Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site During Idiopathic Outflow Tract Ventricular Arrhythmia Ablation
Conditions: Ventricular Outflow Tract Tachycardia
Sponsor: Abbott Medical Devices

Cover Page 
Title of the study: Usefulness of Unipolar and Bipolar Electrograms in 
Predicting Successful Ablation Site During Idiopathic Outflow Tract 
Ventricular Arrhythmia Ablation 
 
NCT number: NCT02722577 
 
Type of document: Study Protocol and Statistical Analysis Plan 
 
Date of document: March 1, 2016 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 1 of 34 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
Reference:  
CRD_801 
 
EGM Analysis in Idiopathic OTVA 
“Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site 
during Idiopathic Outflow Tract Ventricular Arrhythmia Ablation” 
Clinical Investigation Plan (CIP) 
 
 
Sponsor  
 
 
 
St. Jude Medical, Inc. 
Address: 15900 Valley View Ct.  
      Sylmar, CA 91342 
Country: USA 
Tel: + 1 408 522 6856 
Representative: Timothy A. Fayram, MS 
 
 
       Vice President, Research 
 
 
 
Clinical Coordinating   
Name: Prof. Shu Zhang  
Investigator                             Hospital: Fuwai Hospital 
Address: No. 167 Beilishi Road,  
      Xicheng District, Beijing 
Country: China 
Tel: +86 10 88398700 
Fax: +86 10 88396412 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 2 of 34 
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without the express written consent of St. Jude Medical  
PRINICPAL INVESTIGATOR SIGNATURE PAGE 
EGM Analysis in Idiopathic OTVA 
“Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site during 
Idiopathic Outflow Tract Ventricular Arrhythmia Ablation” 
Clinical Investigation Plan (CIP) 
 
Version A 
Reference #: CRD_801 
 
I have read and agree to adhere to the clinical investigational plan and all regulatory requirements 
applicable in conducting this clinical study. 
 
 
Principal Investigator 
 
Printed name: 
____________________________________ 
Signature: _______________________________________ 
Date:  ____________________ 
 
 
 
 
 
 
 
 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 3 of 34 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
 
Coordinating Investigator/ National Investigator/ Medical Advisor 
SIGNATURE PAGE 
 
 
EGM Analysis in Idiopathic OTVA 
“Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful Ablation Site during 
Idiopathic Outflow Tract Ventricular Arrhythmia Ablation” 
Clinical Investigation Plan (CIP) 
 
Version A 
Reference #: CRD_801 
 
 
I have read and agree to adhere to the clinical investigational plan and all regulatory requirements 
applicable in conducting this clinical study.   
 
 
Coordinating Investigator/Medical Advisor, PI   
 
Printed name: 
____________________________________ 
 
Signature: _______________________________________ 
 
Date:  ____________________ 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 4 of 34 
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without the express written consent of St. Jude Medical  
Table of Contents 
 
Synopsis ................................................................................................................................................................... 6 
1.0
1.1 Study Flow Chart .................................................................................................................................................. 7 
1.2 Study Contacts ...................................................................................................................................................... 7 
Clinical Coordinating Investigator .............................................................................................................................. 7 
Sponsor 7 
 
Background and Justification for Clinical Study ..................................................................................................... 8 
2.0
 
Risks and Benefits of the Clinical Study .................................................................................................................. 9 
3.0
3.1 Description of subject population ......................................................................................................................... 9 
Inclusion criteria ........................................................................................................ Error! Bookmark not defined. 
Exclusion criteria ....................................................................................................... Error! Bookmark not defined. 
3.2 Anticipated clinical benefits ................................................................................................................................. 9 
3.3 Anticipated adverse events and adverse device effects ........................................................................................ 9 
3.4 Residual risks associated with the study, as identified in the risk analysis report ................................................ 9 
3.5 Risks associated with participation in the clinical study .................................................................................... 10 
3.6 Risk-to-benefit rationale ..................................................................................................................................... 10 
 
Study Design .......................................................................................................................................................... 10 
4.0
4.1 Purpose ............................................................................................................................................................... 10 
4.2 Study Design and Scope ..................................................................................................................................... 10 
Number of subjects required to be included in the study .......................................................................................... 10 
Estimated time needed to enroll this subject population ........................................................................................... 10 
4.3 Objectives ........................................................................................................................................................... 10 
Primary Objective ..................................................................................................................................................... 10 
Secondary Objective ................................................................................................................................................. 10 
4.4 Endpoints ............................................................................................................................................................ 10 
Primary Endpoint ...................................................................................................................................................... 10 
Secondary Endpoint .................................................................................................................................................. 11 
4.5 Inclusion and Exclusion Criteria ........................................................................................................................ 11 
Inclusion Criteria ...................................................................................................................................................... 11 
Exclusion Criteria ..................................................................................................................................................... 11 
4.6 Subject Population .............................................................................................................................................. 11 
Subject Screening ..................................................................................................................................................... 11 
Point of Enrollment ................................................................................................................................................... 11 
4.7 Informed Consent Process .................................................................................................................................. 12 
General process ......................................................................................................................................................... 12 
 
Device under Investigation .................................................................................................................................... 12 
5.0
5.1 Device Description ............................................................................................................................................. 12 
5.2 Device Accountability (if applicable) ................................................................................................................. 12 
5.3 Device Handling & Storage ................................................................................................................................ 12 
 
Procedures .............................................................................................................................................................. 12 
6.0
6.1 Study Flow Chart ................................................................................................................................................ 12 
6.2 Procedures .......................................................................................................................................................... 13 
6.3 Enrollment Visit ................................................................................................................................................. 14 
Patient Informed Consent Process ............................................................................................................................ 14 
Demographics and Medical History ......................................................................................................................... 15 
12-lead ECG ............................................................................................................................................................. 15 
6.4 Ablation Procedure Visit .................................................................................................................................... 15 
Mapping and EGM Recording .................................................................................................................................. 16 
Ablation16 
6.5 Scheduled Follow-ups ........................................................................................................................................ 16 
6.6 Description of activities performed by Sponsor Representatives ....................................................................... 16 
6.7 Subject study completion ................................................................................................................................... 17 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 5 of 34 
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without the express written consent of St. Jude Medical  
6.8 Any Known or Foreseeable Factors that May Compromise the Outcome of the Clinical Study or the Interpretation of 
the Results ................................................................................................................................................................... 17 
6.9 Criteria and Procedures for Subject Withdrawal or Discontinuation ................................................................. 17 
 
Compliance to CIP ................................................................................................................................................. 18 
7.0
7.1 Statements of Compliance .................................................................................................................................. 18 
7.2 Adherence to the Clinical Investigation Plan ..................................................................................................... 18 
7.3 Repeated and serious non-compliance ................................................................................................................ 19 
 
Adverse Event ........................................................................................................................................................ 19 
8.0
8.1 Definitions .......................................................................................................................................................... 19 
Medical device .......................................................................................................................................................... 19 
Adverse Event (AE) .................................................................................................................................................. 20 
Serious Adverse Event (SAE) ................................................................................................................................... 20 
Adverse Device Effect (ADE) .................................................................................................................................. 20 
Serious Adverse Device Effect (SADE) ................................................................................................................... 21 
8.2 Procedure for assessing, recording and reporting adverse events ....................................................................... 21 
8.3 Subject Death ..................................................................................................................................................... 22 
Procedure for recording and reporting subject death ................................................................................................ 22 
8.4 COMPLAINT ..................................................................................................................................................... 22 
 
Data Management .................................................................................................................................................. 23 
9.0
9.1 Data Management Plan ....................................................................................................................................... 23 
9.2 Document and data control ................................................................................................................................. 23 
Traceability of documents and data .......................................................................................................................... 23 
Recording data .......................................................................................................................................................... 23 
 Regulatory Inspections ........................................................................................................................................... 24 
10.0
 Statistical considerations ........................................................................................................................................ 24 
11.0
11.1 Statistical design, hypotheses, method and analytical procedures ...................................................................... 24 
11.2 Sample size ......................................................................................................................................................... 24 
11.3 The provision for an interim analysis, when applicable ..................................................................................... 25 
11.4 The treatment of missing, unused or spurious data, including drop-outs and withdrawals ................................ 25 
 Document Retention .............................................................................................................................................. 25 
12.0
 Amendments to Clinical Investigational Plan ........................................................................................................ 25 
13.0
 Investigation Suspension or Termination ............................................................................................................... 26 
14.0
14.1 Premature termination of the whole clinical study or of the clinical study in one or more investigational sites.26 
14.2 Resuming the study after temporary suspension ................................................................................................ 27 
14.3 Study conclusion ................................................................................................................................................ 27 
 Publication Policy .................................................................................................................................................. 27 
15.0
 Bibliography .......................................................................................................................................................... 28 
16.0
Appendix A: Abbreviations .............................................................................................................................................. 30 
Appendix B: CIP Revision History................................................................................................................................... 31 
Appendix C: List of Clinical Investigation Sites and IRB/EC .......................................................................................... 32 
Appendix D: Sample Informed Consent ........................................................................................................................... 33 
Appendix E: Case Report Forms ...................................................................................................................................... 34 
 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 6 of 34 
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without the express written consent of St. Jude Medical  
 SYNOPSIS  
1.0
Title: 
Usefulness of Unipolar and Bipolar Electrograms in Predicting Successful 
Ablation Site during Idiopathic Outflow Tract Ventricular Arrhythmia 
Ablation 
 
Acronym: 
EGM Analysis in Idiopathic OTVA 
Purpose: 
Investigate the value of unipolar and bipolar electrograms (EGM) for 
predicting the successful ablation site for idiopathic outflow tract 
ventricular arrhythmia (OTVA) 
Objectives: 
Primary Objective: 
Evaluate the predictive value of using reversed polarity in adjacent bipolar 
EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS 
method) for identifying successful ablation site 
 
 
Secondary Objective: 
Evaluate the feasibility of enhancing uni-QS method’s performance by 
using its morphology characteristics such as descending slope and 
symmetry 
Endpoints: 
Primary Endpoint:  
Predictive values of the bi-RP method and uni-QS method for successful 
ablation 
Secondary Endpoint: 
Predictive value of a new method by combining bi-RP and uni-QS for 
successful ablation.  
Design: 
The study is an acute, non-randomized, feasibility study in Fuwai Hospital, 
China. 
Devices used: 
Any commercially available SJM quadripolar RF ablation catheters in 
China. 
Study Population 
Approximately 20 patients meeting the specific criteria. 
 
Inclusion/Exclusion 
Criteria  
Inclusion Criteria: 
- 
Patients scheduled to undergo ablation for idiopathic OTVA 
- 
Have the ability to provide informed consent for study 
participation. 
Exclusion Criteria 
- 
Be currently participating in any other investigational study 
- 
Be less than 18 years of age 
- 
Be pregnant 
- 
Has any other conditions that are not suitable for catheter ablation 
(including but are not limited to active whole-body infection or 
sepsis, coagulation or hemorrhage disorder history) 
Data Collection 
Data will be collected at: 
Enrollment and OTVA ablation visit. 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 7 of 34 
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without the express written consent of St. Jude Medical  
 
1.1 
Study Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                         Figure 1: Study flow from enrollment to end of protocol 
 
1.2 
Study Contacts 
Clinical Coordinating Investigator 
Prof. Shu Zhang  
Fuwai Hospital 
No. 167 Beilishi Road,  
Xicheng District, Beijing 
China 
+86 10 88398700 
Sponsor 
Timothy A. Fayram, MS 
Vice President, Research 
Tel: + 1 408 522 6856 (Office) 
tfayram@sjm.com 
 
Eligibility Screening 
End of Protocol 
Patient Informed Consent 
Enrollment 
(Baseline characteristics, medical history, 12-lead ECG, etc.) 
 
Ablation Procedure 
(Map of local activation times, QRS morphology of the 
clinical VA on 12-lead ECG, unipolar and bipolar EGM 
recordings at the ablation sites prior to energy delivery) 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 8 of 34 
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without the express written consent of St. Jude Medical  
 BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY 
2.0
Currently, the first-line therapy for symptomatic Ventricular Arrhythmia (VA) patients is still 
antiarrhythmic drugs1. Unfortunately, drug therapy is not always effective and can be hindered by side 
effects1-3. As an alternative, Radiofrequency Catheter Ablation (RFCA) has been shown to be highly 
effective in treating focal idiopathic VAs in the outflow tract (OT), with acute success rates greater than 
80%1,4-6. Although RFCA is generally considered a safe procedure, serious complications may still 
occur1,7-8. Therefore, it is important to minimize the number of lesions while achieving an effective 
treatment.  
 
The classic strategy to guide RFCA is based on local activation time (LAT) map and the presence of a 
QS morphology in the unipolar electrograms (uni-QS)9-12. However, the actual LAT at the successful 
ablation site may vary a lot among patients, and the area demonstrating a unipolar QS morphology may 
be larger than the focal source9-12. In practice, these factors may greatly affect the efficiency of the 
physicians to locate the focal source and cause unnecessary ablation lesions. Thus, more specific criteria 
are needed to help guide the search for successful ablation site. 
 
The presence of reverse polarity in adjacent bipolar electrograms (bi-RP) has been demonstrated in 
pulmonary vein isolation procedure using circular catheter based on the hypothesis that the excitation 
wavefront propagates radially from the breakthrough site in the pulmonary vein14. A similar approach 
using the reversal initial deflection of adjacent bipolar electrograms has been demonstrated in patients 
with accessory pathways and focal atrial tachycardia15. Lately, Carine et al., in a retrospective analysis, 
showed that a method combining the use of LAT and bi-RP phenomenon in focal right ventricular 
outflow tract (RVOT) arrhythmias could yield a higher specificity for identifying successful ablation 
sites than the conventional LAT plus unipolar QS morphology method16. 
 
The proposed study aims to evaluate the predictive value of bi-RP and uni-QS for identifying successful 
ablation site. It will also evaluate the feasibility to enhance uni-QS method’s performance by using uni-
QS and its morphology characteristics such as descending slope and symmetry.  
 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 9 of 34 
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without the express written consent of St. Jude Medical  
  RISKS AND BENEFITS OF THE CLINICAL STUDY 
3.0
3.1 
Description of subject population 
The inclusion/exclusion criteria for participation in this study is specified in section 4.5. This study will 
attempt to recruit consecutive subjects who meet all inclusion criteria and does not meet any exclusion 
criteria for study enrollment. A signed Informed Consent Form (ICF) for study participation must be 
obtained by the principal investigator (PI) or designated personnel prior to subject enrollment. 
3.2 
Anticipated clinical benefits 
There is no direct benefit to the studied patient because we simply collect electrograms during the 
ablation procedure. However, findings from this study may help physicians to develop more efficient 
ablation strategy and potentially benefit future patients.  
3.3 
Anticipated adverse events and adverse device effects 
There are no adverse events associated with the additional data collection for this study. Possible 
adverse events (in alphabetical order) associated with the standard RFCA include but are not limited to 
the following: 
 Allergic reactions to contrast media (agents) 
 Arrest (cardio) 
 Arrest (respiratory) 
 Arrhythmias 
 Air embolism 
 Bleeding (non-hematoma) 
 Cardiac perforation 
 Cardiac tamponade 
 Damage to the conduction system 
 Damage to the coronary arteries 
 Death 
 Endocarditis  
 Groin hematoma 
 Heart failure 
 Hemothorax 
 Myocardial ischemia 
 Myocardial Infarction 
 Phrenic nerve injury 
 Periprocedural death 
 Stroke or transient ischemic attack  
 Thromboembolism 
 Valve injury 
 Vascular injury 
3.4 
Residual risks associated with the study, as identified in the risk analysis report 
The risks in this study are similar to the risks associated with standard RF ablation procedure for OTVA. 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 10 of 34
 
 
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without the express written consent of St. Jude Medical  
3.5 
Risks associated with participation in the clinical study 
Participation in this study does not provide additional risk to the subjects who will nevertheless undergo 
RF ablation for OTVA. No additional device or catheter will be inserted during the procedure, nor 
should the procedure time be lengthened due to participation in this study. As with any interventional 
procedure, participation in this study has risks and complications that are associated or anticipated with 
percutaneous vascular access and catheter ablation.  
3.6 
Risk-to-benefit rationale 
There is no additional risk more than the risks associated with standard RF ablation procedure for 
OTVA. Findings from this study may help physicians to develop more efficient ablation strategy and 
potentially benefit future patients. 
 
 STUDY DESIGN 
4.0
4.1 
Purpose 
The purpose of this clinical study is to investigate the value of unipolar and bipolar EGM for predicting 
the successful ablation site for idiopathic OTVA. 
4.2 
Study Design and Scope 
The study is an acute, non-randomized, feasibility study. 
• 
Approximately 20 subjects meeting the inclusion criteria will be enrolled in this study 
• 
The estimated time to enroll the required patients is 6 months 
• 
The study will be conducted in one medical center, the Fuwai Hospital in Beijing, China. 
Number of subjects required to be included in the study 
Approximately 20 subjects meeting the inclusion criteria will be enrolled in this study.  
Estimated time needed to enroll this subject population 
The estimated time to enroll this subject population is 6 months. The study may continue up to 12 
months, dependent on the rate of enrollment and the regulatory timeline. 
4.3 
Objectives 
Primary Objective 
Evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and 
unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site 
Secondary Objective 
Evaluate the feasibility of enhancing uni-QS method’s performance by using its morphology 
characteristics such as descending slope and symmetry. 
4.4 
Endpoints 
Primary Endpoint 
Predictive values of the bi-RP method and uni-QS method for successful ablation 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 11 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
Secondary Endpoint 
Predictive value of a new method by combining bi-RP and uni-QS for successful ablation. 
4.5 
Inclusion and Exclusion Criteria 
A subject, who meets all of the inclusion criteria, and none of the exclusion criteria, is eligible to 
participate in this study.  
 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study or lost to 
follow-up) will be accounted for and documented, assigning an identification code linked to their names, 
alternative identification or contact information. 
 
This log will be kept up to date throughout the clinical study by the principal investigator or his/her 
authorized designee. To ensure subject privacy and confidentiality of data this log must be maintained 
throughout the clinical study at the clinical site. 
 
To participate in this clinical subject, the subject must meet all of the following inclusion criteria: 
Inclusion Criteria 
Subjects are eligible for clinical study participation if they meet all of the following inclusion criteria: 
 Patients scheduled to undergo ablation for idiopathic OTVA 
 Have the ability to provide informed consent for study participation. 
 
Exclusion Criteria 
Patients will be excluded from the study if they meet any of the following exclusion criteria: 
 Be currently participating in any other investigational studies 
 Be less than 18 years of age 
 Be pregnant 
 Has any other conditions that are not suitable for catheter ablation (including but are not limited to 
active whole-body infection or sepsis, coagulation or hemorrhage disorder history) 
4.6 
Subject Population  
Subject Screening 
All subjects presenting at the investigational site can be screened by a member of the investigational 
team previously trained on the CIP and delegated to do so. 
 
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 ICF will be obtained. 
Point of Enrollment 
Subjects are considered enrolled in the study from the moment the subject has provided written ICF. 
(Refer to section 4.7 for the Informed Consent Process).  

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 12 of 34
 
 
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without the express written consent of St. Jude Medical  
 
4.7 
Informed Consent Process 
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 St. Jude Medical within 5 
working days and to the reviewing center’s IRB/EC consistent with the center’s IRB/EC reporting 
requirements.  
 DEVICE UNDER INVESTIGATION  
5.0
5.1 
Device Description 
All the devices and systems (including software) used in this study are commercially approved in China. 
Including the following items: 
 
 Any standard fluoroscopy equipment used in the Fuwai Hospital 
 Any standard EP recording systems used in the Fuwai Hospital 
 Any SJM quadripolar ablation catheters (e.g. the Safire Ablation Catheter) 
 Any SJM ablation therapy hardware (e.g. the 1500T series Cardiac Ablation Generator, Cool Point 
Irrigation Pump) 
 The SJM Ensite Velocity Cardiac Mapping System 
 
5.2 
Device Accountability (if applicable) 
Device accountability is not required. 
5.3 
Device Handling & Storage 
All products used in this study are commercially approved. 
 PROCEDURES 
6.0
6.1 
Study Flow Chart 
Refer to section 1.1 for the study flow chart 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 13 of 34
 
 
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without the express written consent of St. Jude Medical  
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 St. Jude Medical receives written approval from the IRB/EC 
and relevant regulatory authorities and all required documents have been collected from the Fuwai 
Hospital. 
 
Table 1: List of all study specific activities/procedures 
 
                Visit 
 
 
Study Activity 
Enrollment 
Ablation 
Procedure 
 
Informed Consent Process 
X 
 
Verification of Inclusion and Exclusion Criteria 
X 
 
Demographics and Medical History 
X 
 
12-lead ECG 
X 
 
Record Unipolar EGM during mapping 
 
X 
Record Bipolar EGM during mapping 
 
X 
Record successful/unsuccessful ablation sites 
 
X 
Adverse Event 
(X) 
(X) 
Withdrawal 
(X) 
(X) 
Deviation 
(X) 
(X) 
Death 
(X) 
(X) 
X: Mandatory CRFs 
(X) : CRF will  be completed if applicable 
 
The following table lists all Case Report Forms (CRFs) that are to be completed during the respective 
visits. Mandatory CRFs are identified with an “X”. CRFs that are optional or have to be completed only 
in case of a certain event (i.e. Death) are marked with an “(X)” 
 
Table 2: Case report forms 
 
                   Visit 
 
 
CRFs  
Enrollment 
Ablation 
Procedure 
Enrollment  
X 
 
Baseline 
X 
 
Ablation Procedure  
 
X 
Adverse Event  
(X) 
(X) 
Withdrawal 
(X) 
(X) 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 14 of 34
 
 
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without the express written consent of St. Jude Medical  
                   Visit 
 
 
CRFs  
Enrollment 
Ablation 
Procedure 
Deviation 
(X) 
(X) 
Death 
(X) 
(X) 
X: Mandatory CRFs 
(X) : CRF will  be completed if applicable 
 
6.3 
Enrollment Visit  
Patient Informed Consent Process 
The following enrollment activities are performed after the subject has been screened and must occur 
before any study procedure/visit. 
 
 The principal or delegated study personnel are responsible for screening all potential subjects to 
determine subject eligibility for the study 
- 
Inform the eligible patient verbally about the investigation and provide the information sheet 
and consent to the patient. 
- 
Provide ample time to the patient to read and understand the information sheet and PIC and 
to consider participation in the clinical investigation. 
- 
Obtain the signature and date from the eligible patient on the Ethics Committee (EC) 
approved PIC. 
- 
If an eligible patient does not sign and date the PIC, he cannot participate in the investigation. 
No further protocol required activities are performed. 
- 
Obtain the signature and date from the PI or delegated investigator on the EC approved PIC. 
- 
The subject is enrolled in the investigation when the patient signed the EC approved PIC. 
- 
Provide one original signed version of the PIC to the subject (signed by both subject and 
investigator). 
- 
File second original signed version of the PIC in the Investigator Site Binder (ISB).   
 
 Record enrollment information (name of the study, date of consent and Inclusion/exclusion 
information) in the hospital records and complete and submit the Enrollment CRF in a timely 
manner (recommended within 5 days)  
 Notification of enrollment to the sponsor will take place only when the sponsor receives the 
enrollment form  
 
NOTE: As soon as the subject signs the ICF, adverse events need to be reported according to the 
guidelines mentioned in section 8.2. 
 
If a subject does not meet all inclusion criteria or meets any of the exclusion criteria, the subject cannot 
participate in the study and cannot be enrolled.  
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 15 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
In case the subject was already consented to participate in the study, but does not meet 
inclusion/exclusion criteria, the following actions will be taken. 
 
If study procedure has not occurred: 
 Document enrollment information (name of the study, date of consent and inclusion/exclusion) in 
the hospital records; complete the Enrollment and Withdrawal Forms. The form must be 
authorized / approved by the principal or delegated investigator. 
o Inform the subject about the withdrawal.  
o The EC/IRB and CA should be notified appropriately about any deviations with regards to 
obtaining the informed consent. 
 
 If study procedure has occurred: 
 Document enrollment information (name of the study, date of consent and inclusion/exclusion) in 
the hospital records; complete the Enrollment and Withdrawal Forms. The form must be 
authorized / approved by the principal or delegated investigator. 
o Complete study deviation for inclusion/exclusion not met 
o Inform the subject about the withdrawal.  
o The EC/IRB and CA should be notified appropriately about any deviations with regards to 
obtaining the informed consent. 
Demographics and Medical History 
 Demographics - include subject’s Age and Gender 
 Medical History - include subject’s height, weight, blood pressure (measurements taken during 
visit), cardiovascular history (most recent value closest to baseline visit), risk factors, relevant 
co-morbidities, previous cardiac procedures, VA diagnosis, and medication (only chronic 
cardiac related medication). 
12-lead ECG  
Standard 12-lead ECG will be collected. In addition, prior documentation of 12-lead ECG with VAs will 
be collected if available.  
 
6.4 
Ablation Procedure Visit 
In case the patient’s VA is not present and cannot be induced before the ablation procedure, the ablation 
should not be performed according to the 2009 EHRA/HRS Expert Consensus on Catheter Ablation of 
Ventricular Arrhythmias1. The following actions will be taken: 
o Inform the subject about the withdrawal.  
o Complete the Withdrawal CRF. The form must be authorized / approved by the principal or 
delegated investigator 
 
The ablation procedure will be performed according to the Fuwai hospital’s standard practice. During 
the ablation procedure, any clinical adverse events or protocol deviations are to be noted on the 
appropriate forms. The following information will be collected at the ablation procedure visit: 
 Date of procedure 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 16 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
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 The unipolar EGM, the bipolar EGM pairs as defined below, and the 12-lead surface ECG. 
 Nonsuccessful and successful ablation sites tagged on the map. 
 Acute success rate  
 Indicate model and number of mapping and ablation catheters used in the procedure  
 Adverse Events, Death, and/or Protocol Deviation notification (if applicable) 
 
Mapping and EGM Recording 
A quadripolar ablation catheter will be used to map the target site. Specifically, the unipolar EGM is 
recorded from the distal electrode (M1) of the mapping catheter and filtered at 0.5~100Hz. The bipolar 
EGMs are recorded from the distal (M1-M2), mid (M2-M3), and proximal (M3-M4) electrode pairs of 
the mapping catheter, respectively, and filtered at 30~500Hz. LAT is measured using the distal electrode 
pair and is defined as the interval between the initial sharp peak of the EGM and the onset of the VA 
QRS. The presence of the bi-RP is evaluated between the distal and mid electrode pairs and is defined as 
a rapid simultaneous deflection in the opposite direction of the initial part of the bipolar EGM occurring 
before the onset of the VA QRS. All the unipolar EGM, bipolar EGMs, and the 12-lead surface ECG 
will be displayed on the monitor for the physician’s reference and stored on the electrophysiology 
recording system and on the Ensite Velocity mapping system for off-line analysis. To guarantee accurate 
electroanatomic activation mapping and to avoid annotation of catheter-induced premature ventricular 
contractions (PVCs), the VA QRS morphology of each acquired mapping point will be compared to a 
12-lead QRS template of the clinical arrhythmia.  
Ablation 
Radiofrequency energy will be applied at 30W with a maximum temperature of 55 oC for regular 
ablation catheter, and 35 to 40W with a maximum temperature of 43 oC for irrigated ablation catheter. If 
the VA is not abolished within 10 seconds of RF ablation, the energy application will be terminated and 
the ablation site will be tagged as a nonsuccessful site on the map. If the VA is abolished within 10 
seconds, the energy application will be continued for a total of 90 seconds and the site will be tagged as 
a successful site on the map. The procedure endpoint is reached when the targeted VA did not occur 
spontaneously after a waiting period of 30 minutes and could not be induced by electrical programmed 
stimulation before and after isoproterenol infusion and Valsalva maneuver.  
 
6.5 
Scheduled Follow-ups 
No follow-up visits or records are required for this study. 
 
6.6 
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. 
 
Sponsor personnel will not: 
 Perform the informed consent process 
 Practice medicine 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 17 of 34
 
 
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 Provide medical diagnosis or treatment to subject 
 Discuss a subject’s condition  or treatment with a subject without the approval and presence of a 
health care practitioner 
 Independently collect clinical study  data 
 Complete or sign study’s Case report Forms 
 
6.7 
Subject study completion 
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. 
6.8 
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. 
6.9 
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 withdrawal, 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: 
 
 Subject refuses to continue participating in the study 
 Subject does not meet the inclusion/exclusion criteria and does not require additional follow-up for 
safety reasons. 
 Subject is deceased (cause must be documented) 
 Subject’s non-compliance 
 Subject’s participation is terminated by the PI or investigator, although the subject consented, since 
participation is no longer medically appropriate 
 Subject’s VA is not present or inducible before the ablation procedure 
 
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.   
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
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 COMPLIANCE TO CIP 
7.0
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 St. Jude Medical. 
 
As sponsor, St. Jude Medical 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, such 
information will be incorporated into the informed consent, as applicable. 
 
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.  
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 19 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
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 St. Jude Medical. 
 
Regulations require Investigators obtain approval from St. Jude Medical 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 CRF. 
 
To obtain approval, the Principal Investigator may call or email and discuss the potential deviation with 
St. Jude Medical or designee prior to initiating any changes.   
 
All deviations must be reported to appropriate regulatory authorities in specified timelines (if 
appropriate). 
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: 
 Visiting the investigator 
 Contacting the investigator by telephone 
 Contacting the investigator in writing 
 Retraining of the investigator 
 
If an investigator is found to be repeatedly non-compliant with the signed agreement, the CIP or any 
other conditions of the clinical study, the Sponsor will either secure compliance or, at its sole discretion, 
terminate the investigator’s participation in the clinical study. 
 
 ADVERSE EVENT 
8.0
8.1 
Definitions 
Medical device 
Any instrument, apparatus, implement, machine, appliance, implant, software, material or other similar 
or related article 

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Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 20 of 34
 
 
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 Intended by the manufacturer to be used, alone or in combination, for human beings for one or 
more of the specific purpose(s) of 
o Diagnosis, prevention, monitoring, treatments or alleviation of disease, 
o Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury, 
o Investigation, replacement, modification, or support of the anatomy or of a physiological 
process, 
o Supporting or sustaining life, 
o Control of conception, 
o Disinfection of medical devices and 
 Which does not achieve its primary intended action in or on the human body by pharmacological, 
immunological or metabolic means, but which may be assisted in its intended function by such 
means 
 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device under study. 
 
This definition includes events related to the investigational medical device or the comparator. 
This definition includes events related to the procedures involved. 
 
Serious Adverse Event (SAE) 
An adverse event that led to: 
 Death 
 A serious deterioration in the health of the subject, that either resulted in: 
o A life-threatening illness or injury OR 
o A permanent impairment to a body structure or a body function OR 
o An in-patient or prolonged hospitalization OR 
o A medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body OR 
 Fetal distress, fetal death or a congenital abnormality or birth defect 
A planned hospitalization for a pre-existing condition, or a procedure required by the CIP is not 
considered a serious adverse event. 
 
Adverse Device Effect (ADE) 
An adverse event related to the use of an investigational medical device. 
 
This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 21 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational medical device. 
 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
8.2 
Procedure for assessing, recording and reporting adverse events  
Safety surveillance within this study and the safety reporting both performed by the investigator, starts 
as soon as the subject is enrolled in this study (date of signature of the informed consent). The safety 
surveillance and the safety reporting will continue until the last investigational visit has been performed, 
the subject is deceased, the subject/investigator concludes his participation into the study or the 
subject/investigator withdraws the subject from the study, except as otherwise specified in the CIP. 
 
All adverse event data including deaths will be collected throughout the clinical study by the 
investigator and reported to the Sponsor on a dedicated CRF.  
 
Records relating to the subject’s subsequent medical course must be maintained and submitted (as 
applicable) to the Sponsor until the event has subsided or, in case of permanent impairment, until the 
event stabilizes and the overall clinical outcome has been ascertained. Adverse events will be monitored 
until they are adequately resolved.  The status of the subject’s condition should be documented at each 
visit.   
 
The investigator will report the event to the IRB/EC per their reporting requirements.  
 
Reportable events to sponsor are considered:  
 All Serious Adverse Events whether or not device/procedure related (SAEs and SADEs) 
 Adverse Device Effects (ADE) Note: ADEs include procedure related events as well. 
 Death events 
 
All above events will be reported to the Sponsor, as soon as possible, but no later than 72 hours of first 
learning of the event. 
 
The Sponsor will ensure that all events are reported to the relevant authorities as per regulations.  
 
Should an AE occur, the investigator is requested to record AE information in the hospital records, 
document the information into the Adverse Event CRF according to the timelines mentioned above.  
Refer to Table 2 “Case Report Forms”. 
 
Additional information such as  clinic notes or other forms of medical records may be requested, when 
required, by the Sponsor in order to support the appropriate classification of the AEs and reporting of 
AEs to regulatory authorities. 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 22 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
The investigator must notify the IRB/EC, if appropriate, in accordance with national and local laws and 
regulations, of the AEs reported to the Sponsor. 
 
All adverse events will be reported as per applicable regulatory requirements.  
8.3 
Subject Death 
Procedure for recording and reporting subject death 
All subject deaths are to be documented and reported to the sponsor within 72 hours after becoming 
aware of the event. 
 
Should a death event occur, the investigator is requested to record death information in the hospital 
records, immediately document the information on the Death CRF and submit it to SJM. All subject 
deaths are to be documented and reported to the sponsor within 3 days after becoming aware of the 
event. 
 
In order for the data related to deaths to be appropriately analyzed and adjudicated, the investigator is 
required to provide SJM with the appropriate source documentation of the death such as clinic notes or 
other forms of medical records.  
 
A pre-procedure death is defined as death occurrs before the start of the ablation procedure. A peri-
procedure death is defined as death occurs after the start but on the day of the ablation procedure. A 
post-procedure death is defined as death occurs after the day of the ablation procedure. 
 
An Adverse Event CRF should be completed in addition to the Patient Death CRF only if the patient 
death is associated with an adverse event. Otherwise, if there are no AEs associated with death, the 
completion of Patient Death CRF is sufficient.  
 
The 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 Withdrawal form.  
 
The investigator must notify the EC / IRB, if appropriate, in accordance with national and local laws and 
regulations. 
8.4 
COMPLAINT 
Complaints are defined as an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance.  These include malfunctions, use errors and inadequate 
labeling.  
 
Complaint reporting to sponsor: As this is a trial utilizing a market-released product, the investigator 
should notify the SJM Postmarket Surveillance Department by emailing the information about the 
complaint to the local country office or to: complaints_amplatzer@sjm.com or calling 1 6517565400. Please 
contact the local SJM representative for any questions regarding the complaint reporting.  
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 23 of 34
 
 
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 DATA MANAGEMENT 
9.0
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. 
 
Data will be analyzed by the Sponsor and may be transferred to the Sponsor’s locations outside of China 
and/or any other worldwide regulatory authority in support of a market-approval application. 
 
St. Jude Medical respects and protects personally identifiable information that we collect or maintain. As 
part of our commitment, St. Jude Medical 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. 
 
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. 
 
9.1 
Data Management Plan 
CRF data will be captured in a validated electronic database management Oracle Clinical system hosted 
by St. Jude Medical. All received data for the study will be entered by trained and qualified St. Jude 
Medical personnel. An electronic audit trail will be used to track any subsequent changes of the entered 
data. 
 
9.2 
Document and data control 
Traceability of documents and data 
The investigator shall ensure accuracy, completeness, legibility and timeliness of the data reported to the 
sponsor on the CRFs and in all required reports. Where copies of the original source document as well 
as print outs of original electronic source documents are retained, these shall be signed and dated by a 
member of the investigation site team with a statement that it is a true reproduction of the original source 
document. 
 
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. 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 24 of 34
 
 
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without the express written consent of St. Jude Medical  
The CRFs will be signed and dated by the authorized site personnel. Any change or correction to data 
reported on a paper CRF will be dated, initialed and explained if necessary, and will not obscure the 
original entry. 
 
Review of data 
The clinical investigation will be monitored by reviewing the CRFs  approved by the investigators.  
The following activities will occur: 
 All CRFs will be reviewed for completeness and accuracy after uploading into the 
database. 
 The investigator (co-investigator) and/or delegate is notified regarding any missing or 
unclear/inconsistent data. 
 
 REGULATORY INSPECTIONS 
10.0
The investigator and/or delegate should contact St. Jude Medical 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. 
 
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 
11.0
11.1 
Statistical design, hypotheses, method and analytical procedures 
This study is an acute, prospective, non-randomized, feasibility study.  
11.2 
Sample size 
This feasibility study is expected to be conducted in the Fuwai Hospital, Beijing, China. It is designed to 
investigate 20 subjects meeting the inclusion criteria. As a feasibility study, there is no statistical-based 
sample size. Because this study does not require follow-up visits, attrition (i.e. incomplete data set due to 
deviation from protocol) is anticipated to be low - in approximately 5% of patients. In case of substantial 
drop-out rate (more than 10%), an increase in population will be conducted by amendment.  

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 25 of 34
 
 
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without the express written consent of St. Jude Medical  
11.3 
The provision for an interim analysis, when applicable 
An interim analysis may be conducted when the enrollment total count is greater than 10. 
11.4 
The treatment of missing, unused or spurious data, including drop-outs and withdrawals 
In case when a drop-out or withdrawals occurs, the subject’s data will not be included in the study result 
analysis. 
 
DOCUMENT RETENTION 
12.0
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 for a minimum of 2 years 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.   
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 
13.0
Study related documents such as, the CIP, CRFs, ICFs 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 ICF 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 informed of the changes and a new 
consent be signed and dated by the investigator 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 Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 26 of 34
 
 
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without the express written consent of St. Jude Medical  
 
INVESTIGATION SUSPENSION OR TERMINATION 
14.0
14.1 
Premature termination of the whole clinical study or of the clinical study in one or more 
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: 
 The device /  therapy fails to perform as intended 
 Occurrence of USADE which cannot be prevented in future cases 
 Sponsor’s decision 
 Recommendation from DSMB to Steering committee and Sponsor 
 Request from Regulatory bodies 
 Request of Ethics Committee(s)  
 Concern for subject safety and welfare 
 Failure to secure subject Informed Consent prior to any investigational activity 
 Failure to report unanticipated adverse device effects within 72 hours to St. Jude Medical and the 
EC 
 Repeated non-compliance with this CIP or the Clinical Trial Agreement 
 Inability to successfully implement this CIP 
 Violation of the Declaration of Helsinki 2008  
 Violation of applicable national or local laws and regulations 
 Falsification of data, or any other breach of ethics or scientific principles 
 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, St. Jude Medical may suspend the clinical study as appropriate 
while the risk is assessed.  St. Jude Medical will terminate the clinical study if an unacceptable risk is 
confirmed.   
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 27 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
St. Jude Medical 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.   
 
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 St. Jude Medical will keep each other informed of any communication received from 
IRB/EC or regulatory authority.   
 
If for any reason St. Jude Medical suspends or prematurely terminates the study at an individual 
investigational site, St. Jude Medical will inform the responsible regulatory authority, as appropriate, 
and ensure that the IRB/EC are notified, either by the Principal Investigator or by St. Jude Medical.  If 
the suspension or premature termination was in the interest of safety, St. Jude Medical will inform all 
other Principal Investigators.   
 
If suspension or premature termination occurs, St. Jude Medical 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.   
 
 
14.2 
Resuming the study after temporary suspension 
When St. Jude Medical concludes an analysis of the reasons for the suspension, implements the 
necessary corrective actions, and decides to lift the temporary suspension, St. Jude Medical 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. 
 
14.3 
Study conclusion 
The study will be concluded when: 
 All sites are closed AND 
 The Final report generated by St. Jude Medical has been provided to sites or St. Jude Medical has 
provided formal documentation of study closure 
 
 
PUBLICATION POLICY 
15.0
The results of the clinical study will be submitted, whether positive or negative for publication.  
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. 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 28 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
 
This study will be posted on ClinicalTrials.gov and results will be posted on ClinicalTrials.gov as 
required.  
 
 
BIBLIOGRAPHY  
16.0
1. Aliot EM, Stevenson WG, Mendral-Garrote JM, et al. EHRA/HRS Expert Consensus on 
Catheter Ablation of Ventricular Arrhythmias: developed in a partnership with the European 
Heart Rhythm Association (EHRA), a Registered Branch of the European Society of 
Cardiology (ESC), and the Heart Rhythm Society (HRS); in collaboration with the American 
College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm 
2009; 6:886–933. 
2. Kobayashi Y, Miyata A, Tanno K, et al. Effects of nicorandil, a potassium channel opener, on 
idiopathic ventricular tachycardia. J Am Coll Cardiol 1998; 32:1377–1383. 
3. Gill JS, Mehta D, Ward DE, et al. Efficacy of flecainide, sotalol, and verapamil in the 
treatment of right ventricular tachycardia in patients without overt cardiac abnormality. Br 
Heart J 1992;68:392–397. 
4. Borger van der Burg AE, de Groot NM, van Erven L, et al. Long-term follow-up after 
radiofrequency catheter ablation of ventricular tachycardia: a successful approach? J 
Cardiovasc Electrophysiol 2002;13:417– 423. 
5. Calkins H, Kalbfleisch SJ, el-Atassi R, et al. Relation between efficacy of radiofrequency 
catheter ablation and site of origin of idiopathic ventricular 
tachycardia. Am J Cardiol 1993;71:827– 833. 
6. Chinushi M, Aizawa Y, Takahashi K, et al. Radiofrequency catheter ablation for idiopathic 
right ventricular tachycardia with special reference to morphological variation and long-term 
outcome. Heart 1997;78:255–261. 
7. Coggins DL, Lee RJ, Sweeney J, et al. Radiofrequency catheter ablation as a 
cure for idiopathic tachycardia of both left and right ventricular origin. J Am Coll Cardiol 
1994;23:1333–1341. 
8. Zhou L, Keane D, Reed G, et al. Thromboembolic complications of cardiac radiofrequency 
catheter ablation: a review of the reported incidence, pathogenesis and current research 
directions. J Cardiovasc Electrophysiol 1999; 10:611–620. 
9. Weiss C, Willems S, Rueppel R, et al. Electroanatomical mapping (CARTO) of ectopic atrial 
tachycardia: impact of bipolar and unipolar local electrograms annotation for localization the 
focal origin. J Interv Card Electrophysiol 2001; 5:101–107. 
10. Soejima Y, Aonuma K, Iesaka Y, et al. Ventricular unipolar potential in radiofrequency 
catheter ablation of idiopathic non-reentrant ventricular outflow tachycardia. Jpn Heart J 
2004;45:749 –760. 
11. Barlow MA, Klein GJ, Simpson CS, et al. Unipolar electrogram characteristics predictive of 
successful radiofrequency catheter ablation of accessory pathways. J Cardiovasc 
Electrophysiol 2000; 11:146 –154. 
12. Ribbing M, Wasmer K, Monnig G, et al. Endocardial mapping of right ventricular outflow 
tract tachycardia using noncontact activation mapping. J Cardiovasc Electrophysiol 2003; 
14:602– 608. 
13. Azegami K, Wilber DJ, Arruda M, et al. Spatial resolution of pacemapping and activation 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 29 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
mapping in patients with idiopathic right ventricular outflow tract tachycardia. J Cardiovasc 
Electrophysiol 2005; 16:823– 829. 
14. Yamane T, Shah DC, Jais P, et al. Electrogram polarity reversal as an additional indicator of 
breakthroughs from the left atrium to the pulmonary veins. J Am Coll Cardiol 2002; 
39:1337–1344. 
15. Damle RS, Choe W, Kanaan NM, et al. Atrial and accessory pathway activation direction in 
patients with orthodromic supraventricular tachycardia: insights from vector mapping. J Am 
Coll Cardiol 1994; 23:684–692. 
16. Van Huls van Taxis, C, Wijnmaalen AP, den Uijl DW, et al. Reversed polarity of bipolar 
electrograms for predicting a successful ablation site in focal idiopathic right ventricular 
outflow tract arrhythmias. Heart Rhythm, 2011; 8:665-671. 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 30 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
APPENDIX A: ABBREVIATIONS 
 
Select or add abbreviations used 
Abbreviation 
Term 
ADE 
AE 
AF 
ASADE 
CA 
CCI 
CIP 
CRF 
CPRB 
DMP 
EC 
ECG 
EGM 
EMEA 
GP 
ICF 
ICMJE 
IRB 
ISB 
ISO 
LAT 
NA 
OTVA 
PI 
PVI 
RF 
RFCA 
RP 
SADE 
SAE 
SC  
SJM 
USADE 
WMA 
Adverse Device Effect 
Adverse Event 
Atrial Fibrillation 
Anticipated Serious Adverse Device Effect 
Competent Authority 
Clinical Coordination Investigator 
Clinical Investigational Plan 
Case Report Form 
Clinical Project Review Board 
Data Management Plan 
Ethics Committee 
Electrocardiogram 
Electrogram 
Europe, Middle East, Africa 
General Practitioner 
Informed Consent Form 
International Committee of Medical Journal Editors 
Institutional Review Board 
Investigator Site Binder 
International Organization for Standardization 
Local Activation Time 
Not Applicable 
Outflow Tract Ventricular Arrhythmia 
Principal Investigator 
Pulmonary Vein Isolation 
Radiofrequency  
Radiofrequency Catheter Ablation 
Reversed Polarity 
Serious Adverse Device Effect 
Serious Adverse Event 
Steering Committee 
St. Jude Medical 
Unanticipated Serious Adverse Device Effect 
World Medical Association 
 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 31 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
APPENDIX B: CIP REVISION HISTORY 
 
Revision History 
Amendment 
Number 
Version 
Date 
Rationale 
Details 
Not 
Applicable 
VerA 
14AUG2015 First release of CIP 
NA 
 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 32 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
Appendix C: List of Clinical Investigation Sites and IRB/EC 
Site Name:   Fuwai Hospital 
Address:       No. 167 Beilishi Road,  
Xicheng District, Beijing 
China 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 33 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
Appendix D: Sample Informed Consent 
A sample Patient Informed Consent Form will be provided under separate cover. 
 
 
 

Study Document No: SJM-CIP-100090 
Ver. A 
Study Name: EGM Analysis in Idiopathic OTVA 
CIP  
 
CRD_801_EGM OTVA_CIP_VerA                                                                                                                     Page 34 of 34
 
 
This confidential document is the property of St. Jude Medical and shall not be reproduced, distributed, disclosed or used 
without the express written consent of St. Jude Medical  
Appendix E: Case Report Forms 
The final Case Report Forms will be provided under separate cover.