Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
- Conditions
- StrokePatent Foramen OvalePFO
- Interventions
- Device: Standard of Care PFO Closure DeviceDevice: Investigational PFO Closure Device
- Registration Number
- NCT05069558
- Lead Sponsor
- Occlutech International AB
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 450
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care PFO Closure Device Standard of Care PFO Closure Device PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder. Investigational PFO Closure Device Investigational PFO Closure Device PFO closure with the study Occlutech Flex II PFO device.
- Primary Outcome Measures
Name Time Method Effective Closure Rate of PFO Twelve Months
- Secondary Outcome Measures
Name Time Method Non-Fatal Recurrent Stroke Enrollment to 12 Months
Trial Locations
- Locations (48)
Universitätsklinik Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Asklepios Klinik Altona Hamburg
🇩🇪Hamburg, Germany
Amsterdam University Medical Center
🇳🇱Amsterdam, Netherlands
Erasmus University Medical Centre
🇳🇱Rotterdam, Netherlands
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 DC, 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)
🇨🇦Montréal, Quebec, Canada
Institut de Cardiologie de Montréal
🇨🇦Montréal, 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
CardioVasculäre Centrum Frankfurt
🇩🇪Frankfurt, Germany
University Heart Center Lübeck
🇩🇪Lübeck, Germany
University Hospitals Sussex
🇬🇧Brighton, East Sussex, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom