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A Comparative Study of 3D Printing Combined with Ultrasound-Guided versus Radiation-Guided Therapy for Multiple Atrial Septal Defects

A Comparative Study of 3D Printing Combined with Ultrasound-Guided versus Radiation-Guided Therapy for Multiple Atrial Septal Defects

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114777
Enrollment
Unknown
Registered
2025-12-17
Start date
2025-12-17
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Multiple Atrial Septal Defects

Interventions

Experimental Group: 3D Printing Combined with Ultrasound Guidance
Control Group:Radiation Guidance

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 0 Years

Inclusion criteria

Inclusion criteria: (1) Age >= 18 years old; (2) The number of defects is >=2; (3) Accumulated defect diameter >= 5mm.

Exclusion criteria

Exclusion criteria: (1) Primordial foramen type ASD and venous sinus type ASD; (2) Endocarditis and hemorrhagic diseases; (3) Thrombus exists at the placement site of the occluder, and venous thrombosis occurs at the catheter insertion site; (4) Severe pulmonary hypertension leading to right-to-left shunt; (5) Left ventricular ejection fraction <50%; (6) Combine other cardiac malformations requiring surgical intervention.

Design outcomes

Primary

MeasureTime frame
Occlusion Success Rate;

Secondary

MeasureTime frame
Number of implanted occluders;Number of occluder replacements;Operating Time;An adverse event occurred 30 days after surgery;

Countries

China

Contacts

Public ContactWan Junyi

Fuwai Hospital, Chinese Academy of Medical Sciences

wanjy_800911@163.com+86 137 1755 2664

Outcome results

None listed

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