Cleveland, Ohio 44195

  • Ischemic Attack, Transient

Purpose:

The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.


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.


NCT ID:

NCT00201461


Primary Contact:

Principal Investigator
Anthony Furlan, MD
Cleveland Clinic Foundation, Cleveland, OH


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44195
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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