsor or your study doctor for purposes related to the 
study or resulting events or other research. 
 
While using the information in these above mentioned ways, the sponsor may give study data to its 
affiliated companies in the U.S. or other countries. The sponsor may also share the information with 
its research or business partners or companies it hires to provide study-related services. 
Information received during the research study will not be used for any mailing lists or sold to 
anyone for marketing purposes.   
 
Your name or identifying information will not be provided for publications in medical journals. Data 
which has all identifying information removed is called “de-identified data”. Your permission for the 
use, retention, and sharing of your de-identified health information will continue indefinitely.    
 
Your permission for the use, retention, and sharing of your identifiable health information will expire 
once the study is completed and closed. 
 
A description of this clinical study will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results.  You can search the Web site at any time.  Please note 
information may not be available on ClinicalTrials.gov until the study is completed and the device is 
marketed.  
 

 
Study Document No:  SJM-CIP-10178 
Study Name: INTELLECT 2-HF 
Clinical Investigation Plan (CIP) 
 
This confidential document is the property of Abbott and shall not be reproduced, distributed, disclosed or used without the 
express written consent of Abbott. 
86357_CIP Template_Rev_B 
Page 44 of 44 
 
Who can you contact for study information? 
If you have any questions about the study or taking part in this research study, please contact 
Dr. ______________ at ___-___-_____. 
 
In addition, if you have any concerns, complaints or questions about your rights as a research 
study patient or an injury that you believe is a study-related, please contact: 
 
Name of person at IRB/EC: 
 
Title of person at IRB/EC: 
 
IRB/EC phone number: 
 
IRB/EC email, if known: 
 
 
Consent and authorization for participation in this research study 
Taking part in this research study is entirely voluntary. You are making a decision on whether or 
not to take part in the research study.  Your signature indicates that you have read the 
information in this form and have decided to take part in the research study.  You will be given a 
signed copy of this form to keep.   
 
• 
I have read all of the above information in this consent and authorization form. I have had 
the opportunity to ask questions and have received answers concerning areas I did not 
understand.   
• 
I willingly give my consent to participate in this study and to comply with the procedures 
related to it. 
• 
I confirm that my data collected or reviewed during the study will be used in the study 
analysis and my deidentified data may be included in publications. 
• 
I understand that I am free to refuse to participate in the proposed study, without giving any 
reason and without my medical care or legal rights being affected. 
• 
I understand that I am free to withdraw from the proposed study at any time, without giving 
any reason, without my medical care or legal rights being aff ected. 
• 
I give my permission to representatives from the sponsor, [the ethics committee] and the 
regulatory authorities to access and use my medical records.and personal information as 
described in this form. 
• 
I understand that my personal physician may be informed of my participation in this 
research study. 
 
Name of Participant (please print) 
Signature 
Date 
 
 
Name of Person Obtaining 
Consent (please print) 
Signature 
Date