Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Vaikom Mahadevan, MD
Photo of Vaikom Mahadevan
Vaikom Mahadevan

Description

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.

Official Title

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

Details

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.

Keywords

Post-Infarction Ventricular Septal Defect Heart Septal Defects, Ventricular Infarction AMPLATZER™ Post-infarct Muscular VSD Occluder

Eligibility

For people ages 18 years and up

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
  • For living subjects, the 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

Locations

  • University of California at San Francisco accepting new patients
    San Francisco California 94143 United States
  • Banner - University Medical Center Phoenix withdrawn
    Phoenix Arizona 85006 United States

Lead Scientist at UCSF

  • Vaikom Mahadevan, MD
    Professor, Medicine. Authored (or co-authored) 86 research publications. Research interests: Adult congenital heart disease (ACHD) · Congenital cardiac interventions · Structural cardiac interventions including transcatheter valve implantations · Pulmonary hypertension in ACHD including Eisenmenger's syndrome · Tetralogy of Fallot · Fontan circulation.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT03165526
Study Type
Observational
Last Updated