NCT07172464RecruitingNot Applicable
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
Recross Cardio, Inc.8 sites in 1 country30 target enrollmentStarted: October 9, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 8
- Primary Endpoint
- Primary Performance Endpoint - Effective PFO Closure
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) ≤
- •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.
- •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.
- •Active endocarditis or other infection that may preclude implantation of the investigational device.
- •Any valve vegetation or Lambl's excrescence of any left-sided valve.
- •Left ventricular dilated cardiomyopathy with LVEF <35%.
- •Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum and pulmonary arteriovenous malformation.
- •History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD.
- •Severe renal failure ( Stage 4 CKD, eGFR <30) or patient requiring dialysis.
- •Severe liver disease (e.g., documented cirrhosis or active hepatitis).
- •Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).
- •Uncontrolled hypertension, defined as sustained elevated blood pressure >140/90 mm Hg.
- •Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of >50mmHg.
- •Uncontrolled hyperglycemia, defined as HbA1c value >8% (IFCC: >64 mmol/mol).
- •Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding, intracranial or cerebral hemorrhage), or other history of bleeding or coagulopathy.
- •Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.
- •Subjects contraindicated for aspirin or clopidogrel.
- •Subjects not able to discontinue anticoagulation for indications other than then index stroke.
- •Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent illness that would limit life expectancy (e.g., malignancies).
- •Currently an active subject in an investigational drug or device study that could confound the results of this study.
- •Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance/severe pulmonary hypertension.
- •Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).
- •Any prior percutaneous cardiovascular intervention for AF ablation.
Arms & Interventions
Recross P3 Occluder (P3O) System
Experimental
The 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.
Intervention: Recross P3 Occluder (P3O) System (Device)
Outcomes
Primary Outcomes
Primary Performance Endpoint - Effective PFO Closure
Time Frame: 6 months
Effective PFO Closure, at index procedure and at 6 months as measured by TEE, as adjudicated.
Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE)
Time Frame: 30 days
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.
Secondary Outcomes
- Secondary Safety Endpoints - Rate of device-related or procedure-related Serious Adverse Events (SAEs)(30 days; 6 months)
- Secondary Performance Endpoint - Correct device position(6 months)
Investigators
Study Sites (8)
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