N/A
N=165
Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
Heart Septal Defects, Atrial · Atrial Septal Defect
Bottom Line
View on ClinicalTrials.gov: NCT03601039 ↗Enrolled (actual)
165
Serious AEs
23.2%
Results posted
Mar 2026
Primary outcome: Primary: Effective Closure Rate at 360-day Post Operation — 158 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Absnow Absorbable ASD Closure System (Device)
- Age
- Pediatric, Adult, Older Adult · 3+ yrs
- Sex
- All
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effective Closure Rate at 360-day Post Operation |
158 | — |
| PRIMARY The Rate of Common Complication During 360-day Post ASD Closure Operative |
3 | — |
| SECONDARY Immediate Operation Success Rate |
159 | — |
| SECONDARY Device-related AE (Adverse Event) Rate |
33 | — |
| SECONDARY Device-related SAE (Serious Adverse Event) Rate |
10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03601039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.