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OpenTrials
Completed

NCT Number: NCT00578708

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

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.

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Key information

Conditions

Membranous Ventricular Septal Defects

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMPLATZER Membranous VSD Occluder

Device

Device closure with the AMPLATZER Membranous VSD Occluder

Primary outcomes

  1. Closure of perimembranous Ventricular Septal Defects

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Dec 21, 2007
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.