The AMPLATZER Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) The AMPLATZER Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Abbott Medical Devices
Updated on 18 January 2022

Summary

FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER PIVSD Occluder.

Description

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.

The study has five endpoints (safety: acute and chronic survival; effectiveness: technical success, acute and chronic closure).Two cohorts will be utilized to obtain study endpoint data. The first cohort will be comprised of all available Emergency and Compassionate PIVSD Occluder subject data from 2011 until the end of 2016 and these data will be used to determine technical success and acute survival. The second cohort of thirty subjects will be comprised of patients who are successfully implanted with a PIVSD Occluder from 2011 onward at activated study centers. The index procedure must have occurred >6 months prior to enrollment. Subject identification will occur until data on a minimum of 30 subjects with PIVSD Occluders for post myocardial infarct VSD and post-procedure echocardiogram available for evaluation of residual shunt by the echocardiography core laboratory have been enrolled. The thirty subject cohort data will be used to determine acute closure, chronic closure, and chronic survival endpoints.

The study will be conducted at up to 50 centers in the U.S. The expected duration of enrollment is approximately 4 years. The total duration of the clinical study is expected to be 4.5 years.

Details
Condition Post-Infarction Ventricular Septal Defect
Treatment AMPLATZER™ Post-infarct Muscular VSD Occluder
Clinical Study IdentifierNCT03165526
SponsorAbbott Medical Devices
Last Modified on18 January 2022

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