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OCCLUFLEX

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

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Overview

Principal Investigator: David Thaler, MD, PhD

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)

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Grace Lynch, Leidy Guzman

Study details

Inclusion Criteria
  • 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:
    - Symptoms persisting ≥24 hours, or
    - Symptoms persisting <24 hours with MR or CT findings of a new neuroanatomically relevant, cerebral infarct.
Exclusion Criteria
  • MI or unstable angina within 6 months
  • Mitral or aortic valve stenosis or severe regurgitation
  • Exclusion for patients with known causes of ischemic stroke: atrial fibrillation/atrial flutter (chronic or intermittent)
Study Requirements

Baseline screening visit:

  • Medical History
  • Diagnosis of a cryptogenic stroke by the neurologist
  • Diagnosis of a PFO by the cardiologist
  • Hypercoagulable state blood draw

Procedure:

  • PFO implant procedure data collection

1-month & 6-month follow-up:

  • Stroke Assessment
  • Adverse Event collection

12-month follow-up:

  • Stroke Assessment
  • TTE Echo to determine effective closure
  • Adverse event collection

Long-term follow-up:

  • Annual visits until PMA Approval
  • Stroke assessment
  • Adverse event collection
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