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

Abbott Medical Devices35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Membranous Ventricular Septal Defects

Interventions

AMPLATZER Membranous VSD OccluderDEVICE

Device closure with the AMPLATZER Membranous VSD Occluder

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

Closure of perimembranous Ventricular Septal Defects

Time frame: 5 years

Data from ClinicalTrials.gov

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