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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-Infarction Ventricular Septal Defect

Intervention / Treatment
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* Device: AMPLATZER™ Post-infarct Muscular VSD Occluder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First Cohort<br>All available Emergency and Compassionate PIVSD Occluder subject data from 2011 until the end of 2016 will be utilized to determine technical success and acute survival. All subjects belonging to this cohort must have undergone an attempt to close a post-infarct VSD using the AMPLATZER™ PIVSD Occluder. | Device: AMPLATZER™ Post-infarct Muscular VSD Occluder<br>* The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.<br>|
| Second Cohort<br>This cohort will consist of subjects over the age of 18 years who have previously been successfully implanted with the PIVSD Occluder and 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. Therefore, this cohort will be composed of retrospectively enrolled subjects. This cohort will be utilized to determine acute and chronic closure and chronic survival. | Device: AMPLATZER™ Post-infarct Muscular VSD Occluder<br>* The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness Endpoint 1: Technical Success | Technical success occurs when a subject is successfully implanted with a PIVSD device in the ventricular septal defect. An implant attempt occurs when the delivery system is inserted in the subject's vasculature. | End of Implant Procedure | 
| Effectiveness Endpoint 2: Acute Closure | Acute closure is defined as the absence of a residual shunt ≥3 mm, and will be assessed based on an echocardiogram obtained immediately after the successful deployment of the device and up to 7 days post-procedure. | Up to 7 days post-procedure | 
| Effectiveness Endpoint 3: Chronic Closure | Chronic closure is defined as the absence of a residual shunt ≥3 mm at 6 months or later. | 6 Month Visit | 
| Safety Endpoint 1: Acute Survival | Acute survival is defined as survival for at least 24 hours following an attempted PIVSD device implant. | Equal to or greater than 24 hours following an attempted PIVSD device implant | 
| Safety Endpoint 2: Chronic Survival | Chronic survival is defined as survival for at least 183 days from the time of first successful implant. | Equal to or greater than 183 days from the time of first successful implant |