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

NCT03601039 | Completed Results

• 1 other identifier: 42CT（CN）
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Heart Septal Defects, Atrial; Atrial Septal Defect

Keywords

Absnow Absorbable Occluder; ASD Occluder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Immediate Operation Success Rate

  Immediate postoperative

• Device-related AE (Adverse Event) Rate

  5 years post operation

• Device-related SAE (Serious Adverse Event) Rate

  5 years post operation

Study Arms (1)

Absnow Absorbable ASD Closure System

OTHER

All subjects are implanted with Absnow Absorbable ASD Occluder

Device: Absnow Absorbable ASD Closure System

Interventions

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.

Absnow Absorbable ASD Closure System

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (14)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Fuwai Central China Cardiovascular Hospital

Zhenzhou, Henan, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Shenzhen Children's Hospital

Shenzhen, Shenzhen, China

Location

Children's Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Related Publications (5)

• 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.

  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.

  PMID: 9590343 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.

  PMID: 3663810 BACKGROUND

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Shiting Li
• Organization: Lifetech Scientific (Shenzhen) Co., Ltd.

lishiting@lifetechmed.com

+86 13699714609

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 26, 2018
• Study Start: August 25, 2018
• Primary Completion: August 28, 2020
• Study Completion: August 30, 2024
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-01

Locations

CN (14)