Heart device under surveillance: 500 patients tracked for safety
NCT ID NCT04349995
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.
Disclaimer
Read more
Show less
This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for PFO - PATENT FORAMEN OVALE are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Locations
-
Abbott Medical Japan LLC
Mita, Minato, 108-6304, Japan