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Heart device under surveillance: 500 patients tracked for safety

NCT ID NCT04349995

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 500 people who received the Amplatzer PFO Occluder, a device that closes a small hole in the heart called PFO. Researchers tracked serious complications within 30 days and longer-term issues like stroke or blood clots over 3 years. The goal was to confirm the device is safe and works as intended.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Amplatzer PFO Occluder (a device implanted to close a hole in the heart)
What this could lead to
If successful, this confirms the device is safe and effective for closing PFO, potentially reducing stroke risk in certain patients.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove the device is better than no treatment. Risks include device-related complications like blood clots or irregular heartbeat.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

500 people

The number who actually took part.

Started

Oct 2019

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Refer to Amplatzer PFO occluder IFU Exclusion Criteria: * Refer to Amplatzer PFO occluder IFU

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Conditions

The condition(s) this trial relates to.

patent foramen ovale

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pfo - patent foramen ovale

Contacts and locations

Locations

  • Abbott Medical Japan LLC

    Mita, Minato, 108-6304, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.