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

NCT07172464 | Recruiting FDA Device

• 1 other identifier: PL5001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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 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.

Conditions

PFO; PFO - Patent Foramen Ovale; Cryptogenic Stroke; Patent Foramen Ovale; PFO-associated Stroke

Keywords

Patent Foramen Ovale; PFO; Cryptogenic Stroke; PFO Occluder; Transcatheter; PFO-associated stroke

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE)

  Rate of Major Adverse Cardiovascular Events (MACE) at 30 days post-procedure, defined as the composite of cardiac death (CD), myocardial infarction (MI), and stroke events.

  30 days

• Primary Performance Endpoint - Effective PFO Closure

  Effective PFO Closure, at index procedure and at 6 months as measured by TEE, ad adjudicated.

  6 months

Secondary Outcomes (2)

• Secondary Safety Endpoints - Rate of device-related or procedure-related Serious Adverse Events (SAEs)

  30 days; 6 months

• Secondary Performance Endpoint - Correct device position

  6 months

Study Arms (1)

Recross P3 Occluder (P3O) System

EXPERIMENTAL

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.

Device: Recross P3 Occluder (P3O) System

Interventions

Recross P3 Occluder (P3O) System DEVICE

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.

Recross P3 Occluder (P3O) System

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Recross Cardio, Inc.: lead
• MCRA: collaborator

Study Sites (5)

UCLA

Los Angeles, California, 90095, United States

RECRUITING

The Cardiac and Vascular Institute

Gainesville, Florida, 32669, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Prisma Health - Upstate

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, Patent; Ischemic Stroke

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 15, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)