Heart device under surveillance: 500 patients tracked for safety

NCT ID NCT04349995

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

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.

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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

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