Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is:
• Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO.
Participants will:
* Undergo the procedure to implant the P3 Occluder System, if deemed appropriate.
* Visit their doctor at 1 month, 3 months, 6 months, 1 year, and 5 years after the procedure for follow up exams.
* Answer a phone call from study staff at 2 years, 3 years, and 4 years after the procedure to answer a survey.
Gender: All
Ages: 18 Years - 65 Years
PFO
PFO - Patent Foramen Ovale
Cryptogenic Stroke
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