NCT04349995

Amplatzer PFO Occluder Post-marketing Surveillance Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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").

Conditions

• PFO - Patent Foramen Ovale

Interventions

Type	Name	Description
DEVICE	Amplatzer PFO Occluder	Percutaneous PFO closure using Amplatzer PFO Occluder

Timeline

• Start date: 2019-10-01
• Primary completion: 2022-12-14
• Completion: 2026-05-28
• First posted: 2020-04-16
• Last updated: 2024-11-01

Locations

1 site across 1 country: Japan