An observational study in PFO - Patent Foramen Ovale, sponsored by Abbott Medical Devices. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Abbott Medical Devices · Observational
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the Surveillance will register patients with patent foramen ovale (PFO) who have experienced a PFO-related cryptogenic cerebral infarction (including diagnosed paradoxical cerebral embolism) or transient ischemic attack (determined by positive head imaging such as DWI) in whom an Amplatzer PFO Occluder implant was attempted (Marketing Approval No. 30100BZX00024000, date May 28, 2019, hereinafter referred to as "PFO occluder").
134 studies on the registry are indexed under Foramen Ovale, Patent; 46 are open to participants now.
This study's enrollment of 500 is above the median of 226 across 57 observational studies indexed under Foramen Ovale, Patent.
Browse Foramen Ovale, Patent studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be considered registered upon insertion of the Amplatzer PFO Occluder delivery system into the body
Exclusion Criteria:
Percutaneous PFO Closure using Amplatzer PFO occluder
Device: Amplatzer PFO Occluder
Percutaneous PFO closure using Amplatzer PFO Occluder
device- or procedure related SAE rate
device- or procedure related serious adverse events (SAEs) through 30 days
Time frame: up to 30 Days
PE, DVT and ischemic stroke and atrial fibrillation rate
rate of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke and atrial fibrillation beyond 30 days through 3 years
Time frame: beyond 30 days through 3 years
Effective PFO closure
Effective closure of the PFO at 1 year
Time frame: At 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Abbott Medical Devices