The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Primary Effectiveness End Point: Technical Success
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
Time frame: During the procedure
Primary Effectiveness End Point: Acute Procedure Success
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Time frame: At the end of the procedure
Primary Effectiveness End Point: Shunt Closure Success
Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
Time frame: 1-year follow-up visit
Primary Safety Endpoint
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
Time frame: Within 12 months of the procedure
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