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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients

Conditions
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Heart Septal Defects, Atrial, Atrial Septal Defect

Intervention / Treatment
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* Device: Absnow Absorbable ASD Closure System


Participation Criteria
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Eligibility Criteria
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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 ever received heart operation Patients allergic to PLLA Patients refusing to sign the informed consent form Patients with poor compliance on 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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absnow Absorbable ASD Closure System<br>All subjects are implanted with Absnow Absorbable ASD Occluder | Device: Absnow Absorbable ASD Closure System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The successful rate at 30-day post ASD closure operative,which meaning that the TTE or TEE observation shows that residual shunt <5mm at 30-days postoperative. | The successful rate at 30-day post ASD closure operative,which meaning that the TTE or TEE observation shows that residual shunt <5mm at 30-days postoperative. | 30-day post ASD closure operative | 
| The rate of severe complication during 360-day post ASD closure operative | The rate of severe complication during 360-day post ASD closure operative. The severe complication includes all-cause mortality,coronary artery aeroembolism ,cardiac tamponade ,thromboembolism ,occluder dislodgment,repeated migraine, migraine,occluder displacement,mitral regurgitation,heart or aortic root perforation, high degree atrioventricular block and moderate to large residual shunt. | 360-day post ASD closure operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immediate operation success rates | the occluder is 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. | immediate postoperative | 
| Device-related AE (adverse event) rates | AE refers to adverse medical events occurring during clinical trial no matter if they are device-related | 5 years post operation | 
| Device-related SAE (serious adverse event) rates | SAE refers to events occurring in the clinical trial that can lead to death or serious health deterioration, including fatal disease or injure, permanent defects of body structure or function, need for hospitalization or prolonging hospitalization time or medial or operation intervention to avoid permanent defects of body structure or body function, fetal distress, fetal death or congenital anomaly, congenital defects. | 5 years post operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Absnow Absorbable Occluder, ASD Occluder