Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion. (OCCLUFLEX)

• ClinicalTrials.gov Identifier: NCT05069558
• Recruitment Status: Enrolling by invitation
• First Posted: October 6, 2021
• Last Update Posted: July 22, 2022
• Sponsor: Occlutech International AB
• Information provided by (Responsible Party): Occlutech International AB

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Stroke; Patent Foramen Ovale	Device: Investigational PFO Closure Device; Device: Standard of Care PFO Closure Device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion.
• Actual Study Start Date: April 30, 2022
• Estimated Primary Completion Date: October 26, 2025
• Estimated Study Completion Date: October 26, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Investigational PFO Closure Device; PFO closure with the study Occlutech Flex II PFO device.	Device: Investigational PFO Closure Device; Occlutech Flex II PFO Closure Device
Active Comparator: 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.	Device: Standard of Care PFO Closure Device; Amplatzer PFO Occluder and Gore Cardioform PFO Occluder

Outcome Measures

Primary Outcome Measures :

1. Effective Closure Rate of PFO [ Time Frame: Twelve Months ]

Secondary Outcome Measures :

1. Non-Fatal Recurrent Stroke [ Time Frame: Enrollment to 12 Months ]

Other Outcome Measures:

1. Safety: Device and Procedure Related Serious Adverse Events [ Time Frame: Enrollment to Twelve Months, Annually thereafter. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

• Minimum Age: 18 Years and Maximum Age: ≥50 years.
• Myocardial Infarction (MI) or unstable angina within 6 months.
• Mitral or 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.
• Subjects not able to discontinue anticoagulation.
• Qualifying stroke with Modified Rankin score >3.
• Anatomy in which the device would interfere with intracardiac or vascular structures.
• Life expectancy < 2 years.
• 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: Lupus anticoagulant, anticardiolipin Abs, hyperhomocysteinemia, Cancer-related hypercoagulability.
• 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.

Contacts and Locations

Locations

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

United States, Massachusetts

Tufts New England Medical Center

Boston, Massachusetts, United States, 02111

United States, Tennessee

Vanderbilt Medical Center

Nashville, Tennessee, United States, 37232

Canada, Ontario

Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7

Sponsors and Collaborators

Occlutech International AB

More Information

• Responsible Party: Occlutech International AB
• ClinicalTrials.gov Identifier: NCT05069558
• Other Study ID Numbers: OCC2021_02
• First Posted: October 6, 2021
• Last Update Posted: July 22, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Foramen Ovale, Patent; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities