MedTrace Logo

Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients

NCT03601039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2026-03-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Heart Septal Defects, Atrial
  • Atrial Septal Defect

Interventions

DEVICE

Absnow Absorbable ASD Closure System

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.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-25
Primary Completion
2020-08-28
Completion
2024-08-30

Countries

  • China

Study Locations

More Related Trials

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 NCT03601039 on ClinicalTrials.gov