PIVSD Occluder HDE PAS - The AMPLATZER™ Post-infarct Muscular VSD Occluder HDE Post Approval Study
This is a multi-center, observational study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder for use in transcatheter closure of muscular ventricular septal defects following a myocardial infarction in the post approval setting.
Heart & Vascular - Structural Heart Trials,
Heart & Vascular
Sameer Gafoor, MD
Patients who have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder via Emergency and Compassionate 2011 until the end of 2016.
- Over 18 years old
- Patients who have previously been successfully implanted with the AMPLATZER™ PIVSD Occluder
- Subject or subject's legally authorized representative has provided consent to participate in this study
- Subject's post-procedure echocardiogram is evaluable and can be sent to the echocardiography core laboratory for residual shunt assessment