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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
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
(from sponsor)		 Atrial Septal Defect
Related terms Heart Septal Defects, Atrial
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov