Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

Last updated: February 24, 2025
Sponsor: Occlutech International AB
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Standard of Care PFO Closure Device

Investigational PFO Closure Device

Clinical Study ID

NCT05069558
OCC2021_02
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).

Eligibility Criteria

Inclusion

Inclusion Criteria: Subjects with a PFO and cryptogenic stroke:

  • PFO defined as visualization of microbubbles (during Trans Esophageal Echo (TEE)) inthe left atrium within three cardiac cycles of right atrial opacification at restand/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 focalischemia, and either:

  • Symptoms persisting ≥24 hours OR

  • Symptoms persisting <24 hours with Magnetic Resonance Imaging (MRI) or ComputerTomography (CT) findings of a new, neuroanatomically relevant, cerebral infarct.

Exclusion

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 psychologicalconditions that, in the investigator's opinion, could limit the subject's ability toparticipate in the clinical trial or to comply with follow up requirements, orimpact 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 vascularstructures.

  • Life expectancy < 2 years.

  • Participation in another clinical study that can interfere with the results of thisstudy

  • 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% diameterstenosis in the artery supplying the infarcted territory.

  • Another cause of right-to-left shunting (e.g., an Atrial Septal Defect (ASD) or afenestrated 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 deeppenetrating 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 periventricularcaps, or bands (European Task Force on Age-Related White Matter Changes rating scalescore >0).

  • Arterial dissection as the qualifying event.

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Standard of Care PFO Closure Device
Phase:
Study Start date:
April 30, 2022
Estimated Completion Date:
October 26, 2026

Connect with a study center

  • University of Alberta Mazankowski Heart Institute

    Edmonton, Alberta
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • Toronto General Hospital

    Toronto, Ontario
    Canada

    Site Not Available

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

    Montréal, Quebec
    Canada

    Site Not Available

  • Institut de Cardiologie de Montréal

    Montréal, Quebec
    Canada

    Site Not Available

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Site Not Available

  • Rigshospitalet Copenhagen

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Heart and Lung Center, Helsinki University Hospital

    Helsinki,
    Finland

    Site Not Available

  • CHU Grenoble Alpes

    La Tronche, 38700
    France

    Site Not Available

  • Hôpital Privé Jacques Cartier

    Massy, 91300
    France

    Site Not Available

  • CHU Toulouse Rangueil

    Toulouse, 31400
    France

    Site Not Available

  • CardioVasculäre Centrum Frankfurt

    Frankfurt, 60389
    Germany

    Site Not Available

  • Asklepios Klinik Altona Hamburg

    Hamburg, 22763
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitätsklinik Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • University Heart Center Lübeck

    Lübeck, 23538
    Germany

    Site Not Available

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • Erasmus University Medical Centre

    Rotterdam,
    Netherlands

    Site Not Available

  • University Hospitals Sussex

    Brighton, East Sussex
    United Kingdom

    Site Not Available

  • Royal Victoria Hospital

    Belfast,
    United Kingdom

    Site Not Available

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Memorialcare Long Beach Medical Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Keck School of Medicine of University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Los Robles Medical Center

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Colorado Heart and Vascular PC / St. Anthony Hospital

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • South Denver Cardiology Associates

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington DC, District of Columbia 20010
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Cardiovascular Institute of the South

    Houma, Louisiana 70360
    United States

    Site Not Available

  • MaineHealth

    Portland, Maine 04102
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts New England Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Essentia Health

    Duluth, Minnesota 55804
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Virtua Our Lady of Lourdes

    Marlton, New Jersey 080653
    United States

    Site Not Available

  • The Valley Hospital

    Paramus, New Jersey 07652
    United States

    Site Not Available

  • Atrium Health Sanger Heart and Vascular Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio Health Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Vanderbilt Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • HCA Houston Healthcare Medical Center

    Houston, Texas 77004
    United States

    Site Not Available

  • UTHealth Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Sentara Health Research Center

    Norfolk, Virginia 23507
    United States

    Site Not Available

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