Amplatzer PFO Occluder Post-marketing Surveillance Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PFO - Patent Foramen Ovale Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott Medical Japan LLC

Mita, Minato, 108-6304, Japan

About this study

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").

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Refer to Amplatzer PFO occluder IFU

Exclusion criteria

Refer to Amplatzer PFO occluder IFU

Treatment and study plan

AMPLATZER PFO Occluder

Device

Percutaneous PFO closure using Amplatzer PFO Occluder

Primary outcomes

device- or procedure related SAE rate

Time frame: up to 30 Days

device- or procedure related serious adverse events (SAEs) through 30 days
PE, DVT and ischemic stroke and atrial fibrillation rate

Time frame: 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

Time frame: At 1 year

Effective closure of the PFO at 1 year

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: PFO PMS Jpn

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2025
First posted: Apr 16, 2020
Registry last updated: Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed