This study is testing a new device called the Encore PFO closure device. It's designed to close a Patent Foramen Ovale (PFO), which is a small opening between the upper chambers of the heart. This opening can sometimes lead to a type of stroke called cryptogenic stroke, where the cause is unknown. Researchers want to see if the Encore PFO closure device is as safe and effective as other FDA-approved PFO closure devices already on the market. You might be able to join if you are between 18 and 60 years old, have a diagnosed PFO, and have had a cryptogenic stroke within the last 270 days. The study will measure safety and how well the device closes the PFO after 6 months. The current recruitment status is unclear.

Study design

This is a randomized study, meaning participants will be assigned by chance to receive either the Encore PFO closure device or an FDA-approved PFO closure device. The study plans to enroll 500 participants.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for at least 6 months to assess safety and effectiveness.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.