Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients
Phase: NA
Conditions: Heart Septal Defects, Atrial, Atrial Septal Defect
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
 
 
 
Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ 
Absorbable ASD Closure System for ASD Patients 
Name of investigational medical device: Absorbable ASD closure system 
Product model & specification: Full specifications 
Administrative category of investigational medical device: Class III medical device 
Class III medical device requiring clinical trial examination and approval  
Yes 口   No   
Similar product in China Yes 口   No  
Protocol version No. and date: V1.4 - 02 December, 2019 
Clinical trial leader: Guangdong Provincial People's Hospital 
Coordinating investigator: Professor Zhiwei Zhang 
Statistics Institution: Guangdong Cardiovascular Institute  
Statistics director: Director He Li 
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.  
Manufacturer: Lifetech Scientific (Shenzhen) Co., Ltd. 
02 December, 2019 
 
Protocol No.:  42CT (CN) 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
Filling instructions: 
1. For a multicenter clinical trial, only the lead institution is written on the cover page, and other 
participating institutions are listed in the main body of the protocol. 
2. For a multicenter clinical trial, only the principal investigator is written on the cover page.   

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
Terms and Abbreviations 
Number 
Abbreviation 
Definition 
1 
NMPA 
National Medical Products Administration 
2 
ASD 
Atrial Septal Defect 
3 
TTE 
Transthoracic Echocardiography 
4 
TEE 
Transesophageal Echocardiography 
5 
AE 
Adverse Event 
6 
SAE 
Serious Adverse Event 
7 
PLLA 
Poly-L-lactic Acid 
8 
CHD 
Congenital Heart Disease 
9 
IVC 
Inferior Vena Cava 
10 
FDA 
Food and Drug Administration 
11 
SOP 
Standard Operating Procedure 
12 
DSA 
Digital Subtraction Angiography 
13 
LOCF 
Last Observation Carried Forward 
14 
FAS 
Full Analysis Set 
15 
ITT 
Intention to Treat 
16 
PPS 
Per Protocol Set 
17 
SS 
Safety Set 
18 
EDC 
Electronic Data Capture System 
19 
CRF 
Case Report Form 
20 
GCP 
Good Clinical Practice 
21 
GMP 
Good Manufacturing Practices 
22 
CT 
Computed Tomography 
23 
OPC 
Objective Performance Criteria 
 
 
 
 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
Table of Contents 
Synopsis ................................................................................................................................................................................................ 1 
Main body ............................................................................................................................................................................................ 5 
1. 
Sponsor ....................................................................................................................................................................................... 5 
1.1 
Name of sponsor ......................................................................................................................................................... 5 
1.2 
Sponsor address .......................................................................................................................................................... 5 
1.3 
Contact information of sponsor .............................................................................................................................. 5 
1.4 
Social credit code of sponsor ................................................................................................................................... 5 
2. 
List of participating institutions and investigators ............................................................................................................ 5 
3. 
Objectives and contents of clinical trial .............................................................................................................................. 5 
3.1 
Objectives ..................................................................................................................................................................... 5 
3.2 
Contents ........................................................................................................................................................................ 5 
4.  Background information .......................................................................................................................................................... 6 
5. 
Investigational Product ............................................................................................................................................................ 6 
5.1 
Product features .......................................................................................................................................................... 6 
5.2 Product description ........................................................................................................................................................... 7 
5.3 Investigation range .......................................................................................................................................................... 10 
6.  Indications, contraindications and cautions ...................................................................................................................... 10 
6.1 Indications ......................................................................................................................................................................... 10 
6.2 Contraindications ............................................................................................................................................................. 10 
6.3 Cautions ............................................................................................................................................................................. 10 
7.  Overall design .......................................................................................................................................................................... 11 
7.1 Study design ...................................................................................................................................................................... 11 
7.2 
Trial process ............................................................................................................................................................... 18 
7.3 Monitoring plan ............................................................................................................................................................... 24 
8. 
Statistical considerations ...................................................................................................................................................... 25 
8.1 
Statistical design, methods and analysis procedures ....................................................................................... 25 
8.2 
Sample size calculation ............................................................................................................................................ 26 
8.3 
Significance level and power of test of clinical trial .......................................................................................... 31 
8.4 
Expected dropout rate ............................................................................................................................................. 31 
8.5 
Qualified/unqualified criteria for clinical trial results ...................................................................................... 31 
8.6 
Criteria and reason for trial termination based on statistics .......................................................................... 31 
8.7 
Data processing methods ....................................................................................................................................... 31 
8.8 
Statistical analysis plan deviation ......................................................................................................................... 33 
8.9 
Selection criteria for subjects to be included in the analysis and reasons .................................................. 33 
9. 
Data Management .................................................................................................................................................................. 34 
9.1 
Database design ........................................................................................................................................................ 34 
9.2 
Data reception and data entry ............................................................................................................................... 34 
9.3 
Data audit and data query management ............................................................................................................ 34 
9.4 
Database locking and data archiving .................................................................................................................... 35 
10.  Feasibility analysis ................................................................................................................................................................. 35 
10.1 
Analysis of the likelihood of success: ................................................................................................................... 35 
10.2 
Analysis of the likelihood of failure: ..................................................................................................................... 36 
10.3 
Conclusion .................................................................................................................................................................. 36 
11. 
Quality control of clinical trial ......................................................................................................................................... 36 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
11.1 
Quality Assurance ..................................................................................................................................................... 36 
11.2 
Quality control ........................................................................................................................................................... 37 
12. 
Ethical issues and informed consent ............................................................................................................................. 37 
12.1 
Ethical considerations .............................................................................................................................................. 37 
12.2 Examination and approval of trial protocol ............................................................................................................. 38 
12.3 Informed consent procedures and informed consent form ................................................................................ 38 
12.4 Personal data and data protection ............................................................................................................................ 39 
13.  Regulations on reporting AEs and device defects.......................................................................................................... 40 
13.1 
Definition of adverse event .................................................................................................................................... 40 
13.2 
Definition of SAE ....................................................................................................................................................... 43 
13.3 Device deficiencies ........................................................................................................................................................ 44 
14. 
Device management ......................................................................................................................................................... 44 
14.1 
Investigational device management..................................................................................................................... 44 
14.2 Package of device .......................................................................................................................................................... 45 
14.3 Recolloction of surplus devices .................................................................................................................................. 45 
15. 
Protocol Deviation and amendment ............................................................................................................................. 45 
15.1 
Protocol Deviation .................................................................................................................................................... 45 
15.2 Protocol amendment .................................................................................................................................................... 46 
16. 
Data access .......................................................................................................................................................................... 46 
17. 
Finance and insurance ...................................................................................................................................................... 47 
18.   Confidentiality ...................................................................................................................................................................... 47 
19.   Publication agreement of trial results ............................................................................................................................ 47 
20. 
Responsibilities of parties ................................................................................................................................................ 48 
20.1 Sponsor responsibilities ............................................................................................................................................... 48 
20.2 Responsibility of institutions and investigators for the clinical trial .................................................................. 48 
21.  Reference ................................................................................................................................................................................ 49 
22. Supplementary provisions .................................................................................................................................................... 50 
23.  List of participating personnel of clinical trial ................................................................................................................. 52 
Investigator Statement ................................................................................................................................................................... 53 
Appendix 1: List of participating institutions and investigators ............................................................................................ 54 
Appendix 2: Headache questionnaire and evaluation ............................................................................................................ 55 
Appendix 3: MIDAS Migraine Questionnaire and score ......................................................................................................... 56 
 
 
 
 
 
 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
1 
 
Synopsis 
Title of trial: 
Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System 
for ASD Patients 
Sponsor 
Lifetech Scientific (Shenzhen) Co., Ltd. 
Device name 
Absorbable ASD closure system 
Administrative 
category 
Class III medical device 
Study design 
(1) 
Objectives: To evaluate the safety and efficacy of Absnow™ absorbable closure system 
developed and produced by Lifetech Scientific (Shenzhen) Co., Ltd. for ASD patients; 
(2) 
This study is a prospective, multi-center, single-arm OPC clinical trial. It is planned to 
enroll 146 subjects to implant the closure system, carrying out 9 follow-up visits after 
the operation and recording the trial process of each subject in detail. 
(3) 
Primary safety endpoint: Rate of common complications during 360-day post 
operation; 
(4) 
Primary efficacy endpoint: Effective closure rate at 360-day post operation; 
(5) 
The interim report of the clinical trial will be completed after completing the 360-day 
follow-up post operation and obtaining corresponding clinical data and follow-up data. 
A registration application will be submitted to NMPA based on the interim report.  
(6) 
Before the national multi-center trial is officially launched, a pre-trial with a sample 
size of five cases (excluding from the overall effective sample size) will be conducted in 
Guangdong Provincial People's Hospital. 
Indications  
Patients with secundum ASD 
Sample size 
146 cases 
Number of clinical 
trial institutions 
11 
Test time 
(1) 
First patient in (FPI) date: Aug 2018 
(2) 
Subject recruitment time: 6 months 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
2 
(3) 
Completion date of the 360-day follow-up visit of the last subject: March 2020 
Efficacy evaluation 
(1) 
Primary efficacy endpoint: effective closure rate at 360-day post operation (effective 
closure refers to no or only mild-small residual shunt in TTE or TEE observation after 
device implantation); 
(2) 
Secondary efficacy endpoint: immediate operation success rate (immediate operation 
success means that left and right disks are effectively fixed on left and right sides of 
atrial septum respectively and smoothly released without displacement or migration, 
and the delivery system is successfully withdrawn); 
Safety evaluation 
(1) 
Primary safety endpoint: Rate of common complications during 360-day post 
operation (refer to 7.1.7.1 of the main body for details) 
(2) 
Others safety endpoints: 
• Rate of device-related AEs; 
• Rate of SAEs; 
Inclusion criteria 
(only those who 
meet all inclusion 
criteria can be 
enrolled) 
(1)  Age ≥ 3 years, body weight ≥ 10 kg; 
(2) 
Secundum left-to-right shunt ASD with hemodynamic significance; 
(3) 
Distance from the defect edge to coronary vein sinus, superior and inferior vena cava 
and pulmonary vein ≥ 5 mm; to atrioventricular valve ≥ 7 mm; 
(4) 
Atrial septum length (stretched diameter) > diameter of left disk. 
Exclusion criteria 
(those who meet 
any of the 
exclusion criteria 
cannot be 
enrolled) 
(1) 
Patients with primum, venous sinus and unroofed coronary sinus ASD; 
(2) 
Patients with atrial septal defect ≥ 26 mm; 
(3) 
Patients with other structural heart diseases in addition to ASD; 
(4) 
Patients with complication of obstructive pulmonary arterial hypertension or 
Eisenmenger syndrome; 
(5) 
Patients with infective endocarditis; 
(6) 
Patients with hemolysis, hemorrhagic disease or unhealed ulcer within 1 month before 
implantation, or any contraindication to aspirin treatment (except those who can take 
other antiplatelet agents for 6 consecutive months); 
(7) 
Patients with thrombosis (especially in left atrium or left auricle) as shown by 
echocardiography; 
(8) 
Patients with known hypercoagulable state; 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
3 
(9) 
Patients who have undergone heart surgery in the past; 
(10) Patients allergic to PLLA materials; 
(11) Patients refusing to sign the informed consent form; 
(12) Patients who have poor compliance with disease-related treatment and poor 
cooperation with follow-up visits; 
(13) Patients that are in pregnancy or lactation, or planned for pregnancy or get a positive 
pregnancy test result during the screening period; 
(14) Patients that have participated in any clinical trial that may affect the evaluation of the 
device in this trial and not completed or withdrawn from the previous clinical trial 
within 3 months prior to this trial screening period; 
(15) Patients not eligible for this clinical trial (determined by the investigator).  
Device use 
specification 
Apply the investigational devices to the subjects enrolled in the trial. 
Statistical Analysis 
(1) 
SAS 9.4 software will be used for statistical analysis; 
(2) 
This study adopts single-arm OPC design, and uses descriptive and inferential statistics 
for trial evaluation and statistical analysis; 
(3) 
Demographic and baseline data: Mean and standard deviation are used for calculation 
of age. Frequency and composition ratio are adopted for calculation of gender. Mean, 
standard deviation, median, the 25th and 75th quantiles, minimum and maximum 
values are adopted for the calculation of measurement data of vital signs. Frequency 
and composition ratio are used for the calculation of counting data of vital signs. 
Current medical history, past medical history, family history and concomitant 
medication history are described in list, and calculate the frequency and composition 
ratio as per classifications; 
(4) 
Analysis of laboratory tests: Mean, standard deviation, median, the 25th and 75th 
quantiles, minimum and maximum values are adopted for calculation of measurement 
data of laboratory tests such as blood routine, urine routine, liver and kidney function, 
coagulation function, myocardial enzyme, pregnancy test, etc. Whether they are 
within the normal medical reference ranges should be recorded and any test item with 
abnormal values of clinical significance should be listed; 
(5) 
ECG analysis: Frequency and composition ratio are calculated according to the types of 
arrhythmia; 
(6) 
Imaging analysis: Whether the occlusion is successful is determined by chest X-ray and 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
4 
TTE. Frequency and composition ratio are calculated; 
(7) 
Analysis of primary safety endpoint: Rate of common complications of AbsnowTM 
absorbable ASD closure system during 360-day post operation and its 95% confidence 
interval (CI) are calculated; 
(8) 
Analysis of primary efficacy endpoint: Effective closure rate of AbsnowTM absorbable 
ASD closure system at 360-day post operation and its 95% CI are calculated; 
(9) 
Analysis of other safety endpoints: Rates of device-related AEs and SAEs post 
operation are calculated, and SAE cases or trial termination due to AEs should be 
explained; 
(10) Analysis of secondary efficacy endpoint: calculate the success rate of immediate 
process success; 
(11) All statistical inferences are performed at a unilateral significance level of 0.025. 
 
 
 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
5 
 
Main body 
1. Sponsor 
1.1 Name of sponsor 
Lifetech Scientific (Shenzhen) Co., Ltd. 
1.2 Sponsor address 
Cybio electronic building, Langshan 2nd Street, North area of High-tech Park, Nanshan District, Shenzhen, 
Guangdong Province  
Postcode: 518057, Tel: 0755-86026250 
1.3 Contact information of sponsor 
Contact person: Jingyu Lin, mobile phone: 18665696515 
1.4 Social credit code of sponsor 
91440300715217115L 
2. List of participating institutions and investigators 
Appendix 1 (any change of the list of participating institutions will be updated in the appendix rather than 
upgrading the version of the protocol) 
3. Objectives and contents of clinical trial 
3.1 Objectives 
To evaluate the safety and efficacy of AbsnowTM absorbable ASD closure system for ASD patients. 
3.2 Contents 
This clinical trial is a prospective study involving 146 subjects without a control group. AbsnowTM absorbable ASD 
closure system will be used to treat ASD patients. Totally 9 follow-ups will be conducted within 5 years after 
operation. The rate of common complications during 360-day post operation is the primary safety endpoint, and 
the effective closure rate at 360-day post operation is the primary efficacy endpoint. 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
6 
Before the national multi-center trial is officially launched, a pre-trial with a sample size of 5 cases (excluding 
from the overall effective sample size) will be conducted in Guangdong Provincial People’s Hospital. 
4. Background information 
ASD is one of the common congenital heart diseases (CHD), which accounts for about 10% of pediatric CHDs. 
Surgery is the main treatment for ASD at first. Interventional therapy provides a new safe and effective treatment 
for CHD with its advantages of less trauma, confirmed efficacy, short recovery period and no need of 
cardiopulmonary bypass. A large number of clinical reports have shown that using interventional occluders to 
block ASD has a high success rate, good closure effect and low risk of complications. 
At present, ASD occluders that are commonly applied for clinical use are double-sided umbrella-shaped 
structures woven by high-elastic nickel-titanium alloy wires. After reaching the clinical treatment effect, the 
occluders will continue to exist in the human body, which may cause a series of adverse events such as allergy 
and poisoning due to the increase of nickel ion concentration, and even induce cancer; Meanwhile, long-term 
existence of the occluder in vivo may lead to tissue wear, increased the risk of conduction block, and inability to 
receive occlusion of left atrial appendage. 
The researchers of Lifetech Scientific (Shenzhen) Co., Ltd. (hereinafter referred to as Lifetech Scientific) have 
worked hard for many years to develop a novel AbsnowTM absorbable ASD closure system. Its main raw material, 
poly-L-lactic acid (PLLA), is a degradable polymer material with good biocompatibility, which has been widely 
used in cardiovascular surgery, orthopedics and plastic surgery. 
AbsnowTM absorbable ASD closure system has been tested in animal models, with the operation success rate of 
100%. After 6 months of observation, it was found that the myocardial cells and endothelial cells covered on the 
surface of the implanted device were not different from those of the control group (NiTi alloy occluder), while 
the inflammatory reaction was significantly lower than that of the control group. During the observation period, 
there was no device dislocation, migration, or obvious postoperative complications. 
AbsnowTM absorbable ASD closure system produced by Lifetech Scientific has passed the inspection of NMPA 
Shenzhen Medical Device Testing Center, which proves that the closure system meets the technical requirements 
of the product in terms of mechanical strength, physical and chemical properties, biological properties, etc. 
According to the requirements of the Administrative Measures for Medical Device Registration (Bureau Order No. 
4) and the Good Clinical Practice for Medical Devices (Bureau Order No. 25) issued by NMPA, the product has 
been ready for clinical trials. Now Guangdong Provincial People’s Hospital is taken as the lead institution to 
conduct this clinical trial to evaluate the safety and efficacy of Absnow™ absorbable ASD closure system 
developed and produced by Lifetech Scientific. 
5. Investigational Product 
5.1 Product features 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
7 
The product can be recycled and repositioned repeatedly before being completely released, with simple 
operation, good closure effect, and good biocompatibility. 
This product has a significant difference with the current nickel-titanium alloy occluders, which is the 
degradable PLLA polymer material (except for the markers). This material can be gradually degraded and 
absorbed by the human body after implantation, thus reducing the potential short- and medium-term 
complications after implantation, such as thromboembolism, friction injury, perforation, metal mesh 
breakage, and arrhythmia. At the same time, treatments for left heart disease are evolving, including 
percutaneous heart valve repair or replacement, arrhythmia research and treatment (e.g., pulmonary vein 
isolation and left atrial appendage closure), which often require access to the left atrium through the atrial 
septum. The implantation of conventional metal occluders prevents the establishment of the atrial septal 
access, while absorbable occluders avoid this problem. 
5.2 Product description 
5.2.1 Structural components 
⚫ 
AbsnowTM absorbable ASD closure system structural components 
The AbsnowTM absorbable ASD Closure System (as known in Figure 1) consists of an absorbable ASD occlude 
(Figure 2) and a delivery system (Figure 3).  
 
 
Figure 1. The AbsnowTM absorbable ASD Closure System 
⚫ 
AbsnowTM absorbable ASD occluder 
As shown in Figure 2, the AbsnowTM ASD occluder consists of a skeleton, a tip, a screw, sutures, membranes, 
a locker and markers. Biodegradable poly-L-lactide (PLLA) wire is shaped into two flat discs connected to 
each other with a waist that fits the size of the defect and three PLLA membranes are sewn within the two 
discs and the waist with PLLA sutures separately. Moreover, the occlude features a locker in aid of its 
shaping.  

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
8 
 
Figure 2. The AbsnowTM ASD occluder 
⚫ 
AbsnowTM absorbable ASD delivery system 
As shown in Figure 3, the delivery system primarily consists of a delivery cable, a handle, a loader, a 
haemostatic valve and an assistant loader. The control handle includes the locking wheel, the push button 
and the back cover. 
 
Figure 3. Delivery System of the AbsnowTM ASD Closure System 
The AbsnowTM ASD Closure System shall be used in combination with the SteerEaseTM Introducer 
manufactured by Lifetech. 
5.2.2 Specifications 
The specifications of the AbsnowTM absorbable ASD Occluder are shown in Table 2. 
 
Figure 3. Illustration of AbsnowTM ASD occluder 
Table 2. AbsnowTM ASD occluder and recommended delivery sheath sizes 
Unit: mm 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
9 
Device 
Specifications 
Waist 
Diameter 
(d±1.5) 
Left Disc 
Diameter 
(D1±2) 
Right 
Disc 
Diameter 
(D2±2) 
Distance 
between two 
Discs (L1) 
Distance 
between 
Tip 
and Screw (L2) 
LT-AASD-06 
6 
18 
14 
0≤L1≤6 
14 
LT-AASD-08 
8 
20 
16 
0≤L1≤6 
14 
LT-AASD-10 
10 
22 
18 
0≤L1≤6 
14 
LT-AASD-12 
12 
26 
22 
0≤L1≤6 
14 
LT-AASD-14 
14 
28 
24 
0≤L1≤6 
14 
LT-AASD-16 
16 
30 
26 
0≤L1≤6 
14 
LT-AASD-18 
18 
32 
28 
0≤L1≤6 
15 
LT-AASD-20 
20 
34 
30 
0≤L1≤6 
15 
LT-AASD-22 
22 
36 
32 
0≤L1≤6 
15 
LT-AASD-24 
24 
38 
34 
0≤L1≤6 
15 
LT-AASD-26 
26 
40 
36 
0≤L1≤6 
15 
LT-AASD-28 
28 
42 
38 
0≤L1≤6 
15 
LT-AASD-30 
30 
44 
40 
0≤L1≤6 
16 
LT-AASD-32 
32 
46 
42 
0≤L1≤6 
16 
5.2.3 Working mechanism 
The AbsnowTM absorbable ASD closure system works by contracting an umbrella occluder made of 
absorbable material into a sheath of corresponding specifications. Under the guidance of X-ray and 
echocardiography, the occluder is sent into the right atrium through the femoral vein and inferior vena cava, 
and then entre the left atrium through the atrial septal defect. Then, the left and right discs will be released 
in the left and right atria respectively, so that the waist of the occluder can be stuck in the defect position. 
The occluder will be fixed on the atrial septum to block blood shunts, providing conditions for the climbing 
and growth of new tissue cells, and achieving the purpose of treatment. 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
10 
5.3 Investigation range 
Patients with secundum ASD 
6. Indications, contraindications and cautions 
6.1 Indications 
This product is suitable for patients with congenital heart disease secondary to groove ASD confirmed by clinical 
physical examination, chest X-ray and echocardiography, and meets the following conditions: 
(1) Age ≥ 3 years, body weight ≥ 10 kg; 
(2) Secundum left-to-right shunt ASD with hemodynamic significance; 
(3) Distance from the defect edge to coronary vein sinus, superior and inferior vena cava and pulmonary vein ≥ 5 
mm; to atrioventricular valve ≥ 7 mm; 
(4) Atrial septum length (stretched diameter) > diameter of left disk. 
6.2 Contraindications 
(1) Patients of primum, venous sinus and unroofed coronary sinus ASD; 
(2) Patients with atrial septal defect ≥ 26 mm; 
(3) Patients with other structural heart diseases in addition to ASD; 
(4) Patients with complication of obstructive pulmonary arterial hypertension or Eisenmenger syndrome; 
(5) Patients with infective endocarditis; 
(6) Patients with hemolysis, hemorrhagic disease or unhealed ulcer within 1 month before implantation, or any 
contraindication to aspirin treatment (except those who can take other antiplatelet agents for 6 consecutive 
months); 
(7) Patients with thrombosis (especially in left atrium or left auricle) as shown by echocardiography; 
(8) Patients allergic to PLLA materials. 
6.3 Cautions 
6.3.1 Patient selection 
Some high-risk patients will have certain complications after the device implantation, such as device thrombosis.  
If this device is implanted in high-risk patients, it will require closer follow-up visits. High-risk patients include: 
1) 
Device deformation at aortic root; 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
11 
2) 
Defect of inferior vena cava (IVC) margin (risk of thrombosis). 
6.3.2 Intraoperative and postoperative treatment recommendations 
⚫ 
Systemic heparinization should be performed throughout the operation process (100 U/kg for children and 
3,000 U for adults);  
⚫ 
TTE or TEE should be used to assist the occluder placement; 
⚫ 
Aspirin (3-5 mg/(kg·d)) should be taken orally for 6 months after operation; 
⚫ 
Patients at risk of endocarditis should be given intramuscular injection of Benzathine Benzylpenicillin 
(1,200,000 U for adults and ≤ 600,000 U for children) once a month for 6 months. 
7.  Overall design 
7.1 Study design  
7.1.1 Study objectives 
To evaluate whether the effective closure rate of absorbable ASD closure system at 360-day post operation is not 
lower than its OPC, and the rate of common complications during 360-day post operation is not higher than its 
OPC (see 8.2.1 total sample size for details). 
7.1.2 Trial methods and selection basis 
In this study, a prospective, multi-center and single-arm OPC design evaluation method is adopted. 
(1) Prospective: a research method that uses the present as the starting point to follow up the future results. 
Prospective research results can provide evidence of causality and have unified diagnosis, detection and 
evaluation standards for the acquired data. Therefore, the data source and processing controllability are 
good; 
(2)  Multi-center: More than two clinical trial centers are selected to carry out the clinical trial. Using 
multi-center trial can obtain more cases within the same time period than single-center trial and shorten 
the overall clinical trial time. Multi-center trials are completed in different regions by different research 
centers and multiple clinical investigators. Therefore, the results and conclusions have good representation. 
(3)  Single-arm OPC design: Currently, the technique of ASD occlusion has been mature and widely applied to 
clinical use. Besides, a large number of clinical data, large-scale clinical trials, randomized controlled trials 
and systematic reviews (Meta analyses) of traditional metal products on the market have proved the safety 
and efficacy of this transcatheter occlusion (advantages compared with the open-heart surgery). In view of 
the fact that clinical trials of medical devices are often open-label studies, increased attention has been paid 
to non-randomized controlled designs in recent years. Among them, the single-arm OPC design is widely 
used in non-randomized controlled clinical trials of medical devices, which means that the single-arm OPC 
design can also evaluate the safety and efficacy of medical devices. For example, in the review of medical 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
12 
devices by FDA, the application of single-arm OPC design in clinical trials of medical devices has been 
recognized. Lifetech Scientific (Shenzhen) Co., Ltd. has taken the lead in developing the ASD closure system 
with absorbable materials that have good biocompatibility in China. Its traditional metal material ASD 
closure systems have been sold in China and abroad for many years. The heart surgeons have rich 
interventional experience. The treatment has confirmed efficacy and the incidence of common 
complications is predictable. Traditional metal material products on the market, such as GORE® HELEX® 
Septal Occluder (NCT00581308), GORE® CARDIOFORM ASD Occluder (NCT02985684), AMPLATZER Septal 
Occluder (NCT00650936), all adopt single-arm OPC design to apply for FDA registration. Therefore, it is 
feasible to perform single-arm OPC design in this clinical trial. 
7.1.3 Actions to reduce and avoid bias 
(1) Before the start of the trial, the investigators should be trained uniformly to ensure that they fully know and 
understand the trial process and can operate the investigational device skillfully. The investigators must 
strictly follow the trial protocol during the trial. The clinical research associate should carry out quality 
control and monitoring to ensure that the investigators’ operations and implementations are in strict 
accordance with the trial protocol. The above actions will be implemented in the whole implementation 
stage of the trial to reduce the gross errors or operation errors. 
(2) The subjects will be screened strictly according to the inclusion and exclusion criteria of the trial protocol to 
ensure that the trial is carried out strictly according to the protocol. 
(3) The efficacy and safety endpoints of the trial may be influenced by the proficiency and experience of the 
investigators. Therefore, participating investigators should have relevant treatment experiences, thus 
reducing the operation bias on the trial results. 
(4) Data collation and management will be carried out after clinical trial completion. The data analyst will check 
and confirm the data issues through the data query table to avoid recording errors. 
7.1.4 Device use specifications 
SOP for key operations: 
(1)  Introduce the sheath tube and sheath core to the left superior pulmonary vein. 
(2)  Open the package and take out the ASD closure system. 
(3)  Soak the absorbable ASD closure system and loader in the physiological saline. 
(4)  Unscrew the locking wheel and push the pushing control forward to put the occluder into the guide sheath. 
■  Absorbable ASD closure system with specifications below 12: Push the push control to the first red dot 
and directly put the occluder into the guide sheath; 
■  Absorbable ASD closure system with specifications above 12: Push forward the pushing control to put 
part of the occluder into the sheath and repeat the above steps until the occluder is completely put 
into the guide sheath. 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
13 
(5)  Lock the locking wheel, hold the guide sheath with one hand, and pull the bell-mouth loader out of the 
guide sheath while rotating with the other hand; 
(6)  After complete exhaust, push the occluder into the delivery sheath and deliver it to the atrial septum along 
the delivery sheath; 
(7)  Place the distal end of the sheath at the pulmonary vein, and withdraw the sheath under DSA to expose all 
seven markers of the occluder. Adjust the position of sheath and occluder to locate the development site of 
waist at the atrial septal position. Unscrew the locking wheel, pull back the push control to the red dot in 
the middle, and partially release the left atrial disc, waist and part of the right atrial disc of the occluder. 
(8)  Carry out ultrasound to confirm that the two discs of the occluder are in the left and right atria respectively, 
then retract the push control, continue to shape the occluder, and keep the waist of the occluder straightly 
at the atrial septal position. 
(9)  When the push control is about two grids (10 mm) away from the last red dot, pull the steel cable slightly 
backward to make the left disk stick to the atrial septal position. 
(10) Pull back the push control and push forward the steel cable at the same time until it is about one grid (5 mm) 
away from the last red dot and then stop pushing the push control. Carry out DSA to confirm that all seven 
markers have been displayed and TTE to confirm that the occluder is basically formed, the waist of the 
occluder is located at the atrial septum position, and the left and right atrial discs are close to the atrial 
septum positions on the left and right atrial sides respectively before tighten the locking wheel finally. 
(11) Carry out ultrasound to examine the placement position, shape and residual shunt of the occluder; 
(12) Unscrew the locking wheel and fasten the occluder. Carry out ultrasound to check the position, shape and 
residual shunt of the occluder. 
(13) Release the occluder. 
See the instruction for use (IFU) of the product for specific operation instructions and illustrations. 
7.1.5 Selection of subjects 
7.1.5.1 Inclusion criteria (only those who meet all the following criteria can be enrolled) 
(1) 
Age ≥ 3 years, body weight ≥ 10 kg; 
(2) 
Secundum left-to-right shunt ASD with hemodynamic significance; 
(3) 
Distance from the defect edge to coronary vein sinus, superior and inferior vena cava and pulmonary vein 
≥ 5 mm; to atrioventricular valve ≥ 7 mm; 
(4) 
Atrial septum length (stretched diameter) > diameter of left disk. 
7.1.5.2 Exclusion criteria (those who meet any of the following criteria cannot be enrolled)  
(1)  
Patients of primum, venous sinus and unroofed coronary sinus ASD; 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
14 
(2)  
Patients with atrial septal defect ≥26 mm; 
(3)  
Patients with other structural heart diseases in addition to ASD; 
(4)  
Patients with complication of obstructive pulmonary arterial hypertension or Eisenmenger syndrome; 
(5)  
Patients with infective endocarditis; 
(6)  
Patients with hemolysis, hemorrhagic disease or unhealed ulcer within 1 month before implantation, or 
any contraindication to aspirin treatment (except those who can take other antiplatelet agents for 6 
consecutive months); 
(7)  
Patients with thrombosis (especially in left atrium or left auricle) as shown by echocardiography; 
(8)  
Patients with known hypercoagulable state; 
(9)  
Patients who have undergone heart surgery in the past; 
(10) 
Patients allergic to PLLA; 
(11) 
Patients refusing to sign the informed consent form; 
(12) 
Patients who have poor compliance with disease-related treatment and poor cooperation with follow-up 
visits; 
(13) 
Patients that are in pregnancy or lactation, or planned for pregnancy or get a positive pregnancy test 
result during the screening period; 
(14) 
Patients that have participated in any clinical trial that may affect the evaluation of the device in this trial 
and not completed or withdrawn from the previous clinical trial within 3 months prior to this trial 
screening period; 
(15) 
Patients not eligible for this clinical trial (determined by the investigator). 
7.1.5.3 Dropout Criteria and management 
Subjects who have signed informed consent forms and are screened qualified quit the trial and fail to complete 
the observation period specified in the protocol are called dropout cases, regardless of when and why. The 
criteria for dropout are as follows: 
(1)  
For whatever reason, the subject is unwilling or impossible to continue the clinical trial, and requires to 
withdraw from the clinical trial. 
(2)  
Although the subject does not explicitly propose to withdraw from clinical trial, he/she no longer receive 
treatment and examination and loses to follow-up 
(3)  
The subject presents SAE, and the investigator judges that the subject should withdraw from the clinical 
trial. 
(4)  
The subject has poor compliance. 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
15 
Dropout management: For all dropout cases, the summary form of clinical trial completion should be filled in the 
original records and the reasons for dropout should be analyzed. When the subject drops out, the investigator 
should contact the subject as much as possible, inquire the reason and record the last clinical symptom, and 
complete the evaluation items that can be achieved. If the subject withdraws from the trial due to AE, the 
investigator should take corresponding treatment actions according to the actual situation of the subject. 
7.1.5.4 Trial termination criteria 
Trial termination means that the clinical trial is not ended according to the protocol and discontinued halfway. 
The main purpose of termination is to protect the rights and interests of subjects and ensure the quality of trial. 
In addition to the Article 5 mentioned below, the sponsor and the investigators should jointly negotiate whether 
to terminate the trial: 
(1)  
The trial should be terminated timely due to serious safety problems found during the trial; 
(2)  
The trial should be terminated timely because the product is found to be of no clinical value during the 
trial; 
(3)  
Major error is found in the protocol during the trial, which makes it difficult to evaluate the product safety 
and efficacy; Or serious deviation occurs during the implementation of the protocol and further 
continuation of the trial will make it difficult to evaluate the product safety and efficacy; 
(4)  
Clinical trial institutions and investigators do not comply with the relevant laws and regulations of the 
clinical trial and the clinical trial protocol, which are not corrected after being pointed out, or are serious, 
or continue to be unchanged; 
(5)  
National Medical Products Administration ordered the termination of clinical trial for some reasons. 
From the perspective of protecting the rights and interests of the subjects, the investigators should continue to 
provide appropriate treatments for the subjects after the trial termination, and inform the subjects in detail of 
the management and related treatments received during the trial. The relevant data of the subjects can still be 
used to evaluate the safety of the product, and the termination of the trial should be timely fed back to the 
sponsor. 
7.1.5.5 Enrollment time 
It is estimated that the first subject will be enrolled in Aug 2018. Each clinical trial institution is expected to enroll 
three subjects every month, with a total time of six months for subject recruitment. 
7.1.5.6 Expected clinical trial duration and determination basis 
The total duration of this trial is five years and six months, and 146 subjects are planned to be enrolled within six 
months. After completing the 360-day visit data post operation, the interim statistical analysis report and the 
interim clinical trial report should be finished. And the registration application should be submitted to the NMPA. 
Then the follow-up of 2-5 years post operation will still be carried out continuously (once a year). 
7.1.5.7 Expected duration of participation of each subject 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
16 
According to the requirements of the trial protocol, each subject should receive screening before operation (-30 
to 0 day), sign the informed consent form after passing the screening, undergo implantation of AbsnowTM 
absorbable ASD closure system, and carry out visits before discharge, 30 days, 90 days, 180 days, 360 days, 2 
years, 3 years, 4 years and 5 years post operation. Any AE/SAE found in the subject during clinical trial should be 
observed until the end or keeping stable. 
7.1.5.8 Number of subjects required for clinical trial 
Sample size: 146 cases 
7.1.6 Efficacy evaluation method 
7.1.6.1 Primary efficacy endpoint and corresponding evaluation, recording and analyzing method and time 
Effective closure rate at 360-day post operation 
Evaluation time: 360-day post operation 
Definition of effective closure: no or only mild-small residual shunt (judging from left-to-right Doppler signal, 
left-to-right shunt signal with diameter < 5 mm) observed by TTE or TEE after device implantation. 
Evaluation method: TEE or TTE 
7.1.6.2 Secondary efficacy endpoint and corresponding evaluation, recording and analyzing method and time 
Immediate operation success rate 
Evaluation time: Immediately post operation 
Immediate operation success means that left and right disks are effectively fixed on left and right sides of atrial 
septum respectively and smoothly released without displacement or migration and the delivery system is 
successfully withdrawn; 
Note: the displacement and migration can be judged by observing whether the position of markers is the same 
as that before release under DSA, and whether the left and right discs are located on both sides of the atrial 
septum under TEE or TTE. 
7.1.7 Safety endpoints and corresponding evaluation, recording and analyzing method and time: 
7.1.7.1 Primary safety endpoint: Rate of common complications during 360-day post operation 
Note: Common complications include (as shown in the following table) 
SN. 
Name 
SN. 
Name 
1 
Occluder displacement 
5 
Residual shunt above medium 
2 
High-grade 
atrioventricular block 
6 
Intractable headache or migraine 
3 
Cardiac tamponade 
7 
Cerebral embolism 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
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4 
Air embolism 
 
 
The definitions of common complications are as follows: 
(1)  Occluder displacement: refers to displacement of occluder to right atrium, right ventricular outflow tract, 
main pulmonary artery, left atrium, etc. due to special anatomical position of ASD, selection of too small 
occluder resulted from incorrect measurement and improper operation, etc. 
(2)  High-grade atrioventricular block: means that there are two or more continuous supraventricular excitations 
(generally sinus P waves) that cannot be transmitted down to the ventricle at an "appropriate" atrial rate 
(≤135 bpm), and this conduction barrier must be caused by block rather than interference induced by 
connection or ventricular ectopic pacing points. 
(3)  Cardiac tamponade: refers to cardiac compression, ventricular filling obstruction and a series of 
hemodynamic abnormalities, such as venous pressure increase and even cardiogenic shock, due to the rapid 
accumulation of fluid in pericardial cavity. 
(4)  Air embolism: refers to inadvertently injection of air into coronary artery due to improper operation of 
occluder implantation. Air embolism can temporarily block blood flow in coronary artery, which may lead to 
acute myocardial infarction, angina pectoris, arrhythmia and cardiac arrest. 
(5)  Residual shunt above medium: left-to-right shunt signal with diameter ≥5 mm, judging from Doppler 
left-to-right signal. 
(6)  Intractable headache or migraine: refers to the syndrome with recurrent headache as the main symptom, 
which may have aura and accompanying symptoms. 
(7)  Cerebral embolism: refers to various emboli (such as endocardial mural thrombus, atherosclerotic plaque, 
fat, etc.) that enter the cerebral artery with blood flow and block blood vessels, which will cause ischemic 
necrosis of brain tissue in the blood supply area of the artery and result in focal neurological deficit when 
collateral circulation cannot be compensated. 
7.1.7.2 Other safety endpoints 
(1) Rate of device-related AEs 
Evaluation time: During the trial 
Definition of device-related AE: refers to AE that is determined by the investigator to be related, possibly related, 
unlikely related to the device or the correlation between AE and device is unable to be judge. However, normal 
postoperative stress reactions, such as fever and constipation, should be distinguished, and those judged by 
investigators as normal postoperative stress reactions do not need to be recorded in adverse events. 
(2) Rate of SAEs 
Evaluation time: During the trial 
Serious adverse events refer to events that cause death or serious deterioration of health, including fatal 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
18 
diseases or injuries, permanent defects of body structure or body functions, hospitalization or prolonged hospital 
stay, and medical or surgical intervention to avoid causing permanent defects to the body structure or body 
functions; or that cause fetal distress, fetal death or congenital abnormalities, congenital defects, in the process 
of the clinical study. 
7.1.8 Device deficiency and corresponding evaluation, recording and analyzing method and time: 
Rate of device deficiencies 
Evaluation time: During the operation 
Definition of device deficiency: refers to the deficiency of the investigational device which presents in the trial 
process, such as label error, plastic thread damage, ineffective fastening or release of the locking piece, 
displacement of shunt blocking membrane, etc. 
7.2 Trial process 
7.2.1 Trial Flowchart 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
19 
 
 
 
Secundum ASD 
Sign the Informed Consent form 
Preoperative screening (inclusion 
and exclusion criteria, laboratory 
tests, ultrasound examination) 
Intraoperative implantation of test 
device in 146 cases (DSA, 
ultrasound) 
Conform 
Non-compliance 
The operation failed. 
Procedure success 
Screen failures 
Other treatments 
Before discharge (ultrasound, 
electrocardiogram) 
Visit after discharge 
30-day post-procedure 
60-day post-procedure 
180-day post-procedure 
360-day post-procedure 
Completion of the 
interim report and 
submission of 
registration application 
to NMPA
2-year post-procedure 
3-year post-procedure 
4-year post-procedure 
5-year post-procedure 
Completion of final report 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
20 
7.2.2 Data collecting summary 
Number of 
visits 
Visit item 
Screening 
stage 
Enrollment stage 
Before 
operation 
Intraoper
ative 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Observation cycle 
-30〜0d 
0d 
Before 
discharge 
30±7d 
90±14d 
180±30d 360±30d 
2y±60d 
3y±60d 
4y±60d 
5y±60d 
Informed consent 
form 
▲ 
 
 
 
 
 
 
 
 
 
 
Demographic data 
▲ 
 
 
 
 
 
 
 
 
 
 
Vital signs 
▲ 
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
Current medical 
history 
▲ 
 
 
 
 
 
 
 
 
 
 
Past history 
▲ 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
▲ 
 
 
 
 
 
 
 
 
 
 
Pregnancy test 
▲ 
 
 
 
 
 
 
 
 
 
 
Urine routine 
▲ 
 
 
 
 
 
 
 
 
 
 
Blood routine 
▲ 
 
▲ 
 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
Liver function 
▲ 
 
 
 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
Kidney function 
▲ 
 
 
 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
Cardiac enzymes 
▲ 
 
▲ 
 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
Coagulation 
function 
▲ 
 
 
 
 
 
 
 
 
 
 
TTE 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
Chest X-ray 
▲ 
 
 
 
 
▲ 
▲ 
 
 
 
 
ECG 
▲ 
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
Medication record 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
 
 
 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
21 
Common 
complications 
 
 
▲ 
▲ 
▲ 
▲ 
▲ 
 
 
 
 
AE 
 
 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
▲ 
Device deficiencies 
 
▲ 
 
 
 
 
 
 
 
 
 
7.2.3 Visit items 
7.2.3.1 Medical history and vital signs 
Demographic data, current medical history, past medical history and vital signs will be collected. 
(1)  Demographic data: sex, date of birth, height and weight 
(2)  Vital signs: blood pressure, pulse, body temperature and respiration 
(3)  Current medical history: symptom duration and admission time 
(4)  Past history: history of allergy, history of dysfunction of important organs (heart, lung, liver and kidney), and 
history of surgery 
(5)  Medication records: CRF only records anticoagulants, antiplatelets and antibiotics 
7.2.3.2 Laboratory examination 
The subjects must undergo complete laboratory tests before operation. The test items should include at least the 
following contents: 
(1)  Pregnancy test: applicable to women of reproductive age 
(2)  Urine routine: urine glucose (GLU), urine protein (PRO), urine red blood cell count (RBC), urine white blood 
cell count (WBC) 
(3)  Blood routine: hemoglobin (Hgb), white blood cell count (WBC), platelet count (PLT), neutrophil percentage 
(NEUT%) 
(4)  Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) 
(5)  Kidney function: serum creatinine (Scr), blood urea nitrogen (BUN) 
(6)  Cardiac enzymes: Creatine kinase-MB (CK-MB), lactate dehydrogenase (LDH) 
(7)  Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT), international 
standardized ratio (INR) 
7.2.3.3 Electrocardiogram examination 
(1) ECG 
7.2.3.4 Imageological examinations 
(1) Echocardiography 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
22 
(2)  Chest X-ray 
7.2.4 Trial Flowchart 
The subjects are required to carry out 9 visits before the end of the trial, specifically as follows: 
7.2.4.1 Preoperative (-30 d - 0 d, outpatient/inpatient visit) 
(1) Sign the Informed Consent form 
(2) Demographic data 
(3) Vital signs 
(4) Current medical history 
(5) Past history 
(6)  Screening according to the inclusion / exclusion criteria; 
(7)  Laboratory tests (pregnancy test, blood routine, coagulation function, urine routine, liver function, kidney 
function, cardiac enzymes) 
(8) Echocardiography 
(9)  Chest X-ray 
(10) ECG 
(11) Medication record 
7.2.4.2 Visit 1 (before discharge, hospitalization visit) 
(1) Vital signs 
(2) Laboratory examination (Blood routine, Cardiac enzymes) 
(3) Echocardiography 
(4) ECG 
(5) Medication record 
(6) Common complications 
(7) AE 
7.2.4.3 Visit 2 (30 ± 7 days post operation, outpatient visit) 
(1) Vital signs 
(2) Echocardiography 
(3) ECG 
(4) Medication record 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
23 
(5) Common complications 
(6) AE 
7.2.4.4 Visit 3 (90 ± 14 days post operation, outpatient visit) 
(1) Vital signs 
(2) Laboratory examination (Blood routine, Liver function, Kidney function, Cardiac enzymes) 
(3) Echocardiography 
(4) ECG 
(5) Medication record 
(6) Common complications 
(7) AE 
7.2.4.5 Visit 4 (180 ± 30 days post operation, outpatient visit) 
(1) Vital signs 
(2) Laboratory examination (Blood routine, Liver function, Kidney function, Cardiac enzymes) 
(3) Echocardiography 
(4) Chest X-ray 
(5) ECG 
(6) Medication record 
(7) Common complications 
(8) AE 
7.2.4.6 Visit 5 (360 ±30 days post operation, outpatient visit) 
(1) Vital signs 
(2) Laboratory examination (Blood routine, Liver function, Kidney function, Cardiac enzymes) 
(3) Echocardiography 
(4) Chest X-ray 
(5) ECG 
(6) Common complications 
(7) AE 
7.2.4.7 Visit 6 (2 years ± 60 days post operation, outpatient visit) 
(1) Vital signs 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
24 
(2) Laboratory examination (Blood routine, Liver function, Kidney function, Cardiac enzymes) 
(3) Echocardiography 
(4) ECG 
(5) AE 
7.2.4.8 Visit 7 (3 years ± 60 d post operation, outpatient visit) 
(1) Vital signs 
(2) Laboratory examination (Blood routine, Liver function, Kidney function, Cardiac enzymes) 
(3) Echocardiography 
(4) ECG 
(5) AE 
7.2.4.9 Visit 8 (4 years ± 60 d post operation, outpatient visit) 
(1) Vital signs 
(2) Echocardiography 
(3) ECG 
(4) AE 
7.2.4.10 Visit 9 (5 years ± 60 d post operation, outpatient visit) 
(1) Vital signs 
(2) Echocardiography 
(3) ECG 
(4) AE 
7.2.5 Medication guidance 
(1) Postoperative heparin anticoagulation for 24 hours; 
(2) Oral administration of Aspirin 3-5 mg/(kg.d) for children and 3 mg/(kg.d) for adults until 6 months post 
operation. 
(3)  Use of antibiotics within 30 min before operation. 
7.3 Monitoring plan 
According to the requirements of Good Clinical Practice for Medical Devices, the sponsor should select qualified 
clinical research associates to perform the monitoring duties on all participating institutions. The number of 
clinical research associates and the monitoring frequency depend on the complexity of clinical trial and the 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
25 
number of participating institutions in the trial. The specific responsibilities include: 
(1)  Validate whether the clinical trial institution has proper conditions before the trial, including whether the 
staffing and training meet the requirements, whether the laboratory is fully equipped and in good working 
condition, and whether a sufficient number of subjects are expected, and whether the participating 
investigators are familiar with the trial requirements; 
(2)  Check whether the clinical trial institutions and investigators comply with relevant laws and regulations, 
Good Clinical Practice for Medical Devices and clinical trial protocol before, during and after the trial; 
(3)  Confirm whether each subject signs an informed consent form before participating in the clinical trial, and 
understand the selection of subjects and the progress of the trial. The visits, tests and examinations that the 
investigators fail to do, and whether mistakes and omissions are corrected, should be clearly and truthfully 
recorded. For revision of informed consent form, the affected subjects who have not finished the clinical 
trial process should be re-signed the form; 
(4)  Confirm that all case report forms are filled in correctly and consistent with the original data, and all errors 
or omissions have been corrected or noted, signed and dated by the investigators; Confirm and record the 
disease type, total number of cases, sex, age and therapeutic effect of each trial; 
(5)  Confirm that withdrawal from the clinical trial or failure to comply with the requirements of the informed 
consent form are recorded, and discuss such situations with the investigators; 
(6)  Confirm that all AEs, complications and other device defects are recorded, and SAEs and device defects that 
may lead to SAEs are reported and recorded within the specified time; 
(7)  Monitor the supply, use, maintenance, transportation, receiving, storage, distribution, processing and 
reclaiming of the test device; 
(8)  Monitor the regular maintenance and calibration of relevant equipment during clinical trial; 
(9)  Ensure that all clinical trial related documents received by investigators are the latest versions; 
(10) A written report should be submitted to the sponsor after each monitoring. The report should include the 
name of the clinical research associates, date, time, place, contents, investigator name, project completion 
status, existing problems, conclusions and corrections to errors and omissions. 
8. Statistical considerations 
8.1 Statistical design, methods and analysis procedures 
The study is a prospective, multi-center and single-arm OPC design clinical trial. In this study, two primary 
endpoints are set, namely: 
(1)  Primary safety endpoint (low-priority index) -- Rate of common complications during 360-day post 
operation; 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
26 
(2)  Primary efficacy endpoint (high-priority index) -- Effective closure rate at 360-day post operation; 
The two indexes in the trial are treated according to the co-primary endpoint. Only when both indexes reach the 
OPC can it be concluded that the investigational device meets the clinical application requirements. 
8.2 Sample size calculation 
8.2.1 Total sample size 
This clinical trial plans to recruit 146 subjects. The sample size determination process is as follows: 
This clinical trial adopts single-arm OPC design and uses effective closure rate at 360-day post operation and the 
rate of common complications during 360-day post operation as the basis for sample size estimation. 
At present, the technique of ASD occlusion is mature and widely used in clinic. A large number of clinical data, 
large-scale clinical trials, randomized controlled trials and systematic evaluations (Meta analyses) of traditional 
metal products on the market have proved the safety and efficacy of this treatment (advantages compared with 
the surgery). The literature data are shown in the table below. 
 
 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
27 
Literatures 
Publishing date 
Device name 
Effective closure rate 
at 360-day post 
operation 
Rate of common complications 
during 360-day post operation 
Sample size 
Zhong-Dong Du, et al. [1] 
2002 
Amplatzer Septal Occluder 
98.5% 
0.65% 
288 
Shinichi Oho, et al. [2] 
2002 
Amplatzer Septal Occluder 
97% 
2.86% 
35 
Sergio Luiz Navarro Braga, et al. [3] 
2004 
Amplatzer Septal Occluder 
95.8% 
4.1% 
49 
Cristiano Oliveira Cardoso, et al. [4] 
2006 
Amplatzer Septal Occluder 
93% 
3.96% 
101 
Thomas K. Jones, et al. [5] 
2007 
GORE HELEX Septal Occluder 
98.1% 
3.4% 
119 
Allen D. Everett, et al. [6] 
2009 
Amplatzer Septal Occluder 
96% 
0.9% 
478 
Tehmina Kazmi, et al. [7] 
2009 
Amplatzer Septal Occluder 
99% 
3.5% 
204 
Alexander J. Javois, et al. [8] 
2014 
GORE HELEX Septal Occluder 
96.7% 
-- 
137 
Sukman T. Putra, et al. [9] 
2015 
Amplatzer Septal Occluder & 
Lifetech Heart ASD occluder 
96.37% 
2.6% 
152 
Daniel R. Turner, et al. [10] 
2017 
Amplatzer Septal Occluder 
98.21% 
1.6% 
1000 
 
 
 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
28 
1)  Effective closure rate at 360-day post operation 
Combining (Meta-analysis) of the one-year effective closure rates reported in each of the above documents 
shows that the one-year treatment success rate of the traditional metal ASD closure system is 98%, and the 95% 
CI is [97%, 99%]. 
 
Combining (Meta-analysis) of the lower limits of 95% CI of one-year effective closure rates of each of the above 
documents shows that 95% CI of lower limits of 95% CI of one-year effective closure rates of traditional metal 
ASD closure system is [94%, 97%]. 
 
2) 
Rate of common complications during 360-day post operation 
Combining (Meta-analysis) of the rates of common complications within one year reported in each of the above 
documents shows that the rate of common complications within one year is 1%, with a 95% CI of [1%, 2%]. 
 
Combining (Meta-analysis) of the upper limits of 95% CI of the rates of common complications in each of the 
above documents within one year shows that the 95% CI of the upper limits of 95% CI of the rate of common 
complications in the traditional metal ASD closure system within one year is [2%, 5%]. 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
29 
 
According to the summary of the results reported in the literatures, the treatment success rate at 360-day post 
operation of the ASD closure systems made of traditional metal materials ranged from 93% to 99%, and the rate 
of common complications during 360-day post operation was between 0.65% and 4.1%. Considering that the 
ASD closure systems made of traditional metal materials have been on the market for nearly 20 years, the 
industry has rich interventional experience and the treatment has confirmed efficacy and predictable incidences 
of common complications. In China, Lifetech Scientific has taken the lead in using absorbable materials that have 
good biocompatibility to develop novel ASD closure system and applied it for clinic use for the first time. At 
present, there is still no similar product on the market. Despite the relevant quality control measures, in 
multi-center clinical trials, there may still be differences in clinical practices (such as interventional techniques 
and evaluation experience) among different centers, resulting in different effects among different centers, 
especially the surgeon's learning curves, which will not only affect the proficiency of operations but also the 
efficacy of the investigational device and the prediction of common complications to a certain extent. In addition, 
we hope this study can make the clinical efficacy evaluation of the investigational device more realistic, fully 
understand the differences between the clinical practice of ASD occlusion with novel absorbable materials and 
the consensus of experts in the ASD occlusion with existing traditional metal occluders, provide objective 
comparative basis for clinical selection of novel absorbable ASD closure system, and also provide reference for 
the formulation and standardization of occlusion guidelines with novel absorbable materials in the future. 
Therefore, according to the results of meta analyses, clinical experience and primary endpoints defined in this 
trial after full discussion with clinical experts and statistical experts, the target and OPC of AbsnowTM ASD closure 
system are set as follows: 
Endpoints 
Target 
Unilateral boundary value of 95% 
CI (OPC) 
Effective closure rate at 360-day 
post operation 
99% 
94% 
Rate of common complications 
during 360-day post operation 
1% 
6% 
Sample size is estimated by SAS9.4 software, and the operation is as follows: 
a) 
Effective closure rate at 360-day post operation 

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The target and OPC of effective closure rate at 360-day post operation are set as 99% and 94%, respectively. SAS 
software calculation indicates that at least 121 patients are needed. Considering a dropout rate of 20%, 146 
patients are required. 
b) 
Rate of common complications during 360-day post operation 
             
 
The target and OPC of rate of common complications during 360-day post operation are set as 1% and 6%, 
respectively. SAS software calculation indicates that at least 121 patients are needed. Considering a dropout rate 
of 20%, 146 patients are required. 
8.2.2 Number of clinical trial subjects of each disease and determination basis 
In this clinical trial, congenital heart disease patients with secundum ASD who need to be implanted with 
occluder were taken as subjects to evaluate the safety and efficacy of AbsnowTM absorbable ASD closure system. 
The number of clinical trial subjects of various diseases is not involved. 
8.2.3 Minimum and maximum number of subjects in each clinical trial institution and determination basis  

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This clinical trial plans to recruit 146 subjects, and it is estimated that 11 clinical trial institutions (centers) will 
participate in this trial. The samples in each center will be balanced during the trial. Combined with the total 
sample size, the number of participating clinical trial institutions, and considering the different number of 
disease sources in each center, each clinical trial institution (center) can recruit no more than 50% of subjects at 
most. 
8.3 Significance level and power 
This trial adopts single-arm design and the significance level α (one-sided) = 0.025, and the power is 80%. 
8.4 Expected dropout rate 
(1)  Dropout refers to the early withdrawal of the subjects during the clinical trial because of various reasons. 
For example, patients voluntarily withdraw the informed consent, lose follow-up and cannot complete the 
whole process of clinical trials due to AEs. 
(2)  In the process of sample size estimation, the expected maximum dropout rate is set at 20%, which refers to 
the proportion of dropout cases. 
8.5 Qualified/unqualified criteria for clinical trial results 
The rate of common complications during 360-day post operation and the effective closure rate at 360-day post 
operation are calculated. If the upper bound of the 95% CI is less than 6% of the preset target value and the 
lower bound of the 95% CI is greater than the preset target value of 94%, it can be considered that the safety and 
efficacy of AbsnowTM absorbable ASD closure system meet the criteria. The two indicators are treated according 
to the co-primary endpoint. It can be concluded that the investigational device meets the clinical application 
requirements only when both indicators reach the OPC 
8.6 Criteria and reason for trial termination based on statistics 
(1)  This clinical trial plans to conduct an interim effect evaluation. All subjects will not receive further 
interventions after the device is implanted. An interim evaluation on the safety and efficacy will be 
conducted after the 360-day follow-up data post operation are obtained. 
(2)  The results of interim effect evaluation do not affect the subsequent follow-ups (visits 6, 7, 8 and 9) and the 
final statistical analysis after the completion of the trial. Therefore, there is no need to set the criteria and 
reasons for trial termination. 
8.7 Data processing methods 
8.7.4 Data statistical methods 

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(1)  
SAS9.4 software is used for the statistical analysis; 
(2)  
This study adopts a single-arm OPC design, and uses descriptive statistics and inferential statistics for trial 
evaluation and statistical analysis;  
(3)  
Demographic and baseline data: Mean and standard deviation are used for calculation of age. Frequency 
and composition ratio are adopted for calculation of gender. Mean, standard deviation, median, the 25th 
and 75th quantiles, minimum and maximum values are adopted for the calculation of continuous variables 
of vital signs. Frequency and composition ratio are used for the calculation of discrete variables of vital 
signs. Current medical history, past medical history, family history and concomitant medication history are 
described in list, and the frequency and composition ratio are used for calculation as per classification; 
(4)  
Analysis of laboratory tests: Mean, standard deviation, median, the 25th and 75th quantiles, minimum and 
maximum values are adopted for calculation of continuous variables of laboratory tests such as blood 
routine, urine routine, liver and kidney function, coagulation function, myocardial enzyme, pregnancy test, 
etc. Whether they are within the normal medical reference ranges should be recorded and any test item 
with abnormal values of clinical significance should be listed; 
(5)  
ECG analysis: Frequency and composition ratio are calculated according to the types of arrhythmia; 
(6) 
Imaging analysis: Whether the occlusion is successful is determined by chest X-ray and TTE. Frequency and 
composition ratio are calculated; 
(7)  
Analysis of primary safety endpoint: Rate of common complications of absorbable ASD closure system 
during 360-day post operation and its 95% CI are calculated; 
(8)  
Analysis of primary efficacy endpoint: Effective closure rate of AbsnowTM absorbable ASD closure system 
at 360-day post operation and its 95% CI are calculated; 
(9)  
Analysis of other safety endpoints: Rates of device-related AEs and SAEs are calculated after operation, 
and explanations for trial termination due to AEs and SAEs occurred should be provided; 
(10)  Analysis of secondary efficacy endpoint: Immediate operation success rate is calculated; 
(11)  All statistical inferences are carried out at unilateral and significance level of 0.025. 
8.7.2 Missing and unreasonable data 
The trial should ensure that the data records are 100% correct, especially the primary endpoints. For missing, 
unused and irrational data or data of withdrawal subjects, strict review should be conducted. The basic statistical 
principles for processing these data are as follows: 
(1)  The details of each dropout subject will be described; 
(2)  The last observation carried forward (LOCF) method will be applied for the missing values of the main 
evaluation indicators; 
(3) The missing values of qualitative or quantitative secondary endpoints are not carried forward, and are 

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handled according to the missing values; 
(4)  The missing values of all safety endpoints are not carried forward, and are handled according to the missing 
values. 
8.8 Statistical analysis plan deviation  
In principle, only the contents of the statistical analysis plan according to the established protocol can be 
demonstrated in the clinical trial report. In case of other situations, a meeting will be held to discuss with the 
principal investigator and experts, and then whether to modify the statistical analysis plan will be decided 
according to their opinions. 
8.9 Subject selection criteria and reasons 
(1)  Full analysis set (FAS): According to the basic principles of Intention to Treat (ITT), FAS refers to the set of 
subjects that comply with the ITT principles. It includes:  
a) 
Subjects who have been treated with the investigational device, achieved the immediate operation 
success, and have at least one observation data of primary endpoints after baseline;  
b) 
Subjects who have received treatment with the investigational device, but have failed in the 
implantation because of the device itself, regardless of whether there is test device in the body.  
If the implantation is abandoned due to other clinical reasons and there is no investigational device in the 
body, such subjects will not be included in the FAS. The definition of receiving the investigational device 
treatment is that if any part of the device, including the occluder itself and its delivery device, contact with 
human body through vascular approach, it can be considered as receiving the device treatment. FAS will be 
the main data set for baseline data analysis, primary safety and efficacy evaluation. 
(2)  Per protocol set (PPS): refers to subjects who have no serious violation of the study protocol in FAS, have 
good compliance, have not used drugs or treatments that may affect the efficacy evaluation during the trial, 
and have no missing data of primary endpoints. Unless otherwise specified, no carrying forward will be 
performed for the missing data of PPS. Theoretically, PPS should exclude subjects who have not completed 
all the visit plans due to various reasons, except that whether the subject’s ASD has been successfully 
treated can be judged according to the existing results. PPS will be the secondary data set for efficacy 
evaluation. 
(3)  Safety set (SS): It is used for safety evaluation of the clinical trial, including all subjects who have been 
treated with the device at least once. SS will be the main data set of safety analysis. 
(4)  The efficacy evaluation of the device is mainly based on FAS, and PPS is only used as a reference data set for 
efficacy evaluation. Safety evaluation is based on SS. According to the above criteria, the subjects will be 
included in FAS, PPS and SS for interim efficacy evaluation and analysis at 360-day post operation. In the 
fifth year after operation, the subjects will be also included in FAS, PPS and SS for finally efficacy evaluation 

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34 
and analysis according to the above criteria. 
9. Data Management 
9.1 Database design 
(1)  Electronic data capture (EDC) system is used to establish the database for this clinical trial.  
(2)  CRF designers will annotate the final version of the blank CRF form, and describe in detail the necessary 
elements such as variable name, length, type and value domain of database variables. 
(3) The database designer will determine the database creation requirements and the database structure 
according to the CRF and its annotation, and then design the database. 
(4)  The database must be thoroughly tested to ensure that the content and structure of the database are 
consistent with CRF and annotated CRF, the specified data (variables) can be properly entered into the 
database, and the entered data can be correctly exported to the corresponding database variables. 
9.2 Data reception and data entry 
(1)  EDC system is used to establish the database for this clinical trial, and eCRF is adopted to save and transmit 
the trial information of the subjects. EDC is strictly protected by password, and only those who directly 
participate in the research can obtain EDC account number. The authorized staff are responsible for 
inputting the trial data into EDC. 
(2) Before data entry, the data administrator trains the entry staff or investigator on system operation or special 
items of this study. 
(3)  After the data entry starts, the entry staff or investigator should enter the data according to the EDC 
operation guideline and the EDC entry instructions of this project. Data modification caused by entry errors 
or other reasons will be recorded on EDC and confirmed by investigators. The CRA should check the data in 
the database with the original data to ensure that they are consistent. The entered eCRF should be signed 
by the investigators electronically. 
9.3 Data audit and data query management 
(1)  Data audit includes manual data check, and program audit designed to identify wrong and invalid data 
range, data integrity, protocol violation and consistency check. The data administrator should complete the 
writing, approval and other related processes of the data audit plan before the enrollment of the first 
subject, and determine the data audit contents. The programmer should program and test the audit 
program according to the finalized data audit plan. 
(2)  According to the results of manual inspection and program audit, the data administrator will solve the 

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questionable data in the form of data query table, data processing agreement and self-evident correction, 
and update the database according to the answers or descriptions of relevant documents. 
9.4 Database locking and data archiving 
(1)  The clinical trial database must be closed and locked to ensure the consistency and integrity of data results, 
data analysis and data submitted to authorities. 
(2) When all the data have been received and all data sorting has been completed, all queries have been 
answered, all unanswered questions have been clarified, the data review report has been validated, the 
statistical analysis data sets have been clearly divided, and the data quality control has been completed 
(database quality reaches the standard), the data administrator submits a database lock application to the 
project team members. After joint confirmation by the investigator, the sponsor and the project team 
members, the data editing permission of the database is recovered, and the database is locked. Then the 
data administrator shall timely transmit the data to the statistical analysis department. If data correction is 
required, the review, approval and other related processes of the database unlocking application form shall 
be completed to unlock the database, so that the corresponding personnel can enter the database to 
correct the data. 
(3) The data administrator shall establish a data management project folder. When data or record files meet the 
archiving conditions, the data administrator is responsible for archiving them. When the study is completed, 
the data administrator revokes the relevant personnel's database access permissions, creates a copy of the 
database, and archives study documents and data management documents. 
10. Feasibility analysis 
10.1 Analysis of the likelihood of success 
(1)  Relevant clinical trials and post-marketing data reports have proved that metal ASD occluder is safe and 
reliable. Moreover, this kind of products have been reported in clinical use for many years, and their safety 
and efficacy have been verified; 
(2)  The company that produces this device has rich experience, and the product quality meets the 
requirements of the clinical trial. The device has passed the product registration inspection designated by 
NMPA in China; 
(3)  The clinical institutions undertaking this trial all have complete instruments, equipment and technical 
resources; 
(4)  The investigators are outstanding academic leaders in the field of interventional therapy for children with 
congenital heart disease in China. They are physicians with rich experience in clinical trials, have 
participated in GCP and related trainings, and can treat the subjects in strict accordance with the clinical 

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36 
trial protocol. 
10.2 Analysis of the likelihood of failure 
(1)  There are too many subjects who quit the trial due to SAEs; 
(2)  Subjects who lose to follow-up account for more than 20% of the sample size; 
(3)  IFU and labeling information of the device cannot effectively guide the operator; 
(4)  Serious safety problems are found during the trial; 
(5)  Major mistakes are found in the protocol during the trial, leading to difficulty in evaluating the product 
efficacy;  
(6)  The operation of the trial personnel is unskilled. 
10.3 Conclusion 
In conclusion, this device can benefit patients with secundum ASD. This trial is feasible and has a great possibility 
of success. 
11. Quality control of clinical trial 
11.1 Quality Assurance 
11.1.1 Definition 
It refers to planned and systematic activities. The purpose of establishing these activities is to ensure the 
research, generation, citation (recording) and reporting of data according to the requirements of Good Clinical 
Practice for Medical Devices and corresponding laws and regulations. 
11.1.2 Audit 
It refers to the systematic and independent inspection of activities and documents related to clinical trials 
organized by the sponsor to determine whether the implementation of such activities, data recording, analysis 
and reporting conform to the clinical trial protocol, SOPs, Good Clinical Practice for Medical Devices and relevant 
applicable management requirements. 
11.1.3 Inspection 
It refers to the activities of the drug regulatory agencies to review, supervise and manage the relevant 
documents, facilities, records and other aspects of a clinical trial. 
11.1.4 Clinical trial monitoring 
(1)  The sponsor is responsible for comprehensively tracking and auditing the implementation of clinical trial, 

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37 
ensuring that the trial comply with the Good Clinical Practice for Medical Devices and relevant laws and 
regulations, and follow the implementation of the trial protocol. NMPA may also inspect the clinical trial 
during or after the trial. If investigators receive such notices, they should inform the sponsor in time. The 
CRA will carry out regular visits to monitor the progress and completion of the trial. 
(2)  The CRA will check the completeness of the case records, the accuracy of the contents of the case report 
form, verify the trial data, and check the compliance of the investigators with the trial protocol and the 
Good Clinical Practice for Medical Devices, and ensure the accuracy of the distribution, storage and counting 
of investigational devices. 
11.2 Quality control 
11.2.1 Definition  
It is defined as operating techniques and activities under the quality assurance system, such as monitoring. The 
purpose of quality control is to verify that the quality of research-related activities meets the requirements. 
Quality control should be applied to every stage of data processing to ensure that all data are credible and 
correctly processed. 
11.2.2 Research monitoring 
Authorized and qualified CRA will visit the clinical trial institutions regularly according to the monitoring plan, 
check the original data, verify the compliance of the investigators with the protocol and regulations, and assist 
the investigators. 
11.2.3 Laboratory quality control 
Each clinical center laboratory should establish standard operating procedures and quality control procedures, 
and each laboratory test item must adopt the national legal measurement unit. The test report items must be 
complete (including date, test items, test results and normal ranges) with signatures of the relevant personnel. 
Special test items must be specially tested by the special personnel. 
11.2.4 Qualifications of investigators 
The participating investigators of the clinical trial must have professional specialties, qualification and ability for 
the clinical trial. The staff should be relatively stable after the qualification inspection is approved. 
11.2.5 Pre-trial training of investigators 
The sponsor is responsible for the training of investigators before the start of the trial, so as to help the clinical 
trial personnel fully understand and know the overall situation, protocol and CRF. 
12. Ethical issues and informed consent 
12.1 Ethical considerations 

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(1) This clinical trial must follow the Declaration of Helsinki and the relevant medical device clinical trial norms 
and regulations in China. Before the start of the study, the protocol must be approved by the ethics 
committee (EC) of the institutions. 
(2) Before each subject is selected for this study, the investigators have the responsibility to explain the study 
content to the subject in oral or written language in a way that the subject can understand, and to answer 
the subject’s questions seriously. Before enrollment, each subject must be given a written subject informed 
consent form. It is the responsibility of the investigators to obtain the informed consent form before each 
subject enters the study and keep it in the study files. 
(3) The basis of this trial includes the Declaration of Helsinki, Good Manufacturing Practices (GMP) of Medical 
Devices, ICH-GCP and relevant laws and regulations applicable to the People's Republic of China. 
(4) Based on ethical considerations, ICH-GCP and relevant laws and regulations applicable to the People's 
Republic of China, preclinical tests of the investigational device are required before the clinical use. The 
design and implementation of this trial have put the safety of the subjects first. Therefore, in the preclinical 
tests, the biological safety of the materials used should be firstly detected to minimize the potential risks 
when using the materials. In order to clarify the security problem fundamentally, various standards of this 
trial have also been determined. 
12.2 Protocol approval 
Before clinical trial, the investigator shall submit the study protocol, informed consent form and other related 
documents to the medical ethics committee of the hospital which the clinical trial institution belongs to. The 
clinical trial can be started only after obtaining the approval of the ethics committee. Any modification of the 
study protocol must be approved by the ethics committee before implementation. 
12.3 Informed consent  
(1) Before each subject is enrolled for this study, the investigator is responsible for fully and comprehensively 
introducing the contents and instructions of the informed consent form to the subject or his/her guardian in 
written form, which must include the following contents: 
1)  Objective and description of the trial; 
2)  Procedures, time limit and examination operation of the trial; 
3)  Any foreseeable danger and discomfort to the subject; 
4)  Possible risks and expected benefits; 
5)  The subjects have the right to withdraw from the trial at any stage without discrimination or 
retaliation; 
6)  Other treatment actions that can be taken; 

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7)  Confidentiality of subject data; 
8)  Subject compensation; 
9)  Contact information of the investigator; 
10)  Contact information of the ethics committee. 
(2)  The informed consent form should be written in a language that the subject or guardian can understand. 
Informed consent form should not contain any content that will cause the subjects to give up their 
legitimate rights and interests and exempt the clinical trial institutions and investigators, the sponsors or 
their agents from being responsible. 
(3) Before enrollment, each subject must be given a written informed consent form. The investigator is 
responsible for obtaining informed consent form before each subject enters the study and keeping it in the 
study archives. 
(4)  For incapacitated subjects, if the ethics committee agrees in principle and investigators think that 
participating in clinical trial conforms to own interests of the subjects, they can also be enrolled in this 
clinical trial, but their guardian should sign with date before the trial. 
(5) If a subject and his/her guardian both are incapable of reading, a witness shall be present during the 
consent process. After explaining the consent form in detail and ensuring the oral informed consent is 
consistent with the written informed consent form, the subject or his/her guardian gives oral consent, and 
the witness signs and dates the informed consent form. The witness’s signature and the investigator’s 
signature shall be on the same day. 
(6)  Because this trial involves minors, according to relevant laws and regulations, people aged 3-13, 14-17 and 
over 18 belong to children, teenagers and adults, respectively. Minors aged over 8 must sign corresponding 
informed consent forms and obtain the informed consent forms of their parents or guardians; Minors aged 
3 - 8 only need to obtain the informed consent forms of their parents or guardians. (Refer to the document 
Technical Guidelines for Drug Clinical Trials in Pediatric Populations and General Principles of Civil Law newly 
revised in 2017) 
(7) Please refer to informed consent form for details of informed consent. 
12.4 Personal data and data protection 
(1) All data obtained in clinical trial are subject to data protection. The investigator shall not disclose the 
subjects’ name and other personal information (excluding date of birth/age and gender). 
(2) The CRF and other documents transmitted to the sponsor do not contain names, but only the subject's 
study code. Similarly, statistical evaluation of data can only be performed under the subject's study code. 
Only the investigator can identify the subject’s name and other personal information via the study code. 
(3) If a subject need to be identified by his/her name due to medical reasons during the study process, all 

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relevant personnel are obliged to keep it confidential. 
13. AEs and device deficiencies 
13.1 Definition of adverse event 
AE refers to adverse medical events occurs during clinical trials, whether related to the test medical devices or 
not. The possible AEs in this study include: (1) common complications; (2) Expected or unexpected SAE; (3) 
Expected or unexpected AE 
13.1.1 Grading of adverse events 
Grade refers to the severity of the AE. CTCAE (Version 5.0, released on 27-Jul-2017) displays Grades 1 through 5 
with unique clinical descriptions of severity for each AE based on the following basic criteria: 
CTCAE grading 
Grade 
Clinical description 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not 
indicated. 
Grade 2 
Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL*. 
Grade 3 
Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL** 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
Grade 5 
Death related to AE. 
Remarks 
A semi-colon indicates ‘or’ within the description of the grade. A single dash (-) indicates a Grade is 
not available. Not all Grades are appropriate for all AEs. 
Activities of Daily Living (ADL): 
* Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 
** Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 
13.1.2 Report and handling of AEs 
All AEs observed during the trial must be truthfully recorded in the adverse event form. Investigator should carry 
out targeted treatment and follow-up to AEs until symptoms disappear or become stable. 

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13.1.3 Determination of the relationship between AE and test product and operation 
The subject should evaluate the correlation between the AE and test device or operation, and classify according 
to the following criteria: 
(1) Correlation with test device 
1) 
Definitely relevant: The reaction conforms to the known reaction type of the suspected product. 
2) 
Possibly related: The reaction conforms to the known reaction type of the suspected product; The 
patient's clinical status or other treatment methods may also produce this reaction. 
3) 
Possibly irrelevant: The reaction does not quite conform to the known reaction type of the suspected 
product; The patient's clinical status or other treatment methods may produce this reaction. 
4) 
Definitely irrelevant: The reaction does not conform to the known reaction type of the suspected 
product; The patient's clinical status or other treatment methods may produce this reaction, and the 
disease state may be improved or the reaction may be eliminated by withdrawal of other treatment 
methods, and present again upon the repeated use of other treatment methods. 
5) 
Unable to judge: The reaction is similar to the known reaction type of the suspected product, and 
other treatments used at the same time may also cause the same reaction. 
(2) Correlation with operation 
1) 
Definitely relevant: The reaction conforms to the known reaction type of the operation. 
2) 
Possibly related: The reaction conforms to the known reaction type of the operation; The patient's 
clinical status or other treatment methods may also produce this reaction. 
3) 
Possibly irrelevant: The reaction does not quite conform to the known reaction type of the operation; 
The patient's clinical status or other treatment methods may produce this reaction. 
4) 
Definitely irrelevant: The reaction does not conform to the known reaction type of the operation; The 
patient's clinical status or other treatment methods may produce this reaction, and the disease state 
may be improved or the reaction may be eliminated by withdrawal of other treatment methods, and 
present again upon the repeated use of other treatment methods. 
5) 
Unable to judge: The reaction is similar to the known reaction type of the operation, and other 
treatments used at the same time may also cause the same reaction. 
13.1.4 Possible AEs in this trial and corresponding treatments 
13.1.4.1 Common complications and corresponding treatments 
(1) Occluder dislocation: Preoperative multi-sectional measurements of ASD size are helpful for selection of 
indications and occluders. Improper selection of occluder can easily cause dislocation. Through observing 
the position of the development site and the shape of the left and right discs of the occluder by TTE 
combined with chest X-ray, it can be judged whether the occluder falls off. If the occluder falls off, it should 

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be taken out with catcher. If the occluder is large or difficult to take out, the emergency surgery should be 
performed. 
(2) High-grade atrioventricular block: If degree III atrioventricular block occurs during the operation and is still 
not recovered after long-term suspension of operation, the interventional therapy should be abandoned; 
Drug treatment should be given in time if degree III atrioventricular block occurs after operation. The device 
should be removed by surgery and ASD should be repaired if the drug therapy is ineffective; 
(3) Cardiac tamponade: Cardiac tamponade can be judged by TTE. Emergent pericardial puncture should be 
performed for blood drainage and decompression to relieve tamponade, temporarily change the 
hemodynamics, and contend for rescue time. Meanwhile, saline and blood should be infused to correct 
hemorrhagic shock. Furthermore, emergency thoracotomy exploration should be prepared. Strict 
anesthesia management is required and cardiac arrest should be strictly prevented. Sufficient blood should 
be replenished. Blood accumulated in pericardium cavity should be removed during operation. Normal 
systolic and diastolic function of heart should be restored. Heart damage should be repaired accurately. 
Close monitoring of cardiac function and rational application of cardiovascular active drugs are required 
after operation; 
(4) Air embolism: It can be judged by TTE combined with chest X-ray. Oxygen should be inhaled immediately, 
atropine should be given to patients with slow heart rate, and nitroglycerin should be adopted at the same 
time to prevent vasospasm; 
(5) Residual shunt above medium: It can be judged by TTE. If the diameter of residual shunt is larger than 5 mm 
and has hemodynamic significance, it is recommended to block the residual shunt again; 
(6) Intractable headache or migraine: If the subject complains of headache or migraine symptoms, it can be 
judged according to headache score or MIDAS migraine score: headache score > 2 can be judged as 
intractable headache, MIDAS migraine score > 1 can be judged as intractable migraine. Corresponding 
treatments such as hyperbaric oxygenation should be adopted, aspirin should be taken for at least half a 
year after operation, and anticoagulation therapy can be combined if necessary. (Appendix 2: headache 
questionnaire and scoring, Appendix 3: MIDAS migraine questionnaire and scoring); 
(7)  Cerebral embolism: It can be judged by the clinical manifestations of the subjects with the assistance of 
brain CT and TTE. The principle of treatment is to improve brain circulation, prevent re-embolism, eliminate 
brain edema and protect brain function. In acute stage, bed rest should be taken. The respiratory tract 
should be kept unobstructed and cardiac function should be protected. The nutritional status should be 
monitored and the balance of water and electrolytes should be kept. Nursing should be strengthened to 
prevent pneumonia, urinary infection and bedsore. According to the different sources of emboli, 
symptomatic treatments, including general treatment, surgery, interventional surgery, etc., can be adopted. 
Relevant surgical guidelines can be referred for operating procedures. Strict anticoagulation during and after 
operation is the key to prevent embolic events. 
13.1.4.2 Expected and unexpected SAEs and corresponding treatments 

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(1)  All-cause death: refers to death of any cause (including cardiac death, non-cardiac death and unexplained 
death) occurred within the follow-up time. In case of death, the investigator should judge whether it is 
related to the device and report it to the relevant departments according to the SAE reporting process. The 
medical and patient commissioner of the sponsor shall be responsible for coordinating the sponsor 
company and the insurance company to handle the claim settlement procedures; 
(2)  Intima injury and thromboembolism at puncture site: femoral vein intima injury and thromboembolism may 
occur due to repeated introduction of interventional materials during operation, excessive operation time, 
increased blood flow blocking time or rough operation. Thrombolytic therapy is needed and surgery can be 
conducted to remove thrombus if necessary; 
(3)  Arteriovenous fistula or pseudoaneurysm: Intraoperative puncture may lead to arteriovenous fistula or 
pseudoaneurysm. Once it happens, the subject’s hospitalization time may be prolonged. Arteriovenous 
fistula can be treated by surgeries such as fistula repair. Surgical treatment such as ligation of the parent site 
and aneurysm resection should be performed if the hematoma site of pseudoaneurysm cannot be absorbed 
by itself; 
(4)  Other unexpected SAEs. 
13.1.4.3 Expected and unexpected AEs and corresponding treatments 
(1)  
Transient arrhythmia: It is usually diagnosed by ECG, which is mostly transient during operation without 
special treatment; 
(2)  Fever: It can be judged by clinical examination. The investigators usually need to analyze the cause of fever 
and treat it symptomatically; 
(3)  Other unexpected AEs 
13.2 Definition of SAE 
It refers to death or serious deterioration of health during clinical trial, including 
(1)  Fatal illness or injury; 
(2)  Permanent defects in body structure or function; 
(3)  Requiring hospitalization or prolonged hospitalization; 
(4)  Medical or surgical intervention is needed to avoid permanent defects in the body structure or function; 
(5)  Fetal distress, fetal death, congenital abnormality, congenital defect and other events 
13.2.1 Treatment of serious adverse events 
(1) If serious adverse events occur in the clinical trial, the investigator shall immediately take appropriate 
treatment measures, and meanwhile provide a written report to the medical device clinical trial 
management department of the clinical trial institution to which it belongs and notify the sponsor in writing； 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
44 
(2) The medical device clinical trial management department shall provide a written report within 24 hours to 
the corresponding ethics committee, the food and drug regulatory authority and the health and family 
planning department of the province, autonomous region or municipality where the clinical trial institution 
is located； 
(3) In case of deaths, the clinical trial institution and the investigator shall submit all necessary information to 
the ethics committee and the sponsor; 
(4) For SAEs and device deficiencies that may lead to SAEs, the sponsor should report to the drug regulatory 
agencies and the health and family planning department at the same level within 5 working days after being 
informed. The sponsor should also notify other clinical trial institutions and investigators participating in the 
trial, and notify the ethics committees of the clinical trial institutions in time through their medical device 
clinical trial management departments. 
13.3 Device deficiencies 
13.3.1 Definition of device deficiency 
Device deficiency refers to unreasonable risks of medical devices that may endanger human health and life safety 
under normal use conditions in the process of the clinical trial, such as label errors, quality problems, 
malfunctions. 
13.3.2 Possible device deficiencies in this trial 
(1) Possible device deficiencies include label error, plastic thread damage, ineffective fastening or releasing of 
locking pieces, displacement of shunt blocking membrane, etc. 
(2) Device deficiencies are recorded in the device defect record sheet, and device defects that may lead to 
serious adverse events will be reported and recorded within 5 working days. 
(3) If there are device deficiencies before operation, such as label error, plastic thread damage, ineffective 
fastening or releasing of locking piece, displacement of shunt blocking membrane, it is necessary to change 
a new absorbable ASD closure system for operation. In case of device deficiencies such as ineffective 
fastening or releasing of the locking piece during operation, multi-angle adjustment or pulling can be tried, 
and if necessary, the device can be reclaimed or taken out with the catcher. 
14. Device management 
14.1 Investigational device management 
Trial institutions should establish strict registration system for the distribution of investigational device, and the 
sponsor should send the investigational device directly to the clinical trial institutions. The clinical trial 
institutions and the sponsor should establish perfect device receiving procedures, and the records should include 

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45 
the handover date, quantity and serial number. Each trial institution should use a special Record Form for the Use 
of Medical Devices in Clinical Trials, and registers the name of the subject, the date of use, and the signature of 
the device administrator. 
14.2 Package of device 
Investigational device should be uniformly packaged and numbered, and the packaging bag should be marked 
with the number, name, production date, expiration date and the words "test". 
14.3 Recollection of surplus devices 
After the termination of the trial, the sponsor will collect all the investigational devices. The sponsor is 
responsible for destroying the unused medical devices. At the end of the trial, all relevant materials must be 
counted. 
15. Protocol Deviation and amendment 
15.1 Protocol Deviation  
Deviation is an intentional or unintentional failure to comply with the requirements of a clinical trial protocol. 
15.1.1 Actions to control deviation 
Sponsor  
(1) Protocol should be described in clear language. The possible protocol deviations should be considered, and 
the protocol should be designed in a way that minimizes such deviations and ensure that the possible 
deviations from the protocol can be found and confirmed simply and clearly; 
(2) In the investigator meeting and CRA training of the research project, training should be focus on the 
implementation details of the protocol and the report and supervision of protocol deviation.  
Investigator 
(1) At the project approval and evaluation stage before the start of the study, read the study protocol carefully 
and fully discuss the feasibility of the plan in the institution with the sponsor; 
(2)  The investigators should explain to the subjects the importance of comliance during the process of informed 
consent; 
(3)  The investigators should comply with the protocol approved by the ethics committee, and once they realize 
the protocol deviation, they should immediately record and explain the situation. 
15.1.2 Re-training 
In order to ensure that the clinical trial is carried out in strict accordance with the clinical protocol approved by 

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46 
the ethics committee, the investigators need to be retrained for trial protocol if necessary, including but not 
limited to the following situations:  
⚫ 
The investigators' understanding of the protocol is biased;  
⚫ 
New investigators join in the trial and need to train them;  
⚫ 
Trial protocol or plan is changed; 
⚫ 
It is necessary to remind the investigators of the details of the protocol.  
If necessary, investigators can be trained for multiple times. 
15.1.3 Report of protocol deviation 
(1)  If there is a protocol deviation that affects the rights and interests, safety and health of subjects or the 
scientific nature of clinical trial, including requesting and reporting deviations; The investigators should 
timely report to the administrative department of medical device clinical trial of the clinical trial institution, 
and inform the sponsor and report to the ethics committee in time to judge whether the trial can continue; 
(2)  In order to protect the rights, safety and health of the subjects, if the deviation occurs in an emergency 
cannot be reported in time, it should be reported in written form as soon as possible in accordance with 
relevant regulations afterwards; 
(3)  The revision of clinical trial protocol, informed consent form, and other documents, requesting deviation 
and resuming the suspended clinical trial during the clinical trial process should obtain written approval 
from the ethics committee before implementation. 
(4)  The investigators should strictly follow the clinical trial protocol, and should not deviate from the protocol or 
substantially change the protocol without the consent of the sponsor and the ethics committee, or without 
the approval of the NMPA in accordance with the regulations. However, in the case of immediate danger to 
the subject and other emergency situations requiring immediate elimination, it can also be reported in 
written form afterwards.  
15.2 Protocol amendment 
During the trial, if there are major flaws in the clinical trial protocol, such as irrational inclusion/exclusion criteria, 
indications and evaluation indicators, etc., it should be discussed and revised at the researcher coordination 
meetings and then reported to the ethics committee for approval or record after unanimous consent. 
16. Data access 
(1)  The authorized CRA has the right to access and verify the source data/files of the subjects, so as to judge 
whether the investigators conduct the clinical trial according to the requirements of the protocol and 
whether the source data/files are recorded in the patient's medical records in time. The CRA should confirm 
that the source data/files are traceable and verifiable. Meanwhile, the data filled in CRF should correspond 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
47 
to the source data/files; 
(2)  When any person participating in the clinical trial has doubts about the clinical trial data, the investigators 
should provide the source data/files in time for the relevant personnel to verify, and earnestly answers the 
relevant questions; 
(3)  The source data/files should be properly preserved in accordance with the requirements of relevant laws 
and regulations. Any destruction can be carried out only after the signature and confirmation of the sponsor, 
and should meet the requirements of relevant laws and regulations. 
17. Finance and insurance 
(1)  The sponsor of this clinical trial is responsible for providing the medical devices needed for this clinical trial, 
and providing the fees for the test items required in this clinical trial. The sponsor should bear the cost of 
treatment and the corresponding economic compensation for the subjects who have suffered injury or 
death related to clinical trial, except for the damage caused by the fault of medical institutions and their 
medical staff in the diagnosis and treatment activities; 
(2)  The specific requirements of finance and insurance are detailed in the relevant agreements; 
(3)  Medical accidents refer to accidents leading to personal injuries, which is negligently caused by the medical 
institutions and their medical staff in medical activities due to violation of the medical and health 
management measures, administrative regulations, trial protocols and guiding principles. 
18. Confidentiality 
(1) The investigator must keep the study results, protocols and other materials strictly confidential, and shall 
not release such information without the sponsor's written authorization. If any quotation is needed, 
written authorization from the sponsor must also be obtained in advance; 
(2) All personal information of the subjects is private. Except for the relevant study personnel, only the sponsor 
of this study project, members of the ethics committee and the relevant personnel of the State/Local Food 
and Drug Administration can be allowed to access it. The investigator and the sponsor shall keep the 
subjects’ personal information confidential. 
19. Publication agreement of trial results 
The sponsor and the investigator shall agree on the final study report. The study results can be made public as 
scientific literature or submitted to the authorities. This clause is designed to protect trade secret materials. All 
the information about the investigationall device (such as patent application, previously undisclosed production 
technology and basic scientific data provided by the sponsor to investigators, etc.) is regarded as confidential, 
and its ownership belongs to the sponsor. The investigators should not use such information for other purposes 
without the written permission of the sponsor. Before the results of this study are made public or published, the 

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48 
investigators shall allow the sponsor to review the manuscript and make comments, confirm that no confidential 
information is disclosed, and supplement relevant information within 30 days. According to the generally 
accepted principles of scientific research cooperation, the investigators shall discuss the manuscript with relevant 
personnel of the sponsor and reach an agreement prior to publication. 
20. Responsibilities of parties 
20.1 Sponsor responsibilities 
(1)  Select medical institutions according to laws; 
(2) Provide Investigator's Brochure to participating institutions; 
(3) Jointly design and formulate the clinical study protocol of the medical device with participating institutions, 
and sign the protocols and contracts of the medical device agreed by both parties； 
(4)  Provide the investigational devices to participating institutions free of charge; 
(5)  Train the clinical trial personnel; 
(6)  Truthfully and timely report the SAE to the medical products administration departments of the provinces, 
autonomous regions and municipalities responsible for the medical device registration and the safety 
supervision department of NMPA, and notify others medical institutions participating in the clinical trial. 
(7)  Before suspending the clinical trial of medical device, the sponsor should notify the medical institutions, EC, 
the medical products administration departments of the provinces, autonomous regions and municipalities 
responsible for the medical device registration and NMPA, and explain the reasons; 
(8)  For damage caused by the investigational device to the subjects, the sponsor should compensate the 
subjects according to the relevant laws and regulations. 
20.2 Responsibilities of institutions and investigators 
(1) Should be familiar with the relevant information provided by the sponsor, and familiar with the use of 
the investigational device; 
(2) Jointly design and formulate the clinical trial plan with the sponsor, and sign the clinical trial plan and 
contract with the sponsor; 
(3) Faithfully explain the details of the investigational device to the subjects. The subjects must be given 
sufficient time to consider whether to participate in the clinical trial before the trial begins.  
(4) Record the AE of the investigational device truthfully and analyze the reasons. In case of AE events, they 
should be truthfully and timely reported to the drug administration of the province, autonomous region or 
municipality respectively that accepts the application for the medical device registration. The SAE shall be 

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49 
reported within 24 hours of occurrence; 
(5) When AE events occur, investigators should make clinical judgment in time and take measures to protect 
the interests of subjects; If necessary, the ethics committee has the right to immediately suspend the 
clinical trial; 
(6) If the clinical trial is suspended, institutions and investigators should inform the subject, the sponsor, the 
ethics committee, the drug regulatory department and the NMPA of the province, autonomous region or 
municipality that accepts the application for of the medical device registration, and explain the reason; 
(7) Submit a clinical trial report and be responsible for the validity and reliability of the report. 
21. Reference 
[1] Zhong-Dong Du, et al. Comparison Between Transcatheter and Surgical Closure of Secundum Atrial 
Septal Defect in Children and Adults. JACC Vol. 39, No. 11, 2002 June 5, 2002:1836–44 
[2] Shinichi Oho, et al. Results of the U.S. Multicenter Pivotal Study of the HELEX Septal Occluder for 
Percutaneous Closure of Secundum Atrial Septal Defects JACC Vol. 49, No. 22, 2007 June 5, 2007:2215–21  
[3] Sérgio Luiz Navarro Braga, et al. Community Use of the Amplatzer Atrial Septal Defect Occluder: Results 
of the Multicenter MAGIC Atrial Septal Defect Study. Pediatr Cardiol (2009) 30:240–247 
[4] Cristiano Oliveira Cardoso, et al. Transcatheter Closure of Atrial Septal Defects in a Center with Limited 
Resources Outcomes and Short Term Follow-Up. Iran J Pediatr. 2015 December; 25(6): e3906. 
[5] Thomas K. Jones, et al. Transcatheter closure as an alternative and equivalent method to the surgical 
treatment of atrial septal defect in adults Comparison of early and late results. Med Sci Monit, 2009; 15(12): 
CR612-617 
[6] Allen D. Everett, et al. Techniques and outcomes of transcatheter closure of complex atrial septal defects 
– Single center experience. i n d i a n heart journal 6 6(2014) 3 8-4 4 
[7] Tehmina Kazmi, et al. Results of the U.S. Food and Drug Administration Continued Access Clinical Trial of 
the GORE HELEX Septal Occluder for Secundum Atrial Septal Defect. J A C C: C A R D I O V A S C U L A R  I N 
T E R V E N T IO N S  V O L . 7, N O .8, 2 0 1 4: 9 0 5 – 1 2 
[8] Alexander J. Javois, et al. Feasibility of percutaneous closure of atrial septal defects in adults under 
transthoracic echocardiography guidance using the Figulla atrial septal defect occluder device. J Saudi Heart 
Assoc 2018; 30:21–27 
[9] Sukman T. Putra, et al. Closure of ostium secundum atrial septum defect with the atriasept occluder 
Early European experience. Catheterization and Cardiovascular Interventions 75:1091–1095 (2010) 

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[10] Daniel R. Turner, et al. Clinical efficacy and safety of the percutaneous treatment of secundum atrial 
septal defect with the Amplatzer occlude. Arquivos Brasileiros de Cardiologia - Volume 83, Nº Especial, 
Dezembro 2004 
22. Supplementary provisions 
Meaning of academic terms involved in this trial protocol: 
22.1 Medical device clinical trial institution: refers to the medical institution that undertakes the clinical trial of 
medical devices as recognized by NMPA and National Health and Family Planning Commission. Unless otherwise 
specified, "clinical trial institution" in this protocol refers to "medical device clinical trial institution". 
22.2 Investigational medical device: refers to the medical device to be registered for verifying or validating their 
safety and effectiveness in clinical trials. 
22.3 Sponsor: refers to the institution or organization that initiates, manages and provides financial support for 
clinical trials. 
22.4 Investigator: refers to the person responsible for implementing clinical trials in clinical trial institutions. If 
the trial is conducted by a group of people in a clinical trial institution, the investigator refers to the person in 
charge of the group, which is also called principal investigator. 
22.5 Ethics committee: refers to an independent institution set up by clinical trial institutions to examine the 
scientific and ethical nature of clinical trial items of medical devices. 
22.6 Medical device clinical trial management department: refers to the office or department set up in the 
clinical trial institution to be responsible for the organization, management and quality control of medical device 
clinical trials. 
22.7 Multi-center clinical trial: refers to clinical trial conducted in three or more (including three) clinical trial 
institutions according to the same clinical trial protocol. 
22.8 Subject: refers to an individual who is recruited to accept clinical trial of medical device. 
22.9 Informed consent: refers to the process in which the subject confirms to voluntarily participate in the 
clinical trial after being informed of all aspects of the clinical trial, and the signed and dated informed consent 
form should be used as the supporting document. 
22.10 Informed consent form: refers to the documentary evidence that the subjects express their willingness to 
participate in clinical trials. 
22.11 Monitoring: refers to the activity that the sponsor selects special personnel to evaluate and investigate the 
clinical trial institutions and investigators, and verify the data in the clinical trial process, record and report it in 
order to ensure that the clinical trial can follow the protocol, standard operating procedures, Good Clinical 
Practice of Medical Devices and relevant applicable management requirements. 

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51 
22.12 CRA: Clinical research associate refers to the special personnel selected by the sponsor to monitor the 
clinical trial items of medical devices. 
22.13 Audit: refers to systematic and evaluation of independent inspection of activities and documents related 
to clinical trials organized by the sponsor to determine whether the implementation of such activities, data 
recording, analysis and reporting conform to the clinical trial protocol, SOPs, Good Clinical Practice for Medical 
Devices and relevant applicable management requirements. 
22.14 Auditor: refers to the person entrusted by the sponsor to check the clinical trial of medical devices.  
22.15 Inspection: refers to the activities of the drug regulatory agencies to review, supervise and manage the 
relevant documents, facilities, records and other aspects of clinical trial. 
22.16 Inspector: refers to the personnel selected by the regulatory authorities to inspect the clinical trial of 
medical devices. 
22.17 Deviation: refers to the situation of intentionally or unintentionally failing to comply with the 
requirements of clinical trial protocol. 
22.18 Case report form: refers to the document designed according to the clinical trial protocol to record all the 
information and data of each subject obtained during the trial. 
22.19 Endpoint: refers to the index used to evaluate the hypothesis of clinical trials. 
22.20 Source data: refers to the original records of clinical findings, observations and other activities in clinical 
trials and all information in their approved copies, which can be used for reconstruction and evaluation of clinical 
trials. 
22.21 Source file: refers to printed files, visual files or electronic files containing source data. 
22.22 AE: refers to adverse medical events occur during clinical trials, whether related to the investigational 
device or not. 
22.23 SAE: refers to the death or serious aggravation of health during clinical trial, including fatal diseases or 
injuries, permanent defects in body structure or body function, hospitalization or prolonged hospitalization, and 
medical or surgical intervention required to avoid permanent defects in body structure or body function, fetal 
distress, fetal death, congenital abnormality and congenital defect. 
22.24 Device defect: refers to unreasonable risk that may endanger human health and life safety under normal 
use conditions during the clinical trial, such as label error, quality problem, malfunction, etc. 
22.25 Standard operating procedure: refers to the standards and detailed written procedures drawn up for 
effectively implementing and completing each step in clinical trial. 
22.26 Clinical data: refers to the safety and performance information obtained from relevant literatures or 
clinical use of medical devices. 
 

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23. List of participating personnel 
Clinical trial personnel 
Position 
Title 
Department 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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53 
 
Investigator Statement 
I agree: 
1. Carry out the clinical trial in strict accordance with the Helsinki Declaration, the current Chinese 
regulations and the requirements of this trial protocol. 
2. Record all required data accurately in the CRF, and complete the clinical trial report on time. 
3. Only use the device for this clinical trial. The receipt and use of the experimental devices will be 
completely and accurately recorded during the clinical trial, and records will be kept. 
4. Allow clinical research associates, inspectors and regulatory authorities authorized or dispatched by the 
sponsor to supervise, verify and inspect the clinical trial. 
5. Strictly fulfill the clinical trial contract/agreement signed by both parties. 
I have read all of the clinical trial protocol, including the above statement, and I agree with all of them.  
 
Sponsor Opinion: 
Sign: 
 
                                                Date: 
Investigator Opinion: 
Approval 
Sign: Zhiwei Zhang 
Date: 21 Dec 2019 
Clinical trial institution opinion: 
Approval 
 
Sign: National Drug Clinical Trial Institution of Guangdong Provincial People's Hospital 
Date: 9 Jan 2020 
 

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Appendix 1: List of participating institutions and investigators 
No. 
Institution 
Investigator 
Title 
1 
Guangdong Provincial People’s Hospital 
Zhiwei Zhang 
Professor/Director 
2 
Fuwai Hospital, Chinese Academy of Medical Sciences  
Xiangbin Pan 
Professor/Director 
3 
Shanghai Children's Medical Center Affiliated to Shanghai 
Jiaotong University School of Medicine 
Fen Li 
Professor/Director 
4 
Xinhua Hospital Affiliated to Shanghai Jiaotong University 
School of Medicine 
Sun Chen 
Professor/Director 
5 
Shenzhen Children's Hospital 
Cong Liu 
Professor/Director 
6 
Children's Hospital Affiliated to Zhejiang University School of 
Medicine 
Fangqi Gong 
Professor/Director 
7 
Jiangsu Provincial People's Hospital 
Xiangqing Kong 
Professor/Director 
8 
Children's Hospital of Chongqing Medical University 
Qijian Yi 
Professor/Director 
9 
The First Affiliated Hospital of Guangxi Medical University 
Kai Huang 
Professor/Director 
10 
The Second Xiangya Hospital of Central South University 
Zhenfei Fang 
Professor/Director 
11 
The Second Affiliated Hospital of Wenzhou Medical University 
Rongzhou Wu 
Professor/Director 
12 
Fuwai Central China Cardiovascular Hospital 
Taibing Fan 
Professor/Director 
13 
General Hospital of Northern Theater Command 
Qiguang Wang 
Professor/Director 
14 
Fujian Medical University Union Hospital 
Lianglong Chen 
Professor/Director 

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Appendix 2: Headache questionnaire and evaluation 
This questionnaire is used to express how you feel about headache and the negative impact of headache on 
your life. Please choose one answer from five choices. 
1. When you have a headache, how often does severe pain occur? 
A. Never  
B. Seldom 
 C. Sometimes  
D. Often  
E. Always  
2. Does the headache limit your ability to daily activities, such as housework, work, school, or social 
activities? 
A. Never  
B. Seldom 
 C. Sometimes  
D. Often  
E. Always  
3. Do you often wish to lie down when you have a headache? 
A. Never  
B. Seldom 
 C. Sometimes  
D. Often  
E. Always  
4. In the past 4 weeks, do you often feel tired due to headache and feel powerless in work or daily 
activities? 
A. Never  
B. Seldom 
 C. Sometimes  
D. Often  
E. Always  
5. In the past 4 weeks, do you often feel bored and restless due to headache? 
A. Never  
B. Seldom 
 C. Sometimes  
D. Often  
E. Always  
6. In the past 4 weeks, have you been unable to concentrate on work and daily activities due to headache? 
A. Never  
B. Seldom 
 C. Sometimes  
D. Often  
E. Always  
Evaluation: 
Choose A: 6 scores, choose B: 8 scores, choose C: 10 scores, choose D: 11 scores, choose E: 13 scores. 
Add up the corresponding points for all the answers. 
Total score range: 36 - 78 
Level 1: ≤49, no or minor impact 
Level 2: 50-55, moderate impact 
Level 3: 56-59, significant impact 
Level 4: ≥60, seriously impact 

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Appendix 3: MIDAS Migraine Questionnaire and score 
Five questions were asked to assess the time lost (days) due to migraine over a three-month period. The 
time loss mainly means paid work, household work, family and social activities. The MIDAS score is 
obtained by adding all days lost. 
1. In the past 3 months, how many days have you been unable to go to work or school due to headache? 
            Days  
2. In the past 3 months, how many days have you partially affected your work or study due to headache 
(efficiency was decreased by more than half)? 
            Days  
3. In the past 3 months, how many days have you been unable to do housework due to headache? 
            Days  
4. In the past 3 months, how many days have you partially affected your housework due to headache 
(efficiency was reduced by more than half)? 
            Days  
5. In the past 3 months, have you missed visiting friends and relatives, parties, entertainment such as 
watching TV, playing cards and other similar activities due to headache? 
            Days  
Total days:            Days  
 
Score definition of MIDAS Migraine Disability Assessment Questionnaire 
Grading 
Degree 
Disable Level 
Suggestion 
0-5 
I 
Slight 
or 
infrequent 
impact 
There is little need for medical intervention. Simple symptomatic 
treatment can be used with OTC drugs when seizures occur, but the 
following conditions should be noted: 
1. Evaluate the impact of days off due to headache on subjects' life 
2. Subjects with infrequent but severe headache need regular 
treatment 
3. Subjects whose headaches are not effectively relieved by 
painkillers alone need standardized treatment 

Clinical Trial to Evaluate the Safety and Efficacy of Absnow™ Absorbable ASD Closure System for ASD Patients 
57 
6-10 
II 
Mild 
or 
frequent 
impact 
Subjects usually have headache for a long time or severe degree, 
which cannot be completely relieved by analgesic alone and has 
obvious influence on life. Standardized treatment is needed in the 
acute phase. 
11-20 
III 
Moderate 
impact 
Headache has serious influence on life. Standardized treatment is 
needed in the acute phase. 
>21 
IV 
Serious 
impact 
Need preventive treatment.