Unknown statusInterventionalNot ApplicableUpdated May 8, 2019
Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER | NCT00578708 | Trialant
CompletedInterventionalPhase 1Updated Feb 4, 2019
Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER
ClinicalTrials.gov ID
NCT00578708
Lead Sponsor
Abbott Medical DevicesINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
35Actual
Last Update Posted
Feb 4, 2019Actual
Start Date
Sep 2003
Primary Completion Date
Mar 2010Actual
Completion Date
Sep 2010Actual
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.
Membranous Ventricular Septal Defects
AMPLATZER Membranous VSD Occluder
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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