At a glance
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Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients
In Brief
A clinical study evaluating Absnow Absorbable ASD Closure System for Heart Septal Defects, Atrial and Atrial Septal Defect. Completed, enrolled 165 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.