The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Public ClinicalTrials.gov record NCT03165526. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03165526
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 131 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2018 (Actual)
- Primary completion
- Nov 29, 2021 (Actual)
- Completion
- Nov 29, 2021 (Actual)
- Last update posted
- Oct 10, 2024
2018 – 2021
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94143 | — |
| Shands at the University of Florida | Gainesville | Florida | 32610 | — |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21287 | — |
| Spectrum Health Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | — |
| Buffalo General Hospital | Buffalo | New York | 14203 | — |
| Lenox Hill Hospital | New York | New York | 10021 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| UNC Regional Physicians Carolina Cardiology | High Point | North Carolina | 27262 | — |
| Good Samaritan Trihealth Hospital | Cincinnati | Ohio | 45220 | — |
| Memorial Hermann Hospital | Houston | Texas | 77030 | — |
| Baylor Scott & White | Plano | Texas | 75093 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| Providence Medical Research Group | Spokane | Washington | 99204 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03165526, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 10, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03165526 live on ClinicalTrials.gov.