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.
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;
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;
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