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

NCT07529028 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

  • Atrial Septal Defect

Interventions

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.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • Fuwai Yunnan Cardiovascular Hospital

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Lanzhou University Second Hospital

    collaborator OTHER

  • The Children's Hospital of Zhejiang University School of Medicine

    collaborator OTHER

  • Beijing Anzhen Hospital

    collaborator OTHER

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2031-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529028 on ClinicalTrials.gov