Offered by: Nemours
Location: Delaware Valley
Closure of Muscular Ventricular Septal Defects With the Amplatzer® Muscular VSD Occluder Post Approval Study
What is the trial about?
A ventricular septal defect (VSD) is an opening between the right and left lower chambers of the heart. This opening may allow blood from the left heart chamber to cross the VSD into the right side of the heart. The AMPLATZER® Muscular VSD Occluder is approved by the FDA to close this type of opening. The purpose of this study is to gather more information about how effective the AMPLATZER® Muscular VSD Occluder is a closing a hole in the heart, as well as collecting information about longterm safety of the device.
Who can participate?
This study will include children with ventricular septal defects requiring closure with the AMPLATZER® Muscular VSD Occluder.
What is involved?
Patients will be followed for 5 years post implant. Data will be collected during this time.
Contact Nemours Clinical Trials
Trial Name: Closure of Muscular Ventricular Septal Defects With the Amplatzer® Muscular VSD Occluder Post Approval Study