Clinical trial NCT05069558: Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Patent Foramen Ovale
PFO
Lead sponsor: Occlutech International AB
Sponsor class: INDUSTRY
First posted: 2021-10-06
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Effective Closure Rate of PFO
timeFrame: Twelve Months
Secondary outcomes:
measure: Non-Fatal Recurrent Stroke
timeFrame: Enrollment to 12 Months
Other outcomes:
measure: Safety: Device and Procedure Related Serious Adverse Events
timeFrame: Enrollment to Twelve Months, Annually thereafter.
Locations:
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Medical Center
state: California
city: Lakewood
country: United States
facility: Colorado Heart and Vascular PC / St. Anthony Hospital
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates
state: Colorado
city: Washington DC
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Portland
country: United States
facility: MaineHealth
state: Maine
city: Boston
country: United States
facility: Tufts New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Houston
country: United States
facility: HCA Houston Healthcare Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Edmonton
country: Canada
facility: University of Alberta Mazankowski Heart Institute
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montreal (CHUM)
state: Quebec
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montréal
state: Quebec
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Helsinki
country: Finland
facility: Heart and Lung Center, Helsinki University Hospital
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Frankfurt
country: Germany
facility: CardioVasculäre Centrum Frankfurt
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona Hamburg
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg
city: Lübeck
country: Germany
facility: University Heart Center Lübeck
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Centre
city: Brighton
country: United Kingdom
facility: University Hospitals Sussex
state: East Sussex
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
Study officials:
affiliation: Tufts Medical Center and Tufts University School of Medicine
name: David Thaler, MD, PhD, FAHA
role: STUDY_CHAIR
affiliation: OhioHealth Heart & Vascular
name: Steven Yakubov, MD, FACC, MSCAI
role: STUDY_CHAIR
References: