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PROTEA-PFO Study: Testing a New Device for PFO-Related Stroke

This study is testing a new heart device called the Recross P3 Occluder (P3O) System. It's for people aged 18 to 65 who have a PFO (Patent Foramen Ovale), which is a small opening between the upper chambers of the heart, and have had a stroke that might be linked to this PFO. The study wants to see if the P3 Occluder System is safe and effective at closing the PFO to help prevent future strokes. Doctors will look at how many serious heart problems occur within 30 days and how well the PFO is closed after 6 months. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive the Recross P3 Occluder (P3O) System. It aims to enroll 30 participants.
What's involved
You would undergo the procedure to implant the P3 Occluder System. You would also have doctor visits at 1, 3, 6 months, 1 year, and 5 years, plus phone calls at 2, 3, and 4 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after the procedure, with primary outcomes measured at 30 days and 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07172464

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

Recruiting
NAAges 18–65InterventionalDevice feasibility
Recross Cardio, Inc.
~30 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Recross P3 Occluder (P3O) System

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE)
Measured over 30 days
+1 more outcome measured

Conditions

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

Explore related trials

Cryptogenic strokePatent Foramen Ovale

Where it's being run

5 sites across 5 states
California1
Florida1
Massachusetts1
New York1
South Carolina1

Who to contact

Cynthia Santellan
[email protected]
310-794-4797
Email the study team

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What this trial measures

  • Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE)30 days

    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.

  • Primary Performance Endpoint - Effective PFO Closure6 months

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