The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
Completed
Conditions studied: Post-Infarction Ventricular Septal Defect
In brief
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.
Key facts
- Study ID
- NCT03165526
- Run by
- Abbott Medical Devices
- People needed
- 131
- Starts
- 2018-10-01
- Expected to finish
- 2021-11-29
- Last updated by the study team
- 2024-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California at San Francisco — San Francisco, California, United States
- Shands at the University of Florida — Gainesville, Florida, United States
- Johns Hopkins University Hospital — Baltimore, Maryland, United States
- Spectrum Health Butterworth Hospital — Grand Rapids, Michigan, United States
- University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States
- Buffalo General Hospital — Buffalo, New York, United States
- Lenox Hill Hospital — New York, New York, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Duke University — Durham, North Carolina, United States
- UNC Regional Physicians Carolina Cardiology — High Point, North Carolina, United States
- Good Samaritan Trihealth Hospital — Cincinnati, Ohio, United States
- Memorial Hermann Hospital — Houston, Texas, United States
- Baylor Scott & White — Plano, Texas, United States
- Swedish Medical Center — Seattle, Washington, United States
- Providence Medical Research Group — Spokane, Washington, United States
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
- Marshfield Clinic — Marshfield, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.