Safety and Efficacy of the AbsnowTM II Absorbable Atrial Septal Defect Closure System for Atrial Septal Defect Closure Therapy

A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the AbsnowTM II absorbable atrial septal defect occluder system for atrial septal defect closure therapy. A parallel controlled comparison will be conducted using the Cera atrial septal defect occluder manufactured by the same company as the control device, to evaluate the safety and efficacy of the AbsnowTM II absorbable ASD occluder system in the treatment of ASD occlusion.

NCT Number	NCT07529028
Lead Sponsor	Lifetech Scientific (Shenzhen) Co., Ltd. Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital, Fuwai Yunnan Cardiovascular Hospital, Guangdong Provincial People's Hospital, Chinese PLA General Hospital, Lanzhou University Second Hospital, The Children's Hospital of Zhejiang University School of Medicine, Beijing Anzhen Hospital
Conditions	Atrial Septal Defect
Enrollment	236 participants
Start Date	2026-04
Primary Completion	2027-12 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-14