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

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Ventricular septal defects
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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

Interventional

Primary Outcome

Closure of perimembranous Ventricular Septal Defects

Condition

Membranous Ventricular Septal Defects

Intervention

AMPLATZER Membranous VSD Occluder

Study Arms / Comparison Groups

 1
Description:

Publications

* 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

Device

Estimated Enrollment

35

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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00578708

Organization ID

AGA-008

Secondary IDs

G020202

Responsible Party

Sponsor

Study Sponsor

Abbott Medical Devices

Study Sponsor

, ,

Verification Date

February 2019