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

Membranous Ventricular Septal Defects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578708
• Other study ID #: AGA-008
• Secondary ID: G020202
• Status: Completed
• Phase: Phase 1
• Start date: September 2003
• Est. completion date: September 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Membranous Ventricular Septal Defects

Intervention

Device:
• AMPLATZER Membranous VSD Occluder
Device closure with the AMPLATZER Membranous VSD Occluder

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Columbus Children's Hospital	Columbus	Ohio
United States	University of Minnesota	Minneapolis	Minnesota
United States	Columbia University	New York	New York
United States	Children's Hospital UN/CU)	Omaha	Nebraska
United States	Washington University Medical Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of perimembranous Ventricular Septal Defects		5 years