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New heart device aims to prevent strokes in patients with a hole in the heart

NCT ID NCT05069558

Disease control Sponsor: Occlutech International AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the Occlutech Flex II PFO Occluder, which is used to close a small hole in the heart (PFO) that can cause strokes. The trial involves 450 people who have had a stroke with no clear cause and a PFO. Researchers want to see if the new device works as well as standard devices at closing the hole and preventing future strokes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Occlutech Flex II PFO Occluder (a device implanted to close a hole in the heart)
What this could lead to
If successful, this device could offer a safe and effective alternative for closing PFOs, potentially reducing stroke risk in patients with unexplained strokes.
What could go wrong
This is a non-inferiority trial, meaning it aims to show the new device is as good as existing ones, not better. The study is active but not recruiting, and results are pending. Device procedures carry risks like infection or blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subjects with a PFO and cryptogenic stroke: * PFO defined as visualization of microbubbles (during Trans Esophageal Echo (TEE)) in the left atrium within three cardiac cycles of right atrial opacification at rest and/or with Valsalva. * Cryptogenic stroke defined as a stroke of unknown cause. * Stroke defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either: * Symptoms persisting ≥24 hours OR * Symptoms persisting \<24 hours with Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) findings of a new, neuroanatomically relevant, cerebral infarct. Exclusion Criteria: * Age \< 18 years * Myocardial Infarction (MI) or unstable angina within 6 months. * Severe mitral valve stenosis, severe aortic valve stenosis, or severe regurgitation. * Left Ventricle Ejection Fraction (LVEF) \<35%. * Uncontrolled hypertension or diabetes mellitus despite medications. * Subjects contraindicated for aspirin or clopidogrel. * Presence of other comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results. * Qualifying stroke with Modified Rankin score \>3. * Anatomy in which the device would interfere with intracardiac or vascular structures. * Life expectancy \< 2 years. * Participation in another clinical study that can interfere with the results of this study * Exclusion for patients with known causes of ischemic stroke: * Atrial fibrillation/atrial flutter (chronic or intermittent). * Left Ventricle (LV) aneurysm, intracardiac thrombus, or tumor. * Mitral or aortic valve vegetation or prosthesis. * Aortic arch plaques protruding \>4 mm into the lumen. * Atherosclerosis or arteriopathy of intra- or extracranial vessels with \>50% diameter stenosis in the artery supplying the infarcted territory. * Another cause of right-to-left shunting (e.g., an Atrial Septal Defect (ASD) or a fenestrated atrial septum). * Presence of an arterial hypercoagulable state. * Lacunar infarct probably due to intrinsic small vessel as the qualifying event, defined as an ischemic stroke in the distribution of a single, small deep penetrating vessel in a patient with any of the following: * A history of hypertension (except in the first week post stroke). * A history of diabetes mellitus. * Age ≥50 years. * MRI or CT with leukoaraiosis greater than symmetric, well-defined periventricular caps, or bands (European Task Force on Age-Related White Matter Changes rating scale score \>0). * Arterial dissection as the qualifying event.

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Conditions

The condition(s) this trial relates to.

patent foramen ovale stroke disorder intracranial embolism prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Patent foramen ovale PFO Stroke

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus, Denmark

  • Amsterdam University Medical Center

    Amsterdam, Netherlands

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016, United States

  • Asklepios Klinik Altona Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 22763, Germany

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHU Grenoble Alpes

    La Tronche, 38700, France

  • CHU Toulouse Rangueil

    Toulouse, 31400, France

  • CardioVasculäre Centrum Frankfurt

    Frankfurt, 60389, Germany

  • Centre Hospitalier de l'Université de Montreal (CHUM)

    Montreal, Quebec, Canada

  • Colorado Heart and Vascular PC / St. Anthony Hospital

    Lakewood, Colorado, 80228, United States

  • Erasmus University Medical Centre

    Rotterdam, Netherlands

  • Essentia Health

    Duluth, Minnesota, 55804, United States

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004, United States

  • Heart and Lung Center, Helsinki University Hospital

    Helsinki, Finland

  • Hôpital Privé Jacques Cartier

    Massy, 91300, France

  • Institut de Cardiologie de Montréal

    Montreal, Quebec, Canada

  • Los Robles Medical Center

    Thousand Oaks, California, 91360, United States

  • MaineHealth

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43214, United States

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

  • Rigshospitalet Copenhagen

    Copenhagen, 2100, Denmark

  • Royal Victoria Hospital

    Belfast, United Kingdom

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Toronto General Hospital

    Toronto, Ontario, Canada

  • Tufts New England Medical Center

    Boston, Massachusetts, 02111, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • University Heart Center Lübeck

    Lübeck, 23538, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Hospitals Sussex

    Brighton, East Sussex, United Kingdom

  • University of Alberta Mazankowski Heart Institute

    Edmonton, Alberta, Canada

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • Universitätsklinik Heidelberg

    Heidelberg, Germany

  • Vancouver General Hospital

    Vancouver, British Columbia, Canada

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232, United States

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