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

LifeTech Scientific

Status

Enrolling

Conditions

Atrial Septal Defect

Heart Septal Defects, Atrial

Treatments

Device: Absnow Absorbable ASD Closure System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03601039

42CT（CN）

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 estimated patients

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

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