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.
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.
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.
Single group
Recross P3 Occluder (P3O) System
DeviceThe Recross P3 Occluder (P3O) is being developed for the purpose of transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients with PFO-associated stroke.
Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE)
Rate of Major Adverse Cardiovascular Events (MACE) at 30 days post-procedure, defined as the composite of cardiac death (CD), myocardial infarction (MI), and stroke events.
Primary Performance Endpoint - Effective PFO Closure
Effective PFO Closure, at index procedure and at 6 months as measured by TEE, as adjudicated.
Secondary Safety Endpoints - Rate of device-related or procedure-related Serious Adverse Events (SAEs)
Rate of device-related or procedure-related Serious Adverse Events (SAEs) at 30 days. Rate of device-related or procedure-related Serious Adverse Events (SAEs) at 6 months.
Secondary Performance Endpoint - Correct device position
Correct device position as assessed at 6 months on echocardiography, assessed by TTE or TEE.
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Recross Cardio, Inc.
Lead sponsor
MCRA
Collaborator
