NCT07529028

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is expected to be conducted at multiple centers, adopting a prospective, multicenter, randomized controlled, non-inferiority design, and is divided into the following two phases: * Roll-in Phase: Each study center may enroll 1 to 3 roll-in subjects. Investigators will implant the absorbable atrial septal defect occluder system to gain procedural familiarity with the investigational device. (Roll-in subjects will not be included in the confirmatory trial statistical analysis.) * Confirmatory Trial: A prospective, multicenter, randomized controlled, non-inferiority trial design will be adopted. A total of 236 eligible subjects are planned for enrollment. Qualified subjects will be randomly assigned in a 1:1 ratio to either the test group or the control group. Subjects in the test group will receive treatment with the absorbable atrial septal defect occluder system manufactured by Lifetech Scientific (Shenzhen) Co., Ltd. Subjects in the control group will receive treatment with the Cera atrial septal defect occluder manufactured by the same company. All subjects will undergo assessments at screening, pre-discharge, and follow-up visits at 1 month, 3 months, 6 months, and 12 months post-procedure. A clinical summary will be prepared after completion of all 12-month follow-up evaluations to support product registration application. After trial completion, all subjects will be followed long-term for 2 to 5 years to evaluate the long-term safety of the device.

Conditions

• Atrial Septal Defect

Interventions

Type	Name	Description
DEVICE	Absnow II Absorbable Atrial Septal Defect Occluder System	To evaluate the efficacy and safety of the AbsnowTM II absorbable atrial septal defect occluder system in the treatment of atrial septal defect.
DEVICE	Cera Atrial Septal Defect Occluder	The Cera atrial septal defect occluder produced by the same company serves as the control group.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2031-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-14