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

ConditionAtrial Septal Defect
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorLifetech Scientific (Shenzhen) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged≥3years, body weight≥10 kg, regardless of gender;

Patients with secundum atrial septal defect (ASD) with left-to-right shunt and evidence of right ventricular volume overload (echocardiography indicating right ventricular enlargement);

ASD diameter≥5 mm and<26 mm;

The distance from the ASD rim to the openings of the superior/inferior vena cava and pulmonary veins≥5mm, and the distance to the atrioventricular valve≥7mm;

Disqualifiers

Primum, sinus venosus, and unroofed coronary sinus types of atrial septal defect (ASD);

Patients with ASD diameter≥26 mm;

Combined with other structural heart diseases requiring treatment besides ASD;

Complicated with severe pulmonary hypertension or Eisenmenger syndrome;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Absnow II Absorbable Atrial Septal Defect Occluder System

    Device

    To evaluate the efficacy and safety of the AbsnowTM II absorbable atrial septal defect occluder system in the treatment of atrial septal defect.

  • Cera Atrial Septal Defect Occluder

    Device

    The Cera atrial septal defect occluder produced by the same company serves as the control group.

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Occlusion success rate

Time frame
12 Months post-procedure

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lifetech Scientific (Shenzhen) Co., Ltd.

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

Fuwai Yunnan Cardiovascular Hospital

Collaborator

Guangdong Provincial People's Hospital

Collaborator

Chinese PLA General Hospital

Collaborator

Lanzhou University Second Hospital

Collaborator

The Children's Hospital of Zhejiang University School of Medicine

Collaborator

Beijing Anzhen Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: