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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00578708

Enrollment

Registered

2007-12-21

Start date

2003-09-30

Completion date

2010-09-30

Last updated

2019-02-04

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

Conditions

Membranous Ventricular Septal Defects

Keywords

membranous, ventricular, septal, defect, VSD

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.

Interventions

DEVICEAMPLATZER Membranous VSD Occluder

Device closure with the AMPLATZER Membranous VSD Occluder

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Closure of perimembranous Ventricular Septal Defects	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026