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Prospective study on the safety and effectiveness of percutaneous closure of ventricular septal defect with completely degradable occluder guided by ultrasound alone

Prospective study on the safety and effectiveness of percutaneous closure of ventricular septal defect with completely degradable occluder guided by ultrasound alone

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082183
Enrollment
Unknown
Registered
2024-03-22
Start date
2024-03-22
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Ventricular septal defect

Interventions

Experimental group:The VSD was closed by percutaneous intervention with completely degradable occluder under the guidance of pure ultrasound
Control group:The VSD was closed by percutaneous intervention with conventional Nitinol occluder under the guidance of pure ultrasound

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 70 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria of the experimental group were: (1) age > 1 year, weight > 10kg; (2) Congenital ventricular septal defect (perimembranous type) was diagnosed with a diameter range of 3-14mm and had hemodynamic effects; ? The distance from the defect margin to the aortic valve was =3mm. (4) Subjects who can understand the purpose of the trial and voluntarily participate in and sign informed consent, and are willing to accept relevant examinations and clinical follow-up. The inclusion criteria of the control group were: (1) age > 1 year, weight > 10kg; (2) Congenital ventricular septal defect (perimembranous type) was diagnosed with a diameter range of 3-14mm and had hemodynamic effects; ? The distance from the defect margin to the aortic valve was =3mm. ? Do not agree to the use of fully degradable sealers.

Exclusion criteria

Exclusion criteria: The experimental group and the control group were excluded according to the following criteria: patients with any of the following conditions were excluded: ? mild or more aortic regurgitation; ? Severe pulmonary hypertension with bilateral shunt or right-to-left shunt; (3) Cardiac ultrasonography suggested anatomic unsuitable occlusion; Associated with ventricular septal defects or other heart malformations requiring surgical treatment; ? Infective endocarditis, or the presence of other infectious diseases.

Design outcomes

Primary

MeasureTime frame
successful occluder implantation rate;no or less than 2mm residual shunt;

Secondary

MeasureTime frame
the rate of occluder-related complications;

Countries

China

Contacts

Public ContactMai Chen

The First Affiliated Hospital of Guangxi Medical University

921126@sr.gxmu.edu.cn+86 187 7674 3915

Outcome results

None listed

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