Registry That Aims to Understand the Definition Used and Treatment Options Utilized by Clinicials for CRT Non-responders
Conditions: Heart Failure
Sponsor: Abbott Medical Devices

Clinical Investigation Plan Cover Page 
87173 CIP Posting Cover Page Ver B 
Template 
Page 1 of 1 
NCT Number: NCT01805154 
ADVANCE CRT Registry 
ADVANCE Cardiac Resynchronization Therapy Registry 
Study Document No: 60046199 
Version C 
Date: 17-DEC-2015 
Sponsor 
St. Jude Medical, Inc. 
15900 Valley View Court 
Sylmar, CA 91342 
USA 

ADVANCE CRT REGISTRY 
December 17, 2015 
 
60046199/C 
STUDY PROTOCOL 
FOR THE
ADVANCE CRT REGISTRY 
December 17, 2015 

 
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Table of Contents 
 
 
Table of Contents .................................................................................................................... 1 
1.0 
Introduction ..................................................................................................... 2 
2.0 
Purpose............................................................................................................. 3 
3.0 
Clinical Protocol .............................................................................................. 3 
3.1 
Study Design and Scope ................................................................................... 3 
3.1.1 Additional Data ................................................................................................. 5 
3.2 
Sample Size ....................................................................................................... 5 
3.3 
Study Duration .................................................................................................. 5 
3.4 
Patient Selection................................................................................................ 5 
3.4.1 Inclusion Criteria .............................................................................................. 5 
3.4.2 Exclusion Criteria ............................................................................................. 6 
3.5 
Study Procedures .............................................................................................. 6 
3.5.1 Enrollment (< 30 days post device implant) ..................................................... 7 
3.5.2 Follow-Ups: ...................................................................................................... 9 
3.5.2.1 
6 Month Follow-Up: Required In-Office Visit ......................................... 11 
3.5.2.2 
3, 9, 12-Month and Subsequent Follow-Ups – In Office .......................... 13 
3.5.2.3 
3, 9, 12-Month and Subsequent Follow-Ups – Remote ............................ 14 
3.5.3 Unscheduled Follow-up Visits ........................................................................ 14 
4.0 
Protocol Deviations ....................................................................................... 15 
5.0 
Adverse Events .............................................................................................. 15 
5.1 
Definitions....................................................................................................... 15 
5.1.1 Adverse Event (AE) ........................................................................................ 15 
5.1.2 Serious Adverse Event (SAE) ......................................................................... 16 
5.2 
Procedure for assessing, recording and reporting AE and SAE ..................... 17 
6.0 
Other Reported Events ................................................................................. 17 
7.0 
Health Care Utilization/Hospitalization Visits ........................................... 18 
8.0 
Deaths ............................................................................................................. 18 
9.0 
Withdrawals .................................................................................................. 19 
10.0 
Statements of compliance ............................................................................. 20 
11.0 
Risk Analysis ................................................................................................. 20 
12.0 
Investigator Information .............................................................................. 20 
13.0 
Consent Materials ......................................................................................... 21 
14.0 
IRB Information............................................................................................ 21 
15.0 
Other Institutions .......................................................................................... 21 
16.0 
Records and Reports..................................................................................... 21 
17.0 
Publication ..................................................................................................... 22 
18.0 
References ...................................................................................................... 23 
Appendix A ......................................................................................................................... 25 
 
 
 
 
 

 
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1.0 
Introduction 
Therapeutic benefit of cardiac resynchronization therapy (CRT) in patients with 
advanced heart failure (HF) is well established.1-3  CRT has been shown to restore the 
coordination of cardiac contraction and relaxation resulting in improved exercise 
tolerance, cardiac reverse remodeling, and improved survival in advanced HF patients 
with interventricular conduction delay.  Studies of mechanisms and outcomes suggest 
that the therapeutic benefit is mediated by device-induced resynchronization, thus 
leading to continued research focus on identifying patients with underlying 
mechanical dysynchrony who are most likely to benefit from CRT.4-9  In spite of 
these efforts, however, the proportion of patients who fail to respond to CRT remains 
significant.10   The mean responder rate from the 15 largest studies is 66.9% based on 
clinical evaluation methods and even lower, 56.9%, using echocardiographic 
parameters.11  Despite this substantial proportion of non-responders, little research 
has been done to understand how non-responders are identified, treated, and followed 
in real world clinical practice. 
 
There is no uniform criterion to determine the response to CRT as clinical studies use 
numerous criteria to define positive response to CRT.12  Furthermore, the CRT 
response is very sensitive to the criteria used as the recent article by Fornwalt et al12 
demonstrated that the response rate in sub-group of PROSPET study patients ranged 
from 32% to 91% based on 15 different response criteria used in many CRT clinical 
studies.  Development of research-based guidance is made more difficult due to the 
fact that these response criteria are mostly applied in controlled studies.  Real-world 
clinical criteria and their corresponding response rates are still largely unknown. 
 
Furthermore, once patients are determined to be non-responders, the management 
strategy and the specialty and role of health care providers treating the HF patient is 
not well understood.  A few isolated studies of non-traditional left ventricular (LV) 
pacing schemes such as cardiac contractility modulation13
, dual or triple site LV 
pacing14-16, and endocardial LV pacing17  led to higher acute hemodynamic 
improvements or improved clinical outcome.  However, the use of these non-
conventional LV pacing strategies on non-responders in real world practice is 
unknown even though the clinical study evaluating the efficacy of dual-site LV 
pacing is currently being studied18. 
 
In the recent FREEDOM study, a survey was completed by over 100 investigators to 
understand the real world practice pattern on patients receiving CRT device.19  The 
survey provided valuable insights into the method of device parameter optimization, 
the method of evaluation of responders and non-responders, the timing of determining 
the outcome of CRT efficacy, and the device parameter re-optimization pattern 
difference between responder and non-responder.  However, the survey focused 
mainly on CRT patient managements from the device optimization perspective and 
the clinical management of non-responders was not investigated. 
 

 
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International registries can provide us a comprehensive understanding regarding the 
clinical management of CRT-non responders around the world.  Such understanding 
can help us to identify the gaps in knowledge and the area of innovation needed to 
make CRT a better HF therapy option or provide alternative options to better treat 
non-responders. The ADVANCE-CRT Registry/Observation study is aimed at 
elucidating non-responder care in clinical practice settings around the globe.  Among 
the unknowns of interest are the criteria for prescribing CRT for HF management, 
rate of non-responders, methods of identifying non-responders, treatment options 
employed by clinicians to improve response, clinicians most involved in deciding 
each patient’s course of care, and healthcare system encounters and utilization. 
2.0 
Purpose 
The intent of this registry/ observational study is to understand comprehensive 
clinical care strategies for CRT patients especially non-responders in real world 
clinical practice.  The study should provide understanding of the following  
 Rate of non-responders to CRT 
 Commonly used definitions of response to CRT 
 Treatment strategies employed to treat HF in the non-responder population  
 Efficacy of treatment strategies used to treat non-responders 
 Identification of the decision-making process in the care of non-responders 
 Characterization of the management pathway and related therapies following 
declaration of non-response to CRT 
 Role of remote-monitoring in treating and monitoring non-responders 
 
This study may continue up to 4 – 5 years, depending on the rate of enrollment- and 
follow-up timelines.  
3.0 
Clinical Protocol 
3.1 
Study Design and Scope 
This is a worldwide, multicenter, non-randomized registry/observational 
study.  The study will enroll a minimum of 1500 CRT patients from up to 70 
centers worldwide. The goal of the study is to have a maximum of 500 CRT 
non-responders patients identified and assessed. Hence, the final number of 
enrolled CRT patients in the study will depend on the number of CRT 
patients needed to reach a maximum of 500 CRT non-responders. Patients 
who are successfully implanted with St. Jude Medical CRT-D/P devices will 
be eligible for enrollment in the study up to 30 days post implant of the 
device.  Once enrolled, all patients will be followed every 3 months   for12 
months after implant.  The responder/non-responder evaluation will occur 
during the 6 month office visit and criteria used to determine the response to 
CRT will be captured.  All visits except for Enrollment,6-Month, and 12-

 
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Month visits may be performed as in the office or by telephone.  Merlin.net 
remote follow-up is optional but encouraged. 
 
The study will be complete when the last enrolled patient has been followed 
for 12 months post implant. Arrhythmic episodes and relevant device 
parameters that can affect CRT outcome such as % biventricular pacing, 
AT/AF burden, and % PVC will be collected at each in-office device 
interrogation. All clinical events such as hospitalizations, ER visits, Urgent 
Care visits, death, etc. will also be collected.  Any re-optimization of the 
device, i.e., AV/VV interval optimization, LV lead repositioning and pacing 
vector reconfiguration, as well as modified/new clinical therapies 
administered in attempt to improve the patient’s HF condition will be 
collected.  In addition, specialty of clinicians managing and providing care 
for CRT patients will be noted. 
Figure 1. Study Flow Diagram 
Study Flow Diagram 
New CRT device and LV lead implant
Enrollment and Informed Consent < 30 days post-
implant
3-month visit (in-office or remote)
9-month visit (in-office or remote) 
6-month in-office visit with 
response evaluation
12-month visit (in-office only) 
 
 

 
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3.1.1 Additional Data 
 Demographics: gender, age, height, weight, race/ethnicity (if 
available) 
 Medical history 
 Implanted devices (model and serial number) 
 NYHA class, Patient Global Assessment (PGA)  
 Medication 
 Echo measurements 
 12 Lead ECG 
 Minnesota Living with Heart Failure (MLWHF) and EQ5D quality 
of life score 
 Modified specific activity score (SAS) 
 Clinical events and healthcare utilization 
 Electrical lead measurements and device diagnostics 
 Device session record 
 Responder/Non-responder evaluation criteria 
 Device 
re-optimization 
and 
clinical 
therapy 
modification 
administered to improve the heart failure condition of patients 
 HF management profile for study center  
3.2 
Sample Size  
The study will enroll at least 1500 CRT patients from estimated 70 centers 
worldwide in order to identify and assess a maximum 500 CRT non-
responders. 
3.3 
Study Duration 
The last patient enrolled will be followed for 1 year after implant.  patient 
participation in the study   will be completed when the in-office 12 month visit 
has been completed.   
3.4 
Patient Selection 
The investigational centers will attempt to recruit patients who meet the 
study inclusion criteria for possible study enrollment. 
3.4.1 Inclusion Criteria 
Eligible patients will meet all of the following: 
 
1. Patient willing and able to sign informed consent 
2. Patients implanted with any market-approved St. Jude Medical 
CRT-D/P device with no prior LV lead placement  

 
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3.4.2 Exclusion Criteria  
Patients will be excluded if they meet any of the following: 
 
1. Are likely to undergo heart transplantation within the next 12 
months 
2. Are less than 18 years of age 
3. Are pregnant or planning to become pregnant during the duration 
of the study  
4. Are currently participating in a clinical investigation that includes 
an active treatment arm  
5. Have a life expectancy of less than 6 months 
3.5 
Study Procedures 
All required study procedures at each specified interval are outlined in the 
table below.  
 
Upon site activation, CRT patient management strategies will be characterized 
via a one-time site survey (Practice Characteristics Survey Form).  Data 
collected will request information such as: 
 
 Outpatient practice setting, i.e., university, non-university, teaching  
 Presence of and involvement of an HF clinic for HF/CRT management 
 Staffing, i.e., number of physicians, HF nurses, electrophysiologists and 
interventionalists 
 Number of HF and CRT patients managed annually  
 Presence of any special clinic/protocol in caring for CRT non-responders 
 
Table 1: Data Reporting Schedule 
 
 
Enrollment 
In-office F/U at 
6 months 
Other In-office 
F/Us 
Remote F/Us 
Medical History 
 
 
 
 
Medications 
 
 
 
 
Cardiac Events/Health Care 
Utilization 
 
 
 
 
12 Lead ECG 
 
‡ 
‡ 
 
Lead Electrical 
Measurements 
 
 
 
 
Echo Measurements (EF at 
minimum) 
 
‡ 
‡ 
 

 
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Device Diagnostics e.g., 
AT/AF burden, % 
biventricular pacing, # of 
VT/VF episodes, etc. 
 
 
 
 
Responder/Non-responder 
evaluation 
 
 
** 
 
NYHA 
 
 
 
 
Patient Global Assessment 
 
 
* 
* 
Modified SAS 
‡ 
‡ 
‡ 
 
MLWHF and 
EQ5DQuestionnaires 
‡ 
‡ 
‡ 
 
Device Re-Optimization 
(e.g., AV/VV optimization, 
LV lead revision) intended to 
improve HF condition 
 
‡ 
‡ 
 
Any new treatment or 
modification of existing 
therapy provided to improve 
HF condition 
 
‡ 
‡ 
 
: Standard of care, ‡: Report if performed, *: until the 12 month visit: **: for 9 mo and 12, mo office visits 
only 
3.5.1 Enrollment (< 30 days post device implant) 
Obtaining Consent 
Patients deemed eligible and willing to participate in the Study must 
sign a Consent Form prior to study enrollment.  A template of the 
Informed Consent Form is provided in Appendix A.  The signed 
informed consent form must be filed in the hospital/clinic patient 
medical chart with the study patient’s documentation and be available 
for monitoring and auditing. 
 
Enrollment 
A patient is considered enrolled once they have signed an informed 
consent and have been successfully implanted with an approved St. 
Jude Medical CRT-D/P device within the last 30 days prior to 
enrollment.  Device implant information will be collected after 
enrollment and patients may be enrolled in Merlin.net for remote 
follow-up. The following information should be collected at the 
Enrollment Visit: 
 
Required Patient Data 
 Informed consent 
 Demographic information if available 

 
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 Pre-Implant NYHA class 
 12 Lead ECG 
o Intrinsic ECG rhythm with QRS width, PR interval, and the 
morphology, i.e., normal, LBBB, or RBBB conduction pattern.  
Intrinsic ECG printout should be provided 
o ECG printout with final device programming should be 
provided if available 
 Pre-Implant Echo data including ejection fraction (EF) at minimum 
 Medical history, i.e., coronary artery disease (CAD), myocardial 
infarction (MI), prior cardiac interventions, arrhythmia history, 
other comorbid conditions, etc. 
 If MI is noted, the location of MI should be provided 
 Size of scar should be provided if available 
 Detailed medication information 
 Details of patient HF education if provided 
 
Required Implant/Device Data 
 Implanted pulse generator and lead information, i.e., model, serial 
number, pocket location (pulse generator), lead position 
 Final LV lead electrodes locations and reasons for selecting the 
final pacing location and configuration 
 AV/VV interval values and optimization method used, i.e., 
QuickOpt, echo-guided, ECG, out of box setting, etc. 
 Lead electrical measurements, i.e., capture threshold, sensing, 
impedance 
 LV electrical delay (QLV) if available: QLV will be measured 
from ECG and LV IEGM recordings obtained from the Merlin 
programmer if done at the Enrollment Visit (data requested if not 
done as standard of care) 
 Device diagnostics such as % BiV pacing, % Atrial pacing, AT/AF 
burden, VT/VF episodes etc. 
 Electronic device session record (uploaded via EDC) 
 
Optional Data (enrollment, 6 month and12 month visit) 
 Minnesota Living With Heart questionnaire Failure (MLWHF) and 
EQ5D  
 Modified specific activity score (SAS) evaluation 
 
The following Case Report Forms (CRF) should be completed: 
 Enrollment Form 
 Medical History Form 
 Medication Form 
 MLWHF and EQ5D Questionnaires – optional 

 
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3.5.2 Follow-Ups:   
Recommended follow-up visit schedules are as follows.  Patients will 
have follow-up visits every 3 months for the first 12 months.  Patients 
can be followed in-office or remotely except for the required in-office 
6 month and 12 month visit. Follow up visit intervals and windows are 
calculated based on the CRT system implant date – not the Enrollment 
Visit date.   
. 
Follow-up visits type 
Visit Window 
6 Month In-Office Visit 
6 month from the implant date ± 
60 days 
Other Visits (remote or in-office) 
Visit Month from the implant date 
± 30 days  
 
 
In this study, each patient’s response to CRT will be evaluated at the 
6-month in-office visit using two criteria.  They are 1) Clinical 
Composite Score (CCS)20 and 2) study center-specific criteria. The 
CCS consists of NYHA assessment, Patient Global Assessment 
(PGA), HF events, and cardiovascular death.  The center-specific 
criteria are what the center uses for evaluating CRT response in 
routine HF management.  Some commonly used criteria used for 
determining a response to CRT are left ventricular remodeling 
parameters from echocardiogram, functional assessments such as 6 
minute walk test and NYHA, clinical events or combination of any of 
those.  In this study, the number of non-responders to CRT will be 
based on the CCS.  However, the study center will provide details of 
their response evaluation as well.  
 
The CCS includes 4 components: NYHA class, Patient Global 
Assessment (PGA), HF events, and cardiovascular death.  The NYHA 
Class assessment and PGA are determined by an assessor interviewing 
patients about their symptoms. Specifically, the PGA will be a single 
interview question that asks the patient to categorize how they feel 
compared to before they received their CRT implant as either: 
 
 Markedly better 
 Moderately better 
 Slightly better 
 No change 
 Slightly worse 
 Moderately worse 
 Markedly worse 
 

 
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In this study an HF event is defined as any one of the following when 
the subject has symptoms and/or signs consistent with congestive heart 
failure:  
 Hospitalization for HF ≥ 24 hours 
 Hospitalization for HF<24 hours (i.e. outpatient treatment, 
observational care, ER, Urgent Care, and physician’s office visit) 
requiring administration of IV diuretics, inotropes, and/or 
vasodilators 
 
Finally, cardiovascular death is defined as sudden cardiac death; heart 
failure death; myocardial infarction related; or ‘other’ such as 
pulmonary embolism, peripheral thromboembolism, stroke, deaths due 
to vascular procedure, or other major cardiovascular event.  
 
Using the CCS and decision algorithm described in Figure 2, patients 
are categorized as Improved, Worsened or Unchanged based on the 
following rules:  
 
“Improved” – patients that demonstrate: 
 At least a one-class improvement in NYHA Class OR 
improvement 
by 
PGA 
(“moderately 
better” 
or 
“markedly better”) 
AND 
 No HF events as described above 
AND 
 No cardiovascular death 
 
“Worsened” – patients that demonstrate: 
 Worsening in NYHA Class OR worsening by PGA 
(“moderately worse” or “markedly worse”) 
OR 
 Presence of HF events as described above 
OR 
 Cardiovascular death 
 
“Unchanged” – patients that are neither “Improved” nor “Worsened”. 
 
Patients who are “Improved” using the above definition relative to the 
Enrollment Visit will be considered as Responders.  Patients that are 
“Worsened” or “Unchanged” relative to the Enrollment Visit will be 
grouped together as Non-Responders. 
 
Device settings may be re-optimized, medication may be altered, or 
patient compliance issues, if any, may be addressed to improve the HF 
conditions regardless of their responder or non-responder status.  If 

 
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any measures are taken to improve the HF condition of patients, such 
information should be provided in follow-up CRFs.   
  
Figure 2. Decision algorithm to classify response to CRT based on 
CCS 
Has the patient experienced a heart failure event as 
described in section 3.5.2 ?
WORSENED
Has the NYHA functional class worsened or the 
patient’s global assessment worsened (“worse” or 
“markedly worse”)?
WORSENED
Has the NYHA functional class improved or the 
patient’s global assessment improved (“better” or 
“markedly better”)?
UNCHANGED
IMPROVED
NO
NO
NO
YES
YES
YES
Did the patient have a cardiovascular death as 
described in section 3.5.2 ?
YES
NO
WORSENED
 
3.5.2.1 
6 Month Follow-Up: Required In-Office Visit 
The 6 month follow-up should occur at the office of the physician 
managing the patient. 
 
Required Patient Data 
 Detailed medication information 
 Cardiac events and health care utilization 
 Device diagnostics such as % pacing, AT/AF burden and VT/VF 
episodes, etc. 
 Type of clinicians involved and the treatment provided during the 
visit.  If the patient was seen by other clinicians before the visit and 
after the previously scheduled visit, type of clinicians involved and 
the treatment provided should be provided as well 
 Patient global assessment (PGA) and NYHA  
 Responder/non-responder criteria used which might include: 
o Echo-based: Remodeling assessment such as EF, LVESV, 
LVEDV  
o Clinical: Functional Assessment such as NYHA, 6MHWT, 
MLWHF, SAS, time on treadmill 
o Clinical: Symptoms of HF, HF hospitalization, administration 
of intravenous (IV) inotrope or diuretic therapy, etc. 
o Composite: Any combination of factors 

 
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o Others 
 Electronic device session record (uploaded via EDC) 
 
Required Data if Procedures Performed  
 12 Lead ECG with QRS width, PR interval, and the morphology, 
i.e., normal, LBBB, or RBBB conduction pattern 
 12 Lead ECG printout with final device programming if EP 
procedures are performed on patients  
 Any device re-optimizations or new/modified medical therapies 
intended to improve the hemodynamics or HF condition of 
patients.  They can be one or more of the following. 
o Device re-optimization 
 Device parameters optimization including AV/VV 
intervals, lead repositioning, insertion of extra leads, and 
lead replacement 
 Pacing configuration modifications especially for the 
Quadripolar lead and reasons for the changes 
o Treatment of an arrhythmia to improve biventricular pacing 
 Treatment of SVT, VT, or frequent PVCs 
o Modification of existing clinical therapy or new therapy 
attempted to improve HF condition 
 Medication change, e.g. dose adjustments of 
neurohormonal blockers, beta blockers, loop diuretics, etc. 
 Address compliance issues 
 Medication 
 Salt/water restriction 
 HF education  
o Treatment of other co-morbid conditions 
o Other treatments/device re-optimization used to improve the 
HF status of patients 
 Minnesota Living With Heart questionnaire Failure (MLWHF) and 
EQ5D  
 Modified specific activity score (SAS) evaluation 
 
The following Case Report Forms (CRF) should be completed: 
 6 Month Follow-Up Form 
 Medication Form 
 Clinical Composite Score Form 
 Health Care Utilization Form if applicable 
 Adverse Event From if applicable 
 Treatment Form if applicable 
 System Revision Form if applicable 
 MLWHF and EQ5D Questionnaires if applicable 
 

 
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3.5.2.2 
3, 9, and12-Month Follow-Ups – In Office 
Any follow-up except the 6-month and 12- month follow-up may be 
done remotely or as an in-office visit.  The following information will 
be reported for a follow-up that is performed in-office.  
 
Required Patient Data 
 Detailed medication information 
 Cardiac events and health care utilization 
 Device diagnostic data 
 Type of clinicians involved and the treatment provided during the 
visit.  If the patient was seen by other clinicians before the visit and 
after the previously scheduled visit, type of clinicians involved and 
the treatment provided should be provided as well 
 NYHA evaluation  
 Patient global assessment (PGA) if the follow-up is 12 month or 
less  
 Status of patient’s response (responder or non-responder) to CRT 
based on study center-specific criteria (for 9-month and 12-month, 
office visits only) 
 Echo data including ejection fraction (EF) at minimum* 
 Electronic device session record (uploaded via EDC) 
 
*At least 1 per year 
 
Required Data if Procedures Performed 
 12 Lead ECG with QRS width, PR interval, and the morphology, 
i.e., normal, LBBB, or RBBB conduction pattern 
 12 Lead ECG printout with final device programming if EP 
procedures are performed on patients  
 Any device re-optimizations or new/modified medical therapies 
intended to improve the hemodynamics or HF condition of 
patients.  They can be one or more of the followings. 
o Device re-optimization 
 Device parameters optimization including AV/VV 
intervals, lead repositioning, insertion of extra leads, and 
lead replacement 
 Pacing configuration modifications especially for the 
Quadripolar lead and reasons for the changes 
o Treatment of an arrhythmia to improve biventricular pacing 
 Treatment of SVT, VT, or frequent PVCs 
o Modification of existing clinical therapy or new therapy 
attempted to improve HF condition 
 Medication change, e.g. dose adjustments of 
neurohormonal blockers, beta blockers, loop diuretics, etc. 
 Address compliance issues 

 
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 Medication 
 Salt/water restriction 
 HF education  
o Treatment of other co-morbid conditions 
o Other treatments/device re-optimization used to improve the 
HF status of patients 
 Minnesota Living With Heart questionnaire Failure (MLWHF) and 
EQ5D  
 Modified specific activity score (SAS) evaluation 
 
The following Case Report Forms (CRF) should be completed: 
 3 Month Follow-Up Form for 3 month visit 
 Follow-Up Form  for other visits 
 Medication Form 
 Health Care Utilization Form if applicable 
 Adverse Event From if applicable 
 Treatment Form if applicable 
 MLWHF and EQ5D Questionnaires if applicable 
 System Revision Form if applicable 
3.5.2.3 
3 and9 Month Follow-Ups – Remote 
Any follow-up except the 6-month follow-up may be done remotely or 
as an in-office visit.  The following information will be reported for a 
follow-up that is performed remotely.  
  
Required Patient Data 
 Detailed medication information 
 Cardiac events and health care utilization 
 Patient global assessment (PGA) if the follow-up is less than 12 
months 
 Information regarding the role of remote follow-up in patient 
management  
 
The following Case Report Forms (CRF) should be completed: 
 Follow-up Form  
 Medication Form 
 Health Care Utilization Form if applicable 
3.5.3 Unscheduled Follow-up Visits  
A heart failure related clinic visit at any time other than a regularly 
scheduled visit is considered an unscheduled visit. Follow-up CRF 
should only be completed via the EDC system.  If any device re-
optimization or clinical therapy modification was provided to improve 
the HF condition of patient, Treatment form should be completed.  

 
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The following Case Report Forms (CRF) should be completed: 
 Follow-up Form 
 Treatment Form if applicable 
 Adverse Event From if applicable 
 
 
4.0 
Subject Study Completion 
Patient participation in the study is complete when each enrolled patient completes the 12 
month follow-up visit.  Patient participation for patients who have already completed the 12 
month visit is considered complete upon the approval of this revised protocol by IRB/EC.     
5.0 
Protocol Deviations  
Investigators are required to adhere to the study protocol, signed Investigator’s 
Agreement, applicable federal (national) or state/local, laws and regulations, and any 
conditions required by the IRB/Ethics Committee or applicable regulatory authorities. 
 
A protocol deviation is used to describe situations in which the study protocol was not 
followed.  All deviations from the study protocol must be reported to St. Jude 
Medical. In addition, all deviations must be reported to the reviewing IRB/Ethics 
Committee and Competent Authorities, if applicable, per their reporting requirements.  
 
The investigator must notify St. Jude Medical and the reviewing IRB/Ethics 
Committee of any deviation from the study protocol that affects the rights, safety or 
well-being of the subject or the scientific integrity of the study, including those which 
occur under emergency circumstances as soon as possible, but not later than 72 hours 
after the investigator becomes aware of the deviation.   
6.0 
Adverse Events 
6.1 
Definitions 
6.1.1 Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
patients, users or other persons, whether or not related to the medical 
device.  Adverse events can be further categorized into procedure or 
device related in the following definitions. 
 

 
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Procedure Related: The AE is deemed related to the procedure if it 
occurred during the procedure or if it is directly related to the 
procedure but was not directly caused by the device 
 
Device Related:  The AE is deemed device related if it was directly 
caused by device 
 
Potential adverse events include: 
Allergic reaction to contrast media 
AV nodal reentrant tachycardia 
Bodily rejection phenomena 
Cardiac/coronary sinus dissection 
Cardiac/coronary sinus perforation 
Cardiac tamponade 
Coronary sinus or cardiac vein thrombosis 
Endocarditis 
Excessive bleeding  
Hematoma/seroma 
Induced atrial or ventricular arrhythmias 
Infection due to procedure or implanted devices 
Lead dislodgement 
Lead/ Port damage 
Local tissue reaction; formation of fibrotic tissue 
Loss of pacing and / or sensing due to dislodgement or mechanical 
malfunction of the pacing lead 
Myocardial irritability 
Myopotential sensing 
Pectoral/diaphragmatic/phrenic nerve stimulation 
Pericardial effusion 
Pericardial rub 
Pnemothorax/hemothorax 
Prolonged exposure to fluoroscopic radiation 
Pulmonary edema 
Renal failure from contrast media used to visualize coronary veins 
Rise in threshold and exit block 
Thrombolytic or air embolism 
Valve damage 
 
6.1.2 Serious Adverse Event (SAE) 
An adverse event that: 
 Led to death 
 Led to a serious deterioration in the health of the subject that either 
resulted in  
 A life-threatening illness or injury OR 

 
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 A permanent impairment to a body structure or a body function 
OR 
 An in-patient 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 OR 
 A malignant tumor 
 Led to foetal distress, foetal death or a congenital abnormality or 
birth defect 
 
A planned hospitalization for a pre-existing condition, or a procedure 
required by the health care professional is not considered a serious 
adverse event. 
6.2 
Procedure for assessing, recording and reporting AE and SAE  
All SAEs are to be documented and reported to the sponsor within 10 days for 
US sites and 72 calendar hours for sites outside US after becoming aware of 
the event or per local regulatory timelines. 
 
 
All AEs are to be documented and reported no later than 10 working days 
after becoming aware of the event. Non-Serious Adverse Events 
documentation and reporting are limited to cardiovascular events.  
 
Should an AE and SAE occur, complete and submit an AE form to St. Jude 
Medical.  
 
Return any explanted devices or leads to St. Jude Medical for analysis.  
 
Additional information can be requested, if necessary, by the Sponsor for 
reporting of AEs to regulatory authorities. The investigator must notify the 
IRB or Ethics Committee, if appropriate, in accordance with national and 
local laws and regulations. 
 
NOTE: If an adverse event is documented at the patient’s last follow up visit, 
both the notification and follow-up information on the AE CRF are to be 
provided to the sponsor. 
7.0 
Other Reported Events 
Other Reported Events are any other clinical event that is submitted by the 
investigator which is not caused by or associated with the study device and/or system 
component(s) and/or defined as an Adverse Event in section 5.0.  

 
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8.0 
Health Care Utilization/Hospitalization Visits  
For US sites, any clinical event resulting in an inpatient hospital stay, ER visit, 
observational visit, outpatient visit, or urgent care visit must be reported to St. Jude 
Medical via the Health Care Utilization Form using the EDC system within 10 
working day of the center becoming aware of the patient’s admission to the hospital. 
A planned hospitalization for a pre-existing condition, or a procedure required by the 
health care professional is not considered a hospitalization. 
 
For all countries except US, any hospitalizations must be reported to St. Jude Medical 
via the AE form using the EDC system within 72 calendar hours of the center 
becoming aware of the patient’s admission to the hospital.  
9.0 
Deaths 
All patient deaths that occur during this investigation must be reported to St. Jude 
Medical within 10 days of the center becoming aware of the death for US sites and 
within 72 calendar hours of the center becoming aware of the death for all sites 
except US.  Adverse Event form should be completed for death for all sites except 
US. Adverse Event form is not required for death for US sites.  Notification of death 
should include a detailed statement of the pertinent events and be signed by the 
investigator in addition to the appropriate case report forms (Patient Death form and 
Patient Withdrawal form). It is the investigator’s responsibility to notify the 
IRB/MEC per the IRB/MEC policy. Details of death and the following information, if 
available, should be provided in a letter to St. Jude Medical by the investigator 
summarizing the patient’s course since enrollment in the study: 
 
 
Date and time of death 
 
Place death occurred (e.g. hospital, nursing home, patients home) 
 
If death was witnessed 
 
Identification of the rhythm at the time of death, if known (include any available 
documentation) 
 
Cause of death 
 
Any other circumstances surrounding the death 
 
Approximate time interval to death from the initiating event. 
 
Autopsy report (if performed) 
 
Whether it was device and/or procedure related 
 
Whether it was related to the study 
 
Device configuration at the time of death 
 
Provide clinical notes and witness statements. If possible, interrogate the pulse 
generator. Retrieve and print all episode diagnostics, IEGMs, and programmed 
parameters. If applicable, the pulse generator should then be programmed OFF.  
 

 
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Every attempt should be made to explant the pulse generator and/or leads intact. Any 
explanted devices or leads should be returned to St. Jude Medical for analysis 
promptly. In the event that the device is not explanted, the above procedure must be 
followed to retrieve the data. The reason the pulse generator and/or lead(s) are not 
being returned to St. Jude Medical must be stated clearly on the case report form. 
10.0 Withdrawals 
Withdrawal is defined as termination of participation of a patient from a clinical trial. 
All reasonable efforts should be made to retain the subject in the clinical trial until 
completion of the clinical trial. Reasons for withdrawal include, but are not limited to 
the following: 
 
 
Patient Death 
 
Patient and/or Family Request 
 
Patient Participation terminated by Investigator 
 
Sponsor Request 
 
System Explant 
 
Lost to Follow-up: A patient is considered lost to follow up when reasonable 
efforts to contact the patient have been exhausted and study personnel have 
abandoned such efforts. Reasonable efforts is defined as a minimum of two 
documented phone calls made by personnel at the study center to the patient or 
emergency contact and a certified letter was sent to the last known address  
A Withdrawal and other applicable CRFs (e.g. Death or AE) should be completed and 
sent to St. Jude Medical. 
In order to build a comprehensive database for the treatment options and HF 
progression of CRT non-responders, it is important that patients are retained in the 
registry for the entire duration of the registry.  If there is a potential withdrawal in the 
registry, please contact a member of the study team to see if there is anything that can 
be done to keep the patient in the registry.  
 
 

 
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11.0 Statements of compliance 
The study will be performed in accordance with the most current versions of the 
World Medical Association (WMA) Declaration of Helsinki, ISO 14155 and any 
regional and/or national regulations and will be compliant to this International 
Standard and any regional and national regulations, as appropriate. 
 
The investigator shall not start enrolling patients or requesting informed consent prior 
to obtaining IRB/Ethics Committee approval and Competent Authority approval, if 
applicable, until receiving authorization from the sponsor in writing for the study. 
 
If additional requirements are imposed by the IRB/Ethics Committee or Competent 
Authority they shall be followed, if appropriate. 
12.0 Risk Analysis 
The risks involved with this study are similar to those associated with implantation 
and follow-up of other commercially available CRT systems. There are no additional 
risks to the patients enrolled in this study.   
13.0 Investigator Information 
This clinical study will be conducted by investigators with experience and/or 
willingness to be trained in the use of the device therapy for the treatment of heart 
failure patients with CRT devices.  A principal investigator should have experience in 
and/or will be responsible for: 
 
 
Conducting the clinical investigation in accordance with the signed agreement 
with St. Jude Medical, the study plan, GCP guidelines, and any conditions of 
approval imposed by the IRB/MEC 
 
Providing signed Investigator/Co-Investigator (s) Agreement  
 
Providing signed Financial Disclosure Form for Clinical Investigators  
 
Providing IRB/MEC Approved Informed Consent  
 
Collection and archiving of data obtained pursuant to the requirements of the 
investigational plan during the course of the study and after the study has been 
completed 
 
Screening and selecting appropriate patients 
 
It is acceptable for the principal investigator to delegate one or more of the above 
functions to an associate or co-investigator, however, the principal investigator 
remains responsible for the proper conduct of the clinical investigation, complying 
with the investigational plan and collecting all required data. In clinical investigations 
involving active implantation of an investigational product, the investigation is not 
transferable to other implant centers attended by the investigator unless prior approval 
is obtained from St. Jude Medical. 

 
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14.0 Consent Materials 
Failure to obtain informed consent from a patient prior to study enrollment should be 
reported to St. Jude Medical within 5 working days and to the reviewing IRB 
consistent with the IRB’s reporting requirements. 
15.0 IRB Information 
IRB/MEC approval for the study and informed consent will be required prior to 
beginning the study. A copy of the IRB/MEC approval and corresponding informed 
consent must be forwarded to St. Jude Medical prior to authorization of the institution 
to begin the study.  Any withdrawal of IRB approval should be reported to St. Jude 
Medical within 5 working days of the withdrawal of approval. 
 
Institutional Review Board (IRB/MEC) for participating Institutions 
A list of IRBs for Institutions participating in the study will be provided upon request. 
16.0 Other Institutions 
The name and address of each institution or investigator, at which a part of the 
investigation may be conducted, that has not been identified under IRB information, 
will be provided upon request. 
17.0 Records and Reports 
The principal investigator (PI) shall maintain all essential study documents from 
prior, during and (as specified) after the study on file at the site for a minimum of 15 
years after the termination of this study, or longer as per local laws, whichever is 
later.   
 
The PI must contact the sponsor prior to destroying or archiving off-site any records 
and reports pertaining to this study to ensure that they no longer need to be retained 
on-site. 
 
All original patient files must be stored for the longest possible time permitted by the 
regulations at the hospital, research institute, or practice in question. If archiving can 
no longer be maintained at the site, the investigator will notify the sponsor. 
 
All data and documents shall be made available on request of the relevant authorities 
in case of an audit. 
 

 
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The sponsor will archive and retain all essential study documents from prior, during 
and (as specified) after the study as per requirements. 
18.0 Publication 
This study will be posted on ClinicalTrials.gov and results will be posted on 
ClinicalTrials.gov as required.   
 
 

 
 
 
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19.0 References 
 
 
Reference List 
 
 
(1)  Abraham WT, Fisher WG, Smith AL et al. Cardiac resynchronization in chronic heart 
failure. N Engl J Med 2002 June 13;346(24):1845-53. 
 
(2)  Bristow MR, Saxon LA, Boehmer J et al. Cardiac-resynchronization therapy with or 
without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 
2004 May 20;350(21):2140-50. 
 
(3)  Cleland JG, Daubert JC, Erdmann E et al. The effect of cardiac resynchronization on 
morbidity and mortality in heart failure. N Engl J Med 2005 April 14;352(15):1539-
49. 
 
(4)  Jansen AH, Van Gelder BM. Visual LV motion and invasive LV dp/dtmax for 
selction and optimization of cardiac resynchronization therpay. Neth Heart J 
2008;16:S32-S35. 
 
(5)  Yu CM, Fung JW, Zhang Q et al. Tissue Doppler imaging is superior to strain rate 
imaging and postsystolic shortening on the prediction of reverse remodeling in both 
ischemic and nonischemic heart failure after cardiac resynchronization therapy. 
Circulation 2004 July 6;110(1):66-73. 
 
(6)  Yu CM, Gorcsan J, III, Bleeker GB et al. Usefulness of tissue Doppler velocity and 
strain dyssynchrony for predicting left ventricular reverse remodeling response after 
cardiac resynchronization therapy. Am J Cardiol 2007 October 15;100(8):1263-70. 
 
(7)  Bax JJ, Bleeker GB, Marwick TH et al. Left ventricular dyssynchrony predicts 
response and prognosis after cardiac resynchronization therapy. J Am Coll Cardiol 
2004 November 2;44(9):1834-40. 
 
(8)  Yu CM, Bleeker GB, Fung JW et al. Left ventricular reverse remodeling but not 
clinical improvement predicts long-term survival after cardiac resynchronization 
therapy. Circulation 2005 September 13;112(11):1580-6. 
 
(9)  Zhang Q, van Bommel RJ, Fung JW et al. Tissue Doppler velocity is superior to 
strain imaging in predicting long-term cardiovascular events after cardiac 
resynchronisation therapy. Heart 2009 July;95(13):1085-90. 
 (10)  Chung ES, Leon AR, Tavazzi L et al. Results of the Predictors of Response to CRT 
(PROSPECT) trial. Circulation 2008 May 20;117(20):2608-16. 

 
 
 
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 (11)  Bax JJ, Gorcsan J, III. Echocardiography and noninvasive imaging in cardiac 
resynchronization therapy: results of the PROSPECT (Predictors of Response to 
Cardiac Resynchronization Therapy) study in perspective. J Am Coll Cardiol 2009 
May 26;53(21):1933-43. 
 (12)  Fornwalt BK, Sprague WW, BeDell P et al. Agreement is poor among current criteria 
used to define response to cardiac resynchronization therapy. Circulation 2010 May 
11;121(18):1985-91. 
 (13)  Pappone C, Augello G, Rosanio S et al. First human chronic experience with cardiac 
contractility modulation by nonexcitatory electrical currents for treating systolic heart 
failure: mid-term safety and efficacy results from a multicenter study. J Cardiovasc 
Electrophysiol 2004 April;15(4):418-27. 
 (14)  Lenarczyk R, Kowalski O, Kukulski T et al. Mid-term outcomes of triple-site vs. 
conventional cardiac resynchronization therapy: a preliminary study. Int J Cardiol 
2009 March 20;133(1):87-94. 
 (15)  Lenarczyk R, Kowalski O, Sredniawa B et al. Triple-site versus standard cardiac 
resynchronization therapy study (TRUST CRT): clinical rationale, design, and 
implementation. J Cardiovasc Electrophysiol 2009 June;20(6):658-62. 
 (16)  Sassara M, Achilli A, Bianchi S et al. Long-term effectiveness of dual site left 
ventricular cardiac resynchronization therapy in a patient with congestive heart 
failure. Pacing Clin Electrophysiol 2004 June;27(6 Pt 1):805-7. 
 (17)  Derval N, Steendijk P, Gula LJ et al. Optimizing hemodynamics in heart failure 
patients by systematic screening of left ventricular pacing sites: the lateral left 
ventricular wall and the coronary sinus are rarely the best sites. J Am Coll Cardiol 
2010 February 9;55(6):566-75. 
 (18)  Pierre Bordachar M. Dual-Site LV Pacing in CRT Non Responders: Multicenter 
Randomized Trial.  2012.  
 
 (19)  Gras D, Gupta MS, Boulogne E, Guzzo L, Abraham WT. Optimization of AV and 
VV delays in the real-world CRT patient population: an international survey on 
current clinical practice. Pacing Clin Electrophysiol 2009 March;32 Suppl 1:S236-
S239.  
 
  (20)  Packer M. Proposal for a new clinical end point to evaluate the efficacy of drugs and 
devices in the treatment of chronic heart failure. J Card Failure 2001;7:176-82. 
 
 
 
 
 
 

 
 
 
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Appendix A 
 
Informed Consent for ADVANCE-CRT Registry 
Introduction 
You are being asked to take part in this research study because your doctor has determined 
that you may qualify to take part in the ADVANCE CRT Registry/Observational study.  This 
form explains why this research 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.  This study is sponsored by St. Jude Medical.  
 
Please read this form, and ask your study doctor any questions about the study so that you 
can have your questions answered before you decide if you want to take part in the study.  
Please take your time and talk about this information with your family, friend, or family 
doctor.   
 
This consent form may contain some words that you do not understand.  Please ask the study 
doctor or the study staff to explain any words or information that you do not understand. 
 
If you agree to be in the study, you will need to sign this form.  Taking part in this study is 
entirely voluntary.  You may decide not to participate without penalty or loss of benefits to 
which you are otherwise entitled.  This is not a consent form for the CRT system 
implantation. 
Background 
In heart failure, the heart cannot pump enough blood to the body.  The basic function of the 
heart is to deliver oxygen-rich blood to the body.  When the heart is unable to deliver enough 
oxygen-rich blood, it results in heart failure.  The implanted device has the ability to pace 
both the right and left side of your heart to improve your heart's ability to pump.  Pacing both 
sides of your heart may help your heart to beat more effectively which may improve your 
heart failure symptoms.  This type of therapy is called Cardiac Resynchronization Therapy 
(CRT). 
 
A CRT system has three (3) wires (also known as leads or electrodes).  The leads are inserted 
through your veins, positioned in your heart and after testing, connected to the device.  These 
wires allow information to travel between your heart and the device, and help the device to 
monitor your heart.  The study doctor will use x-rays to be sure that the wires are positioned 
correctly.  Your CRT can be a CRT-P (Pacemaker) or CRT-D (Defibrillator).  After testing is 
finished, a pocket for the device will be made under the skin in the left or right upper chest 
near the shoulder and the incision will be closed. 
 

 
 
 
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Cardiac resynchronization therapy (CRT) has proven to be beneficial in advanced heart 
failure (HF) patients.  However, there is a sub-set of patients who do not respond optimally to 
CRT therapy (non-responders) and little attention has been paid to understanding how non-
responders are identified, treated and followed-up, especially in real world practice. 
Purpose 
The purpose of this registry is to understand comprehensive clinical care strategies for CRT 
patients, especially non-responders in real-world clinical practice.  The registry aims to 
provide an understanding of the rate of non-responders to CRT, treatment strategies used to 
treat the non-responders and the role of remote-monitoring in the continued care of non-
responders. 
Visit Schedule and Procedures 
If you are implanted with a market approved St. Jude Medical CRT system you will be 
eligible for enrollment in the registry within 30 days post-implant of the device.  Once 
enrolled, you will be followed every 3 months until 12 months post- implant.  The 
responder/non-responder evaluation will occur during the 6 month office visit and criteria 
used for determining the response to CRT will be recorded.   
Enrollment (< 30 days post device implant) 
After you have voluntarily signed the informed consent form the following evaluations will 
be obtained: 
 Medical History – pertinent cardiac and health information including NYHA 
Classification (your current heart failure status assessed by your study physician) 
 Medications - your current medications 
 ECG – check your heart rhythm 
 Echocardiogram – Pre-implant  imaging to determine how your heart is pumping 
 Device Session Record-  device check of your CRT System 
 
 
Month 6 In-office Visit  
The following evaluations will be done: 
 Current health status regarding your heart 
 Medications – collect information regarding your current medications 
 Device Session Record – device check of your CRT System 
 Patient Global Assessment (PGA) – a single interview question to see how you are 
feeling as compared to pre-implant.   
 NYHA Classification – assessed by qualified study personnel 
 Responder/Non-Responder Evaluation – determined by your study physician 
 EKG and Echocardiogram –if requested by your study doctor per standard of care 
 Any reprogramming of your device or any new treatment or modification of your 
current treatment will be collected 
 
 

 
 
 
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Month 3, 9, and 12Follow-Up Visits  
3 and 9 month visits may be done in your doctor’s office or remotely via Merlin home 
transmitter system and a phone call follow-up.  12 month visit is required to be done in your 
doctor’s office. 
The following evaluations will be done: 
 Current health status  regarding your heart 
 Medications – collect information regarding your current medications 
 Device Session Record – device check of your CRT System 
 Patient Global Assessment (PGA) – a single interview question to see how you are 
feeling as compared to pre-implant.  *Done up through Month 12 Visit. 
 EKG and Echocardiogram – collected if requested by your study doctor per standard 
of care 
 Any reprogramming of your device or any new treatment or modification of your 
current treatment will be collected 
 NYHA Classification- assessed by qualified study personnel at all office visits 
 For office visits done at 9 and 1236 month visits, status of your response to CRT will 
be evaluated by your study physician (or “study provider”). 
 
Optional 
The following questionnaires can be administered at Enrollment, 6 and 12 month visits 
 Modified Specific Activity Scale (SAS) Questionnaire- contains questions about your 
activity level to help assess your heart failure 
 Minnesota Living With Heart Failure (MLWHF) Questionnaire – contains questions 
about the effects of heart failure and treatments for heart failure on your quality of life 
 EQ5D Questionnaire – contains health related questions to assess a quality of life 
score 
 
There may be a representative of the sponsor at your study visits and the representative may 
carry out some of the study procedures.  The study doctor may direct a representative from 
the sponsor to collect the signal information.  At the study doctor’s direction, the sponsor 
representative may also program your device or run tests to see if your device is working as 
expected.  The sponsor’s representative will work under the direction of your study doctor or 
other care provider. 
Duration 
The registry will enroll at least 1500 CRT patients from estimated 70 centers worldwide in 
order to identify and assess a maximum 500 patients who are identified as CRT non-
responders.   Patient participation in the study  is completed upon completion of the 12 
month follow-up visit.    
Risks 

 
 
 
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You are not undergoing any experimental techniques or procedures.  Your doctor will review 
the risks related to a standard CRT System implantation in a separate consent form.  The St. 
Jude Medical CRT System has been previously approved by the FDA or by or similar 
government agencies in other countries. If you are pregnant or planning to become pregnant, 
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.    
 
There may be other risks to you that are not known at this time. 
Benefits 
You may or may not benefit directly from participating in this study.   However, the 
information gathered in this study will add to the understanding of treatment options for 
patients with heart failure. 
Alternatives  
Your doctor will discuss other options available to you. Your decision to be in this registry is 
voluntary.  You do not have to be in the registry if you do not want to, and you can change 
your mind at any time.  There will be no penalty to you, and you will not lose any benefits.  
Your regular medical care at this registry center will not change if you decide not to 
participate. 
 
Your doctor or sponsor can withdraw you from the registry at any time, even if you want to 
continue to be in the registry.  This could happen if: 
 
 Your doctor believes it is best for you to stop being in the registry. 
 You do not follow directions about the registry. 
 The sponsor stops the registry for any reason. 
 
If you decide to discontinue participation in this study, tell your doctor or study staff.  If you 
stop being in the registry early, your doctor or study staff may ask you some questions about 
being in the registry.  They may also ask to have additional information collected to help 
your withdrawal from the study happen safely. 
Confidentiality 
If you decide to take part in this study, your medical records and personal information will be 
kept private to the extent allowed by federal, state, and local law.  No personal information 
about you, your illness, or your treatment will be made public.  
 
Information (data) collected from the study will be sent to St. Jude Medical.  A special code 
(letter and number combination) will be used to identify your personal information.  
 

 
 
 
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The data may be given to governmental agencies, for example: the Food and Drug 
Administration (FDA) or similar government agencies in other countries.  St. Jude Medical 
may export data to countries where different data protection laws apply.   
Only information about your medical condition as it relates to the CRT System will be 
provided to St. Jude Medical.  In order to verify study data, monitors from governmental 
agencies (for example: FDA), St. Jude Medical, Contract Research Organizations hired by  
St. Jude Medical and the Institutional Review Board (IRB)/Ethics Committee (EC) will also 
have the right to review your medical records as they relate to this study.  Data collected 
during the study may be used for publication(s) but the publications will not include your 
name or any information that can identify you.  In addition, data collected during this study 
may be used for future research, but your name and information that can readily identify you 
will not be used. 
 
A description of this clinical trial will be available at 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 this web site at any 
time.  
 
If you receive medical care from a doctor other than your study doctor while taking part in 
this study, you agree that your medical records will be made available for the collection of 
data related to this study.  To help our study center obtain those medical records, you give 
permission to provide access to your medical records that may include device records, office 
visits, laboratory results, surgical/operative reports, medication reports, autopsy report and 
death certificate. 
Costs  
You, your insurance company or government health care is responsible for the costs of all 
tests, procedures and devices that are standard medical treatment for your condition.  This is 
care that would be performed whether or not you participated in this study. There is no 
guarantee that your insurance company will cover 100% of these costs.  You should check 
with your insurance company to verify coverage or payments of these procedures.   
 
The sponsor of this study is paying for cost of data capture and items that are not deemed 
standard of care/routine care in the study to the study center.  
Compensation 
No payment will be made to you for taking part in this study. 
   
 
 
 
 
 
 

 
 
 
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What if you are injured because of the study?   
If you are injured as a direct result of taking part in this study, medical treatment will be 
available to you.  You, or your insurance company, will be responsible for all costs incurred as 
a result of that treatment.  No other arrangement has been made for financial payments or other 
forms of compensation (such as lost wages, lost time or discomfort) with respect to such 
injuries.  You do not waive any legal rights by signing this consent form. 
 
During the study, if you experience any medical problems or illnesses from taking part in this 
study, please contact Dr. ______________ at ___-___-_____. 
What are your rights if you decide to take part in this 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 study.  
 
You may stop taking part in the study at any time without giving any explanation, and there 
will be no 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 -
___-___-_____.  A decision to withdraw or to not take part in the study will not affect the 
quality of medical care that you receive.  Your decision will not result in any penalty or loss 
of benefits to which you are otherwise entitled or affect your future medical care.  
 
Your doctor or the sponsor, St Jude Medical, may decide to withdraw you from the study at 
any time without your consent.  If it is felt to be in your best interest, or if the study is 
stopped, your doctor may withdraw you from this research.  If you have a problem as 
described in the risks section, or if you become ill during the research, you may have to stop 
participating in the study, even if you would like to continue.  Your study doctor will make 
this decision.  Your study doctor or designee will discuss with you what follow-up is required 
if you decide to withdraw, or are withdrawn from the study before the study is finished.  
 
If important information is learned during the course of this study, your doctor will be 
notified by St. Jude Medical.  You will be told of any important new information that is 
learned during the course of this research study that may affect your condition or your 
willingness to continue to take part in this study. 
 
                                                                                                                                                         
Questions 
If you have any questions about the study or taking part in this study, please contact Dr. 
______________ at ___-___-_____. 
 

 
 
 
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In addition, if you have questions about your rights as a research patient, or if you have 
complaints, concerns, or questions about the research, please contact ______________ at -
___-___-_____. 
 
You are making a decision on whether or not to take part in the study.  Your signature 
indicates that you have read the information in this form and have decided to take part in 
the study.  You will be given a signed copy of this form to keep.   
 
 
___________________________________  
 
 
     
Printed Name of Patient  
 
 
___________________________________  
___________  
     
Signature of Patient   
 
 
 
Date 
 
 
 
___________________________________  
___________  
     
Signature of Person Obtaining Consent 
 
Date