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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absnow Absorbable ASD Closure System | Other | All subjects are implanted with Absnow Absorbable ASD Occluder |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Absnow Absorbable ASD Closure System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 360-day post operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China | |||
| Children's Hospital of Chongqing Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Jie Ren. Biodegradable Poly(Lactic Acid): Synthesis, Modification, Processing and Applications. Tsinghua University Press, Beijing and Springer-Verlag Berlin Heidelberg 2010 | ||
| Background | Catia Bastioli. Handbook of Biodegradable Polymers. Rapra Technology Limited Shawbury, Shrewsbury, Shropshire, SY4 4NR, UK. | ||
| Background | Lakshmi S. Nair, Cato T. Laurencin. Biodegradable polymers as biomaterials. Prog. Polym. Sci. 32 (2007) 762-798. | ||
| 9590343 | Background | 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. |
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A total of 179 subjects were screened, of which 165 were successfully enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Absnowâ„¢ Absorbable ASD Closure System | Participant underwent transcatheter implantation of investigational device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 2, 2019 | Feb 12, 2026 |
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| 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 | 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 | 5 years post operation |
| Chongqing |
| Chongqing Municipality |
| China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| Fuwai Central China Cardiovascular Hospital | Zhenzhou | Henan | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Jiangsu Provincial People's Hospital | Nanjing | Jiangsu | China |
| General Hospital of Northern Theater Command | Shenyang | Liaoning | China |
| Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | China |
| Shenzhen Children's Hospital | Shenzhen | Shenzhen | China |
| Children's Hospital Affiliated to Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
| 3663810 | Background | Leenslag 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. |
| Implant Attempt |
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| Implanted with the study device (FAS) |
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| Completed discharge visit |
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| Completed 30d visit |
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| Completed 90d visit |
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| Completed 180d visit |
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| Completed 360d visit |
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| Completed 2y visit |
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| Completed 3y visit |
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| Completed 4y visit |
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| COMPLETED |
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| NOT COMPLETED |
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Excluding subjects with failed implant attempt and without implant attempt
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| ID | Title | Description |
|---|---|---|
| BG000 | Absnowâ„¢ Absorbable ASD Closure System | All subjects implanted with Absnow Absorbable ASD Occluder. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 360-day post ASD closure operative |
|
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| |||||||||||||||||||||||||||
| Primary | 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. | Posted | Count of Participants | Participants | 360-day post operation |
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| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Immediate postoperative |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | 5 years post operation |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | 5 years post operation |
|
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From enrollment until end of follow-up, up to 5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group - Implant Attempted | Among all enrolled patients (165), subject without implant attempt (1) was excluded, leaving 164 subjects for tracking AEs throughout their study periods. | 0 | 164 | 38 | 164 | 126 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Infectious mononucleosis | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Renal abscess | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis bacterial | Infections and infestations | Systematic Assessment |
| ||
| Periodontitis | Infections and infestations | Systematic Assessment |
| ||
| Pharyngeal abscess | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Mycoplasma infection | Infections and infestations | Systematic Assessment |
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| Pneumonia mycoplasmal | Infections and infestations | Systematic Assessment |
| ||
| Cardiac septal defect residual shunt | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Foetal disorder | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Colon cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Conjunctival neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | Systematic Assessment |
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| Intracranial aneurysm | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Atrial septal defect repair | Surgical and medical procedures | Systematic Assessment |
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| Hernia hiatus repair | Surgical and medical procedures | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Snoring | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Cyclic vomiting syndrome | Gastrointestinal disorders | Systematic Assessment |
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| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | Systematic Assessment |
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| Device dislocation | Product Issues | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
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| Myocardial necrosis marker increased | Investigations | Systematic Assessment |
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| Atrial septal defect | Congenital, familial and genetic disorders | Systematic Assessment |
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| Major depression | Psychiatric disorders | Systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | Systematic Assessment |
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| Photoelectric conjunctivitis | Eye disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Cardiac septal defect residual shunt | Injury, poisoning and procedural complications | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shiting Li | Lifetech Scientific (Shenzhen) Co., Ltd. | +86 13699714609 | lishiting@lifetechmed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2021 | Feb 12, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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