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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplatzer PFO Occluder Post-marketing Surveillance Study
- ClinicalTrials.gov ID
- NCT04349995
- Acronym / sponsor ID
- PFO PMS Jpn / ABT-CIP-10278
- Conditions
- PFO - Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amplatzer PFO Occluder | – | Device: Amplatzer PFO OccluderPercutaneous PFO Closure using Amplatzer PFO occluder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be considered registered upon insertion of the Amplatzer PFO Occluder delivery system into the body
Key inclusion criteria (1 listed)
- Refer to Amplatzer PFO occluder IFU
Key exclusion criteria (1 listed)
- Refer to Amplatzer PFO occluder IFU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplatzer PFO OccluderPercutaneous PFO closure using Amplatzer PFO Occluder | Device | Amplatzer PFO Occluder |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PFO - Patent Foramen Ovale, run by Abbott Medical Devices at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
device- or procedure related SAE rate (time frame: up to 30 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.