AMPLATZER™ Cardiac Plug Observational Post-Approval Study
Conditions: Non-valvular Atrial Fibrillation (NVAF)
Sponsor: Abbott Medical Devices

 
 
Clinical Investigation Plan Cover Page 
 
 
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written consent of Abbott. 
87173 CIP Posting Cover Page Ver C 
Template 
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NCT Number: NCT02954237 
ACP PAS China 
AMPLATZER™ Cardiac Plug Observational Post-Approval Study 
Study Document No: SJM-CIP-10153   
Version D 
Date: 04-JUN-2018 
 
 
Sponsor 
 
 
             Abbott Medical 
                                                      5050 Nathan Lane North 
                                                      Plymouth, MN 55442 
                                                      USA 
 
 
 
 
 
 
 
 
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
Template: 86357 Rev. A 
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disclosed or used without the express written consent of St. Jude Medical 
 
Reference:  
SJM-CIP-10153 
 
 
ACP PAS China 
AMPLATZERTM Cardiac Plug Observational Post-Approval Study 
Clinical Investigation Plan (CIP) 
 
 
 
 
 
 
Sponsor 
                   St. Jude Medical Coordination Center BVBA 
The Corporate Village Da Vincilaan 11 - Box F1  
1935 Zaventem,  
Belgium 
 
 
 
 
Clinical Coordinating        Prof. Zhang Shu  
Investigator 
                   Fuwai Hospital 
North Lishi Road, Xicheng District 
Beijing 
China 
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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PRINICPAL INVESTIGATOR  
SIGNATURE PAGE 
AMPLATZERTM CARDIAC PLUG OBSERVATIONAL POST-APPROVAL STUDY  
CLINICAL INVESTIGATIONAL PLAN 
 
Version D 
Reference #: SJM-CIP-10153 
 
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:               ____________________________________ 
Clinical Site Name     ____________________________________ 
Clinical Site Number    ____________________________________ 
 
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
 
 
Coordinating Investigator 
SIGNATURE PAGE 
 
AMPLATZERTM CARDIAC PLUG OBSERVATIONAL POST-APPROVAL STUDY  
CLINICAL INVESTIGATIONAL PLAN 
Version D 
Reference #: SJM-CIP-10153 
 
 
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, etc.  
 
Printed name: 
      Prof. Zhang Shu, MD, PhD  
 
Signature: ______________________________ 
 
Date: ____________________ 
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Table of Contents 
Page 
 
Synopsis ................................................................................................................................ 8 
1.1 
STUDY CONTACTS ............................................................................................................... 14 
 
INTRODUCTION ................................................................................................................. 15 
 
Background and Justification for Clinical Study .................................................................... 15 
 
Risks and Benefits of the Clinical Study ............................................................................... 17 
4.1 
DESCRIPTION OF SUBJECT POPULATION ........................................................................ 17 
4.2 
ANTICIPATED CLINICAL BENEFITS .................................................................................... 17 
4.3 
ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS ............................ 17 
4.4 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY ........................... 17 
4.5 
RESIDUAL RISKS ASSOCIATED WITH THE DEVICE ......................................................... 17 
4.6 
STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS ........................ 17 
4.7 
RISK-TO-BENEFIT RATIONALE ............................................................................................ 18 
 
Study Design ....................................................................................................................... 18 
5.1 
PURPOSE ............................................................................................................................... 18 
5.2 
STUDY DESIGN AND SCOPE ............................................................................................... 18 
5.2.1 Number of subjects required to be included in the study ..................................................... 18 
5.2.2 Estimated time needed to enroll this subject population ...................................................... 18 
5.2.3 Justification for study design ................................................................................................. 18 
5.3 
OBJECTIVES .......................................................................................................................... 19 
5.3.1 Primary Objectives ................................................................................................................ 19 
5.3.2 Additional Objectives ............................................................................................................ 19 
5.4 
ENDPOINTS ........................................................................................................................... 19 
5.4.1 Primary Endpoints ................................................................................................................ 19 
5.4.2 Descriptive Endpoints ........................................................................................................... 20 
5.5 
INCLUSION AND EXCLUSION CRITERIA ............................................................................ 20 
5.5.1 Inclusion Criteria ................................................................................................................... 20 
5.5.2 Exclusion Criteria .................................................................................................................. 20 
5.6 
INFORMED CONSENT PROCESS ........................................................................................ 21 
 
Device ................................................................................................................................. 21 
6.1 
DEVICE DESCRIPTION ......................................................................................................... 21 
6.2 
DEVICE ACCOUNTABILITY (if applicable) ............................................................................ 22 
6.3 
DEVICE HANDLING AND STORAGE .................................................................................... 22 
 
Procedures .......................................................................................................................... 22 
7.1 
SCREENING & ENROLLMENT & BASELINE VISIT ............................................................. 25 
7.2 
IMPLANT/PROCEDURE/PRE-DISCHARGE ......................................................................... 27 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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7.3 
SCHEDULED FOLLOW-UPS ................................................................................................. 27 
7.4 
INTERIM/UNSCHEDULED VISITS ........................................................................................ 27 
7.5 
DESCRIPTION OF ACTIVITIES PERFORMED BY SPONSOR REPRESENTATIVES ........ 27 
7.6 
SUBJECT STUDY COMPLETION .......................................................................................... 27 
7.7 
CRITERIA AND PROCEDURES FOR SUBJECT WITHDRAWAL OR DISCONTINUATION 28 
 
Compliance to CIP ............................................................................................................... 28 
8.1 
STATEMENTS OF COMPLIANCE ......................................................................................... 28 
8.2 
ADHERENCE TO THE CLINICAL INVESTIGATION PLAN................................................... 29 
8.3 
REPEATED AND SERIOUS NON-COMPLIANCE ................................................................. 30 
 
Adverse Event, Adverse Device Effect, Device Deficiency .................................................. 30 
9.1 
DEFINITIONS ......................................................................................................................... 30 
9.1.1 Adverse Event (AE) .............................................................................................................. 30 
9.1.2 Serious Adverse Event (SAE) ............................................................................................... 30 
9.1.3 Adverse Device Effect (ADE) ................................................................................................ 31 
9.1.4 Serious Adverse Device Effect (SADE) ................................................................................ 31 
9.2 
PROCEDURE FOR ASSESSING, RECORDING, AND REPORTING ADVERSE EVENTS 31 
9.3 
SUBJECT DEATH ................................................................................................................... 32 
9.3.1 Procedure for recording and reporting subject death ........................................................... 32 
9.4 
DEVICE DEFICIENCY (DD)/COMPLAINTS ........................................................................... 32 
 Data Management ............................................................................................................... 32 
10.1 DATA MANAGEMENT PLAN ................................................................................................. 33 
10.2 DOCUMENT AND DATA CONTROL ..................................................................................... 33 
10.2.1 Traceability of documents and data ...................................................................................... 33 
10.2.2 Recording data...................................................................................................................... 33 
 Monitoring ............................................................................................................................ 34 
 Regulatory Inspections ........................................................................................................ 34 
 Statistical considerations ..................................................................................................... 34 
13.1 PRIMARY ENDPOINTS .......................................................................................................... 34 
13.1.1 Primary safety endpoint (Short Term) .................................................................................. 34 
13.1.2 Primary safety endpoint (Long-Term) ................................................................................... 35 
13.1.3 Primary effectiveness endpoint:............................................................................................ 36 
13.2 DESCRIPTIVE ENDPOINTS .................................................................................................. 37 
13.3 SAMPLE SIZE ......................................................................................................................... 38 
13.4 SUCCESS CRITERIA ............................................................................................................. 38 
13.5 INTERIM ANALYSIS ............................................................................................................... 38 
13.6 STATISTICAL CRITERIA FOR TERMINATION ..................................................................... 38 
13.7 DEVIATIONS FROM STATISTICAL PLAN ............................................................................ 38 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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 Document Retention ............................................................................................................ 38 
 Amendments to Clinical Investigational Plan ....................................................................... 39 
 Outsourcing of duties and functions (if applicable) ............................................................... 39 
16.1 PROJECT MANAGEMENT .................................................................................................... 39 
 Investigation Suspension or Termination ............................................................................. 39 
17.1 PREMATURE TERMINATION OF THE WHOLE CLINICAL STUDY OR OF THE CLINICAL 
STUDY IN ONE OR MORE INVESTIGATIONAL SITES ....................................................... 39 
17.2 RESUMING THE STUDY AFTER TEMPORARY SUSPENSION .......................................... 41 
17.3 STUDY CONCLUSION ........................................................................................................... 41 
 Publication Policy ................................................................................................................ 41 
 Bibliography ......................................................................................................................... 41 
Appendix A: aBBREVIATIONS ..................................................................................................... 46 
Appendix B: CIP Revision History ................................................................................................ 47 
Appendix C: DECLARATION OF HELSINKI................................................................................. 49 
Appendix D: LIST OF CLINICAL INVESTIGATION SITES ........................................................... 50 
Appendix E: SAMPLE INFORMED CONSENT ............................................................................ 51 
Appendix F: CASE REPORT FORMS .......................................................................................... 61 
Appendix G: Definitions of Potential Adverse Event ..................................................................... 62 
Appendix H: Modified Rankin Scale (mRS) .................................................................................. 64 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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 SYNOPSIS  
Title: 
AMPLATZERTM Cardiac Plug Observational Post-Approval Study 
Acronym: 
ACP PAS China  
Purpose: 
To observe the safety and effectiveness of the AMPLATZERTM Cardiac Plug 
(ACP) device in Chinese population indicated for use of AMPLATZERTM 
Cardiac Plug after its market approval by China FDA (CFDA). 
Objectives: 
Primary Objectives 
(1) To evaluate short term (0 - 7 days post-procedure) safety of 
AMPLATZERTM Cardiac Plug implantation in Chinese population 
(2) To evaluate long term safety of AMPLATZERTM Cardiac Plug 
implantation in Chinese population through 2 years 
(3) To evaluate effectiveness of AMPLATZERTM Cardiac Plug 
implantation in Chinese population through 2 years 
Additional Objectives 
(1) To evaluate the occurrence of ischemic stroke or systemic embolism 
through 
5 
years 
in 
Chinese 
population 
implanted 
with 
AMPLATZERTM Cardiac Plug  
(2) To evaluate long term safety of AMPLATZERTM Cardiac Plug 
implantation in Chinese population through 5 years 
(3) To evaluate immediate successful implantation rate of the 
AMPLATZERTM Cardiac Plug in the left atrial appendage (LAA) 
during the procedure 
Endpoints: 
Primary Endpoints 
1. Short Term Safety 
Major adverse events within 7 days after the procedure: short term 
occurrence of death, stroke (ischemic or haemorrhagic), systemic 
embolism, or procedure or device-related complications requiring 
major cardiovascular or endovascular intervention. 
2. Long Term Safety 
The 2-year occurrence of device embolization, device erosion, 
clinically significant device interference with surrounding structure, 
device thrombus, device fracture, device infection (endocarditis / 
pericarditis), device perforation, device laceration, or device allergy.  
3. Effectiveness 
The 2-year rate of the composite of ischemic stroke or systemic 
embolism 
Descriptive Endpoints 
1. Rate of ischemic stroke or systemic embolism through 5 years post-
implant 
2. Occurrence of composite of damage to blood vessel or organ or 
damage to adjacent organs at implant, device dislodgement, device 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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fracture, device erosion, or pericardial tamponade through 5 years 
post-procedure  
3. Device success rate - defined as device deployed and implanted in 
correct position 
4. Rate of closure of the left atrial appendage - defined as residual jet 
around the device of ≤ 5mm, based on the 45-day TEE 
Design: 
This is a prospective, multi-centre, single arm, post approval, observational 
study. The clinical study will be conducted at up to 35 sites in China. 
Approximately 343 subjects will be enrolled in this study. 
(1) Patients who are eligible for an ACP based on the approved 
indications can be enrolled in this study.  
(2) Each patient will be followed up for 5 years.  
(3) Baseline, procedure, and pre-discharge evaluations will be required. 
(4) Hospital visit will be required at 45 days, 6 months, 12 months and 
24 months. 
(5) The 36-, 48- and 60-month follow up visits will be conducted by 
telephone contact with proper record.  
 
The total study duration is expected to be approximately 7 years; this 
observational study will begin enrolment in Q4 of 2016.  
Per CFDA requirement, an annual report of ADE and SADE observed in this 
study will be submitted to CFDA.  
 
Testing required: 
 
Baseline evaluation: Informed consent, cardiovascular and medical 
history, 
physical 
examination, 
12-lead 
electrocardiogram 
(ECG),CHA2DS2-VASc score and individual components of the score, 
HAS-BLED score, Neuroimaging (brain MRI or CT scan), modified 
Rankin Scale and medication assessment 
 
Procedure: Transesophageal echocardiogram (TEE), Angiogram, 
medication and adverse event (AE) assessment 
 
Post procedure/Pre-Discharge: Transthoracic echocardiogram (TTE), 
medication assessment, AE assessment 
 
45day (+45 days): TEE, medication assessment, AE assessment 
 
6M (+/- 3 weeks): Medication and AE assessment  
 
12M and 24M (+/- 6 weeks): Medication and AE assessment 
 
36M, 48M and 60M(+/- 6 weeks): Phone contact follow-up for 
medication and AE assessment 
 
Interim/unscheduled visits: Per subject or physician discretion  
 
Suspected Stroke / TIA Evaluation: 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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 
All subjects suspected of a stroke should be seen by a stroke neurologist 
for evaluation and appropriate neurological testing (i.e. magnetic 
resonance imaging (MRI), computed tomography (CT)) 
 
In the event of a confirmed stroke or TIA, the modified Rankin Scale 
assessment  should be performed 90 days after the event and a TEE 
should be conducted to verify the presence of device-related thrombus 
within 14 days from the date the site becomes aware of the event  
Justification for study 
design 
A single-arm observational study is appropriate to observe the safety and 
effectiveness of the ACP device in the post-market setting in China. The 
study includes a short-term safety endpoint, a long-term safety endpoint, 
and a long-term effectiveness endpoint. 
The safety and effectiveness endpoints in this study are consistent with 
those reported for other studies or publications on left atrial appendage 
occlusion.  
The short-term safety endpoint was chosen to reflect serious procedure-
related complications during the implant procedure for the ACP device, 
resulting in either surgical or endovascular intervention. This endpoint 
appropriately 
captures 
important 
procedural 
complications 
and 
adequately characterizes the short-term safety profile of the procedure 
and the device.  
The long-term safety endpoint is set at 24 months to capture long-term 
complications associated with the ACP device. This safety endpoint is 
based on the recently released Eurointervention consensus document34 
on definitions, endpoints and data collection requirements for left atrial 
appendage occlusion clinical studies  
Finally, the effectiveness endpoint appropriately reflects the occurrence of 
types of events (ischemic stroke or systemic embolism) that the device is 
intended to prevent. This endpoint is consistent with other studies and 
publications on left atrial appendage occlusion. 
The performance goals for this study have been established primarily 
based on publications on the ACP device. Information has also been 
provided to support these performance goals based on outcomes with the 
WATCHMAN™ device. 
Additional descriptive endpoints have been specified to characterize the 
mechanism of action of the device (i.e., device closure) and the long-term 
effects of device implant through 5 years.  
Devices used: 
The AMPLATZERTM Cardiac Plug is a transcatheter, self-expanding 
device intended for use in preventing thrombus embolization from the left 
atrial appendage. The device is constructed from a nitinol mesh and 
consists of a lobe and a disc connected by a central waist. The device is 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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designed to facilitate occlusion. The lobe has stabilizing wires to improve 
device placement and retention. The device has threaded screw 
attachments at each end for connection to the delivery and loading cables. 
The device has radiopaque markers at each end and at the stabilizing 
wires. 
Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) 
Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, 
or 13 Fr) 
Study Population 
Patients who have non-valvular atrial fibrillation (NVAF) and are 
contraindicated to long-term oral anticoagulant; or patients who 
experience stroke or relevant event despite taking warfarin. 
Inclusion/Exclusion 
Criteria  
Inclusion Criteria 
• 
Patient who meets the current indications and per physician discretion 
for ACP implant  
• 
Patient who is ≥ 18 years of age at the time of enrolment. 
• 
Patient who is able to provide written Informed Consent prior to any 
study related procedures. 
Exclusion Criteria 
• 
Patient who is unable to comply with the follow-up schedule 
• 
Patient with the presence of intracardiac thrombus 
• 
Patient with active endocarditis or other infections producing 
bacteraemia 
• 
Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) 
or low risk of bleeding (HAS-BLED score<3) 
• 
Patient where placement of the device would interfere with any 
intracardiac or intravascular structures 
• 
Patient who is under medical conditions not appropriate to participate 
in the study in the opinion of the investigator 
• 
Subject with LAA anatomy that does not accommodate a device per 
the sizing guidelines 
• 
Patient who has a life expectancy of less than 2 years due to any 
condition 
• 
Patient who are currently participating in a clinical investigation that 
includes an active treatment arm. 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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• 
Patient who already had a left atrial appendage closure device 
implanted prior to the study 
Sample Size 
Estimation 
Primary Safety Endpoint(Short Term) 
The following hypothesis will be tested: 
H0: ps ≥ PGs 
H1: ps < PGs 
where ps is the proportion of subjects undergoing the ACP LAA closure 
procedure, who experience an acute safety endpoint event. ps will be 
estimated as a binomial proportion. The assumption for the primary safety 
endpoint event rate is based on outcomes in a large cohort of patients (n = 
1047) reported by Tzikas et al. In that study, a total of 52 patients 
experienced a primary safety endpoint event, which represents an event 
rate of 4.97%. The performance goal, PGs, in this hypothesis is set at 10%. 
Sample sizes are calculated assuming an event rate of 5%. The sample size 
required to reject the null hypothesis with 80% power at the 2.5% 
significance level is 231 subjects. 
 
NOTE: The definitions used for the safety endpoint in various studies 
(PROTECT-AF, PREVAIL, Tzikas et al.) are different, leading to difficulty in 
comparing results across studies and challenges in development of a 
performance goal based on event rates reported in various studies. The 
most appropriate study for development of the performance goal for this 
study is that by Tzikas et al. as it evaluated the ACP device, which is also 
being studied here. The major adverse event rate reported by Tzikas et al. 
is 4.97% and that in PREVAIL, which excluded percutaneous catheter 
drainage of pericardial effusions, snaring of an embolized device, thrombin 
injection to treat femoral pseudoaneurysm, and non-surgical treatments of 
access site complications, is 2.2%. Tzikas et al. reported short term safety 
event rates based on a broader definition of events. Since the short term 
safety endpoint in this study includes a broader definition of events, an event 
rate of 4.97% (as that reported by Tzikas et al.) is well justified for use in this 
study. The performance goal, PGs, is set at 10%, which represents a relative 
risk of 2. 
 
Primary Safety Endpoint (Long-Term) 
The following hypothesis will be tested: 
H0: pl ≥ PGl 
H1: pl < PGl 
where pl is the long-term safety endpoint event rate. pl will be estimated from 
the Kaplan-Meier method. It is assumed that the long-term safety endpoint 
event rate is 5%. The largest components of the long-term safety endpoint 
are expected to be device thrombus and device embolization. Tzikas et al. 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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reported device thrombus in 4.4% (28/632) and device embolization in 1% 
(10/1047) of patients implanted with an ACP. Kefer et al. reported no 
thrombus in 50 patients implanted with the ACP device and no embolization 
in 89 patients implanted with the ACP device. An event rate of 5% is 
assumed for the long-term safety endpoint for the ACP device, which is 
slightly lower than the overall rate of thrombus and embolization reported by 
Tzikas et al. The performance goal, PGl, is set at 10%, which represents a 
relative risk of 2. The sample size is estimated assuming an event rate of 
5%. A sample size of 231 subjects followed through 24 months will provide 
80% power at the 2.5% significance level. Assuming an attrition rate of 25% 
through 24 months, 308 subjects are required to be enrolled in the study. 
 
NOTE: The rates of thrombus and embolization reported for the ACP device 
are comparable with those reported for the Watchman device; the ASAP 
study and the PROTECT-AF trial reported thrombus rates of approximately 
4% and device embolization rates of approximately 1%.  
 
Primary Effectiveness Endpoint: 
The following hypotheses will be tested: 
H0: pe ≥ PGe 
H1: pe < PGe 
where pe is the event rate at 24 months. pe will be estimated by the Kaplan-
Meier method. The assumption for the primary effectiveness endpoint is 
based on the rate of ischemic stroke or systemic embolism reported in 
Tzikas et al. The annualized event rate reported in Tzikas et al was 2.3 per 
100 patient-years. This translates to a 24-month event rate of 4.5%. The 
performance goal, PGe is set at 9%, which represents a relative risk of 2. A 
sample size of 257 subjects followed through 24 months will provide 80% 
power at the 2.5% significance level assuming a 24-month event rate of 
4.5%. Assuming an attrition rate of 25% through 24 months, 343 subjects 
are required to be enrolled in the study.   
 
NOTE: The event rate of 2.3 per 100 patient-years assumed for the ACP 
device is consistent with the event rate observed in the PREVAIL trial.  
Sample size 
The overall sample size required for this study is 343 subjects, which is 
driven by the primary effectiveness endpoint.   
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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1.1 
STUDY CONTACTS 
 
Sponsor 
 
Helen Teng 
Room 1602 Building B 
Jiaming Center Chaoyang Dist 
Beijing  
China  
Tel +86 8775 7825 
hailing.teng@abbott.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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 INTRODUCTION 
This document is a clinical investigational plan for St. Jude Medical’s AMPLATZERTM Cardiac Plug 
(ACP) device post-approval observational study in the Chinese population. China FDA (CFDA) 
approved the ACP device in Sep 2015 and required a post-approval study of the ACP device to 
observe the safety and effectiveness of the ACP device in Chinese population indicated for use of 
ACP device after its market approval. The sponsor of this study is St. Jude Medical Coordination 
Center BVBA.  
 BACKGROUND AND JUSTIFICATION FOR CLINICAL STUDY 
Atrial fibrillation (AF) is the most common sustained heart rhythm disorder1. During AF there are 
multiple simultaneous waves of contractions, which spread in a chaotic manner through both atria. 
This arrhythmia results in rapid, uncoordinated contractions, which decrease the blood pumped 
through the atria. The loss of mechanical efficiency during AF leads to insufficient contractions in the 
left atrium (LA)2. Stagnation of blood flow in the LA leads to hypercoagulability and thus increases the 
risk for thrombus formation in the LA or left atrial appendage (LAA). Approximately 90% of all the 
thrombi in subjects with non-valvular AF (NVAF) forming in the LA originate in the left atrial 
appendage3. The thrombus formation, in turn exposes the patient to thromboembolic events. 
Echocardiographic risk factors for LAA thrombus formation include echocardiographic evidence of 
decreased LAA flow velocity and spontaneous echo contrast within the left atrium and left atrial 
appendage4,5. The normal flow pattern of the LAA is the ejection of blood from the appendage following 
atrial contraction at a velocity greater than 40cm/s2. Agmon et al. found that the relative risk reduction 
of ischemic stroke was 2.6 times greater in patients with LAA flow velocities <20cm/s2 than those with 
higher LAA velocites6. 
Non-valvular AF patients have been assessed to determine the risk of stroke based on the presence 
of independent risk factors. In a study by Gage et al. the CHADS2 index was shown to be a tool to 
predict the risk of stroke in subjects with AF7. The CHADS2 score assigns one point each for the 
presence of congestive heart failure, hypertension, age greater than 75 and diabetes mellitus and two 
points for history of stroke or transient ischemic attack (TIA). The study found that AF patients who 
were not treated with anti-thrombotic agents had an increased risk of stroke ranging from 1.9% to 
18.2% as CHADS2 scores increase from 0 to 6. 
A study by Go et al. reviewed outcome data (11,526 patients) in a large primary care setting and 
confirmed that thromboembolic risk increases progressively with CHADS2 score8. The study also noted 
that oral anticoagulation with warfarin reduces the risk of stroke in most patients with the exception of 
those at lowest risk (CHADS2 score of zero) and highest risk (CHADS2 >5) for stroke. The more recently 
developed CHA2DS2-VASc risk assessment scheme9, which identifies truly low risk subjects, assigns 
two points to age >75 years and previous stroke, TIA or thromboembolism and one point each to 
congestive heart failure or left ventricular dysfunction, hypertension, diabetes, vascular disease, age 
between 65-74 years and female sex. A recent validation10 of these risk schemes in more than 90,000 
patients without oral anticoagulation (OAC) but on aspirin showed annual ischemic stroke rates ranging 
from 0.6% in CHA2DS2-VASc = 1 to 4.8% in CHA2DS2-VASc = 4, and more than 12% for CHA2DS2-
VASc = 9. 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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In a meta-analysis conducted by Andersen et al., warfarin was found to be superior to aspirin and 
placebo in reducing the risk of systemic embolism in subjects with NVAF11. Hart et al. reported that 
adjusted dose warfarin reduces stroke risk by 64% (6 trials) and antiplatelet agents reduce stroke risk 
by 22%12. The study also reported that risk of intracranial hemorrhage was doubled with adjusted-dose 
warfarin compared with aspirin. 
Recently, new drugs (known as novel oral anticoagulant, or NOAC) have been developed with less 
dietary and pharmacological interactions than warfarin and less stringent requirements for frequent INR 
monitoring. Major trials such as RE-LY and ROCKET AF demonstrated that dabigatran and rivaroxaban 
are non-inferior to warfarin in the prevention of stroke or systemic embolism13, 14. The ARISTOTLE trial 
demonstrated apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less 
bleeding, and resulted in lower mortality in subjects with atrial fibrillation15. The ENGAGE AF-TIMI16 trial 
demonstrated both once daily dose regimens of edoxaban were noninferior to warfarin with respect to 
the preventions of stroke or systemic embolism and were associated with significantly lower rates of 
bleeding and death from cardiovascular causes17. A number of characteristics that increase a patient’s 
risk for stroke also increase the patient’s risk for bleeding, therefore an alternative to warfarin and NOAC 
drugs is needed.  
Left atrial appendage occlusion (LAAO) is considered a viable alternative to oral anticoagulation (OAC) 
therapy for stroke prevention in patients with NVAF15-25. Published evidence supporting LAAO is 
provided in large part by the major randomized controlled trials PROTECT AF and PREVAIL15-18. Five-
year results of PROTECT AF showed superiority of the WATCHMAN™ device in mortality and stroke 
reduction compared to optimal medical treatment with warfarin18. 
AMPLATZER™ Cardiac Plug device 
The ACP device (St Jude Medical, St. Paul, MN, USA) is a self-expandable nitinol device, with fixation 
anchors. The ACP device is a first generation device based on AMPLATZER occluder technology 
specifically designed for LAAO.  
The AMPLATZER Cardiac Plug demonstrated favorable feasibility and safety in observational studies 
in Europe26-28. Additionally, Park et al. reported the results of an investigator-initiated retrospective study 
to report on the initial European experience in patients treated with the AMPLATZER Cardiac Plug 
device between December 2008 and November 2009. SJM’s AMPLATZER Cardiac Plug Registry 
results were also presented at EURO PCR in 2012 and 201429-30. In addition, results from a multicenter 
study involving 22 sites and 1047 consecutive patients undergoing implant of the AMPLATZER Cardiac 
Plug device showed a high procedural success rate and a favorable outcome for the prevention of AF 
related thromboembolism31. 
In a comparative study between the AMPLATZER Cardiac Plug and the WATCHMAN devices (40 
patients each), Chun et al.32 found the devices to perform similarly. The rate of successful implantation 
achieved with the ACP device was greater than with the WATCHMAN device (100% vs. 95%) although 
the difference was not statistically significant. TEE at follow-up revealed a significantly higher incidence 
of residual peri-device flow (jet > 5 mm) for the WATCHMAN device compared to the ACP device, 
although this was not associated with an increased incidence of thromboembolic events. This finding is 
consistent with other reports on the ACP device33. 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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In conclusion, percutaneous LAAO devices have emerged as an alternate option for stroke risk reduction 
in non-valvular AF patients at high risk for stroke or not suitable for long-term oral anticoagulant. 
Certificate History 
Date 
Action 
29 September 2015 
CFDA license 
16 October 2012 
CE Mark 
 RISKS AND BENEFITS OF THE CLINICAL STUDY 
4.1 
DESCRIPTION OF SUBJECT POPULATION 
The population intended for this study is patients who have NVAF and are contraindicated to long-
term oral anticoagulant, or patients who experience stroke or relevant event despite taking warfarin. 
4.2 
ANTICIPATED CLINICAL BENEFITS 
Patients suitable to receive the ACP device should be deemed by their physician to have an 
appropriate rationale to seek an alternative to pharmocologic therapy such as the inability to tolerate 
long term OAC. The ACP device is intended to be an alternative when long term OAC therapy is 
unacceptable. A potential benefit of receiving an LAAO device is avoiding long-term OAC, thereby 
lowering the risk of bleeding.  The close follow-up by subjects‘ treating physicians is a potential benefit 
for the subject of participating in this clinical study. 
4.3 
ANTICIPATED ADVERSE EVENTS AND ADVERSE DEVICE EFFECTS 
Anticipated adverse events and adverse device effects may occur during and after the ACP device 
implant procedure. Adverse event definitions are provided in Section 9 and Appendix G. Refer to IFU 
for a complete list of potential anticipated adverse events. 
4.4 
RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL STUDY 
Risks associated with participating in this clinical study are expected to be no different from risks 
associated with undergoing ACP device implant which is a commercially available transcatheter 
device in China. 
4.5 
RESIDUAL RISKS ASSOCIATED WITH THE DEVICE 
The ACP device is market approved in China where the study will be conducted. The risk profile of 
the ACP device implant procedure is described in the IFU.  
4.6 
STEPS THAT WILL BE TAKEN TO CONTROL OR MITIGATE THE RISKS 
The Sponsor will select investigators qualified by training and experienced to participate in this study. 
Participating sites will be selected based upon qualifications of the primary investigator. During the 
study, sites may be subject to quality assurance audits by the Sponsor (or designee), as well as 
monitoring visits to assess data integrity and study compliance. Additionally, the study will have an 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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appointed SJM Clinical Safety team that will review and adjudicate all reported serious adverse events. 
The SJM Clinical Safety team will advise regarding the safety of study subjects. 
4.7 
RISK-TO-BENEFIT RATIONALE 
Risks associated with participating in this clinical study are no different from risks associated with 
undergoing LAAO implant with a commercially available transcatheter device. The close follow-up by 
subjects‘ treating physicians is a potential benefit for the subejct of participating in this clinical study.  
 STUDY DESIGN 
5.1 
PURPOSE 
To observe the safety and effectiveness of the AMPLATZER TM Cardiac Plug device in Chinese 
population indicated for use of AMPLATZER TM Cardiac Plug after its market approval by China FDA 
(CFDA). 
5.2 
STUDY DESIGN AND SCOPE 
This is a prospective, multi-centre, single arm, post-approval observational study.  
5.2.1 
Number of subjects required to be included in the study 
Approximately 343 subjects will be enrolled at up to 35 sites in China in the study (refer to section 13.0 
STATISTICAL CONSIDERATIONS). 
5.2.2 
Estimated time needed to enroll this subject population 
The total study duration is expected to be approximately 7 years, dependent on the rate of enrollment 
and the regulatory timeline. This study will begin enrolment in Q4 of 2016.  
5.2.3 
Justification for study design  
A single-arm observational study is appropriate to observe the safety and effectiveness of the ACP 
device in the post-market setting in China. The study includes a short-term safety endpoint, a long-
term safety endpoint, and a long-term effectiveness endpoint. 
The safety and effectiveness endpoints in this study are consistent with those reported for other 
studies or publications on left atrial appendage occlusion.  
The short-term safety endpoint was chosen to reflect serious procedure-related complications during 
the implant procedure for the ACP device, resulting in either surgical or endovascular intervention. 
This endpoint appropriately captures important procedural complications and adequately 
characterizes the short-term safety profile of the procedure and the device.  
The long-term safety endpoint is set at 24 months to capture long-term complications associated with 
the ACP device. This safety endpoint is based on the recently released EuroIntervention consensus 
document34 on definitions, endpoints and data collection requirements for left atrial appendage 
occlusion clinical studies  

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Finally, the effectiveness endpoint appropriately reflects the occurrence of types of events (ischemic 
stroke or systemic embolism) that the device is intended to prevent. This endpoint is consistent with 
other studies and publications on left atrial appendage occlusion. 
The performance goals for this study have been established primarily based on publications on the 
ACP device. Information has also been provided to support these performance goals based on 
outcomes with the WATCHMAN™ device. 
Additional descriptive endpoints have been specified to characterize the mechanism of action of the 
device (i.e., device closure) and the long-term effects of device implant through 5 years.  
5.3 
OBJECTIVES 
5.3.1 
Primary Objectives 
(1) To evaluate short term (0 - 7 days post-procedure) safety of AMPLATZERTM Cardiac Plug 
implantation in Chinese population. 
(2) To evaluate long term safety of AMPLATZERTM Cardiac Plug implantation in Chinese population 
through 2 years. 
(3) To evaluate effectiveness of AMPLATZERTM Cardiac Plug implantation in Chinese population 
through 2 years. 
5.3.2 
Additional Objectives 
(1) To evaluate the occurrence of ischemic stroke or systemic embolism through 5 years in Chinese 
population implanted with AMPLATZERTM Cardiac Plug  
(2) To evaluate long term safety of AMPLATZERTM Cardiac Plug implantation in Chinese population 
through 5 years  
(3) To evaluate the immediate successful implantation rate of the AMPLATZERTM Cardiac Plug in the 
left atrial appendage (LAA) 
5.4 
ENDPOINTS 
5.4.1 
Primary Endpoints 
1. Short Term Safety 
Major adverse events within 7 days after the procedure: short term occurrence of death, stroke 
(ischemic or haemorrhagic), systemic embolism or procedure or device-related complications 
requiring major cardiovascular or endovascular intervention. 
2. Long Term Safety 
The 2-year occurrence of device embolization, device erosion, clinically significant device 
interference with surrounding structure, device thrombus, device fracture, device infection 
(endocarditis and pericarditis), device perforation, device laceration, or device allergy.  
3. Effectiveness 
The 2-year rate of the composite of Ischemic stroke or systemic embolism 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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5.4.2 
Descriptive Endpoints 
1. Rate of ischemic stroke or systemic embolism through 5 years post-implant  
2. Occurrence of composite of damage to blood vessel or organ or damage to adjacent organs at 
implant, device dislodgement, device fracture, device erosion, or pericardial tamponade through 5 
years post-procedure 
3. Device success rate- defined as device deployed and implanted in correct position 
4. Rate of closure of the LAA - defined as residual jet around the device of ≤ 5mm, based on the 45-
day TEE 
5.5 
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 study (including those withdrawn from the clinical study or lost to follow-up) 
will be accounted for and documented, assigning an identification number 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. 
5.5.1 
Inclusion Criteria 
To participate in this clinical subject, the subject must meet all of the following inclusion criteria: 
• 
Patient who meets the current indications and per physician discretion for ACP implant  
• 
Patient who is ≥ 18 years of age at the time of enrolment 
• 
Patient who is able to provide written Informed Consent prior to any study related procedures. 
5.5.2 
Exclusion Criteria 
Subjects are not eligible for clinical study participation if they meet any of the following exclusion 
criteria: 
• 
Patient who is unable to comply with the follow-up schedule. 
• 
Patient with the presence of intracardiac thrombus 
• 
Patient with active endocarditis or other infections producing bacteraemia 
• 
Patient who has low risk of stroke (CHA2DS2-VASC score is 0 or 1) or low risk of bleeding 
(HAS-BLED score<3) 
• 
Patient where placement of the device would interfere with any intracardiac or intravascular 
structures 
• 
Patient who is under medical conditions not appropriate to participate in the study in the 
opinion of the investigator.  
• 
Patient with LAA anatomy that does not accommodate a device per the sizing guidelines 
• 
Patient who has a life expectancy of less than 2 years due to any condition 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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• 
Patient who are currently participating in a clinical investigation that includes an active 
treatment arm 
• 
Patient who already had a left atrial appendage closure device implanted prior to the study 
5.6 
INFORMED CONSENT PROCESS 
Prior to enrolling in the clinical study and conducting device implant procedure, all subjects will be 
consented, as required by applicable regulations and the site’s IRB/EC. Informed consent must be 
obtained from each subject prior to device implant procedure. 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 site’s IRB/EC/ consistent with the site’s IRB/EC reporting requirements.  
 DEVICE 
6.1 
DEVICE DESCRIPTION 
AMPLATZERTM Cardiac Plug (Figure 1) is a transcatheter, self-expanding device intended for use in 
preventing thrombus embolization from the left atrial appendage. The device is constructed from a 
nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to 
facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The 
device has threaded screw attachments at each end for connection to the delivery and loading cables. 
The device has radiopaque markers at each end and at the stabilizing wires. 
The ACP device is recommended for use with the AMPLATZER TorqVue® 45º x 45º Delivery Sheath. 
Refer to the Figure1 and Table 1 as below and IFU for more information about the device.  
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Figure 1:  The ACP device and key components 
 
 
A. Screw attachments 
 
 
 
 
B. Waist of device 
C. Lobe 
D. Marker Bands 
E. Stabilizing wires 
F. Platinum thread 
G. Disc 
Table 1: Model numbers and key dimensions of the ACP device and delivery system 
Part Number 
ACP Lobe/ 
Device Size 
Left Atrial Disc 
Size (mm) 
Lobe Length 
(mm) 
TorqVue Delivery 
System 
9-ACP-007-016 
16mm 
20 
6.5 
9F 
9-ACP-007-018 
18mm 
22 
6.5 
10F 
9-ACP-007-020 
20mm 
24 
6.5 
10F 
9-ACP-007-022 
22mm 
26 
6.5 
10F 
9-ACP-007-024 
24mm 
30 
6.5 
13F 
9-ACP-007-026 
26mm 
32 
6.5 
13F 
9-ACP-007-028 
28mm 
34 
6.5 
13F 
9-ACP-007-030 
30mm 
36 
6.5 
13F 
6.2 
DEVICE ACCOUNTABILITY (if applicable) 
The ACP device has been approved by CFDA and is commercially released in China. Therefore, there 
are no additional tracking requirements for this study. Information regarding opened, introduced, and 
implanted devices will be recorded in the Procedure eCRF and out of service eCRF in case of explant.   
6.3 
DEVICE HANDLING AND STORAGE 
Please refer to IFU.  
 PROCEDURES 
This study will be conducted in accordance with the clinical protocol and IFU. All persons participating 
in the conduct of the study will be qualified by education, training, or experience to perform study-
related tasks.  
The study will not commence until SJM receives written approval from the EC and relevant regulatory 
authorities, and all required documents have been collected from the participating sites. 
Figure 2 below describes the study flowchart for subject screening, consent, enrollment and follow-
up through the 5-year follow-up visit. Table 2 below outlines the testing and assessments required per 
study visit interval for subjects who are implanted with an ACP device. Table 3 below outlines the 
eCRFs to be completed for subjects and as per the recommended study visit intervals. 
A 
D 
D 
G 
B 
C 
E 
F 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Follow up of enrolled subjects (required): 
- Pre discharge 
●TTE 
●AE assessment 
●Medication assessment 
- 45 days post implant (office visit) 
●TEE 
●AE assessment 
●Medication assessment 
- 6 months (office visit) 
●AE assessment 
●Medication assessment 
- 12 months and 24 months (office visit) 
●AE assessment 
●Medication assessment 
- 36 months , 48 months and 60 months 
(phone contact) 
●AE assessment 
●Medication assessment 
Consented Screen 
Failure Subjects: 
Potential Subjects 
Informed Consent and Screening 
Enrolled Subjects– 
Successful implant 
Enrolled Subjects– 
Unsuccessful implant 
- Meets l/E criteria 
- Procedure 
●TEE 
●Angiography with 
fluoroscopy 
●Medication and AE 
assessment 
- Device successfully 
implanted 
- Meets l/E criteria  
- Dilator / delivery system 
introduced but no device 
implanted 
- Subject withdrawn 7 days 
after procedure 
 Complete 
Screening, Baseline, 
Procedure, Out of 
service, Withdrawal 
and AE CRFs 
 
- Does not meet l/E 
criteria 
- Dilator / delivery 
system not 
introduced 
- Subject not enrolled 
Complete 
Screening CRF 
Figure 2: Study flowchart for subject screening, consent, enrollment and follow-up 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Table 2: Study visits and activities 
Visits 
 
Study  
Activities 
Screening 
&Enrollment 
& Baseline 
 
Procedure 
 
Post- 
Procedure/ 
Pre-
Discharge 
45 days 
(+ 45 days) 
6M 
(+/- 3 
weeks) 
12M, 
24M 
(+/- 6 
weeks) 
 
36M,48M 
and 60M 
 (+/- 6 
weeks, 
Phone 
contact) 
Interim/ 
unscheduled 
Follow-up 
Informed 
Consent 
Process 
X 
 
 
 
 
 
 
 
- 
Physical 
examination 
- Cardiovascular 
and 
medical 
history  
- 
CHA2DS2-
VASc score  
- 
HAS-BLED 
score 
X 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
Medication3 
Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
Angiography 
 
X 
 
 
 
 
 
 
TTE 
 
 
X 
 
 
 
 
 
TEE 
X1 
X 
 
X 
 
 
 
X2 
Neuroimaging 
(brain MRI or CT 
scan) 
X4 
 
 
 
 
 
 
 
Modified Rankin 
Scale 
X 
 
 
 
 
 
 
X5 
Adverse 
Event 
Assessment 
 
X 
X 
X 
X 
X 
X 
X 
1The Baseline TEE is optional if a TEE is performed on the day of procedure to rule out the presence of 
intracardiac thrombus (including left atrial appendage thrombus) and to assess the size and shape of the LAA. 
If an exclusion is noted on the TEE and the procedure does not occur, the patient is not enrolled.  
2If stroke or TIA is confirmed, complete TEE within 14 days after the awareness of the event. 
3Assessment for antithrombotic medication 
4 Neuroimaging can be performed any time from 2 months prior to implant 
5Perform modified Rankin Scale assessment 90 days after a confirmed stroke or TIA 
  
 
Table 3: Study visits and electronic case report forms  
Visits 
  
  
eCRF 
Screening 
&Enrollment 
& Baseline 
Procedure 
Post- 
Procedure/ 
Pre-
Discharge 
45 
days 
6M 
12M 
and 
24M 
36M, 
48M 
and 
60M 
Interim/ 
unscheduled 
Follow-up 
Baseline  
X 
 
 
 
 
 
 
 
Screening 
X* 
 
 
 
 
 
 
 
Procedure 
 
X 
 
 
 
 
 
 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Visits 
  
  
eCRF 
Screening 
&Enrollment 
& Baseline 
Procedure 
Post- 
Procedure/ 
Pre-
Discharge 
45 
days 
6M 
12M 
and 
24M 
36M, 
48M 
and 
60M 
Interim/ 
unscheduled 
Follow-up 
Follow Up  
 
 
X 
X 
X 
X 
X 
X** 
Medication 
X 
 
X 
X 
X 
X 
X 
X** 
*for screening failure subject, only screening eCRF is required to be completed.  
**Complete if stroke or TIA is confirmed 
Additional eCRFs, reports and assessment noted below should be completed upon occurrence, and/or 
as applicable:  
 
Withdrawal eCRF 
 
Adverse Event eCRF  
 
Protocol Deviation eCRF 
 
Death eCRF 
 
Out of service eCRF 
 
Modified Rankin Scale (Appendix H) (complete 90 days after confirmed stroke or TIA) 
If a stroke/TIA is suspected, the subject should be seen by a stroke neurologist for evaluation and 
appropriate neurological testing (i.e. CT or MRI, and CTA or MRA). If a stroke or TIA is confirmed, the 
modified Rankin Scale eCRF should be completed 90 days after the event and a TEE is required 
within 14 days from the date the site becomes aware of the event to confirm device placement, LAA 
flow parameters and presence/absence of device-related thrombus.  
7.1 
SCREENING & ENROLLMENT & BASELINE VISIT  
The following baseline and enrollment activities are performed as part of the screening process:  
 
Informed consent process 
 
Physical examination  
 
Cardiovascular and medical History 
 
CHA2DS2-VASc score 
CHA2DS2 -VASc 
Score 
Congestive heart failure/LV dysfunction 
1 
Hypertension 
1 
Age > 75 
2 
Diabetes mellitus 
1 
Stroke/TIA/TE 
2 
Vascular disease [prior myocardial infarction, peripheral 
artery disease or aortic plaque] 
1 
Age 65-74 
1 
Sex category [i.e. female gender] 
1 
 
 
HAS-BLED score: 
HAS-BLED 
Score 
Hypertension history (uncontrolled, > 160 mmHg systolic) 
1 
Abnormal 
renal 
function/renal 
disease 
(dialysis 
transplant, creatinine > 2.6 mg/dL or > 200µmol/L) 
1 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Liver disease (cirrhosis, bilirubin > 2x normal AST/ALT/AP 
> 3x normal) 
1 
Stroke history 
1 
Bleeding, anemia, or predisposition to bleeding 
1 
Labile INR (Unstable/high INR’s, or poor time (< 60% time 
in therapeutic range) 
1 
Elderly - Age > 65 years 
1 
Drugs - Medication usage predisposing to bleeding 
(antiplatelet agents, NSAIDs) 
1 
Alcohol usage history (> 8 drinks/week) 
1 
  
 
12-lead ECG 
 
TEE (optional if a TEE is performed on the day of procedure) 
 
Antithrombotic medication assessment 
 
Neuroimaging (brain MRI or CT scan)  
 
Modified Rankin Scale 
 
The principal investigators or delegated study personnel are responsible for screening all 
potential subjects to determine subject eligibility for the study. 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. The subject is enrolled in the study when consent has been 
obtained and the dilator/delivery system is introduced.  
Enrollment information (name of the study, date of consent and enrollment criteria, etc.) will be 
recorded in the hospital records and eCRF. Complete and submit the screening eCRF in a 
timely manner (recommended within 5 days). Notification of enrollment to the sponsor will take 
place only when the sponsor receives the Screening eCRF form. 
The following terms will be used to describe potential study participants who do not fully 
implement the study:  
o Consented Screen Failure - Subjects who sign the Informed Consent Form but do not 
meet the eligibility criteria. These subjects will not be considered enrolled in the study. 
Document the enrollment information (name of the study, date of consent and 
enrollment criteria, etc.) in the hospital records; complete the Screening form.  
o Enrolled Subject – Unsuccessful implant - Subjects are enrolled but the device was 
not implanted. The subject will be withdrawn 7 days after procedure. Document the 
enrollment information (name of the study, date of consent and enrollment criteria, etc.) 
in the hospital records; The Baseline, Screening, Procedure, Out of service and 
Withdrawal eCRFs should be completed (withdrawal should occur at least 7 days after 
the attempted procedure). 
Adverse events will be reported from the time the dilator/device delivery system has been introduced 
to the time the subject concludes the study. An Adverse Event eCRF should be completed, as 
applicable. 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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7.2 
IMPLANT/PROCEDURE/PRE-DISCHARGE 
After it is verified that the subject meets preliminary study enrollment criteria, the implant procedure 
can be scheduled.  
The procedure TEE can serve as the baseline TEE to rule out the presence of intracardiac thrombus 
(including left atrial appendage thrombus) and to assess size and shape of the LAA. 
See the IFU for procedural and post-procedural instructions (refer also to Table 2). 
7.3 
SCHEDULED FOLLOW-UPS 
Scheduled office visits occur at 45 days (+45 days), 6M (+/- 3 weeks) 12M (+/- 6 weeks) and 24 M (+/- 
6 weeks) post procedure;  
Phone contact follow up visits occur at, 36M (+/- 6 weeks), 48M (+/- 6 weeks) and 60 M (+/- 6 weeks) 
post procedures. 
Refer to Table 2 for required follow-up testing and assessments. 
7.4 
INTERIM/UNSCHEDULED VISITS 
Interim/unscheduled visits will be considered those that occur in addition to the required visit interval 
schedule. If an unscheduled or interim visit occurs, an adverse event assessments eCRF or deviation 
form, as applicable should be completed to capture data collected at the visit. In the event of a 
confirmed stroke or TIA, TEE should be conducted within 14 days from the date the site becomes 
aware of the event and the modified Rankin Scale eCRF should be completed 90 days after the event. 
7.5 
DESCRIPTION OF ACTIVITIES PERFORMED BY SPONSOR REPRESENTATIVES 
Trained Sponsor personnel may perform certain study activities to ensure compliance to the clinical 
protocol. Monitoring may be performed by SJM and/or authorized designees according to the CFDA 
regulations, the monitoring plan and applicable SJM standard operating procedures and work 
instructions. Qualified monitors will ensure investigators comply with this clinical protocol and CFDA 
regulations.  
To ensure study personnel accept, understand and complete their assigned responsibilities, monitors, 
field clinical personnel, and/or clinical country managers, may perform periodic site visits during the 
course of the study. These actions will help to ensure the continued acceptability of the facilities, 
compliance to the clinical protocol and relevant regulations, and the maintenance of complete records. 
Monitoring will include review and resolution of missing or inconsistent results and source document 
verification (i.e. comparison of submitted study results to original reports) to assure the accuracy of 
the reported data. 
Sponsor representatives will periodically request source documents, resolution of discrepancies, 
submission of echocardiography imaging etc. for data cleaning and reporting purposes.  
7.6 
SUBJECT STUDY COMPLETION 
Subjects will complete their participation in the study at the 5-year follow-up visits and will return to 
receiving medical care per their physician’s recommendations. 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
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7.7 
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: 
• 
Subject refuses to continue participating in the study 
• 
Withdraw subjects who have an unsuccessful implant 7 days after the date of the attempted 
procedure. 
• 
Subject is deceased (cause must be documented) 
• 
Subject’s non-compliance 
• 
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 study charts and/or medical record. 
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 study charts and/or medical record. 
Note: If a subject misses one or more of the scheduled follow up visits (inclusive of the assigned visit 
windows), this will be considered as a missed visit. The subject may therefore still return for 
subsequent visits and will not be excluded from the study. 
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 
8.1 
STATEMENTS OF COMPLIANCE 
The study will be performed in accordance with the most current versions of the World Medical 
Association (WMA) Declaration of Helsinki and CFDA regulations and will be compliant to this 
International Standard and CFDA regulations, as appropriate. 

 
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Observational Post-approval Study  
Clinical Investigational Plan 
 
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The investigator will not start enrolling subjects or requesting informed consent from any subject prior 
to obtaining IRB/EC approval and authorization from the sponsor in writing for the study. The subject 
must sign the study informed consent form prior to implant procedure. 
If additional requirements are imposed by the IRB/EC or CFDA, 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 the sponsor, St. Jude Medical has taken up local insurance policy 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 
8.2 
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 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. Under emergency circumstances, deviations from 
the CIP to protect the rights, safety and well-being of human subjects may proceed without prior 
approval of the sponsor and the EC. Such deviations shall be documented and reported to the sponsor 
and the EC as soon as possible, but no later than 5 working days. 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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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). 
8.3 
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, ADVERSE DEVICE EFFECT, DEVICE DEFICIENCY 
9.1 
DEFINITIONS 
9.1.1 
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. 
9.1.2 
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 

 
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Observational Post-approval Study  
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• 
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. 
9.1.3 
Adverse Device Effect (ADE) 
An adverse event related to the use of the 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. 
This definition includes any event resulting from the use error or from intentional misuse of the 
investigational medical device. 
9.1.4 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
9.2 
PROCEDURE FOR ASSESSING, RECORDING, AND REPORTING ADVERSE EVENTS  
Safety surveillance within this study and the safety reporting performed both by the investigator and 
Sponsor starts as soon as the procedure begins, which is defined as the time the dilator/device delivery 
system has been introduced into the body. The safety surveillance and the safety reporting will 
continue until the last 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. 
For the purposes of this study, the following AEs will be collected: 
 
All AEs (regardless of seriousness) 
 
All SAEs (regardless of relatedness) 
 
In addition, the following event types will also be reported 
 
device embolization, device erosion, clinically significant device interference with surrounding 
structure, device thrombus, device fracture, device infection (endocarditis / pericarditis), device 
perforation, device laceration, or device allergy 
All AE data will be collected throughout the clinical study and will be reported to the Sponsor through 
the EDC system. The Investigator will record all AE on the appropriate eCRF as soon as possible, but 
no later than 5 working days of first learning of the event. 
For any SAE (including deaths) and any SADE, the investigator shall notify the Sponsor through the 
EDC system immediately (but no later than 3 working days) of the investigator’s awareness of the 
event and provide the Sponsor with all necessary documentation needed. The Sponsor will notify 
relevant regulatory authorities and all the other participating sites no later than 5 working days after 
awareness of the event. 

 
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Observational Post-approval Study  
Clinical Investigational Plan 
 
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The investigator and Institution will report SAE (including deaths) and SADE to the IRB/EC / relevant 
regulatory authorities no later than 24 hours of first learning of the event per CFDA’s regulations.  
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. Additional information may be 
requested, when required, by the Sponsor in order to support the reporting of AEs to regulatory 
authorities. 
Adverse events will be monitored by the investigator until they are adequately resolved. The status of 
the subject’s condition should be documented at each follow-up visit.  
All adverse events will be reported as per applicable regulatory requirements.  
9.3 
 SUBJECT DEATH 
9.3.1 
Procedure for recording and reporting subject death 
All subject deaths with all necessary documentation needed are to be reported to the Sponsor 
immediately upon the investigator’s awareness of the event. An Adverse Event eCRF should be 
completed and include additional detail surrounding the death and cause of death. The principal 
investigator should also record any observed device deficiencies, that may be applicable.  
9.4 
DEVICE DEFICIENCY (DD)/COMPLAINTS 
A Device Deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. 
Device deficiencies include malfunctions, use errors, and inadequate labeling. 
Device deficiencies will be reported per country reporting timeline requirements to the Sponsor and 
are recorded outside of the study database through the EPIQ Complaint system or on a Product Event 
Report Form.  
If the device deficiency involves an adverse event as described in the protocol, the Investigator shall 
notify the Sponsor by completing the AE form through EDC as applicable and must provide the 
Sponsor with all necessary documentation needed. 
If the device deficiency does not involve a reportable AE per protocol, the Investigator should notify 
the SJM Product Surveillance Department by submitting the information about the device deficiency 
to the local country office or to: Complaints_amplatzer@sjm.com or calling +1 651-756-5400 as soon 
as possible after becoming aware of the device deficiency. Please contact the local SJM 
representative to coordinate product returns as applicable. 
 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. 

 
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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 collected or maintained for 
this clinical investigation. The privacy of each subject and confidentiality of his/her information will be 
preserved in reports and when publishing any data. Confidentiality of data will be observed by all 
parties involved at all times throughout the clinical study. All data will be secured against unauthorized 
access. 
Electronic CRFs will be used in this study, as noted below and in the data management plan. Informed 
consent documents will be translated to Chinese, as applicable. If additional documentation is required 
for any reason (e.g. procedural notes for an adverse event), it is to be appropriately redacted/de-
identified prior to being sent to SJM. Source documents will be collected and translated, as needed, 
for reporting, 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. 
10.1 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 system hosted by St. Jude 
Medical. Only authorized site personnel will be permitted to enter the CRF data through the electronic 
data capture (EDC) system deployed by St. Jude Medical. An electronic audit trail will be used to track 
any subsequent changes of the entered data. 
10.2 DOCUMENT AND DATA CONTROL 
10.2.1 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.  
10.2.2 Recording data 
Source documents will be created and maintained by the investigational site team throughout the 
clinical study. 
The data reported on the eCRFs will be derived from, and be consistent with, these source documents, 
and any discrepancies will be explained in writing. 
The CRFs will be signed and dated (validated eCRF) by the authorized site personnel, as specified in 
the Data Management Plan. 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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 MONITORING  
It is the responsibility of St. Jude Medical as the sponsor of the study to ensure the study is conducted, 
recorded, and reported according to the approved protocol, subsequent amendment(s), applicable 
regulations, and guidance documents. Monitoring will be conducted according to the St. Jude Medical 
Clinical Monitoring standard operating procedure. 
Prior to beginning the study, St. Jude Medical will contact the investigator or designee to discuss the 
study and data requirements. A St. Jude Medical monitor will periodically review the subject records 
and associated source documents.  
The investigator shall make subject and study records available to the clinical monitor for monitoring.  
 REGULATORY INSPECTIONS 
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 
13.1 PRIMARY ENDPOINTS 
There are three primary endpoints: two safety endpoints and one effectiveness endpoint.  
13.1.1 Primary safety endpoint (Short Term)  
The short term safety endpoint is the proportion of subjects who experience an major adverse events 
(short term occurrence of death, stroke (ischemic or haemorrhagic), systemic embolism, or 
procedure or device-related complications requiring major cardiovascular or endovascular 
intervention) 7 days after the procedure. 
Hypothesis: 
H0: ps ≥ PGs 
H1: ps < PGs 

 
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where ps is the proportion of subjects undergoing the ACP LAA closure procedure, who experience 
an acute safety endpoint event. The assumption for the primary safety endpoint event rate is based 
on outcomes in a large cohort of patients (n = 1047) reported by Tzikas et al. In that study, a total of 
52 patients experienced a primary safety endpoint event, which represents an event rate of 4.97%. 
The performance goal, PGs, in this hypothesis is set at 10%.  
NOTE: The definitions used for the safety endpoint in various studies (PROTECT-AF, PREVAIL, 
Tzikas et al.) are different, leading to difficulty in comparing results across studies and challenges 
in development of a performance goal based on event rates reported in various studies. The most 
appropriate study for development of the performance goal for this study is that by Tzikas et al. as 
it evaluated the ACP device, which is also being studied here. The major adverse event rate reported 
by Tzikas et al. is 4.97% and that in PREVAIL, which excluded percutaneous catheter drainage of 
pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral 
pseudoaneurysm, and non-surgical treatments of access site complications, is 2.2%. Tzikas et al. 
reported short term safety event rates based on a broader definition of events. Since the short term 
safety endpoint in this study includes a broader definition of events, an event rate of 4.97% (as that 
reported by Tzikas et al.) is well justified for use in this study. The performance goal, PGs, is set at 
10%, which represents a relative risk of 2. 
Analysis Methods: 
The proportion of subjects experiencing a primary safety endpoint, ps, will be estimated from the 
binomial model. The 97.5% upper confidence bound for the proportion of subjects experiencing a 
safety event will be calculated using the exact binomial method. The 97.5% upper confidence bound 
for the proportion must be less than 10% in order to declare success. The upper confidence bound 
will be calculated using the Clopper-Pearson exact method for a binomial proportion. 
The performance goal assumes that LAA closure occurs in isolation of other cardiac procedures.  If 
the short-term primary safety endpoint is not met, then an additional analysis may be performed 
excluding subjects who had a cardiac ablation performed in combination with the ACP LAA closure 
procedure. Excluding subjects who had a cardiac ablation performed in combination with the LAA 
closure procedure may result in a substantially smaller sample size to evaluate this endpoint; 
therefore, in this additional analysis, the point estimate for the short-term primary safety endpoint 
will be descriptively compared to the performance goal, PGs.  
Sample Size Determination: 
Sample sizes are calculated assuming an event rate of 5%. The sample size required to reject the 
null hypothesis with 80% power at the 2.5% significance level is 231 subjects. 
Analysis Population: 
Enrolled subjects will be included in this analysis.  
13.1.2 Primary safety endpoint (Long-Term) 
The long-term safety endpoint is the 2-year occurrence of device embolization, device erosion, 
clinically significant device interference with surrounding structure, device thrombus, device fracture, 
device infection (endocarditis / pericarditis), device perforation, device laceration, or device allergy. 

 
Study Document No:  SJM-CIP-10153  Ver. D 
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Observational Post-approval Study  
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Hypothesis: 
H0: pl ≥ PGl 
H1: pl < PGl 
where pl is the long-term safety endpoint event rate. It is assumed that the long-term safety endpoint 
event rate is 5%. The largest components of the long-term safety endpoint are expected to be device 
thrombus and device embolization. Tzikas et al. reported device thrombus in 4.4% (28/632) and 
device embolization in 1% (10/1047) of patients implanted with an ACP. Kefer et al. reported no 
thrombus in 50 patients implanted with the ACP device and no embolization in 89 patients implanted 
with the ACP device. An event rate of 5% is assumed for the long-term safety endpoint for the ACP 
device, which is slightly lower than the overall rate of thrombus and embolization reported by Tzikas 
et al. The performance goal, PGl, is set at 10%, which represents a relative risk of 2.  
NOTE: The rates of thrombus and embolization reported for the ACP device are comparable with 
those reported for the Watchman device; the ASAP study and the PROTECT-AF trial reported 
thrombus rates of approximately 4% and device embolization rates of approximately 1%.  
Analysis Methods: 
Kaplan-Meier survival analysis will be used to estimate the event rate of at 24 months (731 days 
post implant). The 97.5% upper confidence bound for the event rate must be less than 10% in order 
to declare success. The standard error will be calculated using the Greenwood method. 
Sample Size Determination: 
The sample size is estimated assuming an event rate of 5%. A sample size of 231 subjects followed 
through 24 months will provide 80% power at the 2.5% significance level. Assuming an attrition rate 
of 25% through 24 months, 308 subjects are required to be enrolled in the study. 
Analysis Population: 
Enrolled subjects will be included in this analysis. 
13.1.3 Primary effectiveness endpoint: 
The primary effectiveness endpoint is the composite endpoint of ischemic stroke or systemic 
embolism at 2 years. 
Hypothesis: 
H0: pe ≥ PGe 
H1: pe < PGe 
where pe is the event rate at 24 months. The assumption for the primary effectiveness endpoint is 
based on the rate of ischemic stroke or systemic embolism reported in Tzikas et al. The annualized 
event rate reported in Tzikas et al was 2.3 per 100 patient-years. This translates to a 24-month event 
rate of 4.5%. The performance goal, PGe is set at 9%, which represents a relative risk of 2.  
NOTE: The event rate of 2.3 per 100 patient-years assumed for the ACP device is consistent with 
the event rate observed in the PREVAIL trial.  
Analysis Methods: 

 
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Kaplan-Meier survival analysis will be used to estimate the event rate of at 24 months (731 days 
post implant). The 97.5% upper confidence bound for the event rate must be less than 9% in order 
to declare success. The standard error will be calculated using the Greenwood method. 
Sample Size Determination: 
A sample size of 257 subjects followed through 24 months will provide 80% power at the 2.5% 
significance level assuming a 24-month event rate of 4.5%. Assuming an attrition rate of 25% 
through 24 months, 343 subjects are required to be enrolled in the study. 
Analysis Population: 
Enrolled subjects who receive an implant of the ACP device will be included in the analysis. 
13.2 DESCRIPTIVE ENDPOINTS 
The following endpoints will be summarized using descriptive statistics. 
Rate of ischemic stroke or systemic embolism through 5 years post-implant: 
Kaplan-Meier survival analysis will be used to estimate the rate of ischemic stroke or systemic 
embolism through 5 years post-implant. Subjects who receive an implant of the ACP device will be 
included in the analysis. 
Occurrence of composite of damage to blood vessel or organ or damage to adjacent organs at 
implant, device dislodgement, device fracture, device erosion or pericardial tamponade through 5 
years post-procedure : 
Kaplan-Meier survival analysis will be used to estimate the rate of occurrence of the composite of 
device dislodgement, device fracture, device erosion, pericardial tamponade, damage to blood 
vessel or organ at implant access or damage to adjacent organs through 5 years post procedure. 
Subjects who receive an implant of the ACP device will be included in the analysis. 
Device success rate- defined as device deployed and implanted in correct position: 
The count and proportion of subject with device success will be summarized. Subjects who receive 
an implant of the ACP device will be included in the analysis. 
Rate of closure of the LAA - defined as residual jet around the device of ≤ 5mm, based on the 45-
day TEE: 
The count and proportion of subject with closure of the LAA will be summarized. Subjects who 
receive an implant of the ACP device will be included in the analysis. 
Reporting: 
The following data will be summarized and reported annually to CFDA. 
• 
Investigator sites and enrollment status 
• 
Demographic and baseline characteristics 
• 
Serious Adverse events 
• 
Protocol deviation 

 
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Observational Post-approval Study  
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• 
Procedural results (procedure success, implanted device size, procedure duration) 
• 
Device closure 
13.3 SAMPLE SIZE 
The overall sample size required for this study is 343 subjects, which is driven by the primary 
effectiveness endpoint.   
To ensure enrolment balance across centers, the maximum number of subjects for each center is 
20% of the total sample size. There is no requirement for the minimum number of subjects within 
each center. 
13.4 SUCCESS CRITERIA 
The study has three primary endpoints for safety and effectiveness. All three endpoints must be met 
in order to declare success.  
13.5 INTERIM ANALYSIS 
No interim analyses are planned for this study. 
13.6 STATISTICAL CRITERIA FOR TERMINATION 
There are no statistical criteria for termination of this study. 
13.7 DEVIATIONS FROM STATISTICAL PLAN 
If any deviations from the original statistical plan occur, such deviations will be documented in the 
clinical study report or statistical report containing the analysis results. 
 
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 for a minimum of 10 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.  

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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AMENDMENTS TO CLINICAL INVESTIGATIONAL PLAN 
Study related documents such as, CIP, eCRFs, 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 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. 
 
OUTSOURCING OF DUTIES AND FUNCTIONS (IF APPLICABLE) 
The sponsor may transfer any or all of the duties and functions related to the clinical study, including 
monitoring, to an external organization (such as a CRO or individual contractor), but the ultimate 
responsibility for the quality and integrity of the clinical study will reside with the sponsor. All 
requirements applying to the sponsor will also apply to the external organization inasmuch as this 
organization assumes the clinical study related duties and functions of the sponsor. 
16.1 PROJECT MANAGEMENT 
The project management of this study will be performed by Abbott on behalf of St. Jude Medical 
Coordination Center BVBA: 
 
Abbott 
Room 1602 Building B 
Jiaming Center Chaoyang District 
Beijing 
China  
 
INVESTIGATION SUSPENSION OR TERMINATION 
17.1 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: 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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• 
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 (refer to Appendix C) 
• 
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.  
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 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
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.  
 
17.2 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. 
17.3 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 
The results of the clinical study are planned to 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. 
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 public database.  
 
BIBLIOGRAPHY  
1. Fuster V, Ryden LE, Cannom D. ACC/AFA/ESC Guidelines for the management of subjects with 
atrial fibrillation. A report of the American College of Cardiology/American Heart Association task 
force on practice guidelines and the European Society of Cardiology Committee for practice 
guideline (writing committee to revise the 2001 Guidelines for management of subjects with atrial 
fibrillation). Am Coll Cardol. 2006 48:e149. 
2. Ostemayer SH, Reisman M, Kramer PH, Matthews RV, Gray WA, Block PC, Omran H, Bartorelli 
AL, et al. Percutaneous left atria appendage occlusion (PLAATO SYSTEM) to prevent stroke in 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
high risk subjects with non-rheumatic atrial fibrillation: results from the international multicenter 
feasibility trials. J AM Coll Cardiol. 2005 Jul 5; 46 (1): 9-14. 
3. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical subjects with 
atrial fibrillation. Ann Thorac Surg. 1996; 61:755-9. 
4. Stollberger C, Schneider B, Finsterer J. Elimination of the left atrial appendage to prevent stroke 
or embolism? Anatomic, physiologic, and pathophysiologic considerations. Chest 2003; 
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5. Miller VT, Rothrock JF, Pearce LA, Feinberg WM, Hart RG, Anderson DC, Ischemic stroke in 
subjects with atrial fibrillation: effect of Aspirin according to stroke mechanism. Stroke prevention 
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6. Agmon Y, Khandheria BK, Gentile F, Seward JS. Echocardiographic assessment of the left atrial 
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7. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical 
classification schemes for predicting stroke: results from the national registry of atrial fibrillation. 
JAMA. 2001; 285(22):2864-70. 
8. Go AS, Hylek EM, ChangY, Phillips KA, Henault LE, Capra AM, Jensvold NG, Selby JV, Singer 
DE. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials 
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9. Lip G, Nieuwlaat R, Pisters R, Lane D, Crijns H. Refining clinical risk stratification for predicting 
stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the 
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bleeding in 182,678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur 
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11. Andersen LV, Vestergaard P, Deichgraeber P, Lindholt JS, Mortensen LS, Frost L. Warfarin for 
the prevention of systemic embolism in subjects with nonvalvular atrial fibrillation: a meta-analysis. 
Heart. 2008; 94(12):1607-13 
12. Hart RG, Pearce LA, Aguilar MI. Adjusted-dose warfarin versus aspirin for preventing stroke in 
subjects with atrial fibrillation. Ann Intern Med. 2007; 147(8):590-2. 
13. Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgre J, Yang S, Alings M, 
Kaatz S, Hohnloser SH, Diener HC, Franzosi MG, Huber K, Reilly P, Varrone J, Yusuf S. Risk of 
bleeding with two doses of dabigatran compared with warfarin in older and younger patients with 
atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-
LY) Trial. Circulation. 2011; 123(21): 2363-2372. 
14. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey 
GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KAA, Califf RM, and the 
ROCKET AF steering committee for the ROCKET AF investigators. Rivaroxaban versus warfarin 
in nonvalvular atrial fibrillation. N Engl J Med 2011; 365:883-891. 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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15. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell 
J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes 
M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, 
Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; 
ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial 
fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92.  
16. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz 
MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, 
Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. N Engl J Med. 
2013 Nov 28;369(22):2093-104.  
17. Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbiner M, Mullin CM, Sick P; PROTECT 
AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for 
prevention of stroke in patients with atrial fibrillation: A randomized non-inferiority trial. Lancet 
2009; 374:534-42. 
18. Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage 
closure: results from the Watchman left atrial appendage system for embolic protection in patients 
with AF (PROTECT AF) clinical trial and the continued access registry. Circulation. 2011; 123:417-
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19. Holmes DR, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective 
randomized evaluation of the Watchman left atrial appendage closure device in patients with atrial 
fibrillation versus long-term warfarin therapy: The PREVAIL trial. J Am Coll Cardiol. 2014; 64:1-
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20. Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Kar S, Halperin J, Whisenant 
B, Swarup V, Holmes D. Long term results of PROTECT AF: The mortality effects of left atrial 
appendage closure versus warfarin for stroke prophylaxis in AF. Heart Rhythm Society 2013 
Scientific Sessions; May 9, 2013; Denver, Co. 
21. Gangireddy Sr, Halperin JL, Fuster V, Reddy VY. Percutaneous left atrial appendage closure for 
stroke prevention in patients with atrial fibrillation; an assessment of net clinical benefit. Eur Heart 
J. 2012; 33:2700-8. 
22. Park HW, Bethencourt A, Sievert H, Santoro G, Meier B, Walsh K, Lopez-Minquez JR, Meerkin 
D, Valdes M, Ormerod O, Leithauser B. Left atrial appendage closure with AMPLATZER cardiac 
plug in atrial fibrillation: Initial European experience. Catheter Cardiovasc Interv. 2011; 77:700-6. 
23. Urena M, Rodes-Cabau J, Freixa X, Saw J, Webb JG, Freeman M, Horlick E, Osten M, Chan A, 
Marquis JF, Champagne J, Ibrahim R. Percutaneous left atrial appendage closure with the 
AMPLATZER cardiac plug device in patients with non-valvular atrial fibrillation and 
contraindications for anticoagulation therapy. J Am Coll Cardiol. 2013; 62:96-102. 
24. Meerkin D, Butnaru A, Dratva D, Bertrand OF, Tzivoni D. Early safety of the AMPLATZER cardiac 
plug for left atrial appendage occlusion. Int J Cardiol. 2013; 168:3920-5. 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
25. Nietlspach F, Gloekler S, Krause R, Shakir S, Schmid M, Khattab AA, Wenaweser P, Windecker 
S, Meier B. AMPLATZER left atrial appendage occlusion single center 10-year experience. 
Catheter Cardiovasc Interv. 2013; 82:283-9. 
26. Bartus K, Han FT, Bednarek J, Myc J, Kapelak B, Sadowski J, Lelakowski J, Bartus S, Yakubov 
SJ, Lee RJ. Percutaneous left aptrial appendage suture ligation using the LARIAT device in 
patients with atrial fibrillation: initial clinical experience. J Am Coll Cardiol. 2013; 62:108-18. 
27. Camm AJ, Lip GY, De Caterina R, Savelieve I, Atar D, Hohnloser SH, Hindricks G, Kirchof P: 
ESC Committee for Practice Guidelines (CPG). The 2012 focused update of the ESC guidelines 
for the management of atrial fibrillation. Developed with the special contribution of the European 
Heart Rhythm Association. Eur Heart J. 2012; 33-2719-47. 
28. Park JW, Bethencourt A, Sievert H, Santoro G, Meier B, Walsh K, Lopez-Minquez JR, Meerkin D, 
Valdés M, Ormerod O, Leithäuser B. Left atrial appendage closure with AMPLATZER cardiac plug 
in atrial fibrillation: Initial European experience. Catheterization and Cardiovascular Interventions, 
2011; 77: 700–706. 
29. Walsh K, Sievert H, Lickfett L, Omran H, Hennen B, Schraeder R, Garcia E, Park JW, Schillinger 
W, Lopez-Minguez JR, Valdes M, Ormerod O, Neuzil P, Hildick-Smith D, Lezaun R: Left atrial 
appendage closure with the AMPLATZER cardiac plug: Results of the European post-market 
observational study. Presented at EURO PCR May 2012. 
30. Sievert H, Park JW, Schillinger W, Lickfett L, Lopez-Minquez JR, Omran H, Walsh K, Ormerod O, 
Neuzil P, Schraeder R, Hildick-Smith, D: Long-term follow-up from a left atrial appendage 
occlusion European multicentre post market observational study. Presented at EURO PCR May 
2014. 
31. Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-
Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbäcker T, Kanagaratnam P, Nietlispach F, Aminian 
A, Kasch F, Freixa X, Danna P, Rezzagh M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim 
R, Schillinger W, Meier B, Park JW. Left atrial appendage occlusion for stroke prevention in atrial 
fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2015 
Jan 22;10(10). 
32. Chun K, Bordignon S, Urban V, Perotta L, Dugo D, Furnkranz A, et al. Left Atrial Appendage 
Closure Followed by Six weeks Antithrombotic Therapy – a Prospective Single Center 
Experience. Heart Rhythm. 2013(10):1792-1799. 
33. Gloecker S, Shakir S, Doblie J, Khattab A, Praz F, Guerios E, Koermendy D, Stortecky S, et al. 
Early results of First versus Second generation AMPLATZER Occluders for Left Atrial Appendage 
Closure in Patients with Atrial Fibrillation. Clinical Research in Cardiology. 2015: Published online 
March 2015. 
34. Tzikas A, Holmes DR, Gafoor S, Ruiz CE, Blomström-Lundqvist C, Diener HC, Cappato R, Kar 
S, Lee RJ, Byrne R, Ibrahim R, Lakireddy D, Soliman O, Näbauer M, Schneider S, Brachman J, 
Saver JL, Tiemann K, Sievert H, Camm J, Lewalter T. Percutaneous left atrial appendage 

 
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Observational Post-approval Study  
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
occlusion: the Munich consensus document on definitions, endpoints and data collection 
requirements for clinical studies. LAAO Consensus Document.  
 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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APPENDIX A: ABBREVIATIONS 
 
Select or add abbreviations used 
Abbreviation 
Term 
ADE 
AE 
ANZ 
ASADE 
CA 
CCI 
CIP 
CRF 
CPRB 
DD 
DMP 
EC 
ECG 
eCRF 
EDC 
EMEA 
GP 
IB 
ICMJE 
IRB 
ISB 
ISO 
MP 
NA 
PI 
POA 
RDC 
SADE 
SAE 
SC  
SJM 
USADE 
WMA 
Adverse Device Effect 
Adverse Event 
Australia – New Zealand 
Anticipated Serious Adverse Device Effect 
Competent Authority 
Clinical Coordination Investigator 
Clinical Investigational Plan 
Case Report Form 
Clinical Project Review Board 
Device Deficiency 
Data Management Plan 
Ethics Committee 
Electrocardiogram 
Electronic Case Report Form 
Electronic Data Capture 
Europe, Middle East, Africa 
General Practitioner 
Investigator Brochure 
International Committee of Medical Journal Editors 
Institutional Review Board 
Investigator Site Binder 
International Organization for Standardization 
Monitoring Plan 
Not Applicable 
Principal Investigator 
Power of Attorney 
Remote Data Capture 
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-10153  Ver. D 
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Observational Post-approval Study  
Clinical Investigational Plan 
 
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APPENDIX B: CIP REVISION HISTORY 
 
Revision History 
Amendment 
Number 
Version 
Date 
Rationale 
Details 
Not 
Applicable 
A 
28JUN2016 
First release of CIP 
NA 
 
B 
31AUG2016 
As required in the CFDA license, add 
event “pericardial tamponade” and 
“device erosion” in 2nd descriptive 
endpoints; 
For Study Population in the CIP, copy 
the indications in the CFDA license and 
keep using “contraindicated for long-
term oral anticoagulant…”; 
Specify the contraindications in the 
exclusion criteria according to the IFU; 
Add “Patient who already has been 
exposed to another investigational 
product” into exclusion criteria; 
Add the baseline brain CT or MRI and 
provide reimbursement; 
Update the information of Delivery 
Sheath recommended for use with ACP; 
Medication assessment will be in a 
separate eCRF form due to data point 
requirement; 
Revise the confidentiality section of the 
ICF according to the SOP “ICF 
development tool”. 
Refer to 
the CIP. 
 
C 
15Feb2017 
For keeping consistent with CFDA 
approved indications of ACP, modify the 
wording of study population by using 
“relevant” to replace “thromboembolic” in 
the CIP 
 
Modify one of the exclusion criteria 
“Patient who already has been exposed 
to another investigational product” to 
“Patient who are currently participating in 
a clinical investigation that includes an 
active treatment arm.” 
 
Add “Patient who will have cardiac 
ablation in the same procedure as LAAO 
implantation” into exclusion criteria 
Refer to 
CIP 

 
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Observational Post-approval Study  
Clinical Investigational Plan 
 
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Extend the time window of 45-day follow 
up visit from “+ 2 weeks” to “+ 45 days”. 
 
Specify the time window of baseline 
neuroimaging test. 
 
Update the device deficiency-reporting 
requirement. 
 
Remove the steering committee. 
 
Remove the name of the insurance 
company from the informed consent 
form. 
Add Modified Ranking Scale 
assessment at baseline visit and up to 
90 days after a confirmed stroke or TIA 
 
D 
02/05/2018 
Remove exclusion criterion, “Patient who 
will have cardiac ablation in the same 
procedure as LAAO implantation” 
 
 
 
 

 
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Observational Post-approval Study  
Clinical Investigational Plan 
 
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Appendix C: DECLARATION OF HELSINKI 
The 2013 version of the Declaration of Helsinki is available at: 
http://www.wma.net/en/20activities/10ethics/10helsinki/. Please check the website during the course 
of the study for updated revisions most current version. 
 
 

 
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Observational Post-approval Study  
Clinical Investigational Plan 
 
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Appendix D: LIST OF CLINICAL INVESTIGATION SITES  
A list of Clinical Investigational sites will be kept under a separate cover and is available upon request.  
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Appendix E: SAMPLE INFORMED CONSENT 
INFORMED CONSENT FORM 
 
STUDY TITLE AND NUMBER:  
AMPLATZERTM Cardiac Plug Observational Post-Approval
Study (CRD_881) 
SPONSOR: 
St. Jude Medical Coordination Center BVBA (SJM) 
PRINCIPAL INVESTIGATOR: 
______________________________________________ 
SITE NAME: 
______________________________________________ 
Introduction  
This form explains why this research study is being done and what your role will be if you decide to 
participate in this research study. This form also talks about the possible risks that may happen if you 
take part in this research study. The study is sponsored by SJM. This company manufactures medical 
devices to treat various medical conditions. 
 
Please read this form, and ask your study doctor any questions you may have about the study so your 
questions are answered before you decide if you want to take part in the study. Please take your time 
and talk about this information with your family, friends, or family doctor.  
 
This consent form may contain some words that you do not understand. It is important that you 
understand what is in this form. It will explain the different activities you will be asked to do or 
participate in if you take part in the study and what the risks might be; whether or not you do take part 
is entirely your choice. Please ask the study doctor or the study staff to explain any words or 
information that you do not understand. 
 
If you decide you want to take part in the study, you will be asked to sign the consent section before 
any study-specific activities are performed. By signing this form you are telling us that you: 
• 
Understand what you have read 
• 
Consent to take part in the study  
• 
Consent to have the tests and treatments that are described 
 
• 
Consent to the use of your personal and health information as described. 
 
Taking part in this study is entirely voluntary. If you do not wish to take part, you do not have to. You 
will receive the best possible care whether or not you take part in the study. Refusing participation will 
not involve any penalty or loss of benefit. If you decide to take part in this study, you must sign your 
name at the end of this form. No study activity can be performed until you sign this form. 
 
What is the purpose of this study? 
The purpose of the AMPLATZERTM Cardiac Plug Observational Post-approval Study (ACP PAS 
China) is to observe the safety and effectiveness of the ACP device in Chinese population indicated 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
for use of ACP after its market approval by China FDA (CFDA). Data collected for the study will be 
used to assess closure of the left atrial appendage and complications after the procedure, and the 
percentages of stroke and systemic embolism. The purpose of the study is also to evaluate the 
success rate of the ACP device implant. 
 
Why am I being invited to take part in this study? 
You are being asked to take part in this study because your doctor has determined you have 
nonvalvular atrial fibrillation and are not suitable for long-term oral anticoagulant, or you experienced 
stroke or relevant event despite taking warfarin.  
 
Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers 
of the heart (ventricles) and cause them to beat in a regular way. During atrial fibrillation, the electrical 
signals in your heart are abnormal and cause the upper chambers of the heart to beat too fast and 
irregularly. 
 
This irregular beating of the heart leads to a slowing of the blood flow in the upper chambers of the 
heart. In the left upper chamber there is a small pouch called the left atrial appendage (LAA). Slowing 
of blood, especially in the LAA, may cause blood clots to form. Blood clots can move from the LAA 
and travel to the brain, causing a stroke or transient ischemic attack (TIA), also called a ministroke. 
These blood clots can also travel to other parts of the body and block blood vessels.  
 
The commercially available ACP could be beneficial to you because it may decrease the chance of a 
new blood clot forming and moving from your heart’s left atrial appendage to other parts of your body. 
Figure 1 shows the ACP device in its final position in the LAA. 
 
Figure 1.  Placement of the ACP device in the left atrial appendage 
 
Your doctor has given you this form to tell you about the AMPLATZERTM Cardiac Plug Observational 
Post-Approval Study and to ask for your consent to participate. Once you understand the study and 
agree to take part, your signature on the last page of this form documents your willingness to 
participate. 
 
What is the device being tested?  

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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The ACP device is a self-expanding device which is made from a nitinol mesh and has a lobe and a 
disc connected by a central waist. The lobe has small wires that help keep the device in place. The 
device has screw attachments at each end so it can be delivered to the heart. The device has special 
metal bands at each end that allow it to be seen on fluoroscopy, which is a kind of x-ray. The ACP 
device has CFDA approval and is commercially available in CHINA. 
 
 
 
A. Screw attachments 
 
 
 
 
B. Waist of device 
C. Lobe 
D. Marker Bands 
E. Stabilizing wires 
F. Platinum thread 
G. Disc 
 
Figure 2.  The ACP device and its key components 
 
What will be requested from you if you take part in this research study? 
The tests done for the study are part of standard of care for atrial fibrillation patients who will receive 
an ACP device and would be done even if you were not in the study.  There are no experimental 
procedures in this study. Your doctor will report adverse events to the Sponsor and the appropriate 
regulatory authorities. Table 1 describes study activities and procedures 
 
Table 1.  
Study Activities/Procedures 
Visits 
 
Study  
Activities 
Screening 
&Enrollment 
& Baseline 
 
Procedure 
 
Post- 
Procedure/ 
Pre-
Discharge 
45 
days 
(+45 
days) 
6M 
(+/- 3 
weeks) 
12M, 
24M 
(+/- 6 
weeks) 
36M,48M 
and 60M 
(+/- 6 weeks, 
Phone 
contact) 
Interim/ 
unscheduled 
Follow-up 
Informed Consent 
Process 
X 
 
 
 
 
 
 
 
- Physical 
examination 
- Cardiovascular 
and medical 
history 
- CHA2DS2-VASc 
score  
- HAS-BLED 
score 
X 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
Medication3 
Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
Angiography 
 
X 
 
 
 
 
 
 
A 
D 
D 
G 
B 
C 
E 
F 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Visits 
 
Study  
Activities 
Screening 
&Enrollment 
& Baseline 
 
Procedure 
 
Post- 
Procedure/ 
Pre-
Discharge 
45 
days 
(+45 
days) 
6M 
(+/- 3 
weeks) 
12M, 
24M 
(+/- 6 
weeks) 
36M,48M 
and 60M 
(+/- 6 weeks, 
Phone 
contact) 
Interim/ 
unscheduled 
Follow-up 
TTE 
 
 
X 
 
 
 
 
 
TEE 
X1 
X 
 
X 
 
 
 
X2 
Neuroimaging 
(brain MRI or CT 
scan) 
X4 
 
 
 
 
 
 
 
Modified 
Rankin 
Scale 
X 
 
 
 
 
 
 
X5 
AE Assessment 
 
X 
X 
X 
X 
X 
X 
X 
 
1The Baseline TEE is optional if a TEE is performed on the day of procedure to rule out the presence of 
intracardiac thrombus (including left atrial appendage thrombus) and to assess the size and shape of the LAA. 
If an exclusion is noted on the TEE and the procedure does not occur, the patient is not enrolled. 
2If stroke or TIA is confirmed, complete TEE within 14 days after the awareness of the event. 
3Assessment for antithrombotic medication 
4 Neuroimaging can be performed any time from 2 months prior to implant  
5Perform modified Rank Scale assessment 90 days after a confirmed stroke or TIA 
 
 
Screening/Baseline Evaluation  
This research study includes a screening/baseline evaluation to determine if you are a candidate for 
the study. Your doctor or other study personnel will ask you medically related questions.  
Your data from the following tests will be collected after you agree to be part of this study and sign this 
document. These tests are common tests for someone with atrial fibrillation, and might be performed 
even if you do not join this study:  
• 
Physical examination 
• 
Cardiovascular and medical history 
• 
12-lead electrocardiogram - used to measure the electrical activity of the heart by placing 
electrodes on the chest, arms, and legs 
• 
CHA2DS2-VASc – a set of questions used to assess the level of risk for stroke 
• 
HAS-BLED scale – a set of questions used to assess the level of risk for bleeding events 
• 
Transoesophageal echocardiography (TEE) – used to show how well your heart chambers and 
valves are working and to detect possible blood clots in the heart, and in the sac around your heart  
o Note the Baseline TEE is optional if a TEE is performed the day of procedure 
• 
Modified Rankin Scale – a commonly used scale for measuring the degree of disability or 
dependence in the daily activities of people who have suffered a stroke or other causes of 
neurological disability 
• 
Neuroimaging (brain MRI or CT scan) – brain MRI is a painless test that takes pictures of your 
head/brain using magnetic field and radio waves. Brain CT scan is a painless test that takes 
pictures of your head/brain using X-ray images.  

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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• 
Medication assessment – you will be asked to confirm which antiplatelet and blood-thinning 
medications you are taking 
Once all study required tests have been completed, your doctor will decide if you qualify to take part 
in the AMPLATZERTM Cardiac Plug Observational Post-Approval study. If you do not qualify for the 
study, your participation will end and you will not be enrolled in the study.   
 
Procedure  
If you meet all of the inclusion criteria and none of the exclusion criteria, you will be scheduled for the 
ACP implant procedure which takes about 1-2 hours. If you are taking antiplatelet or blood-thinning 
medications, your doctor will tell when you should stop them before your implant procedure. 
Conscious sedation (medicine that will make you relaxed and sleepy yet awake) or general anesthesia 
(medicine that will make you sleep) will be used. Your doctor will first perform a TEE of your heart to 
determine the size of your LAA, and to ensure there are no blood clots in your heart. 
Transoesophageal echocardiography (TEE) is a test that uses sound waves to create high-quality 
moving pictures of the heart and its blood vessels. Your doctor will not continue with the procedure if 
the TEE shows your LAA is not suitable for the implant or if there is a thrombus (blood clot) in your 
heart. Your doctor may decide you do not need the ACP or that another type of surgery or commercially 
available device would be better for you. If you meet any of the exclusion criteria during the procedure, 
you will not be enrolled in the study. 
If your doctor determines you meet all of the inclusion criteria and none of the exclusion criteria, a 
small incision will be made in your groin area to insert a delivery catheter through a vein in your leg. A 
catheter is a sterile, flexible, hollow tube that is put into a blood vessel to let fluids in or out of your 
body, or to deliver medical devices to your heart. The doctor will make a small puncture through your 
septum (the muscular tissue that separates the two sides of the upper heart), in order to gain entry 
into the upper left heart chamber to place the ACP.  
You are considered enrolled in the study when consent is signed and dilator/delivery system is 
introduced in your body. An appropriately sized ACP will be passed through the catheter and placed 
in your LAA. To ensure the ACP is placed correctly in your LAA, your doctor will use routine 
measurements such as angiography and TEE. Angiography is a medical imaging technique used to 
visualize the inside of blood vessels and organs of the body, with special interest in the arteries, veins, 
and the heart chambers. This is done by injecting a radio-opaque contrast agent into the blood vessel 
and imaging using x-ray based techniques such as fluoroscopy. After your doctor is satisfied with the 
position of the device, the catheter is removed. The ACP will remain permanently in your heart. Over 
time, the tissue in your body will cover and grow around the device to further hold it in place. After the 
procedure, you may have some minor pain in the groin area where the catheter was inserted.  
If you meet all of the inclusion and none of the exclusion criteria, and dilator/delivery system is 
introduced but you did not receive the device (unsuccessful implant), you will be followed for 7 days. 
Your participation will then end and you will be withdrawn from the study. 
 
Pre-Discharge Visit 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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You may be kept overnight for observation after the procedure. A pre-discharge transthoracic 
echocardiography (TTE) will be done to assess for any post procedure complications and to verify the 
position of the device in your heart. A TTE is another type of echocardiogram that uses high-pitched 
sound waves sent through a transducer (a hand-held plastic instrument which looks like a microphone) 
that is placed on different areas of your chest. The transducer picks up echoes of the sound waves as 
they bounce off the different parts of your heart and turns them into moving pictures of your heart that 
can be seen on a video screen. Your health and medication status will be assessed. If you are 
discharged on antiplatelet medication, it is recommended you take aspirin for six months and 
Clopidogrel following the routine standard of care. Your doctor will determine when you should 
discontinue antiplatelet medications or warfarin. If you discontinue any of these medications before 
your 6 month visit, you should tell your doctor.  
 
Follow-up Visits 
It is important to keep all follow-up appointments scheduled for you. The study requires in clinic follow-
up visits about 45 days, 6, 12 and 24 months after your procedure. These visits take approximately 
half a day. During these visits you will be asked about your health and the medications you are taking. 
You will also undergo a TEE at your 45-day visit to make sure your ACP has not moved and has 
closed your LAA.  
The study requires telephone visits at 3, 4 and 5 years after your procedure. The telephone visits will 
take about 30 minutes. Your doctor or nurse will call you and ask about your health and the 
medications you are taking.  
You will be notified of your discontinuation date, which could occur a minimum of 5 years after your 
procedure date depending on the duration of the study. 
Interim/Unscheduled Visits 
If you are seen by your doctor in addition to the recommended visits listed in Table 1, you will be 
asked about your health and the medications you are taking.  
If you had a stroke or TIA, a Modified Rankin Scale assessment will be performed about 90 days after 
the event to assess the degree of your disability and dependence in daily activities.  You are required 
to have a TEE if you have a stroke or TIA. You may be seen by a neurologist and additional testing 
may be performed. The results from the TEE will be used to make sure the ACP is still in the correct 
location and that your LAA is closed. 
How long will the study last and how many will take part? 
If you agree to take part in this research study, your involvement will last 5 years. About 343 people 
will take part in this research study at about 35 sites in China.  
What are the possible risks and discomforts? 
There are risks, discomforts, and inconveniences associated with any study to you (or to an embryo, 
unborn child or nursing infant if you become pregnant). These deserve careful thought. The risks are 
listed below but will vary from person to person. There may be other risks that are unknown at this 
time. You should talk with your study doctor if you have any questions. 
Risks with Baseline and Follow-Up Testing  

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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You may experience some anxiety when asked about your health, medications, and neurological 
status. You may be inconvenienced by traveling to the study site for your study visits. 
Risks and Complications with the Implant Procedure and the study device 
Your doctor will explain the risks and discomforts of the implant procedure and the risks of the 
commercially available ACP. Your participation in this research study should not involve additional 
risks. 
New findings  
Your doctor will discuss with you important new information that is learned during the course of this 
study that may affect your condition or willingness to continue to take part in this research study. You 
will also be informed of the reasons for changes to the clinical protocol. If you decide to withdraw due 
to the new findings, your doctor will arrange the necessary steps for your care to continue outside of 
the study. 
What are the risks for women of childbearing age? 
If you are pregnant, if you become pregnant, or if you are breast-feeding during this study, you or your 
child may be exposed to radiation. Subjects who become pregnant while taking part in the study should 
tell their study doctor right away. Care should be taken to minimize the radiation exposure. 
Residual Risks 
The overall events from a risk perspective are similar with respect to minimally invasive implantable 
therapy. Complication rates are within expected ranges and the risk/benefit profile is similar to 
alternative therapies. 
What are the possible benefits to you or others? 
If you decide to take part in this study and have an ACP implanted, you may not need to be on long-
term oral anticoagulation therapy.   
The close follow-up by your treating physicians is a potential benefit of participating in this clinical 
study. 
The information gathered in this study may benefit others by adding to the understanding of treatment 
options for patients with nonvavular atrial fibrillation.  
If you do not want to take part in this research study, what other options are available to you? 
If you choose not to participate in this study at this time, your doctor will discuss other options available 
to you. Treatment options may include the use of commercially available devices including the ACP 
outside of the study, surgery and/or drugs to prevent the occurrence of blood clots, which can cause 
stroke, or not having any treatment at all. 
If you choose to take part in this study, what are the costs? 
There is no extra cost for participating in this study, but the standard costs for the ACP LAA Occlusion, 
the procedure and the follow-up visits, which are standard of care will be covered by your medical 
insurance plan as usual.  
Will you receive payment for taking part in this research study? 
You may be eligible for reimbursement ( 200 RMB for each office visit ) to help cover the costs of travel 
expenses associated with each follow-up visit required in protocol and the reimbursement to help 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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cover the standard cost of Neuroimaging (brain MRI or CT scan) at baseline visit. The protocol required 
telephone follow-up is not a visit entitled to such reimbursement. 
What if the device needs to be removed? 
In the event your ACP or any part has to be removed, it may be returned to SJM for analysis. Should 
you withdraw from this study and choose to have your ACP or any part of it removed, the cost will be 
your responsibility. 
In the event of your death, your implanted ACP may be removed and returned to the sponsor for 
analysis. The study doctor will get your family’s approval prior to removing the device.  
Insurance 
To compensate for financial loss due to study-related damage to health, the manufacturer has 
concluded legally prescribed clinical trial insurance coverage for all subjects. During the period of the 
clinical trial other medical treatment should only take place in consultation with the investigator, with 
the exception of emergency situations. Upon suspicion of study-related damage to health, you must 
immediately notify the treating investigator so that he can inform the insurance office on your behalf. 
You can expect to receive a copy of the report. 
What if you are injured because of this study? 
If you suffer any injuries, illnesses, or complications as a direct result of the device issue or as a direct 
result of participation in this study, the Sponsor will take the responsibility according to the laws. 
During the study, if you experience any injuries, illnesses, or complications from taking part in this 
research study, please contact Dr. ______________ at ___________. 
What are your rights if you decide to take part or stop participation in this research study? 
Your signature on this consent form means that you have received information about this research 
study and that you agree to be a part of the research study.  
You may stop taking part in the research study at any time without penalty or loss of benefits to which 
you are otherwise entitled. If you wish to stop taking part in this research study for any reason, you 
should contact Dr. _____________ at___________.  
If you withdraw your consent during the study, the study doctor and relevant study staff will not collect 
additional personal information from you, although personal information already collected will be 
retained to ensure that the results of the research study project can be measured properly and to 
comply with the law. You should be aware that data collected by the Sponsor up to the time you 
withdraw will be part of the study results. 
Your study doctor or designee will discuss with you what follow-up is required if you decide to withdraw, 
or are withdrawn from the research study before the study is finished. The Sponsor can suspend or 
prematurely terminate the study for safety, business purposes, or other reasons. 
How will your information be kept confidential? 
To help keep your medical file and personal information confidential, only certain authorized people 
will have access to your records. These include the researchers in your hospital who are part of this 
study, the Sponsor, its affiliates and representatives of SJM that perform study-related services in the 
United States (U.S.), Europe and other countries, the regulatory authorities and/or the ethical 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
committees, insofar as this relates to this study. The goal of this access is to follow-up on the study 
progress, to verify the study data and procedures, and to ensure that the information collected for this 
study is accurate. Your study doctor or one of his/her colleagues will supervise the access to your 
personal records.  
Your personal data will be key-coded using a unique patient number before they are processed with 
the purpose not to permit your identification, except if necessary for the purpose of the trial or for 
regulatory obligations. Your coded study data will be processed manually as well as by computer and 
analyzed during and after the study.  
Your coded personal data may be transferred outside of the European Economic Area, including to 
the U.S., for purposes that include, without limitation, processing, monitoring, auditing and control of 
the study or the conduct of inspections by the relevant authorities, medical product development, 
additional scientific analysis of the study data and obtaining approval to use and market medical 
products resulting from, or related to the study. Your coded study data may be transferred to other 
countries where data protection laws may not be as strict as in your own country. However, SJM has 
taken security measures to ensure your identity will not be disclosed. 
You have a right to access your personal data and to have any justifiable corrections made. If you 
wish to do so, you should request this to your study doctor. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will include 
a summary of the results. You can search this Web site at any time. 
By signing the Patient Informed Consent form, you authorize the Sponsor to use the information 
obtained during the study for scientific communications and publications in medical journals without 
disclosing your name and any other information that could identify you. By signing, you also agree that 
your General Practitioner may be informed of your participation in this study unless you specifically 
request not to do so. 
Who can you contact for study information? 
If you have any questions about the study or taking part in this research study, or if you have suffered 
a study-related injury, please contact Dr. ______________ at ___________. 
 
In addition, if you have any concerns, complaints or questions about your rights as a research study 
participant or an injury that you believe is a study-related, please contact the EC: 
 
Name of EC: 
 
EC phone number: 
 
EC email, if known: 
 
 
Consent and authorization for participation in this research study 
Taking part in this research study is entirely voluntary. You are making a decision on whether or not 
to take part in the research study. Your signature indicates that you have read the information in this 
form and have decided to take part in the research study. You will be given a signed copy of this form 
to keep.  

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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disclosed or used without the express written consent of St. Jude Medical 
 I have read all of the above information in this consent and authorization form. I have had the 
opportunity to ask questions and have received answers concerning areas I did not 
understand.  
 I willingly give my consent to participate in this study and to comply with the procedures related 
to it. 
 I confirm that my relevant anonymized personal data collected during the study will be used in 
the analysis and communicated in publications. 
 I understand that I am free to refuse to participate in the proposed study, without giving any 
reason and without my medical care or legal rights being affected. 
 I understand that I am free to withdraw from the proposed study at any time, without giving any 
reason, without my medical care or legal rights being affected. 
 I give my permission to representatives from the sponsor, [the ethics committee] and the 
regulatory authorities to access my medical records. 
 I understand that my personal physician will be informed of my participation in this research 
study. 
 
Name of Participant
(please print): 
Signature 
Date 
 
Name of Person Obtaining
Consent (please print) 
Signature 
Date 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Appendix F: CASE REPORT FORMS 
Final Case Report Forms may be sent under separate cover with other study documentation / 
information to clinical sites. 
 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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Appendix G: Definitions of Potential Adverse Event 
 
Air Embolus – symptomatic event resulting from the introduction of air into the circulatory 
system 
 
Allergic reaction – idiosyncratic reaction to the device implanted or to nickel 
 
Anesthesia reaction – undesired reaction to anesthetic agent 
 
Arrhythmia – cardiac rhythm disturbance 
 
Bleeding –see Appendix H  
 
Cardiac arrest – failure of the heart to contract 
 
Cardiac tamponade – constriction of the heart causing inefficient contraction resulting from 
accumulation of excess fluid in the pericardium 
 
Death – permanent cessation of all vital bodily functions  
 
Device embolization – movement of the device from its intended location 
 
Device migration – movement of the device within its intended location 
 
Embolic event – acute vascular insufficiency or occlusion of the extremities or any non-
central nervous system organ associated with clinical, imaging, surgical/autopsy evidence 
of arterial occlusion in the absence of other likely mechanism (e.g., trauma, atherosclerosis, 
or instrumentation). When there is presence of prior peripheral artery disease, angiographic 
or surgical or autopsy evidence is required to show abrupt arterial occlusion 
 
Fever – defined as a body temperature > 37.5 or 38.3 °C (99.5 or 100.9 °F)[ 
 
Foreign body embolization – movement of device material, delivery system material, or 
other material from its intended location 
 
Hypotension – sustained systolic blood pressure < 90 mmHg 
 
Hypertension – systolic blood pressure of > 160 mmHg 
 
Infection – invasion and growth of a pathogenic organism within the body  
 
Multi-Organ Failure – the failure of two or more systems, such as the cardiovascular and 
renal systems, and is a common consequence of sepsis (the presence of bacteria in the 
blood) and of shock (very low blood pressure) 
 
Myocardial infarction (heart attack) – the death of heart muscle from the sudden blockage 
of a coronary artery by a blood clot  
 
Perforation – physical penetration of a vessel or the myocardium 
 
Pericardial effusion – abnormal fluid collection around the heart without hemodynamic 
compromise 
 
Renal failure/dysfunction – inability of kidneys to perform normal functions 
 
Respiratory failure – inability of the lungs to perform normal functions  
 
Seizure – uncontrolled electrical activity in the brain, which may produce a physical 
convulsion, minor physical signs, thought disturbances, or a combination of symptoms 
 
Significant Residual Flow – flow > 5 mm jet into the LAA 
 
Stroke – an acute episode (lasting > 24 hours) of focal or global neurological dysfunction 
caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. 
Strokes are characterized as follows35:  
o Ischemic Stroke: an acute episode of focal cerebral, spinal, or retinal dysfunction 
caused by infarction of the central nervous system tissue. Hemorrhage may be a 

 
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Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
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consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke 
with hemorrhagic transformation and not a hemorrhagic stroke.  
o Hemorrhagic Stroke: an acute episode of focal or global cerebral or spinal 
dysfunction caused by intraparenchymal, intraventricular, or subarachnoid 
hemorrhage 
o Undetermined Stroke: an acute episode of focal or global neurological dysfunction 
caused by presumed brain, spinal cord, or retinal vascular injury as a result of 
hemorrhage or infarction but with insufficient information to allow categorization as 
ischemic or hemorrhagic stroke 
 
Thrombus Formation – a blood clot 
 
Transient Ischemic Attack (TIA)– a transient episode (lasting ≤ 24 hours) of focal 
neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute 
infarction on brain imaging 
 
Valvular regurgitation/insufficiency – backflow of blood during contraction of the heart; 
caused by a defective heart valve 
 
Vascular access site injury – damage at vascular access site (e.g., AV fistula, hematoma, 
and aneurysm) 
 
Vessel Trauma/Injury – traumatic injuries that damage an artery or vein 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Document No:  SJM-CIP-10153  Ver. D 
Study Name:  AMPLATZERTM Cardiac Plug 
Observational Post-approval Study  
Clinical Investigational Plan 
 
Template: 86357 Rev. A 
Page 64 of 64 
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 H: Modified Rankin Scale (mRS) 
 
Subject Identifier: ______________________________ 
Rater Name: __________________________________ 
Date: ________________________________________  
 
 
Score 
        Description_______________________________________________________ 
0 
No symptoms at all 
 
1  
 
No significant disability despite symptoms; able to carry out all usual duties and  
activities 
 
2 
Slight disability; unable to carry out all previous activities, but able to look after own 
affairs without assistance 
 
3  
 Moderate disability; requiring some help, but able to walk without assistance 
 
4 
Moderately severe disability; unable to walk without assistance and unable to 
attend to own bodily needs without assistance 
 
5 
Severe disability; bedridden, incontinent and requiring constant nursing care and 
attention 
 
6 
Dead 
 
TOTAL (0-6):    _____