Demonstrate that patent foramen ovale (PFO) closure with the GORE HELEX Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.
- History of recent stroke of unknown origin
- Presence of PFO (“hole in the heart”)
- Other preexisting neurological disorders
- Sensitivity or contraindication to all proposed medical treatments
- Pregnancy or intent to become pregnant during study period
Subjects have a 2:1 chance of receiving the PFO closure procedure for the prevention of stroke to the standard of care medicines for the prevention of stroke.
- Medical history and risk factors
- Neurology evaluation
- Electrocardiogram (ECG) or Holter study
- Transthoracic echocardiography (TTE)
- Transesophageal echocardiography (TEE) with bubble study
- Magnetic resonance imaging (MRI) or Cat scan (CT)
- Magnetic resonance angiography (MRA), duplex sonography, CT angiography or contrast angiography
- Chest fluoroscopy
- Pregnancy test
- Blood tests
- Endovascular PFO closure (for procedure group)
- Medical treatment with aspirin and warfarin and/or other blood thinners.
- 1-2 day inpatient stay (procedure group only)
- Follow up visits every 6 months for 2 years
- Annual follow-up visits until the study is completed (final data is collected from all centers)