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

Overview

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.

Interventions

• Device Recross P3 Occluder (P3O) System
  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.

Primary outcome measures

• Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE) [Time frame: 30 days]
• Primary Performance Endpoint - Effective PFO Closure [Time frame: 6 months]

Secondary outcome measures (2)

• Secondary Safety Endpoints - Rate of device-related or procedure-related Serious Adverse Events (SAEs) [Time frame: 30 days; 6 months]
• Secondary Performance Endpoint - Correct device position [Time frame: 6 months]

Eligibility criteria

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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 5 centers

• UCLA — Los Angeles
• The Cardiac and Vascular Institute — Gainsville
• Tufts Medical Center — Boston
• Columbia University Medical Center/ NewYork Presbyterian Hospital — New York
• Prisma Health - Upstate — Greenville

Identifiers

NCT: NCT07172464 · PL5001 · G240348

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗