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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.
Enrollment
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Volunteers
Inclusion criteria
complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:
Subjects must meet at least one of the following criteria to be considered high risk for standard transatrial or transarterial surgical closure based on anatomical conditions:
Subject/legally authorized representative has signed the informed consent
Subject/legally authorized representative is willing to complete the follow-up requirements of this study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
91 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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