PFOPROTEA-PFONCT07172464
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
A study testing Recross P3 Occluder (P3O) System in people with PFO and PFO - Patent Foramen Ovale, run by Recross Cardio, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PFO, PFO - Patent Foramen Ovale, Cryptogenic Stroke
- What is being tested?
- Recross P3 Occluder (P3O) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Oct 2025to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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).
- Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications).
- Uncontrolled hypertension, defined as sustained elevated blood pressure >140/90 mm Hg.
- Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of >50mmHg.
- Uncontrolled hyperglycemia, defined as HbA1c value >8% (IFCC: >64 mmol/mol).
- Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding, intracranial or cerebral hemorrhage), or other history of bleeding or coagulopathy.
- Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine.
- Subjects contraindicated for aspirin or clopidogrel.
- Subjects not able to discontinue anticoagulation for indications other than then index stroke.
- Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent illness that would limit life expectancy (e.g., malignancies).
- Currently an active subject in an investigational drug or device study that could confound the results of this study.
- Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance/severe pulmonary hypertension.
- Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE).
- Any prior percutaneous cardiovascular intervention for AF ablation.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Peter Zazzali, 617.636.6140, peter.zazzali@tuftsmedicine.org
- Recruiting
The Cardiac and Vascular Institute
Gainsville, Florida, 32669
Marti Roberson, 352-244-0208, mroberson@tcavi.com
- Recruiting
Prisma Health - Upstate
Greenville, South Carolina, 29605
Abigail Anderson, 864-455-7629, abigail.anderson@prismahealth.org
- Recruiting
UCLA
Los Angeles, California, 90095
Cynthia Santellan, 310-794-4797, Csantellan@mednet.ucla.edu
- Recruiting
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, 10032
Yun Joo Park, (925) 872-7977, yp2674@cumc.columbia.edu
About this study
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.
Read more
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
- Being tested
- Recross P3 Occluder (P3O) System
- Keywords
- Patent Foramen Ovale, PFO, Cryptogenic Stroke, PFO Occluder, Transcatheter, PFO-associated stroke
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recross P3 Occluder (P3O) SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Recross P3 Occluder (P3O) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Primary Performance Endpoint - Effective PFO Closure
Effective PFO Closure, at index procedure and at 6 months as measured by TEE, as adjudicated.
Measured: 6 months
Secondary outcomes (2)
Secondary Safety Endpoints - Rate of device-related or procedure-related Serious Adverse Events (SAEs)
Rate of device-related or procedure-related Serious Adverse Events (SAEs) at 30 days. Rate of device-related or procedure-related Serious Adverse Events (SAEs) at 6 months.
Measured: 30 days; 6 months
Secondary Performance Endpoint - Correct device position
Correct device position as assessed at 6 months on echocardiography, assessed by TTE or TEE.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start9 Oct 2025
- Primary completionAug 2026 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFOStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recross Cardio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172464
- Sponsor's protocol ID
- PL5001
- Other IDs
- G240348
- Acronym
- PROTEA-PFO
- Status last verified
- Jul 2026
- First submitted
- 4 Sep 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
- ClinicalTrials.gov ID
- NCT07172464
- Acronym / sponsor ID
- PROTEA-PFO / PL5001
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Recross Cardio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recross P3 Occluder (P3O) System | Experimental | Device: Recross P3 Occluder (P3O) SystemThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recross P3 Occluder (P3O) SystemThe 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 |
Primary outcome
Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE)
Time frame: 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 Closure
Time frame: 6 months
Effective PFO Closure, at index procedure and at 6 months as measured by TEE, as adjudicated.
2 secondary outcomes
Secondary Safety Endpoints - Rate of device-related or procedure-related Serious Adverse Events (SAEs)
Time frame: 30 days; 6 months
Secondary Performance Endpoint - Correct device position
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for PFO
Active, not recruiting
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke, Patent Foramen Ovale
Not yet recruiting
WSO BEAT STROKE Initiative
Stroke, PFO - Patent Foramen Ovale
RecruitingObservational study
Abbott Structural Heart Device Registry
Heart Diseases, ASD - Atrial Septal Defect
Not yet recruitingObservational study
The Cardiovascular Effects of Patent Foramen Ovale in Hypoxia
Patent Foramen Ovale (PFO), High Altitude Pulmonary Edema
Recruiting
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
Stroke, PFO - Patent Foramen Ovale
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recross P3 Occluder (P3O) System in people with PFO and PFO - Patent Foramen Ovale, run by Recross Cardio, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.