CompletedPhase 1

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

United States35 participantsStarted 2003-09

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Closure of perimembranous Ventricular Septal Defects

Timeframe: 5 years

Trial details

NCT IDNCT00578708

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03

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