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

RECRUITINGNA

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

NCT07172464•Recross Cardio, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.
+18 more criteria

Locations (5)

UCLA

Los Angeles, California, United States

The Cardiac and Vascular Institute

Gainesville, Florida, United States

Tufts Medical Center

Boston, Massachusetts, United States

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

Key Dates

Start Date

October 9, 2025

Primary Completion Date

August 1, 2026

Completion Date

February 1, 2031

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

PFOPFO - Patent Foramen OvaleCryptogenic StrokePatent Foramen OvalePFO-associated Stroke

Interventions

Recross P3 Occluder (P3O) System

DEVICE

Non-Invasive Detection of Right-to-Left Cardiac Shunts

NCT07420400

Patent Foramen Ovale (PFO)

View study

RECRUITING

Abbott Structural Heart Device Registry

NCT06590467

Heart DiseasesASD - Atrial Septal Defect+4 more

View study

RECRUITINGNA

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Non-Invasive Detection of Right-to-Left Cardiac Shunts

Abbott Structural Heart Device Registry

A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine

Cerebral Microembolization Associated With PFO Closure

Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography

Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up