Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study

Recruiting now · Not applicable

Conditions studied: PFO, PFO - Patent Foramen Ovale, Cryptogenic Stroke, Patent Foramen Ovale, PFO-associated Stroke

In brief

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.

Key facts

Study ID

NCT07172464

Run by

Recross Cardio, Inc.

People needed

30

Starts

2025-10-09

Expected to finish

2031-02-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center/ NewYork Presbyterian Hospital — New York, New York, United States (enrolling)
• UCLA — Los Angeles, California, United States (enrolling)
• The Cardiac and Vascular Institute — Gainsville, Florida, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Prisma Health - Upstate — Greenville, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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