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

Phase 1

Completed

• Conditions: Membranous Ventricular Septal Defects
• Interventions: Device: AMPLATZER Membranous VSD Occluder

• Registration Number: NCT00578708
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Primary Completion: 2010-03
• Study Completion: 2010-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AMPLATZER Membranous VSD Occluder	-

Primary Outcome Measures

Name	Time	Method
Closure of perimembranous Ventricular Septal Defects	5 years

Trial Locations

Locations (6)

Children's Hospital UN/CU); 🇺🇸 Omaha, Nebraska, United States

Washington University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Columbia University; 🇺🇸 New York, New York, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Columbus Children's Hospital; 🇺🇸 Columbus, Ohio, United States