Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)

Active, not recruiting

Phase 2/3 Results N/A

Eligibility Criteria

Major

Inclusion Criteria

- Age 18-60 years inclusive.
- Positive contrast valsalva bubble study by trans-esophageal echocardiogram (TEE) for patent foramen ovale (PFO), with or without atrial septal aneurysm.
- Stroke or clinically definite TIA (contact study coordinator).
- Be able to comply with follow up over two years.
- Be competent to, or have a legal guardian competent to, provide informed consent following full disclosure of risks and benefits of both treatment arms by a study investigator.
- Venous access capable of accepting a 10F minimum vascular sheath.
- Have, or be willing to, discontinue hormonal based contraceptive use prior to enrollment and for the term of the study.
- Has cardiac anatomy based on enrollment echocardiogram that will allow for placement of the implant if randomized to the implant arm.
- Note: Additional inclusion criteria may apply. Contact study coordinator or principal investigator for details.
Post-randomization - device patients only
- The size of the PFO (measured by indentation with a soft balloon) must be amenable to selection of a STARFlex device.
Major

Exclusion Criteria

- Carotid artery stenosis > 50%.
- Intracranial stenosis > 50% appropriate to symptoms.
- Complex aortic arch atheroma with high risk features for embolism
- Aortic arch, carotid or vertebral artery dissection.
- Mitral or aortic valve stenosis, vegetation, or calcification > 5 mm mitral annular calcification (MAC) thickness.
- Active pregnancy.
- Active infections (contact study coordinator).
- Active infective endocarditis or bacteremia.
- Prosthetic heart valves in any location.
- Anterior MI within 3 months of neurological event.
- Chronic atrial fibrillation
- Thrombus in, or occluded, venous access route.
- Contraindication to heparin, aspirin, clopidogrel, or warfarin, or a known medical condition that requires continuous warfarin.
- Patient enrolled in another investigation study where clinical endpoint interference may occur.
- Permanent pacemaker or inferior vena cava (IVC) filter.
- Serum creatinine > 2.0 mg/dL
- Patients with known vasculitis or neurologic disorder.
- Baseline modified Rankin score of 3 or more.
- Hypercoagulopathies requiring long-term warfarin.
- Note: Additional exclusion criteria may apply.