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ACTIVE NOT RECRUITING

NCT05069558

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

Sponsor: Occlutech International AB

View on ClinicalTrials.gov

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).

Official title: Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2022-05-09

Completion Date

2029-11

Last Updated

2026-03-03

Healthy Volunteers

Conditions

Stroke Patent Foramen Ovale PFO

Interventions

DEVICE

Investigational PFO Closure Device

Occlutech Flex II PFO Closure Device

DEVICE

Standard of Care PFO Closure Device

Amplatzer PFO Occluder and Gore Cardioform PFO Occluder

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.

Locations (48)

Arizona Cardiovascular Research Center

Phoenix, Arizona, United States

Stanford University Medical Center

Stanford, California, United States

Los Robles Medical Center

Thousand Oaks, California, United States

Colorado Heart and Vascular PC / St. Anthony Hospital

Lakewood, Colorado, United States

South Denver Cardiology Associates

Littleton, Colorado, United States

Medstar Washington Hospital Center

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

Rush University Medical Center

Chicago, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

University of Louisville

Louisville, Kentucky, United States

MaineHealth

Portland, Maine, United States

Tufts New England Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Essentia Health

Duluth, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

The Valley Hospital

Paramus, New Jersey, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

HCA Houston Healthcare Medical Center

Houston, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Alberta Mazankowski Heart Institute

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Ottawa Heart Institute

Ottawa, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montreal (CHUM)

Montreal, Quebec, Canada

Institut de Cardiologie de Montréal

Montreal, Quebec, Canada

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet Copenhagen

Copenhagen, Denmark

Heart and Lung Center, Helsinki University Hospital

Helsinki, Finland

CHU Grenoble Alpes

La Tronche, France

Hôpital Privé Jacques Cartier

Massy, France

CHU Toulouse Rangueil

Toulouse, France

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, Germany

Asklepios Klinik Altona Hamburg

Hamburg, Hamburg, Germany

CardioVasculäre Centrum Frankfurt

Frankfurt, Germany

Universitätsklinik Heidelberg

Heidelberg, Germany

University Heart Center Lübeck

Lübeck, Germany

Amsterdam University Medical Center

Amsterdam, Netherlands

Erasmus University Medical Centre

Rotterdam, Netherlands

University Hospitals Sussex

Brighton, East Sussex, United Kingdom

Royal Victoria Hospital

Belfast, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (48)