Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Atrial Septal Defect
  • Heart Septal Defects, Atrial
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 3 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03601039
Collaborators
Not Provided
Investigators
Not Provided