Amplatzer PFO Occluder Post-marketing Surveillance Study (PFO PMS Jpn)

Abbott

Status: Active, not recruiting

Conditions: PFO - Patent Foramen Ovale

Treatments: Device: Amplatzer PFO Occluder

Study type: Observational

Funder types: Industry

Identifiers

NCT04349995

ABT-CIP-10278

Details and patient eligibility

About

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.

Full 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").

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Refer to Amplatzer PFO occluder IFU

Exclusion criteria

• Refer to Amplatzer PFO occluder IFU

Trial design

500 participants in 1 patient group

Amplatzer PFO Occluder

Description:

Percutaneous PFO Closure using Amplatzer PFO occluder

Treatment:

Device: Amplatzer PFO Occluder