Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PF… (NCT07172464) | Clinical Trial Compass
RecruitingNot Applicable
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
United States15 participantsStarted 2025-10-09
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, 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE)