Amplatzer PFO Occluder Post-marketing Surveillance Study | NCT04349995

Studies
Amplatzer PFO Occluder Post-marketing Surveillance Study

NCT04349995

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Jun 1, 2026Actual

Enrollment

500Actual

Phase

Not provided

Conditions

PFO - Patent Foramen Ovale

Interventions

Amplatzer PFO Occluder

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Dec 14, 2022Actual

Completion Date

May 28, 2025Actual

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 14, 2020

First Posted Date

Apr 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2026

Last Update Posted Date

Jun 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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").

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amplatzer PFO Occluder		Percutaneous PFO Closure using Amplatzer PFO occluder	Device: Amplatzer PFO Occluder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amplatzer PFO Occluder	Device	Percutaneous PFO closure using Amplatzer PFO Occluder	Amplatzer PFO Occluder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
device- or procedure related SAE rate	device- or procedure related serious adverse events (SAEs) through 30 days	up to 30 Days
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
Effective PFO closure	Effective closure of the PFO at 1 year	At 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Refer to Amplatzer PFO occluder IFU

Exclusion Criteria:

Refer to Amplatzer PFO occluder IFU

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients will be considered registered upon insertion of the Amplatzer PFO Occluder delivery system into the body

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abbott Medical Japan LLC		Mita	Minato	108-6304	Japan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054092	Foramen Ovale, Patent

Ancestor Terms

ID	Term
D006344	Heart Septal Defects, Atrial
D006343	Heart Septal Defects
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided