Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure

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

This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Recross Cardio, Inc. (industry)
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT07172464 on ClinicalTrials.gov

What this trial studies

The trial implants a novel transcatheter device (P3 Occluder System) to close a patent foramen ovale in selected adults with a recent cryptogenic ischemic stroke and suitable cardiac anatomy. Patients who receive the device will have clinic visits at 1 month, 3 months, 6 months, 1 year and 5 years, plus phone follow-ups at years 2–4 to monitor safety and stroke recurrence. Eligible participants must be 18–65, have imaging-confirmed stroke and PFO with right-to-left shunt on TEE, and a modified Rankin score of 3 or less. An independent committee reviews PFO anatomy for device suitability before implantation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–65 with a confirmed PFO and a recent cryptogenic ischemic stroke, appropriate septal anatomy for the device, and a modified Rankin score of 3 or less.

Not a fit: Patients with an identifiable alternative cause of stroke, PFO anatomy unsuitable for the device, age outside 18–65, or higher disability (mRS >3) are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the device could lower the chance of another stroke by providing a minimally invasive way to close a PFO.

How similar studies have performed: Other transcatheter PFO closure devices have reduced recurrent stroke risk in selected patients, but the P3 Occluder System is a novel device being tested in an early feasibility setting.

Eligibility criteria

Inclusion Criteria:

1. Patient must be ≥ 18 and ≤ 65 years of age
2. 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.
3. 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.
4. Modified Rankin score (mRS) ≤ 3.
5. Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee.
6. Patient is willing and capable of providing informed consent.
7. Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

1. 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.
2. Other arteriopathy of the intracranial or extracranial vessels with \>50% stenosis proximal to the territory of the index stroke.
3. Intracardiac thrombus or tumor.
4. Myocardial Infarction (MI) or unstable angina within the previous 180 days.
5. Life expectancy \< 2 years.
6. Left ventricular aneurysm or akinesis.
7. Moderate to severe mitral valve stenosis or severe mitral regurgitation.
8. Aortic valve stenosis (mean gradient \>20 mmHg) or severe regurgitation.
9. Active endocarditis or other infection that may preclude implantation of the investigational device.
10. Any valve vegetation or Lambl's excrescence of any left-sided valve.
11. Left ventricular dilated cardiomyopathy with LVEF \<35%.
12. Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum and pulmonary arteriovenous malformation.
13. History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD.
14. Severe renal failure ( Stage 4 CKD, eGFR \<30) or patient requiring dialysis.
15. Severe liver disease (e.g., documented cirrhosis or active hepatitis).
16. Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).
17. Uncontrolled hypertension, defined as sustained elevated blood pressure \>140/90 mm Hg.
18. Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of \>50mmHg.
19. Uncontrolled hyperglycemia, defined as HbA1c value \>8% (IFCC: \>64 mmol/mol).
20. 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.
21. Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.
22. Subjects contraindicated for aspirin or clopidogrel.
23. Subjects not able to discontinue anticoagulation for indications other than then index stroke.
24. 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).
25. Currently an active subject in an investigational drug or device study that could confound the results of this study.
26. Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance/severe pulmonary hypertension.
27. Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).
28. Any prior percutaneous cardiovascular intervention for AF ablation.

Where this trial is running

Los Angeles, California and 4 other locations

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

Conditions: PFO, PFO - Patent Foramen Ovale, Cryptogenic Stroke, Patent Foramen Ovale, PFO-associated Stroke, PFO Occluder, Transcatheter, PFO-associated stroke