Actively Recruiting
Early Feasibility Study Evaluating Percutaneous Repair of the Atrial Septum With the Recross P3 Occluder System for PFO-Associated Stroke
Led by Recross Cardio, Inc. · Updated on 2026-03-04
15
Participants Needed
5
Research Sites
235 weeks
Total Duration
On this page
Sponsors
R
Recross Cardio, Inc.
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is studying patients who have a small opening between the upper chambers of the heart, called a Patent Foramen Ovale (PFO), and who have experienced a stroke possibly related to this heart condition. The trial aims to evaluate the safety and effectiveness of a new heart device called the Recross P3 Occluder System for closing the PFO to reduce the risk of future strokes. The study involves implanting the Recross P3 Occluder device into the heart using a minimally invasive procedure to close the PFO. After implantation, participants will have follow-up visits with their doctors at 1 month, 3 months, 6 months, 1 year, and 5 years to monitor their condition and the device. Additionally, study staff will call participants at 2, 3, and 4 years after the procedure to conduct surveys. Participants will undergo exams, including brain imaging to confirm stroke, and heart imaging to evaluate device position and closure effectiveness. The main outcomes measured include the rate of major cardiovascular events at 30 days and the success of PFO closure at 6 months. Safety is monitored through rates of serious adverse events related to the device or procedure. The total participation may last up to 5 years with regular check-ups and long-term follow-up calls.
CONDITIONS
Brief Title
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of Patent Foramen Ovale (PFO) confirmed by heart imaging showing right-to-left shunting
- History of ischemic stroke confirmed by MRI or CT
- Modified Rankin score of 3 or less
- Suitable PFO anatomy for device implantation as assessed by an independent committee
- Ability and willingness to provide informed consent
- Negative pregnancy test within 7 days before the procedure for persons of childbearing potential
You will not qualify if you...
- Other known causes of stroke such as aortic plaques, large artery disease, cardioembolic source, small-vessel disease, or arterial dissection
- Significant arterial narrowing (>50%) near the stroke area
- Intracardiac thrombus or tumor
- Recent heart attack or unstable angina within 180 days
- Life expectancy less than 2 years
- Left ventricular aneurysm or lack of movement
- Moderate to severe mitral valve disease
- Severe aortic valve disease
- Active infection that would prevent device implantation
- Valve vegetations or Lambl's excrescence on left-sided valves
- Severe heart muscle disease with low ejection fraction
- Other right-to-left shunts besides PFO
- History of certain heart rhythm disorders requiring medication or devices
- Severe kidney, liver, or lung disease
- Uncontrolled high blood pressure
- Severe pulmonary hypertension
- Poor blood sugar control (HbA1c >8%)
- Increased bleeding risk or bleeding disorders
- Known blood clotting disorders requiring full anticoagulation
- Contraindication to aspirin or clopidogrel
- Inability to stop anticoagulation drugs unrelated to the stroke
- Any condition that may interfere with study compliance or safety
- Participation in another investigational drug or device study
- Significant valve problems contraindicating PFO closure
- Contraindications for transesophageal or intracardiac echocardiography
- Prior cardiovascular procedures for atrial fibrillation ablation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with follow-up to 6 months
Participants undergo percutaneous repair of the atrial septum using the Recross P3 Occluder (P3O) System to close the patent foramen ovale (PFO).
1 procedure visit and multiple follow-up visits over 6 months
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
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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