Status:
RECRUITING
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
Lead Sponsor:
Recross Cardio, Inc.
Collaborating Sponsors:
MCRA
Conditions:
PFO
PFO - Patent Foramen Ovale
Eligibility:
All Genders
18-65 years
Phase:
NA
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 P...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07172464
Start Date
September 1 2025
End Date
February 1 2031
Last Update
September 24 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32669
2
Tufts Medical Center
Boston, Massachusetts, United States, 02111
3
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, United States, 10032
4
Prisma Health - Upstate
Greenville, South Carolina, United States, 29605