PFO - Patent Foramen Ovale
Conditions
Brief summary
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.
Detailed description
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").
Interventions
DEVICEAmplatzer PFO Occluder
Percutaneous PFO closure using Amplatzer PFO Occluder
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Refer to Amplatzer PFO occluder IFU
Exclusion criteria
* Refer to Amplatzer PFO occluder IFU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| device- or procedure related SAE rate | up to 30 Days | device- or procedure related serious adverse events (SAEs) through 30 days |
| PE, DVT and ischemic stroke and atrial fibrillation rate | beyond 30 days through 3 years | rate of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke and atrial fibrillation beyond 30 days through 3 years |
| Effective PFO closure | At 1 year | Effective closure of the PFO at 1 year |
Countries
Japan
Outcome results
None listed