Amplatzer PFO Occluder Post-marketing Surveillance Study — PFO PMS Jpn  

PFO - Patent Foramen Ovale Clinical Trial

Official title: Amplatzer PFO Occluder Post-marketing Surveillance Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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"). ;

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• PFO - Patent Foramen Ovale

• NCT number: NCT04349995
• Study type: Observational
• Source: Abbott Medical Devices
• Status: Active, not recruiting
• Start date: October 1, 2019
• Completion date: May 28, 2026