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

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Brief Title

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

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.

Study Phase

Phase 1

Study Type


Primary Outcome

Closure of perimembranous Ventricular Septal Defects


Membranous Ventricular Septal Defects


AMPLATZER Membranous VSD Occluder

Study Arms / Comparison Groups



* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

September 2003

Completion Date

September 2010

Primary Completion Date

March 2010

Eligibility Criteria

        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




N/A - N/A

Accepts Healthy Volunteers



, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

Abbott Medical Devices

Study Sponsor

, , 

Verification Date

February 2019