Heart Septal Defects, AtrialNCT03601039
Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
A study testing Absnow Absorbable ASD Closure System in people with Heart Septal Defects, Atrial and Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 14 sites in China.
Trial summary
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Heart Septal Defects, Atrial, Atrial Septal Defect
- What is being tested?
- Absnow Absorbable ASD Closure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 14 sitesChina
- Study dates
- 25 Aug 2018to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥3 , weight ≥10Kg
- Secundum left-to-right shunt ASD with hemodynamic significance
- Distance from the defect edge to coronary vein sinus, superior and inferior vena cava, pulmonary vein≥5mm and AV valve should be ≥7mm
- The atrial septum length (stretched diameter) should be greater than the diameter of left disk
Who cannot join
- Patients of primum, venous sinus and coronary sinus ASD
- Patients with atrial septum defect ≥26mm
- Patients with other structural heart disease in addition to ASD
- Patients with complication of obstructive pulmonary arterial hypertension, Eisenmenger syndrome
- Infective endocarditis patients
- Patients with hemolysis or hemorrhagic disease, unhealed ulcer or any taboo about aspirin (except being able to take other anti-platelet agent for consecutive six months) within one month before implantation
Show all 15Show fewer
- Patients with thrombosis(especially in left atrium or left atrial appendage thrombus) as shown by echocardiography
- Patients with known condition of hypercoagulation status
- Patients who have undergone heart surgery in the past
- Patients allergic to PLLA
- Patients refusing to sign the informed consent form
- Patients with poor compliance on disease-related treatment and poor cooperation on follow-up visits
- Patients that are in pregnancy or lactation, or planned for pregnancy or get a positive pregnancy test result during the screening period
- 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
- The patients considered to be not eligible for this clinical trial by the investigator
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Fujian Medical University Union Hospital
Fuzhou, Fujian
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Children's Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
General Hospital of Northern Theater Command
Shenyang, Liaoning
Shenzhen Children's Hospital
Shenzhen, Shenzhen
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Fuwai Central China Cardiovascular Hospital
Zhenzhou, Henan
About this study
Official title: Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
Read the detailed description
Atrial Septal Defect (hereinafter referred to as "ASD") is a common congenital heart disease (hereinafter referred to as "CHD"), accounting for about 10% of CHD in children.Initially，ASD was treated by surgical operation. Nowdays transcatheter ASD closure, characterized by minimal invasion, definite curative effect, short recovery period, and no need for cardiopulmonary bypass, provides a new safe and effective therapy for CHD. According to a large number of clinical reports, the use of transcatheter closure devices for ASD closure has a high success rate, good closure effect and low risk of complications.
Absnow absorbable ASD closure system has undergone implantation experiments that implant it into animal (pig) ASD models, with the implantation success rate being 100%. Up to 2 years' observation indicated that the cardiomyocytes and endothelial cells covering the implanted device were not different from those of the control group (nickel-titanium alloy occluder) and were of a great number, and the inflammatory response was remarkably lower than that of the control group. During the observation period, all occluders in the trial did not fall off or were displaced, no evident postoperative complications and therefore, this occluder has the feasibility of local application and system safety.
Absnow absorbable ASD closure system developed by LifeTech Scientific passed the registration inspection of CFDA Shenzhen Medical Device Quality Monitoring and Inspection Center, verifying that this closure system conforms to the product technical specification in mechanical strength, physiochemical properties and biological properties. According to the provisions in Measures for Administration of Medical Device Registration (No. 4 Order) and Regulation on Quality Management of Medical Device Clinical Trial (No. 25) issued by CFDA, this product has the conditions for clinical trial.
- Conditions
- Heart Septal Defects, Atrial, Atrial Septal Defect
- Being tested
- Absnow Absorbable ASD Closure System
- Keywords
- Absnow Absorbable Occluder, ASD Occluder
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absnow Absorbable ASD Closure SystemDevice
the eligible subjects who meet the inclusion criteria should sign the ICF before operation (-30 to 0 day), then receive the Absnow absorbable ASD Closure System implantation. The follow-up time will be set as observation point : the next day after operation, 30-day post-operative , 90-day post-operative, 180-day post-operative, 360-day post-operative, 2 year post-operative, 3 year post-operative, 4 year post-operative and 5 year post-operative. If any AE/SAE occurs during clinical trial, the subjects should be observed till such AE/SAE disappear or stable.
| Study group | Role | What they receive |
|---|---|---|
| Absnow Absorbable ASD Closure System | Other | All subjects are implanted with Absnow Absorbable ASD Occluder Receives: Device: Absnow Absorbable ASD Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Closure Rate at 360-day Post Operation
Effective closure rate refers to proportion of patient without or with only mild-small residual shunt in TTE or TEE observation after device implantation
Measured: 360-day post ASD closure operative
The Rate of Common Complication During 360-day Post ASD Closure Operative
Rate of common complication refers to proportion of subject with common complication during the 360day of follow up, common complications include Occluder dislocation, Moderate or larger residual shunt, High-grade atrioventricular block, Intractable headache or migraine, Cardiac tamponade, Cerebral embolism and Air embolism.
Measured: 360-day post operation
Secondary outcomes (3)
Immediate Operation Success Rate
Immediate operation success refers to the occluder being successfully implanted which means left and right disks are effectively fixed on left and right sides of atrial septum, respectively and smoothly released without displacement or falling off and the delivery system and the delivery system is successfully withdrawn.Success rate refers to proportion of subject with such implant success.
Measured: Immediate postoperative
Device-related AE (Adverse Event) Rate
This is one of the secondary safety endpoints, device-related AE rate refers to proportion of subject experienced device-related AEs
Measured: 5 years post operation
Device-related SAE (Serious Adverse Event) Rate
This is one of the secondary safety endpoints, device-related SAE rate refers to proportion of subject experienced device-related SAEs
Measured: 5 years post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start25 Aug 2018
- Primary completion28 Aug 2020
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Septal Defects, AtrialStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601039
- Sponsor's protocol ID
- 42CT（CN）
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2018
- Last updated
- 10 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jie Ren. Biodegradable Poly(Lactic Acid): Synthesis, Modification, Processing and Applications. Tsinghua University Press, Beijing and Springer-Verlag Berlin Heidelberg 2010
Catia Bastioli. Handbook of Biodegradable Polymers. Rapra Technology Limited Shawbury, Shrewsbury, Shropshire, SY4 4NR, UK.
Lakshmi S. Nair, Cato T. Laurencin. Biodegradable polymers as biomaterials. Prog. Polym. Sci. 32 (2007) 762-798.
Suuronen R, Pohjonen T, Hietanen J, Lindqvist C. A 5-year in vitro and in vivo study of the biodegradation of polylactide plates. J Oral Maxillofac Surg. 1998 May;56(5):604-14; discussion 614-5. doi: 10.1016/s0278-2391(98)90461-x.
PubMed 9590343Leenslag JW, Pennings AJ, Bos RR, Rozema FR, Boering G. Resorbable materials of poly(L-lactide). VII. In vivo and in vitro degradation. Biomaterials. 1987 Jul;8(4):311-4. doi: 10.1016/0142-9612(87)90121-9.
PubMed 3663810
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients
- ClinicalTrials.gov ID
- NCT03601039
- Acronym / sponsor ID
- 42CT（CN）
- Conditions
- Heart Septal Defects, Atrial, Atrial Septal Defect
- Keywords
- Absnow Absorbable Occluder, ASD Occluder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 10 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
Detailed description
Atrial Septal Defect (hereinafter referred to as "ASD") is a common congenital heart disease (hereinafter referred to as "CHD"), accounting for about 10% of CHD in children.Initially，ASD was treated by surgical operation. Nowdays transcatheter ASD closure, characterized by minimal invasion, definite curative effect, short recovery period, and no need for cardiopulmonary bypass, provides a new safe and effective therapy for CHD. According to a large number of clinical reports, the use of transcatheter closure devices for ASD closure has a high success rate, good closure effect and low risk of complications.
Absnow absorbable ASD closure system has undergone implantation experiments that implant it into animal (pig) ASD models, with the implantation success rate being 100%. Up to 2 years' observation indicated that the cardiomyocytes and endothelial cells covering the implanted device were not different from those of the control group (nickel-titanium alloy occluder) and were of a great number, and the inflammatory response was remarkably lower than that of the control group. During the observation period, all occluders in the trial did not fall off or were displaced, no evident postoperative complications and therefore, this occluder has the feasibility of local application and system safety.
Absnow absorbable ASD closure system developed by LifeTech Scientific passed the registration inspection of CFDA Shenzhen Medical Device Quality Monitoring and Inspection Center, verifying that this closure system conforms to the product technical specification in mechanical strength, physiochemical properties and biological properties. According to the provisions in Measures for Administration of Medical Device Registration (No. 4 Order) and Regulation on Quality Management of Medical Device Clinical Trial (No. 25) issued by CFDA, this product has the conditions for clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Absnow Absorbable ASD Closure System | Other | Device: Absnow Absorbable ASD Closure SystemAll subjects are implanted with Absnow Absorbable ASD Occluder |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥3 , weight ≥10Kg
- Secundum left-to-right shunt ASD with hemodynamic significance
- Distance from the defect edge to coronary vein sinus, superior and inferior vena cava, pulmonary vein≥5mm and AV valve should be ≥7mm
- The atrial septum length (stretched diameter) should be greater than the diameter of left disk
Key exclusion criteria (15 listed)
- Patients of primum, venous sinus and coronary sinus ASD
- Patients with atrial septum defect ≥26mm
- Patients with other structural heart disease in addition to ASD
- Patients with complication of obstructive pulmonary arterial hypertension, Eisenmenger syndrome
- Infective endocarditis patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absnow Absorbable ASD Closure Systemthe eligible subjects who meet the inclusion criteria should sign the ICF before operation (-30 to 0 day), then receive the Absnow absorbable ASD Closure System implantation. The follow-up time will be set as observation point : the next day after operation, 30-day post-operative , 90-day post-operative, 180-day post-operative, 360-day post-operative, 2 year post-operative, 3 year post-operative, 4 year post-operative and 5 year post-operative. If any AE/SAE occurs during clinical trial, the subjects should be observed till such AE/SAE disappear or stable. | Device | Absnow Absorbable ASD Closure System |
Primary outcome
Effective Closure Rate at 360-day Post Operation
Time frame: 360-day post ASD closure operative
Effective closure rate refers to proportion of patient without or with only mild-small residual shunt in TTE or TEE observation after device implantation
The Rate of Common Complication During 360-day Post ASD Closure Operative
Time frame: 360-day post operation
Rate of common complication refers to proportion of subject with common complication during the 360day of follow up, common complications include Occluder dislocation, Moderate or larger residual shunt, High-grade atrioventricular block, Intractable headache or migraine, Cardiac tamponade, Cerebral embolism and Air embolism.
3 secondary outcomes
Immediate Operation Success Rate
Time frame: Immediate postoperative
Device-related AE (Adverse Event) Rate
Time frame: 5 years post operation
Device-related SAE (Serious Adverse Event) Rate
Time frame: 5 years post operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundJie Ren. Biodegradable Poly(Lactic Acid): Synthesis, Modification, Processing and Applications. Tsinghua University Press, Beijing and Springer-Verlag Berlin Heidelberg 2010
- BackgroundCatia Bastioli. Handbook of Biodegradable Polymers. Rapra Technology Limited Shawbury, Shrewsbury, Shropshire, SY4 4NR, UK.
- BackgroundLakshmi S. Nair, Cato T. Laurencin. Biodegradable polymers as biomaterials. Prog. Polym. Sci. 32 (2007) 762-798.
- Background: PubMed 9590343Suuronen R, Pohjonen T, Hietanen J, Lindqvist C. A 5-year in vitro and in vivo study of the biodegradation of polylactide plates. J Oral Maxillofac Surg. 1998 May;56(5):604-14; discussion 614-5. doi: 10.1016/s0278-2391(98)90461-x.
- Background: PubMed 3663810Leenslag JW, Pennings AJ, Bos RR, Rozema FR, Boering G. Resorbable materials of poly(L-lactide). VII. In vivo and in vitro degradation. Biomaterials. 1987 Jul;8(4):311-4. doi: 10.1016/0142-9612(87)90121-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absnow Absorbable ASD Closure System in people with Heart Septal Defects, Atrial and Atrial Septal Defect, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Closure Rate at 360-day Post Operation (time frame: 360-day post ASD closure operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03601039, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.