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

NCT05069558 | Active Not Recruiting DMC FDA Device

• 1 other identifier: OCC2021_02
• Study Type: interventional
• Target: 450
• Locations: 8 countries
• Sites: 48

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).

Conditions

Stroke; Patent Foramen Ovale; PFO

Outcome Measures

Primary Outcomes (1)

• Effective Closure Rate of PFO

  Twelve Months

Secondary Outcomes (1)

• Non-Fatal Recurrent Stroke

  Enrollment to 12 Months

Other Outcomes (1)

• Safety: Device and Procedure Related Serious Adverse Events

  Enrollment to Twelve Months, Annually thereafter.

Study Arms (2)

Investigational PFO Closure Device

EXPERIMENTAL

PFO closure with the study Occlutech Flex II PFO device.

Device: Investigational PFO Closure Device

Standard of Care PFO Closure Device

ACTIVE COMPARATOR

PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder.

Device: Standard of Care PFO Closure Device

Interventions

Investigational PFO Closure Device DEVICE

Occlutech Flex II PFO Closure Device

Investigational PFO Closure Device

Standard of Care PFO Closure Device DEVICE

Amplatzer PFO Occluder and Gore Cardioform PFO Occluder

Standard of Care PFO Closure Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (48)

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Los Robles Medical Center

Thousand Oaks, California, 91360, United States

Location

Colorado Heart and Vascular PC / St. Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

South Denver Cardiology Associates

Littleton, Colorado, 80120, United States

Location

Medstar Washington Hospital Center

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

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MaineHealth

Portland, Maine, 04102, United States

Location

Tufts New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Essentia Health

Duluth, Minnesota, 55804, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Alberta Mazankowski Heart Institute

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Centre Hospitalier de l'Université de Montreal (CHUM)

Montreal, Quebec, Canada

Location

Institut de Cardiologie de Montréal

Montreal, Quebec, Canada

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

Heart and Lung Center, Helsinki University Hospital

Helsinki, Finland

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

CHU Toulouse Rangueil

Toulouse, 31400, France

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Asklepios Klinik Altona Hamburg

Hamburg, Hamburg, 22763, Germany

Location

CardioVasculäre Centrum Frankfurt

Frankfurt, 60389, Germany

Location

Universitätsklinik Heidelberg

Heidelberg, Germany

Location

University Heart Center Lübeck

Lübeck, 23538, Germany

Location

Amsterdam University Medical Center

Amsterdam, Netherlands

Location

Erasmus University Medical Centre

Rotterdam, Netherlands

Location

University Hospitals Sussex

Brighton, East Sussex, United Kingdom

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David Thaler, MD, PhD, FAHA

  Tufts Medical Center and Tufts University School of Medicine

  STUDY CHAIR

• Steven Yakubov, MD, FACC, MSCAI

  OhioHealth Heart & Vascular

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 6, 2021
• Study Start: May 9, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); DE (5); NL (2); FR (3); GB (2); CA (6); US (27); DK (2)