Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS… (NCT07698951) | Clinical Trial Compass
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Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study
Serbia15 participantsStarted 2026-06-17
Plain-language summary
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, and 1 year after the procedure for follow up exams.
* Answer a phone call from study staff at 2 years and 3 years after the procedure to answer a survey.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient must be ≥ 18 and ≤ 65 years of age
. Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release.
. Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a neuroanatomically relevant cerebral infarct.
. Modified Rankin score (mRS) ≤ 3.
. Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee.
. Patient is willing and capable of providing informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test.
Exclusion criteria
. Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic disease proximal to the territory of the index stroke, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection, presence of left atrial appendage thrombus.
. Other arteriopathy of the intracranial or extracranial vessels with \>50% stenosis proximal to the territory of the index stroke.
. Intracardiac thrombus or tumor.
. Myocardial Infarction (MI) or unstable angina within the previous 180 days.
. Life expectancy \< 2 years.
. Left ventricular aneurysm or akinesis.
. Moderate to severe mitral valve stenosis or severe mitral regurgitation.
. Aortic valve stenosis (mean gradient \>20 mmHg) or severe regurgitation.