Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients

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.

Study Overview

• Status: Completed
• Conditions: Atrial Septal Defect; Heart Septal Defects, Atrial
• Intervention / Treatment: Device: Absnow Absorbable ASD Closure System

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 Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Fuwai Hospital, Chinese Academy of Medical Sciences
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Children's Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
  • Guangxi
    • Nanning, Guangxi, China
      • The First Affiliated Hospital of Guangxi Medical University
  • Henan
    • Zhenzhou, Henan, China
      • Fuwai Central China Cardiovascular Hospital
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital Of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Provincial People's Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • General Hospital of Northern Theater Command
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, 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
  • Shenzhen
    • Shenzhen, Shenzhen, China
      • Shenzhen Children's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Children's Hospital Affiliated to Zhejiang University School of Medicine
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Absnow Absorbable ASD Closure System; All subjects are implanted with Absnow Absorbable ASD Occluder

Device: Absnow Absorbable ASD Closure System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2018
• Primary Completion (Actual): August 28, 2020
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Absnow Absorbable Occluder; ASD Occluder
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects, Atrial
• Other Study ID Numbers: 42CT（CN）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No