Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER

Abbott

Status and phase: Completed; Phase 1

Conditions: Membranous Ventricular Septal Defects

Treatments: Device: AMPLATZER Membranous VSD Occluder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00578708

AGA-008

G020202

Details and patient eligibility

About

The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects.

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with hemodynamically significant Perimembranous ventricular septal defects

Exclusion criteria

• Patients < 8 kg
• Supracristal ventricular septal defects
• Left ventricle to right atrium shunting
• Prolapse of the aortic valve
• Right to left shunting through the defect
• Perimembranous VSD with an aneurysm and multiple shunts which can not be successfully closed with one device
• Patients with <2mm aortic rim
• Sepsis (local/generalized)
• Complex heart lesions such as atrioventricular canal defect or Tetralogy of Fallot.
• Patients who are ASA intolerant
• Unable to be followed for the duration of the clinical trial
• Inability to obtain informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

1

Experimental group

Treatment:

Device: AMPLATZER Membranous VSD Occluder