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

Completed · Phase 1

Conditions studied: Membranous Ventricular Septal Defects

In brief

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.

Key facts

Study ID

NCT00578708

Run by

Abbott Medical Devices

People needed

35

Starts

2003-09-01

Expected to finish

2010-09-01

Last updated by the study team

2019-02-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with hemodynamically significant Perimembranous ventricular septal defects

You may not qualify if…

• 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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University Medical Center — St Louis, Missouri, United States
• Children's Hospital UN/CU) — Omaha, Nebraska, United States
• Columbia University — New York, New York, United States
• Columbus Children's Hospital — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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