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.
NCT03165526
Heart & Vascular - Structural Heart Trials, Heart & Vascular
Sameer Gafoor, MD
Jennifer Nagel
Criteria

First Cohort:

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.

Second Cohort:

  • 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
Jennifer Nagel
206-386-6462
206-215-1500