MediGuide Registry
Conditions: Heart Failure, Cardiac Arrhythmia
Sponsor: Abbott Medical Devices

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
Page 1 of 38
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used without the express written consent of St. Jude Medical
Reference: 
SJM-CIP-10051
MediGuide Registry
Clinical Investigation Plan (CIP)
Sponsor 
St. Jude Medical, Inc.
15900 Valley View Court
Sylmar, CA 91342
U.S.A
Tel: 818-493-2609
Fax: 818-364-5814
Clinical Coordinating 
Dr. Bernard Thibault/Professor of Medicine
Investigator                             Montreal Heart Institute
Department of Cardiology
5000 Belanger Street
Montreal
Canada
Tel: +1 514-376-3330
Date
04-FEB-2015

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
Table of Contents 
 
Synopsis................................................................................................................................................................... 4 
1.1 Study Flow Chart ................................................................................................................................................. 6 
1.2 Study Contacts ..................................................................................................................................................... 6 
 
Background and Justification for Clinical Study ..................................................................................................... 8 
 
Risks and Benefits of the Clinical Study ................................................................................................................. 9 
3.1 Description of subject population......................................................................................................................... 9 
3.2 Anticipated clinical benefits................................................................................................................................. 9 
3.3 Potential reportable adverse events ...................................................................................................................... 9 
 
Study Design.......................................................................................................................................................... 11 
4.1 Purpose............................................................................................................................................................... 11 
4.2 Study Design and Scope..................................................................................................................................... 12 
4.3 Inclusion and Exclusion Criteria........................................................................................................................ 12 
4.4 Subject Population ............................................................................................................................................. 12 
4.4.1 
Subject Screening ....................................................................................................................................... 12 
4.4.2 
Point of Enrollment..................................................................................................................................... 13 
4.4.3 
Description of the IRB/EC specific responsibilities ................................................................................... 13 
4.5 Informed Consent Process.................................................................................................................................. 13 
4.5.1 
General process........................................................................................................................................... 13 
 
Device under Investigation and Control/Comparators (if applicable) ................................................................... 14 
5.1 Device Description............................................................................................................................................. 14 
 
Procedures.............................................................................................................................................................. 14 
6.1 Study Flow Chart ............................................................................................................................................... 14 
6.2 Procedures.......................................................................................................................................................... 15 
6.3 Enrollment Visit................................................................................................................................................. 16 
6.4 Scheduled Follow-ups........................................................................................................................................ 17 
6.4.1 
Pre-discharge .............................................................................................................................................. 17 
6.5 Description of activities performed by Sponsor Representatives....................................................................... 17 
6.6 Subject study completion ................................................................................................................................... 17 
6.7 Any Known or Foreseeable Factors that May Compromise the Outcome of the Clinical Study or the 
Interpretation of the Results........................................................................................................................................ 17 
6.8 Criteria and Procedures for Subject Withdrawal or Discontinuation ................................................................. 17 
 
Compliance to CIP................................................................................................................................................. 18 
7.1 Statements of Compliance.................................................................................................................................. 18 
7.2 Adherence to the Clinical Investigation Plan ..................................................................................................... 19 
7.3 Repeated and serious non-compliance ............................................................................................................... 20 
 
Adverse Event, Adverse Device Effect, Device Deficiency.................................................................................. 20 
8.1 Definitions.......................................................................................................................................................... 20 
8.1.1 
Adverse Event (General Definition)........................................................................................................... 20 
8.1.2 
Serious Adverse Event (SAE)..................................................................................................................... 20 
8.1.3 
Adverse Device Effect (ADE) .................................................................................................................... 21 
8.1.4 
Serious Adverse Device Effect (SADE)..................................................................................................... 21 
8.2 Procedure for assessing, recording and reporting  device deficiencies/complaints, adverse device effects, serious 
adverse events and serious adverse device effects:..................................................................................................... 21 
8.3 Subject Death ..................................................................................................................................................... 22 

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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8.3.1 
Procedure for recording and reporting subject death.................................................................................. 22 
8.4 Device Deficiency (DD)..................................................................................................................................... 23 
 
Data Management.................................................................................................................................................. 23 
9.1 Data Management Plan ...................................................................................................................................... 24 
9.2 Document and data control ................................................................................................................................ 24 
9.2.1 
Traceability of documents and data............................................................................................................ 24 
9.2.2 
Recording data............................................................................................................................................ 24 
 Monitoring............................................................................................................................................................. 24 
 Regulatory Inspections .......................................................................................................................................... 24 
 Statistical considerations........................................................................................................................................ 25 
12.1 Statistical design, hypotheses, method and analytical procedures...................................................................... 25 
12.2 Sample size......................................................................................................................................................... 25 
12.3 In multi-center studies, the minimum and maximum number of subjects to be included for each center.......... 25 
 Document Retention .............................................................................................................................................. 25 
 Amendments to Clinical Investigational Plan........................................................................................................ 26 
 Study Committees.................................................................................................................................................. 26 
15.1 Steering Committee (SC) ................................................................................................................................... 26 
 Investigation Suspension or Termination .............................................................................................................. 26 
16.1 Premature termination of the whole clinical study or of the clinical study in one or more investigational sites.26
16.2 Resuming the study after temporary suspension ................................................................................................ 28 
16.3 Study conclusion ................................................................................................................................................ 28 
 Publication Policy.................................................................................................................................................. 28 
Bibliography .......................................................................................................................................................... 29
Appendix A: Abbreviations.............................................................................................................................................. 31 
Appendix B: CIP Revision History .................................................................................................................................. 35
Appendix C: Declaration of Helsinki ............................................................................................................................... 36 
Appendix F: List of Clinical Investigation Sites and IRB/EC.......................................................................................... 37
Appendix G: Informed Consent ....................................................................................................................................... 38 

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
SYNOPSIS 
Title:
MediGuide Registry
Acronym:
None
Purpose:
The goal of this registry/observational study is to collect data on the 
clinical utility of MediGuide™ system in CRT implantation and EP 
procedures
Objectives:
The intent of this worldwide registry/observational study is to understand 
the utility of the MediGuide™technology in real world clinical practice 
during CRT implantation and study-specific-EP procedures.  The study 
should provide an understanding of the effect of MediGuide™ technology 
on: 
x
The amount of fluoroscopy time and the radiation exposure
x
Total procedure time 
x
Peri-procedural clinical event rate
Additionally, this study will address the following
x
Identification of procedural challenges which may aid in 
developing future MediGuide tools 
x
Evaluation of newly available MediGuide tools during the study
x
Correlation between MediGuide operator experience and the 
radiation exposure amount and time
Design:
This is a worldwide, multicenter, non-randomized registry/observational 
study.  The study will enroll up to 1000 patients from up to 65 centers 
undergoing either CRT implantation or an EP procedure.  The study will 
enroll a minimum of 250 patients for each group.  Patients who are 
undergoing either procedure at study centers equipped with MediGuide™ 
technology utilizing market approved MediGuide™-enabled tools will be 
eligible to participate in this study.  This study may continue for up to 3 
years, depending on the rate of enrollment.
Devices Used:
Market-approved MediGuide™-enabled tools and software
Study Population
CRT Group
All patients from participating sites who are indicated for a CRT-D/P 
device implant, including an upgrade with a new LV lead implant and are 
implanted with St. Jude Medical pulse generators and willing to provide 

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
Page 5 of 38
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used without the express written consent of St. Jude Medical
written Informed Consent can be enrolled in this study.  Patients can be 
implanted with non-St. Jude Medical leads
EP Group
All patients from participating sites who are indicated for an atrial 
fibrillation, atrial flutter or VT ablation procedure for which market 
approved MediGuide™-enabled ablation catheter is available and willing 
to provide written Informed Consent can be enrolled in this study.
Data Collection
Data collection schedule
• CRT patients: Data will be collected for patients undergoing CRT 
implantation at implant and pre-discharge . 
• EP procedures: Data will be collected for patients undergoing an EP 
procedure at the time of the procedure and pre-discharge.

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
1.1
Study Flow Chart
Enrollment
Meets inclusion/exclusion criteria requirements 
for either CRT or EP procedure
EP Procedure
- Study-specific EP procedures will be performed using 
the MediGuide-enabled delivery tools and ablation 
catheter
- Fluoro time and radiation dose will be collected for
a. Catheter insertion
b. Trans-septal puncture
c. Geometry creation/Mapping
e. Ablation
f. Any other steps that require the usage 
   
    of fluoroscopy and contrast
 CRT Implantation
- CRT implant  will be performed using the MediGuide-
enabled delivery tools
-Fluoro time and radiation dose will be collected for
 
a. CS cannulation
b. LV lead placement
c. Any other steps that require the usage  of  
    fluoroscopy and contrast
 Pre-discharge
- Reportable Adverse events
Enrollm
ent
1.2
Study Contacts
Study Director:

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
Kristin Ruffner
One Lillehei Plaza
St. Paul, MN 55417 
Tel: 651-756-6717
Email: kruffner@sjm.com
Study Manager:
John Gill
15900 Valley View Court
Sylmar, CA 91342
U.S.A
Tel: 818-493-2609
Email: jgill@sjm.com

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY
The number of fluoroscopically-guided minimally invasive diagnostic and therapeutic procedures has 
greatly increased in recent years.1 However, the potential injuries from the associated radiation exposure 
are often underestimated. The radiation dose for some interventional procedures may be several orders of 
magnitude greater than that for simple radiographic studies.2, 3 Once the dose exceeds a certain limit, the 
injury becomes progressively more severe with increasing dose, although the true severity of major 
injuries will only become apparent weeks to months after the procedure.4 Very high doses usually produce 
some symptoms within 24 hours of the procedure.  Furthermore, it is known that even sub-threshold 
exposure to radiation under recommended occupational limits has been shown to increase the chance of 
life-time cancer.5
The core principle governing the use of ionizing radiation is ALARA (as low as 
reasonably achievable) and according to this principle there is no magnitude of radiation exposure that is 
known to be completely safe.6, 7 This principle confers a responsibility on all physicians to minimize the 
radiation injury hazard to their patients, to their staff, and to themselves. 
St. Jude Medical ((hereinafter referred to as SJM) has developed a novel 3D electromagnetic navigation 
system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray 
environment.  By projecting the tool’s position and orientation onto the pre-recorded fluoroscopic images, 
the system allows for tracking of tools within pre-recorded x-ray loops while compensating for primary 
and secondary organ motion, thus reducing x-ray exposure during diagnostic and therapeutic cardiac 
procedures for which MediGuide™-enabled tools are available.  
Previous single-center studies have shown that the application of the MediGuide™technology can lead 
to a significant reduction in fluoroscopy burden during ablations of atrial flutter, SVT, and atrial 
fibrillation.8-12 In a recent single-center registry,13 the MediGuide™ navigation system was used for over 
600 cases of ablations for atrial flutter, atrial fibrillation and ventricular tachycardia and implantation of 
cardiac resynchronization therapy (CRT) devices.  In these cases, the median fluoroscopy time was not 
only reduced compared to the traditional fluoroscopy time but the complication rate was lower than
previously-published data.  It was also observed by the same group that the total fluoroscopy time and the 
exposure to radiation was reduced further as the operator gained more experience in working with 
MediGuide™system and tools.14 However, these studies were all conducted at a single center and the 
radiation reduction benefit, complication rate, and operator proficiency across clinics at different 
geographies are unknown.  
The MediGuide registry is sponsored by SJM. The goal of this study is to collect data on the clinical 
utility of MediGuide™ system in CRT implantation and study-specific EP procedures.

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
RISKS AND BENEFITS OF THE CLINICAL STUDY
The risks involved with this study are similar to those associated with MediGuide™enabled implantation 
of commercially available CRT systems and MediGuide™enabled ablation procedures with 
commercially available ablation tools. There are no additional risks to the patients enrolled in this study.
3.1
Description of subject population
Approximately 1000 patients undergoing CRT implant or study-specific EP procedures at study centers 
equipped with MediGuide™ technology utilizing market approved MediGuide™-enabled tools will 
participate in this study.
3.2
Anticipated clinical benefits
Patients participating in this study may be exposed to less radiation due to the reduced fluoroscopy use
when using the MediGuide™ system.
3.3
Potential reportable adverse events 
Anticipated adverse events
Adult respiratory distress syndrome (ARSD)
Air embolism
Allergic reactions to contrast media (agents)
Anemia
Anesthesia reaction
Arrest (cardio)
Arrest (respiratory)
Arrhythmias
AV fistula
Bleeding (non-hematoma)
Cardiac Perforation
Cardiac Tamponade
Cardiac thromboembolism
Cerebrovascular accident/attack
Chest pain/discomfort
Complete AV block
Component damage to ICD or PM
Coronary artery spasm
Coronary artery thrombosis
Coronary sinus dissection

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
Coronary sinus perforation
Death
Decompensated Heart Failure
Diaphragmatic paralysis
Elevated pacing thresholds
Endocarditis
Erosion/extrusion
Exacerbation of pre-existing atrial fibrillation
Gastroparesis
Hematoma
Hemothorax
High DFTs
Infection
Lead dislodgement or lead migration
Lead fracture
Lead insulation damage
Loss of capture
Loss of sensing
Left atrial esophageal fistula
Myocardial Infarction
New or worsened angina
Oversensing
Oversensing resulting in therapy
Pacemaker mediated tachycardia (PMT)
Pectoral stimulation
Pericardial effusion
Pericarditits
Phrenic nerve injury
Phrenic nerve/diaphragmatic stimulation
Pneumothorax
Premature battery depletion

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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Prolonged detection of redetection time
Pulse generator malfunction
Pseudoaneurysm
Pulmonary edema
Pulmonary embolism
Pulmonary vein stenosis
Shock/Hypotension
Stroke
Syncope unknown etiology
Therapy for non-ventricular rhythm
Thromboembolism
Thrombosis
Transient ischemic attack (TIA)
Undersensing
Valvular damage
Vascular access complications
Vasovagal reactions
Ventricular arrhythmia
STUDY DESIGN
4.1
Purpose
The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ 
technology in real world clinical practice during CRT implantation and study-specific-EP procedures.  
The study should provide an understanding of the effect of MediGuide™ technology on: 
x
The amount of fluoroscopy time and the radiation exposure
x
Total procedure time 
x
Peri-procedural clinical event rate
Additionally, this study will address the following
x
Identification of procedural challenges which future MediGuide tools can potentially address 
x
Evaluation of newly available tools during the study

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
x
Correlation between MediGuide™ operator experience and the radiation exposure amount and 
time
This study may continue for up to 3 years, depending on the rate of enrollment and follow-up timelines. 
4.2
Study Design and Scope
This is a worldwide, multicenter, non-randomized registry/observational study.  The study will enroll up 
to 1000 patients from up to 65 centers undergoing either CRT implantation or an EP procedure.  The 
study will enroll a minimum of 250 patients for each group.  Patients who are undergoing either 
procedure at study sites equipped with MediGuide™ technology utilizing market approved 
MediGuide™-enabled tools will be eligible to participate in this study.
Data collection schedule
x
CRT Group: Data will be collected for patients undergoing CRT implantation at implant and pre-
discharge.
x
EP Group: Data will be collected for patients undergoing an EP procedure at the time of the 
procedure and pre-discharge. 
4.3
Inclusion and Exclusion Criteria
CRT Group
All patients from participating sites who are indicated for a CRT-D/P device implant, including an 
upgrade with a new LV lead implant and are implanted with St. Jude Medical pulse generators and 
willing to provide written Informed Consent can be enrolled in this study. Patients can be implanted 
with non-St. Jude Medical leads.  
EP Group
All patients from participating sites who are indicated for an atrial fibrillation, atrial flutter or VT 
ablation procedure for which market approved MediGuide™-enabled ablation catheter is available and 
willing to provide written Informed Consent can be enrolled in this study.
4.4
Subject Population
4.4.1
Subject Screening
All subjects presenting at the study site can be screened by a member of the study team previously 
trained on the CIP and delegated to do so.

Study Document No: SJM-CIP-10051
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Study Name: MediGuide Registry
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Subjects who do not meet the inclusion/exclusion criteria will not be eligible to participate in this study.
Subjects meeting the inclusion/exclusion criteria will be fully informed about the study and asked to 
participate in the study. In case the subject agrees, a duly signed and dated Patient Informed Consent 
will be obtained.
4.4.2
Point of Enrollment
Subjects are considered enrolled in the study if the subject has provided written Patient Informed 
Consent and CRT implant or an EP procedure was attempted.
4.4.3
Description of the IRB/EC specific responsibilities
IRB/EC approval for the study and informed consent will be required prior to beginning the study. A 
copy of the IRB/EC approval and corresponding informed consent must be forwarded to SJM  prior to 
authorization of the institution to begin the study.  Any withdrawal of IRB /EC approval should be 
reported to SJM within 5 working days of the withdrawal of approval. A list of IRBs/ECs for Institutions 
participating in the study will be provided upon request.
4.5
Informed Consent Process
4.5.1
General process
Prior to enrolling in the clinical study and conducting study-specific procedures, all subjects will be 
consented, as required by applicable regulations and the center’s IRB/EC.  Informed consent must be 
obtained from each subject prior to any study related procedures. The consent form must be signed and 
dated by the subject and by the person obtaining the consent.
The principal investigator or his/her authorized designee will conduct the Informed Consent Process. 
This process will include a verbal discussion with the subject on all aspects of the clinical study that are 
relevant to the subject’s decision to participate in the clinical study. 
The subject shall be provided with the informed consent form that is written in a language that is 
understandable to the subject and has been approved by the center’s IRB/EC.  Failure to obtain informed 
consent from a subject prior to study enrollment should be reported to SJM within 5 working days and to 
the reviewing center’s IRB/EC consistent with the center’s IRB/EC reporting requirements. 

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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used without the express written consent of St. Jude Medical
DEVICE UNDER INVESTIGATION AND CONTROL/COMPARATORS (IF 
APPLICABLE)
5.1
Device Description
In this study, any market approved MediGuide™-enabled tools and software will be used.
PROCEDURES
6.1
Study Flow Chart
Figure 2: Flow Chart
Enrollment
Meets inclusion/exclusion criteria requirements 
for either CRT or EP procedure
EP Procedure
- Study-specific EP procedures will be performed using 
the MediGuide-enabled delivery tools and ablation 
catheter
- Fluoro time and radiation dose will be collected for
a. Catheter insertion
b. Trans-septal puncture
c. Geometry creation/Mapping
e. Ablation
f. Any other steps that require the usage 
   
    of fluoroscopy and contrast
 CRT Implantation
- CRT implant  will be performed using the MediGuide-
enabled delivery tools
-Fluoro time and radiation dose will be collected for
 
a. CS cannulation
b. LV lead placement
c. Any other steps that require the usage  of  
    fluoroscopy and contrast
 Pre-discharge
- Reportable Adverse events
Enrollm
ent

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
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6.2
Procedures
The clinical study will be conducted in accordance with the CIP. All parties participating in the conduct 
of the clinical study will be qualified by education, training, or experience to perform their tasks, and 
this training will be documented appropriately.
The clinical study will not commence until SJM receives written approval from the IRB/EC and relevant 
regulatory authorities and all required documents have been collected from the site(s).
Upon site activation, participating clinician’s previous experience in performing CRT or EP cases with 
or without utilizing MediGuide™ enabled tools will be collected via one-time survey.
Table 1: List of all study specific activities/procedures
CRT Group at 
Enrollment
EP Group at 
Enrollment
Discharge
Baseline Demography
X
X
Medical History
X
X
Medications
X
X
12 Lead ECG (most 
recent)
X
Echo Measurements 
(including most recent 
LVEF)
X
X
NYHA
X
Device Session Record
X
Fluoro Time and 
Radiation Dose 
X
X
Electrical Lead 
Measurements for the 
RA, RV and LV Leads
X
Reportable Adverse 
Event/Health Care 
Utilization
(X)
(X)
(X)
Fluoroscopic Views and 
Orientation Angles 
Used 
X
X
(X) if applicable

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Study Name: MediGuide Registry
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6.3
Enrollment Visit 
During the enrollment process, the following baseline data will be collected for all patients.  
Baseline Data (all patients)
x
Patient demographics 
x
Arrhythmia history 
x
Cardiovascular history (including most recent LVEF)
x
Cardiac medications 
x
NYHA class (CRT patients only)
x
12-lead ECG (most recent for CRT patients only)
Additional procedure related data will be collected specific to the procedure. Definitions for the 
beginning and ending of procedural steps are also provided.
CRT Group
x
Devices implanted, i.e., leads and pulse generator
x
MediGuide™ tools used at each step of the procedure if applicable
x
MediGuide™ software version used if applicable
x
Coronary venous anatomy
x
Amount of fluoroscopy time and radiation dose in either cGray·cm2 or μGray·m2 during the 
following steps in the procedure.
i. CS cannulation: From the moment the operator directs the technique to cannulate CS until 
the outer catheter is stable in CS 
ii. LV lead placement: From the moment outer catheter is stable in LV until the suture sleeve 
for LV lead is tied down 
iii. Any other steps that required the usage of fluoroscopy 
x
Electrical lead measurements for the RA, RV and LV leads
x
Device session record
EP Group
x
MediGuide™ tools used at each step of the procedure if applicable
x
MediGuide™ software version used if applicable
x
Mapping software used
x
Ablation parameters
x
Ablation site
x
Amount of fluoroscopy time and radiation dose during the following steps in the procedure
i.
Catheter insertion: Similar to CS cannulation for CRT implant 
ii.
Trans-septal puncture: From the moment of introducing trans-septal sheath until the sheath
is stably paced in LA and the dilator is removed 
iii.
Geometry creation/Mapping: From the beginning of geometry creation until the complete 
creation of geometry including mapping as determined by an operator 
iv.
Ablation: From the beginning of ablation until the last attempt for ablation is made 
v.
Any other steps that required the usage of fluoroscopy 

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Study Name: MediGuide Registry
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Additional Implant/Procedure Related Data (all patients)
x
Total procedure: Skin to skin
x
Total amount of fluoroscopy time and radiation dose 
x
Room time: From the moment the patient enters the operation room until the patient exits the 
operation room
x
Number, experience and type of attending personnel
x
Fluoroscopic views with orientations and angles
x
Types of anesthesia used: conscious sedation vs. general
x
Adverse events, if applicable
6.4
Scheduled Follow-ups
6.4.1
Pre-discharge
During the pre-discharge, adverse events will be reported if applicable.
6.5
Description of activities performed by Sponsor Representatives
Trained sponsor personnel may perform certain activities to ensure compliance to the clinical 
investigational plan and may provide technical expertise.
6.6
Subject study completion
Patient participation in the study is complete upon completion of pre-discharge visit.  When the subject’s 
participation in the clinical study has been completed the subject will return to the medical care as per 
physician’s recommendation.
6.7
Any Known or Foreseeable Factors that May Compromise the Outcome of the Clinical 
Study or the Interpretation of the Results
All foreseeable factors that may compromise the outcome have been taken into account by clinical study 
design and well defined subject selection criteria.
6.8
Criteria and Procedures for Subject Withdrawal or Discontinuation
Subjects must be informed about their right to withdraw from the study at any time and for any reason 
without sanction, penalty or loss of benefits to which the subject is otherwise entitled and withdrawal 
from the study will not jeopardize their future medical care or relationship with the investigator. 
Subjects will be asked to specify the reason for the termination but have the right not to answer.
The investigator may decide to withdraw a subject from the study at any time with reasonable rationale. 
The subject’s future care will not be influenced by a decision, voluntary or otherwise, to withdraw from 
the study. All reasonable efforts should be made to retain the subject in the clinical study until 
completion of the study.
Reasons for subject’s withdrawal include, but are not limited to:

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Study Name: MediGuide Registry
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x
Subject refuses to continue participating in the study
x
Subject does not meet the inclusion/exclusion criteria and does not require additional follow-up for 
safety reasons.
x
Subject is deceased (cause must be documented)
x
Subject’s non-compliance
x
Subject’s participation is terminated by the PI or investigator, although the subject consented, since 
participation is no longer medically appropriate
x
Subject is ‘lost to follow up’: Subject does not adhere to the scheduled follow up visits but has not 
explicitly requested to be withdrawn from the clinical study. (This does not apply to missed visits). 
Site personnel should at all times make all reasonable efforts to locate and communicate with the 
subject in order to achieve subject compliance to the scheduled follow up visits:
1.
A subject will be considered ‘Lost to Follow Up’ after a minimum of 2 phone calls of a 
physician or delegate at the investigational site to the subject or contact. These 2 phone calls 
need to be documented in the subject’s hospital records.
2.
If these attempts are unsuccessful, a letter should be sent to the subject’s last known address 
or general practitioner (GP) and a copy of this letter should be maintained in the subject’s 
hospital records.
If a subject withdraws from the clinical study, the site will record the subject’s reasons for withdrawal, 
on a Withdrawal CRF.
When subject withdrawal from the clinical study is due to an adverse event the subject will be followed 
until resolution of that adverse event or determination that the subject’s condition is stable. The status of 
the subject’s condition should be documented at the time of withdrawal.  
COMPLIANCE TO CIP
7.1
Statements of Compliance
The study will be performed in accordance with the most current versions of the World Medical 
Association (WMA) Declaration of Helsinki, ISO14155 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 will not start enrolling subjects or requesting informed consent from any subject prior 
to obtaining IRB/EC approval and Competent Authority approval, if applicable, and authorization from 
the sponsor in writing for the study.
In case additional requirements are imposed by the IRB/EC or Competent Authority, those requirements 
will be followed, if appropriate. If any action is taken by an IRB/EC, and regulatory requirements with 
respect to the study, that information will be forwarded to SJM.
As sponsor, SJM has taken up general liability insurance in accordance with the requirements of the 
applicable local laws. Appropriate country representative will be utilized to understand the requirements 
for the type of insurance that will be provided for subjects, and such information will be incorporated 
into the informed consent, as applicable

Study Document No: SJM-CIP-10051
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Study Name: MediGuide Registry
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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
If required, additional subject coverage or a study specific insurance will be provided by the Sponsor as 
well.
7.2
Adherence to the Clinical Investigation Plan
A deviation is defined as an event where the clinical investigator, site personnel, sponsor or sponsor 
representative did not conduct the clinical study according to the Clinical Investigational Plan, IRB/EC
requirements or the Investigator Agreement. The investigator is not allowed to deviate from the CIP, 
except as specified under emergency circumstances.
In some cases, failure to comply with the CIP may be considered failure to protect the rights, safety and 
well-being of subjects, since the non-compliance exposes subjects to unreasonable risks. For example, 
failure to adhere to the inclusion/exclusion criteria: these criteria are specifically defined by the Sponsor 
to exclude subjects for whom the device is not beneficial and the use involves unreasonable risks. This 
may be considered failure to protect the rights, safety and well-being of the enrolled subject. Similarly, 
failure to perform safety assessments intended to detect adverse events may be considered failure to 
protect the rights, safety and well-being of the enrolled subject. Investigators should seek minimization 
of such risks by adhering to the CIP.
Simultaneously, in the event that adhering to the CIP might expose the subject to unreasonable risks, the 
investigator is also required to protect the rights, safety and well-being of the subject by intentionally 
deviating from the requirements of the CIP, so that subjects are not exposed to unreasonable risks. 
It is the responsibility of the investigator to provide adequate medical care to a subject enrolled in a 
study.
Regulations require that the PI maintain accurate, complete, and current records, including documents 
showing the date of and reason for every deviation from the Clinical Investigational Plan.  Relevant 
information for each deviation will be documented on a Deviation Case Report Form. The site will 
submit the CRF to SJM.
Regulations require Investigators obtain approval from SJM and the IRB/EC [as required] before 
initiating changes in or deviations from the protocol, except when necessary to protect the life or 
physical well-being of a subject in an emergency.  
Prior approval must be requested when the PI anticipates, contemplates, or makes a conscious decision 
to depart from the CIP, except when unforeseen circumstances are beyond the investigator’s control 
(e.g. a subject who fails to attend a scheduled follow-up visit, a subject is too ill to perform a CIP-
required test, etc.).  All deviations, including those beyond the investigator’s control, must be reported 
on a Deviation CRF.
To obtain approval, the Principal Investigator may call or email and discuss the potential deviation with 
SJM or designee prior to initiating any changes.  

Study Document No: SJM-CIP-10051
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Study Name: MediGuide Registry
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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
The investigator is required to adhere to local regulatory requirements for reporting deviations to 
IRB/EC. All deviations must be reported to appropriate regulatory authorities in specified timelines (if 
appropriate).
Investigator will notify SJM and the reviewing IRB/EC within 5 working days of:
•
Any deviation to protect the life or physical well-being of a subject in an emergency 
•
Any failure to obtain informed consent
Investigators or the designee must notify SJM, Inc. as soon as possible and complete the Deviation CRF.
7.3
Repeated and serious non-compliance
In the event of repeated non-compliance or a one-time serious non-compliance, as determined by the 
Sponsor, a Clinical Research Associate or clinical representative will attempt to secure compliance by 
one or more of the following actions:
x
Visiting the investigator
x
Contacting the investigator by telephone or in writing
x
Retraining of the investigator
If an investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or any 
other conditions of the clinical study, the Sponsor will either secure compliance or, at its sole discretion, 
terminate the investigator’s participation in the clinical study.
ADVERSE EVENT, ADVERSE DEVICE EFFECT, DEVICE DEFICIENCY
8.1
Definitions
8.1.1
Adverse Event (General Definition)
An adverse event in general 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 study.
This definition includes events unrelated to the study medical device, the comparator or procedures 
involved: adverse event (AE) and serious adverse event (SAE).
It also includes events, which are related to the study medical device, the comparator or the procedures 
involved: adverse device effect (ADE) and serious adverse device effect (SADE).
Only Serious Adverse Events (SAE), Adverse Device Effects (ADE) and Serious Adverse Device 
Effects (SADE) will be collected in this study. 
8.1.2
Serious Adverse Event (SAE)
Any untoward medical occurrence, which was not related to the study device, procedure or comparator, 
but resulted in serious injury to a subject or other person. A serious adverse event is one that led to:
x
Death

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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
x
A serious deterioration in the health of the subject, that either resulted in:
o
A life-threatening illness or injury OR
o
A permanent impairment to a body structure or a body function OR
o
An in-patient or prolonged hospitalization OR
o
A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function
x
Fetal distress, fetal death or a congenital abnormality or birth defect
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is not 
considered a serious adverse event.
8.1.3
Adverse Device Effect (ADE)
An adverse event related to the use of a study medical device when the occurrence does not meet the 
definition of serious.
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the study medical device.
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational study medical device.
8.1.4
Serious Adverse Device Effect (SADE)
An adverse event that happens in a subject or other person, is related to the study device, comparator, or 
procedure, and has resulted in any of the consequences characteristic of a serious adverse event.
8.2
Procedure for assessing, recording and reporting  device deficiencies/complaints, adverse 
device effects, serious adverse events and serious adverse device effects: 
The safety surveillance and the safety reporting, both performed by the investigator, will start as soon as 
the subject is enrolled in this study (date of signature of the informed consent and an attempted 
implant/ablation procedure) and will continue until the last study visit has been completed, the subject is 
deceased,  or the subject/investigator withdraws the subject from the study, except as otherwise specified 
in the CIP.
All reportable adverse event data (as described below) including deaths and device deficiency data (if 
applicable) will be collected throughout the clinical study and will be reported to the Sponsor on a 
dedicated case report form or through the EDC system. The Investigator will record all reportable 
adverse events and device deficiencies (if applicable) on the appropriate case report forms. 
Reportable adverse events will be monitored until they are adequately resolved.  Records related to the 
subject’s subsequent medical course must be maintained and submitted (as applicable) to the Sponsor.
The status of the subject’s condition will be documented at each visit.  
Reportable events to sponsor are considered: 

Study Document No: SJM-CIP-10051
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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
x
All Adverse Device Effects (ADEs) (including procedure related events)
x
All Serious Adverse Device Effects (SADEs) (including procedure related events)
x
All Serious Adverse Events (SAEs)
x
All Device Deficiencies (DD) (if applicable), that could have led to a serious adverse device 
effect
o
if either suitable action had not been taken; 
o
if intervention had not been made or
o
if circumstances had been less fortunate
All ADEs, SADEs, SAEs and DD are to be documented and reported to the sponsor within 10 calendar  
days for US sites and 3 calendar days for sites outside US after becoming aware of the event or per local 
regulatory timelines.
The Sponsor will ensure that all events and device deficiencies are reported to the relevant authorities as 
per regulations. 
Additional information may be requested, when required, by the Sponsor in order to support the reporting 
of AEs to regulatory authorities.
For unexpected failure modes or unexpected adverse events, the US site should follow their standard 
reporting practices for medical device reporting (MDR). As defined in 21 CFR 803, a MDR reportable 
event (or reportable event) means: An event that device user facilities become aware of that reasonably 
suggests that a device has or may have caused or contributed to a death or serious injury. A device user 
facility must report deaths and serious injuries that a device has or may have caused or contributed to, 
establish and maintain adverse event files, and submit summary annual reports to FDA.
8.3
Subject Death
8.3.1
Procedure for recording and reporting subject death
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 3 calendar days of the center 
becoming aware of the death for non-US sites. Investigator will complete the Patient Death form. 
Patient’s death is an Early Conclusion of the subject’s participation in the study. Therefore, beside 
completion of a Death CRF, the investigator is required to complete the Termination/Withdrawal form
and Product Out of Service CRF.
Patient death may be an outcome of an adverse event. If the death is related to an AE, all the efforts to 
get AE details should be made by the investigator and an Adverse Event CRF should be completed in 
addition to the Patient Death CRF. If there are no AEs associated with death, completion of Patient 
Death CRF will be sufficient.
By completing the electronic Death CRF the sponsor will be automatically notified.
In case of EDC failure, notify Sponsor via AdverseEvent@sjm.com or via Fax (please refer to the 
Investigator Site Binder, “Sponsor Contact Details” for further details about Fax numbers).

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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
It is the investigator’s responsibility to notify the IRB/EC, if appropriate, in accordance with national 
and local laws and regulations.
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. The reason the pulse generator 
and/or lead(s) are not being returned to St. Jude Medical must be stated clearly on the Death or Out of 
Service form.
8.4
Device Deficiency (DD) 
A Device Deficiency is defined as an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance.
DD include malfunctions, use errors and inadequate labeling.
SJM will appropriately document and manage all DDs.
Device deficiencies in SJM market-released products must be reported per SJM product surveillance 
process. Please notify SJM Tech Service via email at techsvccrm@sjm.com
DATA MANAGEMENT
Overall, the Sponsor will be responsible for the data handling.
The sponsor and/or its affiliates will be responsible for compiling and submitting all required reports to 
governmental agencies.
SJM respects and protects personally identifiable information that we collect or maintain. As part of our 
commitment, SJM is certified to the U.S. - European Union Framework and U.S. – Swiss Safe Harbor 
Framework Agreements regarding human resources and subject clinical trial personal information. The 
privacy of each subject and confidentiality of his/her information will be preserved in reports and when 
publishing any data. Confidentiality of data will be observed by all parties involved at all times 
throughout the clinical study.  All data will be secured against unauthorized access.
Data will be submitted through appropriate forms in EDC.  Additional source documents will be 
submitted via EDC, email, fax, etc.
The Principal Investigator or institution will provide direct access to source data during and after the 
clinical study for monitoring, audits, IRB/EC review and regulatory authority inspections.  As required, 
the Principal Investigator or institution will obtain permission for direct access to source documents 
from the subject, hospital administration and national regulatory authorities before starting the clinical 
study.

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used without the express written consent of St. Jude Medical
9.1
Data Management Plan
A detailed Data Management Plan will be established to ensure consistency of the data. This document 
will include procedures used for data review, database cleaning, and issuing and resolving data queries. 
If appropriate, the DMP may be updated throughout the study duration. All revisions will be tracked and 
document controlled.
CRF data will be captured in a validated electronic database management Oracle Clinical system hosted 
by SJM. Only authorized site personnel will be permitted to enter the data through the electronic data 
capture (EDC) system deployed by SJM. An electronic audit trail will be used to track any subsequent 
changes of the entered data.
9.2
Document and data control
9.2.1
Traceability of documents and data
The investigator will ensure accuracy, completeness, legibility and timeliness of the data reported to the 
sponsor on the CRFs and in all required reports. 
9.2.2
Recording data
Source documents will be created and maintained by the investigational site team throughout the clinical 
study.
The data reported on the CRFs will be derived from, and be consistent with, these source documents, 
and any discrepancies will be explained in writing.
The following data can be recorded directly in the CRFs 
x
Fluoroscopy time
x
Radiation exposure
x
Time for steps in the study
x
MediGuide™-enabled tools used
x
Fluoroscopic views and orientation angles used
The CRFs will be signed and validated by the authorized site personnel. 
MONITORING 
Centralized monitoring will occur through routine internal data review.  This monitoring is designed to 
identify missing and inconsistent data, data outliers, and potential protocol deviations that may be 
indicative of site non-compliance. On site monitoring may occur at the discretion of the sponsor. 
REGULATORY INSPECTIONS
The investigator and/or delegate should contact SJM immediately upon notification of a governmental 
agency inspection at the site. A clinical monitor or designee will assist the investigator and/or delegate 
in preparing for the audit.

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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
An investigator who has authority to grant access will permit authorized governmental agency 
employees, at reasonable times and in reasonable manner, to enter and inspect any establishment where 
devices are held (including any establishment where devices are used or where records or results are 
kept).
An investigator, or any person acting on behalf of such a person with respect to the study, will permit 
authorized governmental agency employees, at reasonable times and in reasonable manner, to inspect 
and copy all records relating to the study.
An investigator will permit authorized governmental agency employees to inspect and copy records that 
identify subjects, upon notice that governmental agency has reason to suspect that adequate informed 
consent was not obtained, or that reports required to be submitted by the investigator, to the Sponsor or 
IRB/EC have not been submitted or are incomplete, inaccurate, false or misleading.
STATISTICAL CONSIDERATIONS
12.1
Statistical design, hypotheses, method and analytical procedures
In this study, no randomization or cross-over will be used. Analysis of the study objectives will be done
using descriptive summary statistics such as the mean, standard deviation, n, and range or a percentage 
along with the numerator and denominator of that percentage. Ninety-five percent confidence intervals 
constructed around the estimated means or percentages will also be calculated.
12.2
Sample size
This is a worldwide, multicenter, non-randomized registry/observational study that aims to enroll up to 
1000 patients from up to 65 centers undergoing either CRT implantation or an EP procedure.  The study
will enroll a minimum of 250 patients for each group. This sample size was chosen to provide 
understanding on the effect of following MediGuide™ technology on.
o
The amount of fluoroscopy time and the radiation exposure
o
Total procedure time 
o
Peri-procedural clinical event rate
12.3
In multi-center studies, the minimum and maximum number of subjects to be included for 
each center
The maximum number of subjects that each center can enroll is 50 patients.  
DOCUMENT RETENTION
The principal investigator (PI) will maintain all clinical study documents from prior, during and (as 
specified) after the clinical study on file at the site until approval from the sponsor after the termination 
of this study, or longer as per local laws, or when it is no longer needed to support a marketing 
application, whichever is later.  

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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
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 subject 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 will be made available on request of the relevant authorities in case of an audit.
The sponsor will archive and retain all essential clinical study documents from prior, during and (as 
specified) after the clinical study as per requirements. 
AMENDMENTS TO CLINICAL INVESTIGATIONAL PLAN
Study related documents such as, the Investigator Brochure (IB), Report of Prior Investigations (RPI) 
CIP, CRFs, Informed Consent form and other subject information, or other clinical study documents will 
be amended as needed throughout the clinical study, and a justification statement will be included with 
each amended section of a document. Proposed amendments to the CIP will be agreed upon between the 
Sponsor and the coordinating investigator (if applicable). 
The amendments to the CIP and the subject’s Informed Consent will be notified to, or approved by, the 
IRB/EC and regulatory authorities, if required. The version number and date of amendments will be 
documented.
The amendment will identify the changes made, the reason for the changes and if it is mandatory or 
optional to implement the amendment.
Any amendment affecting the subject requires that the subject be re-consented at the subject’s next 
follow up.
Changes to, or formal clarifications of, the CIP will be documented in writing and provided to the 
investigators. This information will be incorporated when an amendment occurs.
STUDY COMMITTEES 
15.1
Steering Committee (SC)
The Steering Committee may be used to advise the sponsor during a clinical study, such as in the 
development of the study CIP, during the conduct of the study, during data analysis and/or 
presentation/publication of the study results.  
INVESTIGATION SUSPENSION OR TERMINATION
16.1
Premature termination of the whole clinical study or of the clinical study in one or more 

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used without the express written consent of St. Jude Medical
investigational sites.
The Sponsor reserves the right to stop the study at any stage, with appropriate written notice to the 
investigator. 
Possible reasons for early termination of the study by the sponsor, either at local, national or 
international level, may include, but are not limited to:
x
The device /  therapy fails to perform as intended
x
Occurrence of USADE which cannot be prevented in future cases
x
Sponsor’s decision
x
Request from Regulatory bodies
x
Request of Ethics Committee(s) 
x
Concern for subject safety and welfare
x
Failure to secure subject Informed Consent prior to any investigational activity
x
Failure to report unanticipated adverse device effects within 72 hours to SJM and the EC
x
Repeated non-compliance with this CIP or the Clinical Trial Agreement
x
Inability to successfully implement this CIP
x
Violation of the Declaration of Helsinki 2008 (refer to Appendix C)
x
Violation of applicable national or local laws and regulations
x
Falsification of data, or any other breach of ethics or scientific principles
x
Loss of or unaccounted use of investigational device inventory
The study will be terminated according to applicable regulations.
The investigator may also discontinue participation in the clinical study with appropriate written notice 
to the Sponsor.
Should either of these events occur, the investigator will return all documents to the sponsor; provide a 
written statement as to why the premature termination has taken place and notify the IRB/EC and/or the 
Competent Authority (if applicable). Follow-up for all enrolled subjects will be as per CIP requirements.
A Principal Investigator, IRB/EC or regulatory authority may suspend or prematurely terminate 
participation in a clinical study at the investigational sites for which they are responsible.  
If suspicion of an unacceptable risk to subjects arises during the clinical study or when so instructed by 
the IRB/EC or regulatory authority, SJM may suspend the clinical study as appropriate while the risk is 
assessed.  SJM will terminate the clinical study if an unacceptable risk is confirmed.  
SJM will consider terminating or suspending the participation of a particular investigational site or 
investigator in the clinical study if monitoring or auditing identifies serious or repeated deviations on the 
part of an investigator.  

Study Document No: SJM-CIP-10051
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Study Name: MediGuide Registry
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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
If suspension or premature termination occurs, the terminating party will justify its decision in writing 
and promptly inform the other parties with whom they are in direct communication.  The Principal 
Investigator and SJM will keep each other informed of any communication received from IRB/EC or 
regulatory authority.  
If for any reason SJM suspends or prematurely terminates the study at an individual investigational site, 
SJM will inform the responsible regulatory authority, as appropriate, and ensure that the IRB/EC are 
notified, either by the Principal Investigator or by SJM.  If the suspension or premature termination was 
in the interest of safety, SJM will inform all other Principal Investigators.  
If suspension or premature termination occurs, SJM will remain responsible for providing resources to 
fulfill the obligations from the CIP and existing agreements for following up the subjects enrolled in the 
clinical study, and the Principal Investigator or authorized designee will promptly inform the enrolled 
subjects at his/her investigational site, if appropriate.  
16.2
Resuming the study after temporary suspension
When SJM concludes an analysis of the reasons for the suspension, implements the necessary corrective 
actions, and decides to lift the temporary suspension, SJM will inform the Principal Investigators, 
IRB/EC, or regulatory authority, where appropriate, of the rationale, providing them with the relevant 
data supporting this decision.  
Concurrence will be obtained before the clinical study resumes from the IRB/EC or regulatory authority 
where appropriate.  
If subjects have been informed of the suspension, the Principal Investigator or authorized designee will 
inform them of the reasons for resumption.
16.3
Study conclusion
The study will be concluded when:
x
All sites are closed AND
x
The final report generated by SJM has been provided to sites or SJM has provided formal 
documentation of study closure
PUBLICATION POLICY
A ‘Publication Agreement’ will be signed between the Principal Investigator and the Sponsor either as a 
separate Publication Agreement or within the Clinical Trial Agreement.
For more information on publication guidelines, please refer to the International Committee of Medical 
Journal Editors (ICMJE) on www.icmje.org.
This study will be posted on ClinicalTrials.gov and results will be posted on ClinicalTrials.gov as 
required. 

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used without the express written consent of St. Jude Medical
BIBLIOGRAPHY 
Reference List
(1) S Jacob, P Ramappa, SS Panaich, K Goel, KA Williams. Reduction of radiation doeses in 
cardiac imaging, part i. Curr Cardiovasc Imaging Rep 4, 247-250. 2011. 
Ref Type: Generic
(2) Padovani R, Bernardi G, Quai E, Signor M, Toh HS, Morocutti G, Spedicato L. Retrospective 
evaluation of occurrence of skin injuries in interventional cardiac procedures. Radiat Prot 
Dosimetry 2005;117(1-3):247-50.
(3) Stecker MS, Balter S, Towbin RB, Miller DL, Vano E, Bartal G, Angle JF, Chao CP, Cohen 
AM, Dixon RG, Gross K, Hartnell GG, Schueler B, Statler JD, de BT, Cardella JF. Guidelines 
for patient radiation dose management. J Vasc Interv Radiol 2009 July;20(7 Suppl):S263-S273.
(4) Jeskowiak A, Hubmer M, Prenner G, Maechler H. Radiation induced cutaneous ulcer on the 
back in a patient with congenital anomaly of the upper cava system. Interact Cardiovasc Thorac 
Surg 2011 February;12(2):290-2.
(5) O'Brien B, van der PW. Quantification of risk-benefit in interventional radiology. Radiat Prot 
Dosimetry 2008;129(1-3):59-62.
(6) Musolino SV, DeFranco J, Schlueck R. The ALARA principle in the context of a radiological or 
nuclear emergency. Health Phys 2008 February;94(2):109-11.
(7) Strauss KJ, Kaste SC. ALARA in pediatric interventional and fluoroscopic imaging: striving to 
keep radiation doses as low as possible during fluoroscopy of pediatric patients--a white paper 
executive summary. J Am Coll Radiol 2006 September;3(9):686-8.
(8) Richter S, Doring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac 
resynchronization therapy device implantation using a new sensor-based navigation system: 
results from the first human use study. Circ Arrhythm Electrophysiol 2013 October;6(5):917-23.
(9) Rolf S, Sommer P, Gaspar T, John S, Arya A, Hindricks G, Piorkowski C. Ablation of atrial 
fibrillation using novel 4-dimensional catheter tracking within autoregistered left atrial 
angiograms. Circ Arrhythm Electrophysiol 2012 August 1;5(4):684-90.
(10) Rolf S, John S, Gaspar T, Dinov B, Kircher S, Huo Y, Bollmann A, Richter S, Arya A, 
Hindricks G, Piorkowski C, Sommer P. Catheter ablation of atrial fibrillation supported by novel 
nonfluoroscopic 4D navigation technology. Heart Rhythm 2013 September;10(9):1293-300.
(11) Sommer P, Wojdyla-Hordynska A, Rolf S, Gaspar T, Eitel C, Arya A, Hindricks G, Piorkowski 
C. Initial experience in ablation of typical atrial flutter using a novel three-dimensional catheter 
tracking system. Europace 2013 April;15(4):578-81.

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This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
(12) Sommer P, Piorkowski C, Gaspar T, Eitel C, Derndorfer M, Martinek M, Purerfellner H, Arya 
A, Hindricks G, Rolf S. MediGuide in supraventricular tachycardia: initial experience from a 
multicentre registry. Europace 2013 September;15(9):1292-7.
(13) Sommer P, Richter S, Hindricks G, Rolf S. Non-fluoroscopic catheter visualization using 
MediGuide technology: experience from the first 600 procedures. J Interv Card Electrophysiol
2014 September;40(3):209-14.
(14) Sommer P, Rolf S, Piorkowski C, Gaspar T, Huo Y, Piedra C, Richter S, Bollmann A, Arya A, 
Hindricks G. Non-Fluoroscopic Catheter Visualization in AF Ablation: Experience from 375 
Consecutive Procedures. Circ Arrhythm Electrophysiol 2014 July 19.

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used without the express written consent of St. Jude Medical
APPENDIX A: ABBREVIATIONS

Study Document No: SJM-CIP-10051
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used without the express written consent of St. Jude Medical
Abbreviation
Term

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
Page 33 of 38
This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
ADE
AE
ANZ
ASADE
AV
CA
CCI
CIP
CRF
CRT
CS
DD
DFT
DMP
EC
ECG
eCRF
EDC
EMEA
EP
GP
IB
ICD
ICMJE
IRB
ISB
ISO
LV
LVEF
MP
NA
NYHA
PI
PM
POA
RA
RDC
RV
SADE
SAE
SC 
SJM
USADE
VT
Adverse Device Effect
Adverse Event
Australia – New Zealand
Anticipated Serious Adverse Device Effect
Atrioventricular
Competent Authority
Clinical Coordination Investigator
Clinical Investigational Plan
Case Report Form
Cardiac Resynchronization Therapy
Coronary Sinus
Device Deficiency
Defibrillation Threshold
Data Management Plan
Ethics Committee
Electrocardiogram
Electronic Case Report Form
Electronic Data Capture
Europe, Middle East, Africa
Electrophysiology
General Practitioner
Investigator Brochure
Implantable Cardioverter Defibrillator
International Committee of Medical Journal Editors
Institutional Review Board
Investigator Site Binder
International Organization for Standardization
Left Ventricle
Left Ventricular Ejection Fraction
Monitoring Plan
Not Applicable
New York Heart Association
Principal Investigator
Pacemaker
Power of Attorney
Right Atrial
Remote Data Capture
Right Ventricular
Serious Adverse Device Effect
Serious Adverse Event
Steering Committee
St. Jude Medical
Unanticipated Serious Adverse Device Effect
Ventricular Tachycardia

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
Page 34 of 38
This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
Page 35 of 38
This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
APPENDIX B: CIP REVISION HISTORY

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
Page 36 of 38
This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
Appendix C: Declaration of Helsinki
The most current version of the document will be followed.

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
Page 37 of 38
This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
Appendix F: List of Clinical Investigation Sites and IRB/EC
A list of Clinical Investigational sites and IRB/EC will be kept under a separate cover and is available 
upon request. 

Study Document No: SJM-CIP-10051
Ver. A,
Study Name: MediGuide Registry
Page 38 of 38
This confidential document is the property of St. Jude Medical, Inc. and shall not be reproduced, distributed, disclosed or 
used without the express written consent of St. Jude Medical
Appendix G: Informed Consent
Informed consent will be provided under separate cover.