Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study

NCT07698951 | Recruiting DMC

• 1 other identifier: PL5003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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, and 1 year after the procedure for follow up exams.
• Answer a phone call from study staff at 2 years and 3 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)

• Effective PFO Closure

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

  6 months

• Adverse Cardiovascular Events

  Occurrence of significant adverse events including cardiac death, myocardial infarction, and stroke within 30 days post-procedure

  30 days

Secondary Outcomes (2)

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

  30 days; 6 months

• 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
• SCIRENT Clinical Research and Science d.o.o.: collaborator

Study Sites (1)

Institute for cardiovascular diseases ''Dedinje'', Belgrade

Belgrade, Serbia

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

Central Study Contacts

VP, Clinical Affairs

CONTACT

1.646.583.0352; clinical@recrosscardio.com

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: May 15, 2026
• First Posted: July 13, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)