Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion.

Recruiting

• Conditions: Patent Foramen Ovale; Unclosed atrial septa; 10007963; 10014523

• Registration Number: NL-OMON53694
• Lead Sponsor: Occlutech US LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Subjects with a PFO and cryptogenic stroke:
• PFO defined as visualization of microbubbles (during 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:
o Symptoms persisting >=24 hours, or
o Symptoms persisting <24 hours with MR or CT findings of a new,
neuroanatomically relevant, cerebral infarct.

Exclusion Criteria

General:
• Age <18 years
• MI or unstable angina within 6 months
• Mitral or aortic valve stenosis or severe regurgitation
• 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)
• 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 ASD or a fenestrated atrial
septum)
• Presence of an arterial hypercoagulable state:
o Lupus anticoagulant,
o anticardiolipin Abs,
o hyperhomocysteinemia,
o 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:
o A history of hypertension (except in the first week post stroke)
o A history of diabetes mellitus
o Age >=50 years
o 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: Not specified