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

Not Applicable

Active, not recruiting

• Conditions: Stroke; Patent Foramen Ovale; PFO

• 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

Study Timeline

• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Study Start: 2022-05-09
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-09-03
• Primary Completion: 2025-11-30
• Study Completion: 2026-10-26

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

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

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