Amplatzer PFO Occluder Post-marketing Surveillance Study

PFO - Patent Foramen Ovale Clinical Trial

— PFO PMS Jpn  

Official title:

Amplatzer PFO Occluder Post-marketing Surveillance Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04349995
• Other study ID #: ABT-CIP-10278
• Status: Active, not recruiting
• Start date: October 1, 2019
• Est. completion date: May 28, 2026

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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").

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: May 28, 2026
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Refer to Amplatzer PFO occluder IFU

Exclusion Criteria:

• Refer to Amplatzer PFO occluder IFU

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• PFO - Patent Foramen Ovale

Intervention

Device:
• Amplatzer PFO Occluder
Percutaneous PFO closure using Amplatzer PFO Occluder

Locations

Country	Name	City	State
Japan	Abbott Medical Japan LLC	Mita	Minato

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	device- or procedure related SAE rate	device- or procedure related serious adverse events (SAEs) through 30 days	up to 30 Days
Primary	PE, DVT and ischemic stroke and atrial fibrillation rate	rate of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke and atrial fibrillation beyond 30 days through 3 years	beyond 30 days through 3 years
Primary	Effective PFO closure	Effective closure of the PFO at 1 year	At 1 year