Evaluation of the safety and efficacy of CeraTM Ceramic Membrane Occluder for congenital heart disease: a multi-center, parallel, randomized control trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10001111

Enrollment

Unknown

Registered

2010-12-03

Start date

2008-01-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial septal defect (ASD)/ ventricular septal defect (VSD)/ patent ductus arteriosus(PDA)

Interventions

Group A:ASD Ceramic Membrane Occluder implanted by the puncture through the femoral vein

Group B:ASD occluder implanted by the puncture through the femoral vein

Group C:VSD Ceramic Membrane Occluder implanted by the puncture through the femoral vein and the femoral artery

Group D:VSD occluder implanted by the puncture through the femoral vein and the femoral artery

Group E:PDA Ceramic Membrane Occluder implanted by the puncture through the femoral vein

Group F:PDA occluder implanted by the puncture through the femoral vein

Eligibility

Sex/Gender

All

Age

4 Years to 65 Years

Inclusion criteria

Inclusion criteria: ASD: 1. 2 to 65 years old; 2. Secundum atrial septal defect; 3. Maximum diameter of the defect is less than 40mm of two holes central ASD; 4. Distance between the edge of defect and Coronary sinus/Atrioventricular valve /Right superior pulmonary vein is more than 5mm. VSD: 1. 3 to 65 years old; 2. Ventricular septal defect; 3. Diameter of defect in left ventricular is 3-14mm (child<10mm); 4. Perimembranous defects for the porousof the right ventricular side at least one larger than 2mm; 5. Distance between the edge of defect and the right aortic valve is more than 2mm; 6. No aortic valve prolapse/aortic regurgitation; 7. Left to right shunt. PDA: 1. 4 month to 65 years old; 2. Patent ductus arteriosus; 3. Weight<6kg; 4. The most narrow place is between 2-16mm.

Exclusion criteria

Exclusion criteria: ASD: 1. Severe pulmonary hypertension causes right to left shunt; 2. Primary and venous sinus ASD; 3. Severe muscle disease or valve disease; 4. Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction; 5. Contraindications to antiplatelet agents; 6. Intracardiac thrombus or other serious diseases that may cause death in 3 years. VSD: 1. Heart abnormality; 2. Aortic regurgitation; 3. Anatomic adverse defects; 4. Severe pulmonary hypertension causes right to left shunt; 5. Deep vein thrombosis causes vein occlusion; 6. Contraindications to antiplatelet agents; 7. Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction; 8. Intracardiac thrombus or other serious diseases that may cause death in 3 years. PDA: 1. Heart abnormality depends on PDA; 2. Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction; 3. Severe pulmonary hypertension causes right to left shunt; 4. Deep vein thrombosis causes vein occlusion; 5. Endocarditis, Bacteremia and other Infections; 6. End stage malignant tumor, or other severe disease that may cause death in 3 years.

Design outcomes

Primary

Measure	Time frame
VSD Clinical effect, Immediate success rate;PDA Clinical effect, Immediate success rate;ASD Clinical effect, Immediate success rate;ASD adverse event;	—

Secondary

Measure	Time frame
PDA: The incidence of adverse events;VSD: The incidence of adverse events;	—

Countries

China

Contacts

Public ContactZhiwei Zhang

xiaying@lifetechmed.com+86 20 83827812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026