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
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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