Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study
Conditions: Atrial Fibrillation
Sponsor: Sarawak Heart Centre

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CONFIDENTIAL 
PROPERTY OF CARDIOLOGY DEPARTMENT, SHC 
May not be used, divulged, or otherwise disclosed without the consent of Cardiology 
Department, Sarawak Heart Centre. 
STUDY TITLE 
Left Atrial Appendage Occlusion with The AmplatzerTM 
AmuletTM Device: The Southeast Asia Observational 
Study  
Protocol Number 
: 01 
Protocol ID 
 
: Amulet-SEA-01 
Authors 
 
: Dr. Koh Keng Tat1, Dr. Oon Yen Yee1, Dr. Saravanan Krishinan2, 
Professor Yoga Yuniadi3,4, Dr. Satchana Pumprueg5, Dr. Ivandito Kuntjoro6, Professor Santoso 
Teguh7, Dr. Mann Chandavimol8, Associate Professor Dr. Alan Fong Yean Yip1,9, Dr. Ong Tiong 
Kiam1, Professor Thorsten Lewalter10 
 
1Department of Cardiology, Sarawak Heart Centre, Malaysia 
2Department of Cardiology, Hospital Sultanah Bahiyah, Malaysia 
3Pusat Jantung Nasional Harapan Kita, Indonesia 
4Rumah Sakit Mitra Keluarga Kelapa Gading, Indonesia 
5Siriraj Hospital, Thailand 
6National University Hospital, Singapore 
7Medistra Hospital, Indonesia  
8Ramathibodi Hospital, Thailand 
9Clinical Research Centre, Sarawak General Hospital 
10Department of Cardiology and Intensive Care, Peter Osypka Heart Center, Germany 
 
Document type 
: Project Protocol 
Document status 
: Final  
Protocol Version No. : 1.2 
Release date  
: 27-Oct-2022 
Study funding  
: St. Jude Medical, Abbott 
 

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This protocol is accompanied by/ incorporates the following amendment(s): 
Amendment no. 
Changes 
Reason 
Version 1.1 
Section 12 Confidentiality  
 
Section 
13.3 
Database 
management and structure 
 
To clarify that the data will not 
be shared with the funder or 
other third parties. 
Addition of new section, to 
clarify that the data will not be 
shared with the funder or other 
third parties.  
Version 1.2 
Section 3 Eligibility  
 
Section 
13.2 
Study 
documentation and record 
keeping 
Clarification on the inclusion 
criteria 
Clarification on the duration 
of record keeping after study 
completion.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of contents 
Study title…………………………………………………………………………..…… 
1 
List of abbreviations……………………………………………………………….…… 
5 
Protocol summary………………………………………………………………………. 
6 
Schematic of study design……………………………………………………………… 
8 
1. Background………………………………………………………………………...… 
9 
2. Study objectives……………………………………………………………………… 
9 
3. Eligibility criteria……………………………………………………………………. 
10 
     3.1 Inclusion Criteria………………………………………………………………..       10 
     3.2 Exclusion Criteria……………………………………………………………….       10 
4. Study design…………………………………………………………………………. 
11 
     4.1 Study description…………………………………………….……………….…. 
11 
     4.2 Study outcomes………………………………………………………….…….... 
11 
5. Study duration………………………………………………………………………...     11  
     5.1 Early termination.…………………………………………………………….….      11 
     5.2 Criteria for Suspending or Terminating Study…………………………………..      12 
6. Study interventions…………………………………………………………………...      12 
     6.1 AmplatzerTM AmuletTM..…………………………………………………………      12 
7. Study evaluations/procedures…………………………………………………………      12 
     7.1. Clinical evaluations………………………………………………………………     12 
     7.2 Laboratory evaluations and specimen collection………………………………....     12 
     7.3 Case Report Form (CRF)………………………….…………….……………….      12 
     7.4 Permitted or Non-Permitted Medication……………………………..…………...     12 
8. Statistical considerations………………………………………………………………     13 
     8.1 Details of statistical analysis …………………………….………………….........     13 
     8.2 Sample size …………………………….…………………………………….......      13 
9. Assessment of safety……………………………………………………………….….     13 
     9.1 Serious Adverse Events (SAEs) Definitions……………………………………..      13 
     9.2 Anticipated Adverse Device Effects……………………………………………..      14 
     9.3 Reporting of SAE…………………………………………………………………     14 
     9.4 Follow-up of SAE………………………………………………………………...     14 
10. Ethics and regulatory considerations………………………………………………....     14 
11. Informed consent process…………………………………………………………….     14 
12. Confidentiality…………………………………………………………………….….     15 
13. Data management………………………………………………………………….…     15 
 
     13.1 Data collection……………………………………………………………….…..     15 
     13.2 Study documentation and record keeping……………………………………......     15 
     13.3 Database management and structure……………………………………………..     15     
14. Procedure of handling withdrawal……………………………………………………   16 
 

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15. Risk of procedure……………………………………………………………………..   16 
16. Study Funding………………………………………………………………………….   16 
17. Publication Policy……………………………………………………………………..    16 
     17.1 Authorship Selection……………………………………………………………..     16 
     17.2 Review and Communication Guidelines…………………………………………     17 
18. References…………………………………………………………………………….   18 
19. Appendix……………………………………………………………………………...     19 
Signature Page Principal Investigator………………………………………………….....     20 
 

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List of abbreviations  
 
 
AF 
 
Atrial Fibrillation 
CT 
 
Computed Tomography 
ECG  
Electrocardiogram 
ICE 
 
Intracardiac echocardiogram 
IRB 
 
Institutional Review Board 
LAAO  
Left Atrial Appendage Occlusion 
mRS  
Modified Rankin Scale 
MRI 
 
Magnetic Resonance Imaging 
NICL  
Non-invasive Cardiac Laboratory 
OAC  
Oral anti-coagulants 
REB 
 
Research Ethics Board 
SHC 
 
Sarawak Heart Centre 
TIA 
 
Transient Ischemic Attack 
TOE 
 
Transesophageal Echocardiogram 
TTE 
 
Transthoracic Echocardiogram 
 
 

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Protocol Summary 
Full Title 
Left Atrial Appendage Occlusion with The AmplatzerTM AmuletTM Device: 
The Southeast Asia Prospective Observational Study  
Short Title 
SEA AmuletTM Study 
Principal Investigator 
Dr. Koh Keng Tat 
Sponsor 
Sarawak Heart Centre 
Funder 
St. Jude Abbott Medical 
Primary Objective 
To explore on the short-term and long-term (1 year) safety and efficacy of LAA 
occlusion with the AmplatzerTM AmuletTM Device in the Southeast Asia 
population on a real-world basis.  
Secondary Objectives 
To compare the practice of LAA occlusion with AmplatzerTM AmuletTM Device 
in Southeast Asia population with the European registries.  
Exploratory Objectives 
Cost effectiveness of LAA occlusion with the AmplatzerTM AmuletTM Device in 
the Southeast Asia. 
Study Population 
All-comer study for patients indicated for LAA occlusion with AmplatzerTM 
AmuletTM Device according to the international guidelines 
Study Design 
Multicenter, observational study 
Sample Size 
100 patients 
Accrual Period 
12 months recruitment + 1-year follow-up. 
Study Duration 
Start Date: 1 October 2022 
End Date: 1 October 2024 
Inclusion Criteria 
1. 18 year of age or older 
2. Documented paroxysmal, persistent, or permanent non-valvular atrial 
fibrillation 
3. At high risk of stroke or systemic embolism defined as CHA2DS2-
VASc score of more than or equal to 3.  
4. Deemed suitable for LAA occlusion by the treating physician, who 
might or might not be the investigator.  
5. Able to comply with the required medication regimen post-device 
implant 
6. Able and willing to return for required follow-up visits and examinations 
Exclusion Criteria 
1. With active endocarditis or other infections producing bacteremia 
2. Where placement of the device would interfere with any intracardiac or 
intravascular structures 
3. Reversible cause of AF (i.e. secondary to thyroid disorders, acute 
alcohol intoxication, trauma, recent major surgical procedures) 
4. Hypersensitivity to any portion of the device material or individual 
components of the Amulet LAA closure device 
5. Actively enrolled or plans to enroll in a concurrent clinical study in 
which the active treatment arm may confound the results of this trial 
6. Presence of other anatomic or comorbid conditions, or other medical, 
social, or psychological conditions that, in the investigator’s opinion, 
could limit the patient’s ability to participate in the clinical trial or to 

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comply with follow up requirements, or impact the scientific soundness 
of the clinical trial results. 
Outcomes 
Safety: 
i. 
All-cause and cardiovascular mortality  
ii. 
Bleeding events 
iii. 
Pericardial effusion 
iv. 
Device dislocation and device related thrombus 
v. 
Access site complication 
 
Efficacy: 
i. 
All cause and cardiovascular mortality 
ii. 
Ischemic stroke or transient ischemic attack 
iii. 
Systemic embolization 
iv. 
Occurrence of leak at the device supporting incomplete occlusion of 
the LAA. 
 
Secondary outcomes 
To compare the following with the European registries: 
i. 
Indication for LAA occlusion 
ii. 
Rate of technical and procedural success 
iii. 
Practice of antiplatelet and anticoagulation therapy 
Study Intervention 
Device 
AmplatzerTM AmuletTM Left Atrial Appendage Occlusion Device 
Assessments 
Subjects will be followed through 1 year post implant. 
Required Testing 
• 
Baseline evaluation: Informed consent, history and physical, 12-lead 
electrocardiogram (ECG), CHA2DS2-VASc score, HAS-BLED score, 
Modified Rankin Scale (mRS), medication assessment. Pre-procedural 
Imaging planning with TOE or CT scan 
• 
Procedure: TOE or ICE only when combined with baseline/pre-
procedural imaging, and adverse event assessment 
• 
Post procedure/Pre-discharge: TTE, medication assessment, adverse 
event assessment 
• 
1M to 3M: TOE or CT scan, medication assessment, adverse event 
assessment 
• 
6M (+/- 2 weeks): TOE or CT scan, medication and AE assessment 
• 
12 (+/- 6 weeks): Medication and adverse event assessment 
• 
Interim/unscheduled visits: per physician discretion 
 
 
 

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Baseline visit 
• 
Informed consent 
• 
Demographics and concomitant medications 
• 
Indication for LAA occlusion 
• 
Medical history (mRS, CHA2DS2-VASc score, HAS-BLED score) 
• 
12-lead ECG and echocardiogram 
• 
Pre-procedural imaging with CT scan or TOE  
AmplatzerTM AmuletTM LAAO implant 
• 
Procedural setting and time 
• 
ICE or TOE guided 
• 
Transeptal puncture/sheath/vascular ultrasound 
• 
Number of attempt/changing of device size 
• 
Immediate success and adverse events 
Pre-discharge 
• 
Duration of hospital stay 
• 
Adverse events 
• 
Medications (antiplatelet and OAC) 
1-month to 3-month 
• 
TOE or CT Scan 
• 
Medication assessment 
• 
Efficacy and safety endpoints assessment 
6-month (+/- 2 weeks) 
• 
TOE or CT Scan 
• 
Medication assessment 
• 
Efficacy and safety endpoints assessment 
12-month (+/- 6 weeks) 
• 
Medication assessment 
• 
Efficacy and safety endpoints assessment 
*interim/unscheduled visit per physician discretion 

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1. BACKGROUND 
The safety and efficacy of left atrial appendage occlusion (LAAO) with the AmplatzerTM 
AmuletTM occluder device has been well studied in the European population. This include the 
LAARGE registry (n=641) and the prospective global observational study from the Amulet 
Observational Study Investigators (n=1088).(1, 2) In the LAARGE registry, bleeding events was 
the main indication for LAAO implantation (79.4%). There were 163 (25.7%) of the LAAO 
implanted with AmplatzerTM AmuletTM. Overall, the LAARGE registry demonstrated a favorable 
outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%). On the 
other hand, the Amulet Observational Study was able to demonstrate a reduction of 67% of 
ischemic stroke rate compared to the predicted risk. Closure was complete in 98.4% and device 
related thrombus was only seen in 1.6%.  
 
While the registry studies from the European countries showed a favorable efficacy and safety 
outcomes, there is no data on LAAO with AmplatzerTM AmuletTM from the Asia population. The 
WASP registry, which was comparing LAAO implantation with WATCHMAN device in Asian 
population found that the efficacy of LAAO with WATCHMAN was more pronounced in Asian 
population.(3) Asian population also has a larger LAA ostium diameter and hence required a larger 
LAAO device. The interaction and the influence of the demographic, genetic, health economy, and 
clinical practice in Asia population on the efficacy and safety of AmplatzerTM AmuletTM device is 
unknown. Knowing that Asia population is equivalent to 59.76% of the total world population, it 
is therefore imperative to have a regional study on the safety and efficacy of LAAO with 
AmplatzerTM AmuletTM in the Southeast Asia region. 
  
2. STUDY OBJECTIVES 
The primary objectives of this study:  
To explore on the short-term and long-term (1 year) safety and efficacy of LAA occlusion with the 
AmplatzerTM AmuletTM Device in Southeast Asia population on a real-world basis  
 
The secondary objectives are: 
To compare the practice of LAA occlusion with AmplatzerTM AmuletTM Device in Southeast Asia 
population with the European registries. 

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The exploratory objective: 
To explore the cost effectiveness of LAA occlusion with the AmplatzerTM AmuletTM Device in 
the Southeast Asia. 
 
3. ELIGIBILITY CRITERIA 
This is an all-comer observational study and therefore all patients indicated for LAAO with the 
AmplatzerTM AmuletTM are eligible for the study. Subjects who meet criteria for eligibility will be 
asked to participate. Since this observational study is both retrospective and prospective, subjects 
who had their occluder implanted, been recently implanted or intended to undergo the procedure 
may be considered to participate in the study. Informed consent will be obtained for data collection 
purposes.  
 
3.1 Inclusion Criteria 
 
• 
18 year of age or older 
• 
Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation 
• 
At high risk of stroke or systemic embolism defined as CHA2DS2-VASc score of more than or 
equal to 3.  
• 
Deemed suitable for LAA occlusion by the treating physician, who might or might not be the 
investigator.  
• 
Able to comply with the required medication regimen post-device implant 
• 
Able and willing to return for required follow-up visits and examinations 
3.2 Exclusion Criteria 
• 
With active endocarditis or other infections producing bacteremia 
• 
Where placement of the device would interfere with any intracardiac or intravascular structures 
• 
Reversible cause of AF (i.e. secondary to thyroid disorders, acute alcohol intoxication, trauma, 
recent major surgical procedures) 
• 
Hypersensitivity to any portion of the device material or individual components of the Amulet LAA 
closure device 
• 
Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm 
may confound the results of this trial 
• 
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological 
conditions that, in the investigator’s opinion, could limit the patient’s ability to participate in the 
clinical trial or to comply with follow up requirements, or impact the scientific soundness of the 
clinical trial results. 
 

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4. STUDY DESIGN 
4.1 Study Description 
This is a both prospective and retrospective, multicenter observational study for all patient 
indicated for LAAO with the AmplatzerTM AmuletTM device. 
4.2 Study Outcomes 
Primary outcome: 
Safety: 
i. 
All-cause and cardiovascular mortality  
ii. 
Bleeding events 
iii. 
Pericardial effusion 
iv. 
Device dislocation and device related thrombus 
v. 
Access site complication 
Efficacy: 
i. 
All cause and cardiovascular mortality 
ii. 
Ischemic stroke or transient ischemic attack 
iii. 
Systemic embolization 
iv. 
Occurrence of leak at the device supporting incomplete occlusion of the LAA. 
 
Secondary outcomes 
To compare the following with the European registries: 
i. 
Indication for LAA occlusion 
ii. 
Rate of technical and procedural success 
iii. 
Practice of antiplatelet and anticoagulation therapy 
 
Exploratory outcome: 
To explore on the cost effectiveness of LAAO with AmplatzerTM AmuletTM in the region. 
 
 
5. STUDY DURATION 
The study duration is 12 months of recruitment plus 1 year follow-up for outcomes. Each study 
subject’s participation will last approximately 1 year, including the follow-up for outcomes and 
adverse events.  
5.1 Early Termination 
Participation of this study is entirely voluntary. Not participating in this study will not change 
current standards of care, which are consistent with National Guidelines and international 

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standards. Patients have full autonomy to withdraw from the study if they are unwilling to continue 
the study for whatsoever reasons throughout the study period. 
Before a subject is declared lost to follow-up, all efforts should have been made to contact the 
patient for a final assessment. 
5.2 Criteria for Suspending or Terminating Study 
Not applicable. This is an observational study and not an interventional study, the study aims to 
collect data of patients who had undergone the treatment, undergoing the treatment or will undergo 
the treatment. All the patients are managed under standard of care.  
 
6. STUDY INTERVENTIONS 
6.1 AmplatzerTM AmuletTM LAAO Device 
The AmplatzerTM AmuletTM LAAO 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. Polyester patches are 
sewn into both the lobe and disc 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 that permit Visibility during fluoroscopy. 
 
7. STUDY EVALUATIONS/PROCEDURES 
7.1 Clinical Evaluations 
Data including demographics, CHA2DS2VASc score and HASBLED risk score and other medical 
history, surgical history, routine laboratory investigations, and medications will be collected 
during the screening. 
7.2 Laboratory Evaluations and Specimen Collection 
Not applicable. All blood investigations are as for routine clinical practice. 
7.3 Case Report Form (CRF) 
Please refer to Appendix. 
7.4 Permitted or Non-permitted Medication 

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Medication assessments will be conducted at pre-discharge and all follow-ups. Patients will be 
assessed whether to be prescribed with anticoagulant or/and antiplatelet medications such as 
aspirin, clopidogrel, unfractionated heparin, LMW heparin, warfarin, dabigatran, rivaroxaban, 
apixaban and endoxaban, at various duration. The dose and planned duration will be determined 
by the investigator. There is no non-permitted medication which needs to be avoided by the patient 
after the implant.  
All concomitant cardiac medications, at the time of screening, loading dose, and each visit will be 
recorded in the Case Report Form (CRF).  
 
8. STATISTICAL CONSIDERATIONS 
8.1 Details of statistical analysis 
Descriptive statistics includes percentage, mean with standard deviation, or median with 
interquartile range will be reported, whichever appropriate. Categorical variables will be analysed 
using chi-square test or Fisher’s exact test. Continuous variables will be analysed using 
independent (two variables only) or ANOVA test (more than two variables), or Mann-Whitney 
test (two variables only) or Kruskal-Wallis test (more than two variables) depending on the nature 
of underlying distributions.  Time dependent outcome data will be analysed using Kaplan-Meier 
survival analysis.  
 
8.2 Sample size 
A sample size of 100 patients for the study. This is based on the estimated number of recruitments 
from the participating centers. 
 
9. ASSESSMENT OF SAFETY 
The investigator will monitor the occurrence of Serious Adverse Events (SAEs) for each subject 
during the study. For the purpose of this protocol, adverse events will be assessed from the date of 
informed consent form is signed until up to the end of follow-up.   
9.1 Serious Adverse Events (SAEs) Definitions 
An AE is defined as 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. Lack of drug effect is not an adverse event. 
An AE is classified as “serious” if the event: 

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• Led to death;  
• Led to serious deterioration of a patient that: 
- 
Resulted in a life-threatening illness or injury; 
- 
Resulted in a permanent impairment of a body structure or a body function; 
- 
Required in subjects hospitalization or prolongation of existing hospitalization; 
- 
Resulted in medical or surgical intervention to prevent permanent impairment to a body 
structure or a body function. 
• Led to foetal distress, foetal death or a congenital abnormality or birth defect. 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
study protocol, without serious deterioration in health, is not considered a serious adverse event. 
9.2 Anticipated Adverse Device Effects 
Anticipated adverse device effects are described in the Instruction For Use. 
 
9.3 Reporting of SAE 
The investigator must record all serious adverse events, regardless of treatment or relationship to 
study therapy, as soon as he/she is informed of the event. Investigators must report immediately to 
the Principal Investigator any serious adverse events. 
 
9.4 Follow-up of SAE 
Any serious and or unexpected adverse event should be medically well documented, and the 
information made available as soon as possible.  
 
10. ETHICS AND REGULATORY CONSIDERATIONS 
A copy of the protocol (including protocol amendments), all versions of informed consent forms, 
other information to be completed by participants such as survey instruments or case report forms, 
and any proposed advertising/ recruitment materials must be reviewed and approved by the 
REB/IRB approval and annual Continuing Review throughout the duration of the study. 
 
11. INFORMED CONSENT PROCESS 
Informed consents will be obtained for all prospective data collection. Consent forms describing 
in detail the study intervention, study procedures and risks will be given to each participant and 
written documentation of informed consent is required prior to starting study intervention. 
Participants must sign an informed consent document that has been approved by a participating 
centre’s IEC/IRB if he/she agrees to participate in this study. Each participant should have 
sufficient opportunity to discuss the study and consider the information in the consent process 

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prior to agreeing to participate. Participants may withdraw consent at any time during the course 
of the trial. The informed consent form will be signed and dated by the participant and the person 
who conducted the informed consent discussion. Two informed consent form to be signed. One to 
be kept by the investigators, one to be kept by patients. No photocopy of informed consent form. 
 
12. CONFIDENTIALITY 
Subject’s personal details and medical information obtained in this study is considered confidential 
and will not be disclosed to the funder or third parties other than for the reasons below: 
a. Requirement from regulatory authority 
b. Requirement from ethic committee members 
The study results might be published or presented. However, none of the subject’s personal 
information will be revealed in any of the publications or presentations.  
 
13. DATA MANAGEMENT 
13.1 Data Collection 
All data generated and gathered during the study will be entered into the case report forms (CRF) 
directly and accurately. Every entry must be recorded legibly in black ink. If a correction is needed, 
strikethrough the mistake with a single line, initial and date at the side of the correction. Designated 
staff at participating sites shall enter data required by the protocol into the eCRF. The eCRF system 
is a validated system and conforms to 21 CRF part 11.  
13.2 Study documentation and record keeping 
All the documents in the study will be filed and kept in a locked room with limited access. All 
electronic data will be stored in a password-protected database. The study data and documents will 
be kept up to 7 years after the completion of study. Study data is destroyed after period of storage. 
Only personnel involved in the study and regulatory representatives will have the access to the 
data. The subjects may not access the study data directly.  
13.3 Database management and structure 
All the data will be managed and handled by the study team (the Sponsor) and InnoSignum. 
InnoSignum functions as a CRO-SMO (Site Management Organization) and acts as an 
intermediary to the funder and the Sponsor-site in running the study. The patient’s medical 
information obtained in this study is confidential and will not be disclosed to the funder or other 
third parties. The funder will not involve in the study design or influence/interfere with the conduct 

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of the study. The funder will not have access to the study data or clinical database directly or 
indirectly.  
14. PROCEDURE OF HANDLING WITHDRAWAL 
Study coordinator will explore the reason of withdrawal from study. The reason will be recorded. 
Patients who withdraw from the study will continue their management under the respective 
hospital. Patients who withdraw from the study will be replaced with new patients. 
 
15. RISK OF PROCEDURE 
Not applicable. The study is an observational study which involve data collection for the LAAO 
implantation. 
 
16. STUDY FUNDING 
This is an investigator-initiated research where the investigator or the study site, which is Sarawak 
Heart Centre serves as the Sponsor. The study was supported by an educational research grant 
from St. Jude Abbott Medical (the funder). The funds supported by the funder is mainly used to 
manage the data management and to support the purpose of this study, which is to collect the data 
both retrospectively and prospectively. The LAA occluders that were implanted are funded by 
pensioner Tabung Bantuan Perubatan, Ministry of Health (MoH) or self-paying by the patients.  
 
17. PUBLICATION POLICY 
At the conclusion of the Amulet-SEA-01 study, a manuscript will be prepared for publication in a 
reputable scientific journal regardless of positive or negative results. The scientific validity and 
timing of publications will be evaluated in order to maximize the benefits derived from the 
publication of the clinical data of the study. All records identifying the subject will be kept 
confidential and, to the extent permitted by the applicable laws and/or regulations, will not be 
made publicly available. Permission from the Director General of Health will be obtained for the 
publication of this study.  
17.1 Authorship Selection 
Authors will be selected on the basis criteria of the following: 
• A significant contribution to the design of the clinical study; 
• A significant contribution to patient enrollment in the clinical study; 
• High quality of data as determined by the clinical study requirements; 

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• Demonstration of a high level of interest in the performance of the product and/or the 
unique product feature, and the ability to write, review, edit and present the publication; 
• A demonstration of a good publication history; 
• A willingness to contribute to the publication. 
17.2 Review and Communication Guidelines 
Investigators will receive communication regarding the authorship selection, the publication co-
authors and to which scientific platform the publication will be submitted. Prior to submission of 
a publication, the Publication Committee and all co-authors will review and authorize the 
publication.   
 
 

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18. REFERENCES 
1. 
Brachmann J, Lewalter T, Akin I, Sievert H, Geist V, Zeymer U, et al. Interventional 
occlusion of left atrial appendage in patients with atrial fibrillation. Acute and long-term 
outcome of occluder implantation in the LAARGE Registry. J Interv Card Electrophysiol. 
2020;58(3):273-80. 
 
2. 
Hildick-Smith D, Landmesser U, Camm AJ, Diener HC, Paul V, Schmidt B, et al. Left 
atrial appendage occlusion with the Amplatzer Amulet device: full results of the 
prospective global observational study. Eur Heart J. 2020;41(30):2894-901. 
 
3. 
Phillips KP, Santoso T, Sanders P, Alison J, Chan JLK, Pak HN, et al. Left atrial 
appendage closure with WATCHMAN in Asian patients: 2year outcomes from the WASP 
registry. Int J Cardiol Heart Vasc. 2019;23:100358. 
 

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19. APPENDIX 
 
Appendix A: Schedule of Events 
 
Evaluation 
Baseline LAAO 
implant 
Pre-
discharge 
1-3mo 
6mo 
12mo 
Informed consent (For 
prospective data collection 
only) 
X 
 
 
 
 
 
CRF form 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Indication 
X 
 
 
 
 
 
Clinical examination and 
investigations 
X 
 
X 
X 
X 
X 
mRS, CHA2DS2-VASc, 
HASBLED 
X 
 
 
 
 
 
Medications 
X 
 
X 
X 
X 
X 
CT Scan, TOE or ICE 
X 
X 
 
X 
X 
 
Procedural detail 
 
X 
 
 
 
 
Safety Outcomes 
 
X 
X 
X 
X 
X 
Efficacy Outcomes 
 
X 
X 
X 
X 
X