Validation of CardioMEMS HF System Cardiac Output Algorithm IDE
Conditions: Heart Failure, Cardiac Output
Sponsor: Abbott Medical Devices



 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
Template: 86357 Rev. J 
 
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SITE PRINCIPAL INVESTIGATOR SIGNATURE PAGE 
 
 
 
I have read and agree to adhere to the clinical investigation plan and all regulatory requirements 
applicable in conducting this clinical investigation. 
 
 
Site Principal Investigator 
 
Printed name: 
Signature: 
Date: 
 
 
 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
Template: 86357 Rev. J 
 
Page 3 of 61 
 
 
TABLE OF CONTENTS 
 
1.0 
INTRODUCTION ................................................................................................................ 7 
1.1 
Background and Rationale ........................................................................................................... 7 
 
Background ............................................................................................................................... 7 
 
Rationale for Conducting this Clinical Investigation .................................................................. 8 
2.0 
CLINICAL INVESTIGATION OVERVIEW ........................................................................... 8 
2.1 
Clinical Investigation Objective ..................................................................................................... 8 
 
Primary Objectives .................................................................................................................... 8 
2.2 
Devices Used in the Clinical Investigation .................................................................................... 9 
 
Name of the Devices Under Investigation ................................................................................. 9 
 
Indication for Use ...................................................................................................................... 9 
 
Description of the Devices Under Investigation ........................................................................ 9 
 
Device Accountability .............................................................................................................. 12 
3.0 
CLINICAL INVESTIGATION DESIGN .............................................................................. 12 
3.1 
Clinical Investigation Procedures and Follow-up Schedule ........................................................ 13 
3.2 
Measures Taken to Avoid and Minimize Bias ............................................................................. 14 
3.3 
Site Selection Criteria ................................................................................................................. 14 
3.4 
Suspension or Early Termination of the Clinical Investigation .................................................... 14 
4.0 
ENDPOINTS ..................................................................................................................... 14 
4.1 
Primary Endpoint and Rationale ................................................................................................. 14 
4.2 
Descriptive Endpoints ................................................................................................................. 15 
5.0 
SUBJECT SELECTION AND WITHDRAWAL .................................................................. 15 
5.1 
Subject Population ...................................................................................................................... 15 
5.2 
Subject Recruitment/Screening and Informed Consent .............................................................. 16 
 
Subject Recruitment and Screening ........................................................................................ 16 
 
Informed Consent ................................................................................................................... 16 
5.3 
Eligibility Criteria ......................................................................................................................... 17 
 
General Eligibility Criteria ........................................................................................................ 17 
 
Inclusion Criteria ..................................................................................................................... 18 
 
Exclusion Criteria .................................................................................................................... 18 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
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5.4 
Subject Enrollment ..................................................................................................................... 19 
 
Enrollment of Medicare Beneficiaries...................................................................................... 19 
 
Historically Under-Represented Demographic Subgroups ..................................................... 19 
5.5 
Subject Withdrawal and Discontinuation .................................................................................... 20 
5.6 
Number of Subjects .................................................................................................................... 21 
5.7 
Total Expected Duration of the Clinical Investigation ................................................................. 21 
6.0 
TREATMENT AND EVALUATION OF ENDPOINTS ........................................................ 21 
6.1 
Screening Procedures ................................................................................................................ 21 
 
Screening Failure .................................................................................................................... 22 
 
Baseline Assessments ............................................................................................................ 22 
 
Baseline Imaging Assessments .............................................................................................. 22 
 
Baseline CIP-Required Medication ......................................................................................... 24 
6.2 
Blinding ....................................................................................................................................... 25 
6.3 
Follow-up Assessments .............................................................................................................. 25 
 
Follow-up Imaging Assessments ............................................................................................ 25 
 
Follow-up CIP-Required Medication ....................................................................................... 25 
 
Schedule of Events ................................................................................................................. 26 
6.4 
Requirement for Clinical Laboratories ........................................................................................ 26 
7.0 
Adverse Events ................................................................................................................. 26 
7.1 
Definition ..................................................................................................................................... 26 
 
Adverse Event ......................................................................................................................... 26 
 
Serious Adverse Event............................................................................................................ 27 
 
Device Deficiency/Device Malfunction .................................................................................... 27 
7.2 
Device Relationship .................................................................................................................... 27 
 
Unanticipated Adverse Device Effect [UADE] ......................................................................... 27 
7.3 
Adverse Event and Device Deficiency/Device Malfunction Reporting ........................................ 28 
 
Adverse Event Reporting ........................................................................................................ 28 
 
Unanticipated Adverse Device Effect Reporting to Sponsor and IRB ..................................... 28 
 
Device Deficiency/Malfunction Reporting ................................................................................ 28 
 
Adverse Event Reporting to Country Regulatory Authorities by the Sponsor ......................... 29 
8.0 
STATISTICAL CONSIDERATIONS .................................................................................. 29 
8.1 
Analysis Populations .................................................................................................................. 29 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
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Enrolled Population ................................................................................................................. 29 
 
Per-Protocol (PP) Population .................................................................................................. 29 
8.2 
Statistical Analyses ..................................................................................................................... 30 
 
Primary Endpoint Analyses ..................................................................................................... 30 
 
Descriptive Endpoint Analyses ............................................................................................... 30 
8.3 
Sample Size Calculation ............................................................................................................. 31 
8.4 
Timing of Analysis....................................................................................................................... 32 
8.5 
Subgroup Analysis ...................................................................................................................... 32 
8.6 
Planned Interim Analysis ............................................................................................................ 32 
8.7 
Success Criteria ......................................................................................................................... 32 
8.8 
Deviations from Statistical Plan .................................................................................................. 32 
9.0 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS .................................................... 32 
10.0 
QUALITY CONTROL AND QUALITY ASSURANCE ..................................................... 33 
10.1 
Selection of Clinical Sites and Investigators ............................................................................... 33 
10.2 
CIP Amendments........................................................................................................................ 33 
10.3 
Training ....................................................................................................................................... 33 
 
Site Training ............................................................................................................................ 33 
 
Training Required for the Cardiac MRI Imaging ...................................................................... 33 
10.4 
Monitoring ................................................................................................................................... 33 
10.5 
Deviations from CIP .................................................................................................................... 34 
10.6 
Quality Assurance Audit ............................................................................................................. 35 
11.0 
DATA HANDLING AND RECORD KEEPING ................................................................ 35 
11.1 
Protection of Personally Identifiable Information ........................................................................ 35 
11.2 
Data Management Plan .............................................................................................................. 36 
11.3 
Source Documentation ............................................................................................................... 36 
11.4 
Case Report Form Completion ................................................................................................... 36 
11.5 
Record Retention ........................................................................................................................ 37 
11.6 
Investigational Devices Accountability ........................................................................................ 37 
12.0 
ETHICAL CONSIDERATION ......................................................................................... 37 
12.1 
Institutional Review Board Review and Approval ....................................................................... 37 
13.0 
CLINICAL INVESTIGATION CONCLUSION ................................................................. 37 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
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14.0 
PUBLICATION POLICY ................................................................................................. 37 
15.0 
RISK ANALYSIS ............................................................................................................ 38 
15.1 
Anticipated Clinical Benefits ....................................................................................................... 38 
15.2 
Residual Risks Associated with the Device Under Investigation, as Identified in the Risk 
Management Report / Risk Analysis Report .......................................................................................... 38 
15.3 
Risks Associated with Participation in this Clinical Investigation ................................................ 39 
15.4 
Possible Interactions with Protocol-Required Concomitant Medication ...................................... 39 
15.5 
Steps Taken to Control or Mitigate Risks ................................................................................... 39 
15.6 
Risk to Benefit Rationale ............................................................................................................ 40 
16.0 
APPENDIX I: ABBREVIATIONS AND ACRONYMS ..................................................... 41 
17.0 
APPENDIX II: DEFINITIONS ......................................................................................... 43 
18.0 
APPENDIX III Body Mass Index Calculator ................................................................... 44 
19.0 
Appendix IV: Cardiac MRI Protocol Specific Image Acquisition Outline ........................ 45 
19.1 
First At-Rest Required Image Acquisitions ................................................................................. 45 
19.2 
Second At-Rest Required Image Acquisitions ............................................................................ 45 
19.3 
 ............................................................... 46 
19.4 
Acquisitions ................................................................................................................................ 46 
19.5 
Imaging Parameters ................................................................................................................... 47 
19.6 
Acquisition Planning Guide ......................................................................................................... 49 
 
Localizer/Scout (SSFP) ........................................................................................................... 49 
 
2-Chamber Cine (SSFP) ......................................................................................................... 52 
 
4-Chamber Cine (SSFP) ......................................................................................................... 53 
 
Short Axis Cine ....................................................................................................................... 53 
 
Main Pulmonary Artery – MPA (Phase Contrast) .................................................................... 54 
20.0 
Appendix V: References ................................................................................................ 56 
21.0 
APPENDIX VI: REVISION HISTORY ............................................................................ 58 
22.0 
APPENDIX VII: CIP SUMMARY .................................................................................... 59 
 
 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
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COMPLIANCE STATEMENT:  
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan, the 
Declaration of Helsinki, and the applicable regulatory requirements (such as, 21 CFR Part 50, 21 CFR 
Part 56, 21 CFR Part 812, 21 CFR Part 54, and 21 CFR Part 11). The conduct of the clinical 
investigation will be approved by the Food and Drug Administration (FDA) and the appropriate 
Institutional Review Board (IRB) of the respective investigational site.  
 
1.0 
INTRODUCTION 
This document is a clinical investigation plan (CIP) for the ValIdation of CardioMEMS HF SysTem 
Cardiac Output AlgoRithm (VICTOR) IDE study. The investigation will enroll subjects who have been 
previously implanted with the CardioMEMSTM PA Sensor. This clinical investigation is twofold; in the first 
phase (development phase) data collected will be used to complete development of an algorithm that 
can estimate cardiac output (CO) from CardioMEMS™ HF System readings. The second phase 
(validation phase) of this clinical investigation is intended to compare the CO estimate from the 
CardioMEMS HF System to CO estimates from Cardiac MRI (reference standard). This clinical 
investigation will be conducted under an investigational device exemption (IDE) and is intended to 
support market approval of the CO feature in the United States. This clinical investigation is sponsored 
by Abbott. 
 
This clinical investigation will be conducted in accordance with this CIP. All investigators involved in the 
conduct of the clinical investigation will be qualified by education, training, or experience to perform their 
tasks and this training will be documented appropriately. 
 
1.1 Background and Rationale 
 Background 
Heart failure (HF) is a serious and pervasive disease affecting more than 64 million people worldwide 
and accounts for more than one million hospital admissions each year in the United States (US) and 
Europe alone1. By 2030, the prevalence of developing HF is expected to nearly double2. With symptoms 
including shortness of breath, excessive tiredness, and systemic swelling, HF patients typically suffer 
impairment in functional capacity and quality of life.  Despite current recommendations for evaluation and 
management, HF related morbidity and mortality remain high. HF related hospitalization is the leading 
cause of hospitalization among adults > 65 years of age in the US. Particularly, admission rates following 
HF hospitalization remain high3-4, with > 50% of patients readmitted to the hospital within 6 months of 
discharge3-4.  Since reduction in readmission rates reduces health care costs and improves quality of 
care, public and private payers have increasingly targeted readmission as a focus of pay-for-
performance initiatives5-6.      
 
The majority of HF disease management has focused on surveilling traditional signs and symptoms of 
HF such as weight and vital signs in order to detect decompensation in time to avoid hospitalization. 
However, even when great effort is put into enhancing surveillance of these precursors of 
decompensation using such strategies as telemonitoring, no incremental benefit over routine clinic-based 
care is observed7. Hemodynamic monitoring offers the opportunity to detect changes in pressure that 
occur weeks before the traditional signs and symptoms that prompt a heart failure hospitalization (HFH). 
Because of this, an implantable hemodynamic monitoring system, such as the CardioMEMS HF System, 
is a superior approach to the detection of impending congestion in advance of traditional signs of HF 
decompensation. Pulmonary artery pressure (PAP) information collected via the CardioMEMS HF 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
Template: 86357 Rev. J 
 
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2.2 Devices Used in the Clinical Investigation 
 Name of the Devices Under Investigation 
Table 1 details the devices to be used in this study. The CardioMEMS HF System is currently approved 
by FDA in the US (P100045) and available for market release. The algorithm/software used to estimate 
CO will be considered investigational in this study. 
 
Table 1: Identification of Devices under Investigation 
Device name 
Model 
Manufacturer 
Region/ Country 
Investigational or 
Market Released 
CardioMEMSTM PA Sensor 
and Delivery System 
CM2000 
St. Jude Medical, an 
Abbott Company 
United States 
Market Released  
CardioMEMSTM Hospital 
Electronics System 
CM3000 
CM3100 
St. Jude Medical, an 
Abbott Company 
United States 
Market Released  
MerlinTM Patient Care 
Network 
CM6000 
St. Jude Medical, an 
Abbott Company 
United States 
Market Released  
CardioMEMS Backend 
WebApp 
CM4000 
St. Jude Medical, an 
Abbott Company 
United States 
Market Released 
  
 Indication for Use 
The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery 
pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized 
for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data 
are used by physicians for heart failure management with the goal of controlling pulmonary artery 
pressures and reducing heart failure hospitalizations. 
 Description of the Devices Under Investigation 
The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for monitoring 
and management of HF patients. The system measures PA pressure and heart rate, which clinicians use 
to modify and manage HF treatment. The CardioMEMS HF System consists of an implantable PA 
Pressure Sensor with Delivery System and the Patient and Hospital Electronics Systems, which are 
designed to read the hemodynamic data from the implanted PA Sensor and transmit the data to a secure 
website.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
Template: 86357 Rev. J 
 
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The CardioMEMS PA Sensor and Delivery System features a wireless PA Pressure Sensor mounted to 
a multi-lumen endovascular delivery catheter used by the clinician to introduce and deploy the PA 
Sensor in the target implant location within the distal pulmonary artery to achieve the desired therapeutic 
benefit. Once inserted, the PA Sensor can provide non-invasive diagnostic information regarding a 
patient’s hemodynamic health. Patients can obtain pressure measurements at home or in a clinical 
setting, which are then transmitted to a secure database for clinician use. The clinician can then access 
and evaluate the patient’s transmitted data, develop tailored treatments, and remotely manage the 
patient. 
 
Implantable Sensor (CardioMEMS PA Sensor)  
The CardioMEMS PA Sensor is a passive implant that is placed in a descending branch of the left or 
right pulmonary artery to allow wireless measurement and monitoring of hemodynamic parameters in the 
pulmonary artery. The Sensor housing is fused silica and is encapsulated with silicone. Two 
platinum/iridium marker bands at each end of the Sensor (total of four marker bands) allow the device to 
be visualized under fluoroscopy during the implant procedure (and on imaging/x-ray during follow-up 
visits) and indicate the position of the sensor.  
 
CardioMEMS Delivery System 
The sensor is tethered to an over-the-wire delivery catheter. A right heart catheterization is performed, 
and a hand injected selective pulmonary angiogram is performed via the pulmonary artery catheter to 
define the distal pulmonary artery branch anatomy. An 0.018” guidewire is then advanced through the 
pulmonary artery catheter into the distal pulmonary artery. The pulmonary artery catheter is removed, 
and the delivery system is advanced over the guidewire. Once it is optimally positioned, the sensor is 
separated from the delivery system by releasing the tether wires and the delivery system is then 
removed.  
  
Hospital Electronics System and Patient System 
The CardioMEMS HF System includes the Hospital Electronics System (CM3000) or Hospital System 
(CM3100) which is used by clinicians in the hospital or clinic, and the Patient Electronics System 
(CM1100) which is used for home patient monitoring. The hospital and patient systems are similar except 
for greater functionality in the hospital system, including display and printing (CM3000 only) of the 
pressure data. The Hospital Electronics System (CM3000 and CM3100) can be attached to a pole cart 
and the system software allows pressure measurements to be visualized on the touch screen with 
systolic, diastolic, and mean PA pressures, as well as a waveform. The software on the Patient 
Electronics System prompts and guides the patient to make a PA pressure measurement and 
automatically uploads the information to the website. 
 
Merlin.net Website 
The physician accesses data for each of their patients via a secure website that allows the physician to 
utilize PA pressure measurements in the management of heart failure. When the patient is hospitalized 
or returns to the clinic/office setting, the Hospital Electronics System can be used to obtain PA pressure 
measurements and allows the physician to see not only the pressure data, but also the waveform. When 
the patient returns home the Patient Electronics System can be used to obtain and transmit PA pressure 
measurements to the website for physician access. 
 
The Merlin.net website provides a secure user interface through a website for the clinician to review the 
PA pressure data from the CardioMEMS HF System. 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
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Clinical Investigation Plan 
 
 
 
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Clinical sites will follow each subject until they complete their 3-month visit or withdraw from the study. 
Clinical investigation visits will occur at Baseline and 3 months. Visits will include demographics 
(baseline), medical history (baseline), adverse event information, NYHA classification, vital signs, and 
study measurements including, but not limited to, cMRI and CardioMEMS HF System readings. 
 
3.2 Measures Taken to Avoid and Minimize Bias 
In order to minimize bias, a core lab will be employed to train sites on the collection of cMRI images and 
associated data, collect images and imaging data, and review images and imaging data independently.  
 
3.3 Site Selection Criteria 
In addition to standard site selection criteria, sites in this study will also be selected based on additional 
pre-defined criteria. These additional criteria will be defined in advance of site nomination and will be 
based on the sites ability to perform the imaging assessments required for this trial. In part, the criteria to 
fulfil these assessments will be based on the technical requirements and training outlined in the protocol 
provided from the imaging vendor.   
 
3.4 Suspension or Early Termination of the Clinical Investigation 
While no formal statistical rule for early termination of the clinical investigation for insufficient 
effectiveness of the device under investigation is defined, the Sponsor reserves the right to discontinue 
the clinical investigation at any stage or reduce the follow-up period with suitable written notice to the 
investigator. Possible reason(s) may include, but are not limited to: 
• 
Unanticipated adverse device effect (e.g., UADE) occurs and it presents an unreasonable risk to 
the participating subjects 
• 
Further product development is cancelled 
 
Should the Sponsor discontinue the clinical investigation, sites will follow subjects per routine hospital 
practice with device-related AEs reported to the Sponsor as per vigilance/commercial reporting 
requirements. The investigator shall return all clinical investigation materials (including devices) to the 
Sponsor and provide a written statement to the IRB (if applicable). All applicable clinical investigation 
documents shall be subject to the same retention policy as detailed in Section 11.5 of the CIP.  
 
If the Sponsor suspends or prematurely terminates the clinical investigation at an individual site in the 
interest of safety, the Sponsor will inform all other Principal Investigators. If suspension or premature 
termination occurs, the Principal Investigator or authorized designee will promptly inform the enrolled 
subjects at his/her site, if appropriate, and return patients to their standard medical treatment. A Principal 
Investigator, IRB, or regulatory authority may also suspend or prematurely terminate participation in the 
clinical investigation at the investigational site(s) for which they are responsible. The investigators will 
follow the requirements specified in the Clinical Trial Agreement.  
 
4.0 
ENDPOINTS  
4.1 Primary Endpoint and Rationale 
The primary endpoint of this clinical investigation is to estimate CO from CardioMEMS HF System data. 
The estimated CO will be evaluated for agreement between the CardioMEMS HF System-derived CO 
and the CO values from cMRI in patients with the CardioMEMS HF System. 
 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
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months at time of consent. Patients must meet all general eligibility criteria and provide written informed 
consent prior to sites conducting any investigation-specific procedures not considered standard of care.  
 
5.2 Subject Recruitment/Screening and Informed Consent 
 Subject Recruitment and Screening 
The following assessments are performed as part of the subject recruitment process prior to obtaining 
informed consent: 
• 
Confirmation of prior CardioMEMS PA Sensor implantation. 
 
A member of the site’s clinical investigation team previously trained to the CIP must evaluate patients for 
the general clinical investigation eligibility criteria, and if applicable, will enter the patients into a site-
specific recruitment/screening log.  A patient who does not satisfy all general eligibility criteria prior to 
informed consent is considered a recruitment failure and should not be enrolled in the clinical 
investigation. 
 
Sites will ask patients meeting general inclusion criteria and no general exclusion criteria to sign an 
Informed Consent form following the established Informed Consent process (described in Section 5.2.2) 
if they wish to participate in the clinical investigation. Sites will enter these patients into the 
recruitment/screening log. Once a duly dated and signed Informed Consent form is obtained, sites will 
confirm patients meet all eligibility criteria. 
 
Only subjects who meet all inclusion and no exclusion criteria and have consented to the study are 
considered enrolled in the study. All other subjects should be considered screen failures. The Principal 
Investigator or the delegated clinical investigation personnel will record the screen failure in the hospital 
records and on a recruitment/screening log as required. 
 Informed Consent 
The Investigator or his/her authorized designee (if applicable) will conduct the Informed Consent 
process, as required by applicable regulations and the center’s IRB. This process will include a verbal 
discussion with the patient on all aspects of the clinical investigation that are relevant to the patient’s 
decision to participate, such as details of clinical investigation procedures, anticipated benefits, and 
potential risks of clinical investigation participation. Sites must inform patients 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 patient is otherwise entitled. Withdrawal from the clinical investigation will not 
jeopardize their future medical care or relationship with the investigator.  
 
During the discussion, the Principal Investigator or his/her authorized designee will avoid any improper 
influence on the patient and will respect patient’s legal rights. Financial incentives will not be given to 
patients. Patients may be compensated for time and travel directly related to their participation in the 
clinical investigation. The site shall provide the patient with the Informed Consent form written in a 
language that is understandable to the patient and that has been approved by the center’s IRB. The 
patient shall have adequate time to review, ask questions, and consider participation. The Principal 
Investigator or his/her authorized designee will make efforts to ensure that the patient understands the 
information provided. If the patient agrees to participate, they must sign and date the Informed Consent 
form, along with the person obtaining the consent prior to any clinical investigation-specific procedures. 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
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Clinical Investigation Plan 
 
 
 
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The site will file the signed original in the patient’s hospital or research charts and provide a copy to the 
patient. 
 
Sites should report any failure to obtain informed consent from a patient to the Sponsor within 5 working 
days and to the reviewing center’s IRB according to the IRB’s reporting requirements. 
 
If, during the clinical investigation, new information becomes available that can significantly affect a 
subject's future health and medical care, the Principal Investigator or his/her authorized designee (if 
applicable) will provide this information to the subject. If relevant, sites will ask the subject to confirm their 
continuing informed consent in writing. 
 
5.2.2.1 Special Circumstances for Informed Consent  
This clinical investigation excludes individuals unable to make the decision to participate in a clinical 
investigation on their own or who are unable to fully understand all aspects of the investigation that are 
relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a 
compromised position, expectation of benefits, or fear of retaliatory response. This clinical investigation 
excludes individuals under the age of 18 or age of legal consent from the clinical investigation 
population. 
 
Sites may enroll individuals unable to read or write in this clinical investigation. Sites will obtain informed 
consent through a supervised oral process. An independent witness will be present throughout the 
Informed Consent process. A member of the site’s clinical investigation team previously trained to the 
CIP will read the written Informed Consent form and any other information aloud and explain to the 
prospective subject and will sign and personally date the Informed Consent form. The witness will also 
sign and personally date the Informed Consent form attesting that the information was accurately 
explained, and that informed consent was freely given. In addition, no incentives or financial inducements 
will be provided to these patients for their participation in the clinical investigation. The clinical 
investigation excludes pregnant women. All other aspects of the Informed Consent process will follow 
Section 5.2.2. 
 
In addition, sites must obtain an authorization for use and disclosure of the subject’s protected health 
information, in accordance with the Health Insurance Portability and Accountability Act (HIPAA), from the 
subject.  
 
5.3 Eligibility Criteria 
 General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interview with a 
candidate patient. Patients must meet ALL general inclusion criteria to participate in the clinical 
investigation. If ANY general exclusion criteria are met, the patient is excluded from the clinical 
investigation and cannot be enrolled (recruitment or screen failure depending on whether or not the 
patient has signed the Informed consent [screen failure]). 
 
If any clinical and/or laboratory tests are required for patient screening and are not included in a site’s 
standard tests, they must be completed after written informed consent is obtained.  
 

 
 
Study Name: Validation of CardioMEMS HF System 
Cardiac Output Algorithm (VICTOR) IDE 
 
Validation of CardioMEMS HF System Cardiac Output Algorithm IDE 
Clinical Investigation Plan 
 
 
 
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 Inclusion Criteria 
1. Subject is willing and able to provide written informed consent prior to any clinical investigation-
related procedure. 
2. Subject is implanted with the CardioMEMS PA Sensor for a minimum of 3 months at time of 
consent. 
3. Subject is ≥ 18 years of age. 
4. Subject is willing and able to undergo several cardiac MRI scans. This is including but not limited 
to: 
• 
Subject must have all MRI compatible devices 
• 
Subject must be able to hold their breath during imaging 
• 
Subject must be free of all metal bodies, fragments, or implants that would prohibit MRI 
imaging 
5. Subject is willing and able to upload PA pressure information (i.e., take daily CardioMEMS 
readings and have their hemodynamic information collected at study visits) and comply with the 
follow-up requirements. 
 
 Exclusion Criteria 
1. Subject will receive or is likely to receive an advanced therapy (e.g., mechanical circulatory 
support or cardiac transplant) in the next 6 months. 
2. Subject was implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or 
CRT-Defibrillator (CRT-D) for less than 90 days prior to consent. 
3. Subject is pregnant or planning to become pregnant in the next 6 months. 
4. Subject is enrolled into another trial with an active treatment arm. 
5. Subject has significant congenital heart disease that has not been repaired.  
6. Subject is implanted with mechanical right heart valve(s). 
7. Subject has unrepaired severe valvular disease. 
8. Subject has an anticipated life expectancy of < 6 months. 
9. Subject has an active, ongoing infection, defined as being febrile, an elevated white blood cell 
count, on intravenous antibiotics, and/or positive cultures (blood, sputum, or urine). 
10. Subject has had a major cardiovascular event (e.g., unstable angina, myocardial infarction, 
percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to 
consent. 
11. Subject has any condition that, in the opinion of the Investigator, would not allow for utilization of 
the CardioMEMS HF System to manage the subject using information gained from hemodynamic 
measurements to adjust medications, including the presence of unexpectedly severe pulmonary  
hypertension (e.g., trans-pulmonary gradient >15) at implant RHC, a history of non-compliance, 
or any condition that would preclude ability to obtain CardioMEMS PA Sensor readings and 
paired cardiac MRI data from being collected. 
12. Subjects who, in the opinion of the investigator, are at-risk for serious adverse reaction to 
Dobutamine (ex. subjects with idiopathic hypertrophic subaortic stenosis and subjects who have 
shown previous manifestations of hypersensitivity to Dobutamine) should be excluded from the 
study. 
 
Sites should instruct female patients of childbearing potential to use safe contraception (e.g., hormonal 
contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections 
with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilized regular 

 
 
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partner or subjects using a double barrier contraceptive method. However, this should be explicitly 
justified in special circumstances arising from the clinical investigation design, product characteristics 
and/or clinical investigation population.  
 
5.4 Subject Enrollment 
A patient is considered enrolled in the clinical investigation only when they have met all inclusion and no 
exclusion criteria and have provided written informed consent. If subjects enter the study without meeting 
all the items listed above, they should complete all follow-up requirements. These subjects are 
considered CIP deviations. 
 
 Enrollment of Medicare Beneficiaries 
This clinical investigation will enroll Medicare beneficiaries and therefore conforms to all standards of 
Medicare coverage requirements. The Risks and Benefits section describes how all enrolled subjects, 
including Medicare beneficiaries, may be affected by the device under investigation. Subjects enrolled in 
the clinical investigation are expected to be consistent with the Medicare population based on age and 
as such, the clinical investigation results are expected to be generalizable to the Medicare population. 
 
 Historically Under-Represented Demographic Subgroups 
The Sponsor intends to implement FDA's guidance on sex-specific data in medical device clinical 
investigations to ensure adequate representation of women and other traditionally under-represented 
demographic subgroups in this clinical investigation. As noted in the guidance, some barriers to 
participation of women and ethnic minorities in clinical investigations have traditionally been: 
• Lack of understanding about main obstacles to participation of such subgroups in clinical 
research  
• Inclusion/exclusion criteria potentially not needed to define the clinical investigation population 
may unintentionally exclude specific subgroups  
• Under diagnosis of disease etiologies and pathophysiology leading to under referral of 
demographic subgroups  
• Avoidance of specific subgroups by investigators and Sponsor due to the perception that it takes 
more time and resources to recruit them  
• Fear of fetal consequences (for female participants)  
• Family responsibilities limiting women's ability to commit time for follow-up requirements 
 
The Sponsor will take the following steps to ensure adequate representation of women and racial or 
ethnic minorities in this clinical investigation:  
• 
The Sponsor will provide training to investigational site personnel to ensure adequate 
representation of these demographic subgroups  
• 
The Sponsor will regularly review enrollment data to investigate whether there is under-
representation of these demographic subgroups  
• 
As appropriate and necessary, the Sponsor will retrain sites on the importance of recruiting and 
retaining subjects in the clinical investigation 
• 
The Sponsor will approach sites without bias or consideration for specific demographic subgroups  
 

 
 
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5.5 Subject Withdrawal and Discontinuation 
Each subject meeting all general and screening eligibility criteria shall remain in the clinical investigation 
until completion of the required follow-up period; however, a subject’s participation in any clinical 
investigation is voluntary and the subject has the right to withdraw at any time without penalty or loss of 
benefit. Conceivable reasons for discontinuation may include, but not be limited to, the following: 
• 
Subject death 
• 
Subject voluntary withdrawal  
• 
Subject lost-to follow-up as described below  
• 
Subject’s follow-up is terminated due to subject non-compliance. 
 
Sites must notify the Sponsor of the reason(s) for subject discontinuation. Investigators must also report 
this to their respective IRB as defined by their institution’s procedure(s).  
 
No additional follow-up is required, or data recorded from subjects once withdrawn from the clinical 
investigation, except for the status (deceased/alive). 
 
However, if a subject withdraws from the investigation due to problems related to the safety or 
performance of the device under investigation, the investigator shall ask for the subject's permission to 
follow his/her status/condition outside of the clinical investigation.   
 
In case of subject withdrawal of consent, the site should make attempts to schedule the subject for a final 
clinical investigation visit. At this final follow-up visit, the following will be recorded, with the subject’s 
permission:  
• Subject status (deceased/alive)  
• Any adverse event details prior to withdrawal of consent  
 
Lost-to-Follow-up 
If the subject misses two consecutive scheduled follow-up time points and the attempts at contacting the 
subject detailed below are unsuccessful, then the subject is considered lost-to-follow-up. Site personnel 
shall make all reasonable efforts to locate and communicate with the subject (and document these efforts 
in the source documents), including the following, at each contact time point: 
• 
A minimum of two telephone calls on different days over the specified follow-up windows to 
contact the subject should be recorded in the source documentation, including date, time, and 
initials of site personnel trying to make contact. 
• 
If these attempts are unsuccessful, the site should send a letter (certified if applicable) to the 
subject. 
• 
If a subject misses one or more non-consecutive follow-up contact time points, it will be 
considered a missed visit. The subject may then return for subsequent visits. If the subject misses 
two consecutive time points and the above-mentioned attempts at communicating with the 
subject are unsuccessful, the subject will be considered lost-to-follow-up.  
 
Note: Telephone contact with General Practitioner, non-clinical investigation cardiologist, or relative 
without the presence of the subject or indirect documentation obtained via discharge letters will not be 
considered as subject contact. 
 

 
 
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 Schedule of Events 
 
CIP Activity 
Enrollment/ 
Baseline 
3 Month  
((± 7 days) 
Informed Consent 
Process 
X 
 
Demographics 
X 
 
Physical Examination 
X 
X 
Cardiovascular History 
X 
 
Medical History 
X 
 
Medication 
X 
X 
EF Assessment (Echo) 
X 
X 
NYHA Assessment 
X 
X 
cMRI  
X 
X 
CardioMEMS HF System 
Readings 
X - - - - - - - - - X 
Adverse Event 
As Occurs 
As Occurs 
Deviation 
As Occurs 
As Occurs 
Non-AE Device Issue 
As Occurs 
As Occurs 
Withdrawal 
As Occurs 
As Occurs 
Death 
As Occurs 
As Occurs 
 
6.4 Requirement for Clinical Laboratories 
A core lab will be employed to train imaging personnel, collect images and imaging data, review and 
assess images and imaging data (via an independent reviewer), and store images and imaging data.  
 
 
7.0 
ADVERSE EVENTS 
To comply with worldwide standards and guidelines on clinical investigation adverse event reporting, the 
Sponsor has adopted uniform and worldwide applicable standard definitions and reporting timelines to be 
used and adhered to by the investigators.  
 
7.1 Definition 
 Adverse Event 
An adverse event (AE) is 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 medical device under investigation. 
 
As part of ISO 14155 Section 3.2, the Adverse Event definition has the following notes: 
 

 
 
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Note 1: This definition includes events related to the medical device under investigation. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical devices under 
investigation. 
 Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
 
a) Led to a death, 
b) Led to a serious deterioration in health of the subject, that either resulted in  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient hospitalization or prolongation of existing hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or injury or permanent 
impairment to a body structure or a body function. 
5. chronic disease  
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: A planned hospitalization for a pre-existing condition, or a procedure required by the CIP without a 
serious deterioration in health, is not considered to be an SAE. 
 
 Device Deficiency/Device Malfunction 
Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety, or performance, such as malfunction, misuse or use error and inadequate 
labeling. This includes the failure of the device to meet its performance specifications or otherwise 
perform as intended. Note: performance specifications include all claims made in the labeling of the 
device. 
 
A device malfunction is the failure of a device to meet its performance specifications or otherwise 
perform as intended, when used in accordance with the instructions for use or CIP. 
 
7.2 Device Relationship 
Determination of whether there is a reasonable possibility that an investigational product or device under 
investigation caused or contributed to an AE is to be determined by the Investigator and recorded on 
the appropriate Case Report Form (CRF). Determination should be based on the assessment of 
temporal relationships, evidence of alternative etiology, medical/biologic plausibility, and patient condition 
(pre-existing condition). 
 Unanticipated Adverse Device Effect [UADE] 
Unanticipated  adverse device effect (UADE) refers to any serious adverse effect on health or safety or 
any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or 
death was not previously identified in nature, severity, or degree of incidence in the investigational plan 
or application (including a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
 

 
 
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7.3 Adverse Event and Device Deficiency/Device Malfunction Reporting 
 Adverse Event Reporting 
General AE Reporting 
Safety surveillance and reporting starts as soon as the patient is enrolled and eligible for the study 
specific procedures in the clinical investigation. Adverse events will not be collected for screen failure 
subjects. Safety surveillance and reporting will continue until sites perform the last follow-up visit, the 
subject is deceased, the subject concludes participation in the clinical investigation, or the subject 
withdraws from the clinical investigation. Sites will collect all adverse event data, including deaths and 
device deficiency data, throughout the period defined above and will report these events to the Sponsor 
on a CRF. Sites should update additional information regarding an adverse event on the appropriate 
CRF.  
 
Unchanged, chronic, non-worsening or pre-existing conditions are not AEs and should not be reported.  
 
The Sponsor will provide an offline form to allow the investigator to report SAEs in the event the entry 
cannot be made in the Electronic Data Capture (EDC). This does not replace the EDC reporting system. 
Sites must still enter all information in the EDC system as soon as feasible. 
 
SAE Reporting 
The investigator must report all SAEs to the Sponsor as soon as possible but no later than outlined 
below.  
 
Clinical Site 
Reporting timelines 
All Sites 
Sites must report SAEs to the Sponsor no later than 3 calendar days from the 
day the site personnel became aware of the event or as per the investigative 
site’s local requirements, if the requirement is more stringent than those outlined. 
 
Sites must record the date the site staff became aware that the event met the criteria of an SAE in the 
source document.  The Investigator will further report the SAE to the local IRB/EC according to the 
institution’s IRB/EC reporting requirements. 
 Unanticipated Adverse Device Effect Reporting to Sponsor and IRB 
The Sponsor requires the Investigator to report any UADE to the Sponsor within 3 calendar days of the 
investigator’s knowledge of the event, unless local requirements are more stringent, and to the IRB per 
IRB requirements.  
 Device Deficiency/Malfunction Reporting 
Sites should report all device deficiencies/malfunctions on the appropriate CRF form.  
 
The investigator must report all device deficiencies/malfunctions to the Sponsor as soon as possible but 
no later than outlined below.  
 
 
 
 

 
 
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Subjects providing informed consent are agreeing to allow clinical investigation monitors or regulatory 
authorities, including foreign countries, to review in confidence any records identifying the subjects in this 
clinical investigation. This information may be shared with regulatory agencies; however, the Sponsor 
undertakes not to otherwise release the subject's personal and private information. 
 
10.0 QUALITY CONTROL AND QUALITY ASSURANCE 
10.1 
Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the clinical 
investigation. Sites will be selected based upon review of a recent site assessment, if applicable, and the 
qualifications of the investigators who will participate in the clinical investigation.  
 
10.2 
CIP Amendments  
The Sponsor will provide approved CIP amendments to the Investigators prior to implementing the 
amendment. The Principal Investigator is responsible for notifying the IRB or equivalent committee of the 
CIP amendment (administrative changes) or obtaining IRB’s approval of the CIP amendment (changes in 
subject care or safety), according to the instructions provided by the Sponsor with the CIP amendment.   
 
Sites must document in writing acknowledgement/approval of the CIP amendment by the IRB prior to 
implementation of the CIP amendment. Sites must also provide copies of this documentation to the 
Sponsor. 
 
10.3 
Training 
 Site Training 
All Investigators and clinical investigation personnel are required to attend Sponsor training sessions, 
which may be conducted at an Investigator's meeting, a site initiation visit, or other appropriate training 
sessions. Over-the-phone or self-training may take place as required. Training of Investigators and 
clinical investigation personnel will include, but is not limited to, the CIP requirements, investigational 
device usage, electronic case report form completion, and clinical investigation personnel 
responsibilities. All Investigators and clinical investigation personnel that are trained must sign a training 
log (or an equivalent) upon completion of the training. Prior to signing the training log, Investigators and 
clinical investigation personnel must not perform any CIP-related activities that are not considered 
standard of care at the site.  
 
 Training Required for the Cardiac MRI Imaging 
Sites and Investigators will be required to train with and follow imaging protocol provided by the Imaging 
Core Laboratory. 
 
10.4 
Monitoring  
Sponsor and/or designee will monitor the clinical investigation over its duration according to the CIP-
specific monitoring plan which will include the planned extent of source data verification.  
 

 
 
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Prior to initiating any procedure, the Sponsor monitor (or delegate) will ensure that the following criteria 
are met:  
 
• 
The investigator understands and accepts the obligation to conduct the clinical investigation 
according to the CIP and applicable regulations and has signed the Investigator Agreement. 
• 
The Investigator and his/her staff should have sufficient time and facilities to conduct the clinical 
investigation and should have access to an adequate number of appropriate subjects to conduct 
the clinical investigation.  
• 
Sites must have source documentation (including original medical records) to substantiate proper 
informed consent procedures, adherence to CIP procedures, adequate reporting and follow-up of 
adverse events, accuracy of data collected on case report forms, and device information.  
• 
The Investigator/site will permit access to such records and will maintain a monitoring visit sign-in 
log at the site. The Investigator will agree to dedicate an adequate amount of time to the 
monitoring process. The Investigator and/or research coordinator will be available for monitoring 
visits. It is expected that the Investigator will provide the monitor with a suitable working 
environment for review of clinical investigation-related documents. 
 
10.5 
Deviations from CIP 
The Investigator should not deviate from the CIP for any reason except in cases of medical emergencies 
when the deviation is necessary to protect the rights, safety, and well-being of the subject, or to eliminate 
an apparent immediate hazard to the subject. In that event, the Investigator will notify Sponsor 
immediately by phone or in writing.  
 
The Sponsor will not grant any waivers for CIP deviations.  Sites must report all deviations to the 
Sponsor using the Deviation CRF. The Sponsor will monitor the occurrence of CIP for evaluation of 
investigator compliance to the CIP and regulatory requirements and handle according to written 
procedures. Investigators will inform their IRB or equivalent committee of all CIP deviations in 
accordance with their specific IRB/EC or equivalent committee reporting policies and procedures.  
 
In the event of repeated non-compliance, as determined by the Sponsor, a Sponsor’s monitor or 
company representative will attempt to secure compliance by one or more of the following (and not 
limited to):  
• Visiting the investigator and/or delegate 
• Telephoning the investigator and/or delegate 
• Corresponding with the investigator and/or delegate 
 
Repeated non-compliance with the signed agreement, the CIP, or any other conditions of the clinical 
investigation may result in further escalation in accordance with the Sponsor’s written procedures, 
including securing compliance or, at its sole discretion, the Sponsor may terminate the investigator's 
participation in the clinical investigation.  
 
Deviations from the appropriate informed consent process; Imaging Assessment not obtained per 
protocol; and late SAE reporting are considered major.  
 

 
 
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10.6 
Quality Assurance Audit 
A Sponsor representative or designee may request access to all clinical investigation records, including 
source documentation, for inspection during a Quality Assurance audit.  
 
If an investigator is contacted by a Regulatory Agency in relation to this clinical investigation, the 
Investigator will notify Sponsor immediately. The Investigator and Research Coordinator must be 
available to respond to reasonable requests and audit queries made during the audit process. The 
Investigator must provide the Sponsor with copies of all correspondence that may affect the review of the 
current clinical investigation (e.g., Form FDA 483, Inspectional Observations, Warning Letters, Inspection 
Reports, etc.). The Sponsor may provide any needed assistance in responding to regulatory audits. 
 
 
11.0 DATA HANDLING AND RECORD KEEPING 
Sponsor and/or its affiliates will maintain documentation of the systems and procedures used in data 
collection for the duration of the clinical investigation.  
 
CRF data collection will be performed through a secure web portal and only authorized personnel will 
access the EDC system using a unique username and password to enter, review or correct data. 
Passwords and electronic signatures will be strictly confidential.   
 
The data will be subjected to consistency and validation checks within the EDC system and 
supplemental review by the Sponsor.    
 
At the end of the clinical investigation, completed CRF images with the date-and-time stamped electronic 
audit trail indicating the user, the data entered, and any reason for change (if applicable) will be provided 
to the investigational sites, if requested.  
 
For the duration of the clinical investigation, the Investigator will maintain complete and accurate 
documentation including, but not limited to, medical records, clinical investigation progress records, 
laboratory reports, CRFs, signed ICFs, device accountability records (if applicable), correspondence with 
the IRB and clinical investigation monitor/Sponsor, adverse event reports, and information regarding 
subject discontinuation or completion of the clinical investigation. 
 
11.1 
Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this 
clinical investigation.  
 
The Sponsor implements technical and physical access controls to ensure that Personal Information is 
accessible only to and processed only on a ‘need to know’ basis, including periodic review of access 
rights, and revocation of access when an individual’s employment is terminated or the individual 
transitions to a role that does not require access to Personal Information, and appropriate restrictions on 
physical access to premises, facilities, equipment, and records containing Personal Information. 
 
The Sponsor requires the investigational sites to enter only pseudonymous Personal Information (key-
coded) necessary to conduct the clinical investigation, such as the patient’s medical condition, treatment, 

 
 
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dates of treatment, etc., into Sponsor’s data management systems. The Sponsor discloses as part of the 
clinical investigation informed consent process that some Sponsor representatives still may see Personal 
Information at the participating sites for technical support of the participating physicians on the device 
implant or procedures, monitoring, and quality control purposes. All parties will observe confidentiality of 
Personal Information always throughout the clinical investigation. All reports and data publications will 
preserve the privacy of each subject and confidentiality of his/her information. 
 
The Sponsor data management systems and processes were designed, developed, and tested 
according to industry standards to appropriately safeguard Confidential Information (including any 
Personal Information) against unauthorized access and/or interference by third parties, intrusion, theft, 
destruction, loss, or alteration. Clinical Investigation data are encrypted in transit and at rest.  
 
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable Law 
and industry best practices. 
 
11.2 
Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data review, data cleaning, and 
issuing and resolving data discrepancies. If appropriate, the Sponsor may update the DMP throughout 
the duration of the clinical investigation. The Sponsor will track and document control all revisions. 
 
11.3 
Source Documentation  
Regulations and Good Clinical Practice (GCP) require the Investigator to maintain information in the 
subject’s original medical records that corroborates data collected on the CRFs. To comply with these 
regulatory requirements/GCP, sites should include the following information in the subject record at a 
minimum and if applicable to the clinical investigation: 
• 
Medical history/physical condition of the subject before involvement in the clinical investigation 
sufficient to verify CIP entry criteria 
• 
Dated and signed notes on the day of entry into the clinical investigation referencing the Sponsor, 
CIP number, subject ID number, and a statement that informed consent was obtained 
• 
Dated and signed notes from each subject visit (for specific results of procedures and exams) 
• 
AEs reported and their resolution, including supporting documents, such as discharge 
summaries, catheterization laboratory reports, ECGs, and lab results including documentation of 
site awareness of SAEs and of investigator assessment of device relationship for SAEs. 
• 
CIP-required laboratory reports and assessments, reviewed and annotated for clinical 
significance of out of range results (if applicable).  
• 
Notes regarding CIP-required and prescription medications taken during the clinical investigation 
(including start and stop dates) 
• 
Subject’s condition upon completion of or withdrawal from the clinical investigation 
• 
Any other data required to substantiate data entered into the CRF 
 
11.4 
Case Report Form Completion  
Site research personnel trained on the CIP and CRF completion will perform the primary data collection 
clearly and accurately based on source-documented hospital and/or clinic chart reviews. The investigator 
will ensure accuracy, completeness, legibility, and timeliness of the data reported to the Sponsor on the 

 
 
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expected to be aware of the known and foreseeable safety risks associated with the use of the devices 
including the surgical and/or non-surgical treatment of these conditions. 
 
Risks associated with the use of the device under investigation are minimized through device design, 
investigator selection and training, pre-specified patient eligibility requirements, study monitoring to 
ensure adherence to the protocol. Sites will report all adverse events and device deficiencies to the 
Sponsor and the Sponsor will monitor internally for safety surveillance purposes. 
 
15.6 
Risk to Benefit Rationale 
Congestive HF is a progressive disease and HF patients are generally symptomatic. Symptoms of 
dyspnea and fatigue increase with elevations of pressures within the heart and lungs, leading to 
instances of acute HF decompensation. The CardioMEMS HF System enables clinicians to medically 
manage HF patients by adjusting treatments to keep PA pressures within target ranges to prevent or 
reduce instances of acute HF decompensation. In doing so, the CHAMPION trial demonstrated a 
reduction in rates of HF decompensation resulting in an HFH, in NYHA Class III patients who had a HFH 
within the prior 12 months. In addition to pressure, CO is an important variable to describe hemodynamic 
pathophysiology in patients with HF. Deriving CO as part of remote monitoring with the CardioMEMS HF 
System is expected to produce an accurate assessment of CO without the associated risks and costs of 
traditional methods such as Fick and Thermodilution. CO monitoring using the CardioMEMS HF System 
can potentially provide important information to manage patients with HF. There are no new or additional 
risks related to the study device as part of the study protocol beyond the risks already incurred by the 
study subjects as they will already be implanted with the CardioMEMS PA Sensor and are currently 
using the CardioMEMS HF System. As part of study participation, subjects will undergo a series of cMRI 
scans. Since the CardioMEMS PA Sensor is non-ferrous and MRI conditional, there are no anticipated 
additional risks introduced to trial subjects due to cMRI. Subjects will also be administered a study 
medication to modulate CO. All precautions, including medical supervision during medication 
administration, will be taken to minimize any potential adverse effects from the medication administered 
per protocol. With the appropriate mitigations in place, the risks associated with participation in this study 
are outweighed by the potential benefit of providing CO via remote monitoring without the risks and costs 
associated with other CO assessments.  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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16.0 APPENDIX I: ABBREVIATIONS AND ACRONYMS 
ADE 
Adverse Device Effect 
ADHF 
Acutely Decompensated Heart Failure 
AE 
Adverse Event 
BMI 
Body Mass Index 
BNP 
Brain Natriuretic Peptide 
CHAMPION CardioMEMS™ HF Sensor Allows Monitoring of Pressures to Improve Outcomes 
in NYHA Functional Class III HF Patients 
CI 
Confidence Interval 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CO 
Cardiac Output 
CRT 
Cardiac Resynchronization Therapy 
CRT-D 
Cardiac Resynchronization Therapy – Defibrillator 
CRT-P 
Cardiac Resynchronization Therapy – Pacemaker 
DMP 
Data Management Plan 
DSRC 
Device/System Related Complication 
EDC 
Electronic Data Capture 
EF 
Ejection Fraction 
eGFR 
Glomerular Filtration Rate 
FDA 
Food and Drug Administration 
FMEA 
Failure Mode Effect Analysis 
GCP 
Good Clinical Practice 
GDMT 
Guideline Directed Medical Therapy 
HA 
Hazard Analysis 
HES 
Hospital Electronic System 
HF 
Heart Failure 
HFH 
Heart Failure Hospitalization 
HFpEF 
Heart Failure with Preserved Ejection Fraction 
HFrEF 
Heart Failure with Reduced Ejection Fraction 
HR 
Heart Rate 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
LVEF 
Left Ventricular Ejection Fraction 
MEMS 
Micro-ElectroMechanical Systems 
MEMS-HF 
CardioMEMS European Monitoring Study for Heart Failure 
NT-proBNP 
N-Terminal pro-Brain Natriuretic Peptide 

 
 
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NYHA 
New York Heart Association 
PA 
Pulmonary Artery 
PAS 
Post-Approval Study 
PCWP 
Pulmonary Catheter Wedge Pressure 
PES 
Patient Electronics System 
PMA 
Pre-Market Approval 
RAP 
Risk Analysis Plan 
RHC 
Right Heart Catheterization 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SV 
Stroke Volume 
UADE 
Unanticipated Adverse Device Effect 
VICTOR 
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17.0 APPENDIX II: DEFINITIONS 
• 
NYHA HF Classification: The NYHA HF Classification provides a simple way of classifying the 
extent of HF. It places subjects in one of four categories, based on how much they are limited 
during physical activity: 
o Class I. Patients with HF, but without resulting limitations of physical activity. Ordinary 
physical activity does not cause undue fatigue, palpitation, or dyspnea. 
o Class II. Patients with HF resulting in slight limitation of physical activity. They are 
comfortable at rest. Ordinary physical activity results in fatigue, palpitation, or dyspnea. 
o Class III. Patients with HF resulting in marked limitation of physical activity. They are 
comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, or 
dyspnea.  
o Class IV. Patients with HF resulting in inability to carry on any physical activity without 
discomfort. Symptoms of cardiac insufficiency, anginal syndrome, and dyspnea may be 
present even at rest. If any physical activity is undertaken, shortness of breath is 
increased. 
• 
Hospitalization: Admission to hospital for at least 24 hours. 
• 
Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other 
persons, whether or not related to the investigational medical device under clinical investigation. 
This definition includes events related to the investigational medical device or the comparator. 
This definition includes events related to the procedures involved. 
• 
Serious AE (SAE): An AE that led to: 
o Death 
o A serious deterioration in the health of the subject, that either resulted in: 
 
A life-threatening illness or injury OR 
 
A permanent impairment to a body structure or a body function OR 
 
An inpatient or prolonged hospitalization OR 
 
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 
Note:  A planned hospitalization for a pre-existing condition, or a procedure required by the 
CIP is not considered an SAE. 
• 
Adverse Device Effect (ADE): An AE related to the use of an investigational medical device. 
This definition includes AEs 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): ADE that has resulted in any of the consequences 
characteristic of a serious AE. 
• 
Unanticipated Adverse Device Effect (UADE): As defined in 21 CFR §812.3, any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in nature, 

 
 
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severity, or degree of incidence in the CIP or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects.  
• 
Non-AE Device Issue: any instance when the device fails to perform or does not function 
properly without an associated an adverse clinical outcome. 
• 
Device/System Related Complication (DSRC): An AE that is related or possible related to the 
system (CardioMEMS PA Sensor or other components of the CardioMEMS HF System) and has 
at least one of the following characteristics: 
o is treated with invasive means (other than intramuscular medication or a right heart 
catheterization which is used for diagnostic purposes) 
o resulted in the death of the subject 
o resulted in the explant of the device 
 
 
 
18.0 APPENDIX III BODY MASS INDEX CALCULATOR 
 
Subjects’ BMI will be calculated using the website below:  
 
https://www.nhlbi.nih.gov/health/educational/lose wt/BMI/bmicalc.htm 
 
Enter the subjects Weight and Height and then calculate BMI (print screen for source documentation) 
 
Formulas used to calculate BMI: 
 
English BMI Formula 
BMI = Weight in pounds/ (height in inches x height in inches) x 703 
 
Metric BMI Formula 
BMI = Weight in kilograms/ (height in meters x height in meters)  
 

 
 
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19.0 APPENDIX IV: CARDIAC MRI PROTOCOL SPECIFIC IMAGE ACQUISITION OUTLINE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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20.0 APPENDIX V: REFERENCES  
1. Angermann CE, et al.; MEMS-HF Investigators. Pulmonary artery pressure-guided therapy in 
ambulatory patients with symptomatic heart failure: the CardioMEMS European Monitoring Study 
for Heart Failure (MEMS-HF). Eur J Heart Fail. 2020; Oct;22(10):1891-1901.  
 
2. Cowie MR, de Groote P, McKenzie S, Brett ME, Adamson PB; CardioMEMS Post-Market Study 
Investigators. Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: 
COAST. ESC Heart Fail. 2020; Jun;7(3):865-872.  
 
3. Wexler DJ, et al. Predictors of costs of caring for elderly patients discharged with heart failure. 
Am Heart J. 2001; 142:350-7.  
 
4. Krumholz HM, et al. Patterns of hospital performance in acute myocardial infarction and heart 
failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009; 2:407-13.  
 
5. Kripalani S, Theobald CN, Anctil B, Vasilevskis EE. Reducing hospital readmission rates: current 
strategies and future directions. Annu Rev Med. 2014; 65:471-485. 
 
6. Upadhyay S, Stephenson AL, Smith DG. Readmission Rates and Their Impact on Hospital 
Financial Performance: A Study of Washington Hospitals. Inquiry. 2019; 56.  
 
7. Shavelle, D.M. et al. Reduction in Annual Hospitalization Rate During Pulmonary Pressure-
Guided Therapy for Ambulatory Heart Failure:  1-Year Outcomes from the CardioMEMS Post-
Approval Study. Circ HF. 2020. 
 
8. Abraham, WT, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: 
a randomised controlled trial. Lancet. 2011; 377(9766):658-666. 
 
9. Abraham, WT, et al. CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery 
pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the 
CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61.  
 
10. Lindenfeld et al.  Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised 
controlled trial. Lancet. 2021; (398)10304.  
 
11. Ponikowski P, et al., ESC Scientific Document Group. 2016 ESC guidelines for the diagnosis and 
treatment of acute and chronic heart failure: the Task Force for the Diagnosis and Treatment of 
Acute and Chronic Heart Failure of the European Society of Cardiology (ESC). Developed with 
the special contribution of the Heart Failure Association of the ESC. Eur J Heart Fail. 2016; 
18:891–975. 
 

 
 
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12. Karamanoglu M, Bennett T, Ståhlberg M, et al. Estimation of cardiac output in patients with 
congestive heart failure by analysis of right ventricular pressure waveforms. Biomed Eng Online. 
2011; 10:36.  
 
13. Critchley, L.A.H., Critchley, J.A.J.H. A Meta-Analysis of Studies Using Bias and Precision 
Statistics to Compare Cardiac Output Measurement Techniques. J Clin Monit Comput 15, 85–91 
(1999). https://doi.org/10.1023/A:1009982611386.  
 
14. Linnet K. Necessary sample size for method comparison studies based on regression analysis. 
Clin Chem. 1999 Jun;45(6 Pt 1):882-94. PMID: 10351998. 
 
15. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med 
Res. 1999; Jun;8(2):135-60.  
 
16. Shoemaker WC, Wo CC, Bishop MH, Appel PL, Van de Water JM, Harrington GR, Wang X, Patil 
RS. Multicenter trial of a new thoracic electrical bioimpedance device for cardiac output 
estimation. Crit Care Med. 1994 Dec;22(12):1907-12. PMID: 7988125. 
 
17. Biederman RWW, Doyle M, Correa-Jaque P, Rayarao G, Benza RL. Integrated use of cardiac 
MRI and the CardioMEMS™ HF system in PAH: the utility of coincident pressure and volume in 
RV failure-the NHLBI-VITA trial. Cardiovasc Diagn Ther. 2019; Oct;9(5):492-501.  
 
18. Deal, AM, Pate, VW, Rouby, SE, A SAS Macro for Deming Regression, Presented at Southeast 
SAS Users Group (SESUG) 2009, http://analytics.ncsu.edu/sesug/2009/CC014.Deal.pdf. 
 
19. Tree, M., White, J., Midha, P., Kiblinger, S., and Yoganathan, A. (November 5, 2015). "Validation 
of Cardiac Output as Reported by a Permanently Implanted Wireless Sensor." ASME. J. Med. 
Devices. March 2016; 10(1): 011001. https://doi.org/10.1115/1.4031799 
 
20. Bland, J & Altman, Douglas. (2007). Agreement Between Methods of Measurement with Multiple 
Observations Per Individual. Journal of biopharmaceutical statistics. 17. 571-82. 
10.1080/10543400701329422. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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2. Subject is implanted with the CardioMEMS PA Sensor for a minimum of 
3 months at time of consent. 
3. Subject is ≥ 18 years of age. 
4. Subject is willing and able to undergo several cardiac MRI scans. This is 
including but not limited to: 
• 
Subject must have all MRI compatible devices 
• 
Subject must be able to hold their breath during imaging 
• 
Subject must be free of all metal bodies, fragments, or implants 
that would prohibit MRI imaging 
5. Subject is willing and able to upload PA pressure information (i.e., take 
daily CardioMEMS HF System readings and have their hemodynamic 
information collected at study visits) and comply with the follow-up 
requirements. 
Exclusion Criteria 
1. Subject will receive or is likely to receive an advanced therapy (e.g., 
mechanical circulatory support or cardiac transplant) in the next 6 
months. 
2. Subject was implanted with Cardiac Resynchronization Therapy (CRT)-
Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days 
prior to consent. 
3. Subject is pregnant or planning to become pregnant in the next 6 
months 
4. Subject is enrolled into another trial with an active treatment arm 
5. Subject has significant congenital heart disease that has not been 
repaired  
6. Subject is implanted with mechanical right heart valve(s) 
7. Subject has unrepaired severe valvular disease 
8. Subject has an anticipated life expectancy of < 6 months 
9. Subject has an active, ongoing infection, defined as being febrile, an 
elevated white blood cell count, on intravenous antibiotics, and/or 
positive cultures (blood, sputum, or urine) 
10. Subject has had a major cardiovascular event (e.g., unstable angina, 
myocardial infarction, percutaneous coronary intervention, open heart 
surgery, or stroke, etc.) within 90 days prior to consent 
11. Subject has any condition that, in the opinion of the Investigator, would 
not allow for utilization of the CardioMEMS HF System to manage the 
subject using information gained from hemodynamic measurements to 
adjust medications, including the presence of unexpectedly severe 
pulmonary  hypertension (e.g., trans-pulmonary gradient >15) at implant 
RHC, a history of non-compliance, or any condition that would preclude 
ability to obtain CardioMEMS PA Sensor readings and paired cardiac 
MRI data from being collected 
12. Subjects who, in the opinion of the investigator, are at-risk for serious 
adverse reaction to Dobutamine (ex. subjects with idiopathic 
hypertrophic subaortic stenosis and subjects who have shown previous 

 
 
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manifestations of hypersensitivity to Dobutamine) should be excluded 
from the study