Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRecross Cardio, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Recross P3 Occluder (P3O) System
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Recross Cardio, Inc.
Lead sponsor
SCIRENT Clinical Research and Science d.o.o.
Collaborator
Source ClinicalTrials.gov