N/A
N=131
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Post-Infarction Ventricular Septal Defect
Bottom Line
View on ClinicalTrials.gov: NCT03165526 ↗Enrolled (actual)
131
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Effectiveness Endpoint 1: Technical Success — 76 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AMPLATZER™ Post-infarct Muscular VSD Occluder (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness Endpoint 1: Technical Success |
76 | — |
| PRIMARY Effectiveness Endpoint 2: Acute Closure |
17 | — |
| PRIMARY Effectiveness Endpoint 3: Chronic Closure |
4 | — |
| PRIMARY Safety Endpoint 1: Acute Survival |
75 | — |
| PRIMARY Safety Endpoint 2: Chronic Survival |
37.2; 46.4 | — |
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.
Eligibility 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
- 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
Data sourced from ClinicalTrials.gov (NCT03165526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.