Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07172464

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

Led by Recross Cardio, Inc. · Updated on 2026-03-04

15

Participants Needed

5

Research Sites

277 weeks

Total Duration

On this page

Sponsors

R

Recross Cardio, Inc.

Lead Sponsor

M

MCRA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must be between 18 and 65 years of age
  • Diagnosis of PFO confirmed by visualization of microbubbles in the left atrium per TEE showing right-to-left shunting
  • History of ischemic stroke confirmed by MRI or CT with relevant cerebral infarct
  • Modified Rankin score of 3 or less
  • Appropriate PFO anatomy for device implantation as determined by an independent committee
  • Willing and capable of providing informed consent
  • Negative pregnancy test within 7 days prior to the procedure for persons of childbearing potential
Not Eligible

You will not qualify if you...

  • Stroke caused by other identifiable reasons such as aortic arch plaques, large artery disease, cardioembolic sources, small-vessel disease, arterial dissection, or left atrial appendage thrombus
  • Arteriopathy with more than 50% stenosis proximal to the stroke territory
  • Presence of intracardiac thrombus or tumor
  • Myocardial infarction or unstable angina within the past 180 days
  • Life expectancy less than 2 years
  • Left ventricular aneurysm or akinesis
  • Moderate to severe mitral valve stenosis or severe mitral regurgitation
  • Aortic valve stenosis with mean gradient over 20 mmHg or severe regurgitation
  • Active endocarditis or infection preventing device implantation
  • Any valve vegetation or Lambl's excrescence on left-sided valves
  • Left ventricular dilated cardiomyopathy with ejection fraction under 35%
  • Another source of right-to-left shunts such as atrial septal defect or pulmonary arteriovenous malformation
  • History of atrial arrhythmias or ventricular arrhythmia requiring specific treatments
  • Severe renal failure or dialysis
  • Severe liver disease such as cirrhosis or active hepatitis
  • Severe lung insufficiency needing oxygen or steroids
  • Uncontrolled high blood pressure over 140/90 mm Hg
  • Severe pulmonary artery hypertension with systolic pressure over 50 mmHg
  • Uncontrolled high blood sugar with HbA1c over 8%
  • Increased bleeding risk including severe liver failure, active ulcers, severe bleeding history, or coagulopathy
  • Known hypercoagulable state requiring full anticoagulation
  • Contraindication to aspirin or clopidogrel
  • Inability to stop anticoagulation for reasons other than the index stroke
  • Any condition that could affect compliance or require stopping antiplatelet treatment early
  • Severe concurrent illness limiting life expectancy
  • Participation in another investigational drug or device study that might affect results
  • Significant valve dysfunction or severe pulmonary hypertension contraindicating PFO closure
  • Contraindication for TEE or intracardiac echocardiography
  • Prior percutaneous cardiovascular intervention for atrial fibrillation ablation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

2

The Cardiac and Vascular Institute

Gainesville, Florida, United States, 32669

Actively Recruiting

3

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

4

Columbia University Medical Center/ NewYork Presbyterian Hospital

New York, New York, United States, 10032

Actively Recruiting

5

Prisma Health - Upstate

Greenville, South Carolina, United States, 29605

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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