Closure of Muscular Ventricular Septal Defects with the Amplatzer Muscular VSD Occluder Post Approval Study
Clinical Trial Information
Trial Contact: Cowden, Amanda
Trial Phone: 321.841.5365
This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.
1). Complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. 2).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:
a. Left ventriculotomy or an extensive right ventriculotomy,
b. Failed previous VSD closure,
c. Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or
d. Posterior apical VSDs covered by trabeculae.
e. Overall medical condition