PFO - Patent Foramen OvalePFO PMS JpnNCT04349995
Amplatzer PFO Occluder Post-marketing Surveillance Study
An observational study of PFO - Patent Foramen Ovale, run by Abbott Medical Devices at 1 site in Japan.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PFO - Patent Foramen Ovale
- What is being tested?
- Amplatzer PFO Occluder
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2019to 28 May 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be considered registered upon insertion of the Amplatzer PFO Occluder delivery system into the body
Who may be able to join
- Refer to Amplatzer PFO occluder IFU
Who cannot join
- Refer to Amplatzer PFO occluder IFU
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Being tested
- Amplatzer PFO Occluder
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplatzer PFO OccluderDevice
Percutaneous PFO closure using Amplatzer PFO Occluder
| Study group | Role | What they receive |
|---|---|---|
| Amplatzer PFO Occluder | Percutaneous PFO Closure using Amplatzer PFO occluder Receives: Device: Amplatzer PFO Occluder |
What is being measured
The primary outcome is the main question the study is designed to answer.
device- or procedure related SAE rate
device- or procedure related serious adverse events (SAEs) through 30 days
Measured: 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
Measured: beyond 30 days through 3 years
Effective PFO closure
Effective closure of the PFO at 1 year
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Oct 2019
- Primary completion14 Dec 2022
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFO - Patent Foramen OvaleStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349995
- Sponsor's protocol ID
- ABT-CIP-10278
- Acronym
- PFO PMS Jpn
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2020
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided