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Title Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion.
Therapeutic Area Stroke
Principal Investigator David Thaler, MD, PhD
Min Age 18 Years
Gender Any
Contact Grace Lynch, Leidy Guzman
More Information


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)

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


• 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