The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
The objective of this feasibility study is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Device: AMPLATZER Muscular VSD Occluder
Children's Hospital
Denver, Colorado, United States
Arnold Palmer Hospital
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
Closure of Muscular Ventricular Septal Defects
Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
Time frame: 5 years
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University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University Medical Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbus Children's Hospital
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
...and 1 more locations