Closure I
This is a study to determine whether an investigational septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) in patients with a patent foramen ovale (PFO) and to demonstrate superiority of the investigational device compared to best medical therapy.
Inclusion criteria
- The patient is >/=18 years of age and </=60 years of age
- Patients must have a positive contrast valsalva bubble study by TEE, demonstrating right to left shunting through a PFO during valsalva. An atrial septal aneurysm may or may not be identified.
- Patients must be available for follow-up in accordance with the protocol.
- Patients must be able to provide informed consent, or, if unable, a legal guardian must provide informed consent.
- The vascular access from the femoral vein is expected to accommodate the 10F delivery system.
- Critical cardiac structures are not expected to come in contact with the device (e.g., AV valves and pulmonary veins). (It is recommended that the device be approximately 1 mm from the structure).
- The risks and benefits of both treatments have been fully explained to the patient by the neurologist.>
- Patients must have discontinued use of oral contraceptives before enrollment into the study and agree to avoid future use during the entire study period.
- >Clinical TIA or clinical stroke within 6 months not related to a previously documented PFO or other identifiable cause.
- Patients presenting with a TIA meet the following criteria: either diffusion-weighted MRI (DW-MRI) reveals an acute infarct or the patient experienced transient lateralizing motor weakness, transient speech difficulty, amaurosis fugax or blindness (each lasting less than 24 hours). NOTE: TIAs with symptoms that only include numbness, tingling, imbalance or dizziness will not qualify for enrollment unless there is an associated DW-MRI abnormality within two weeks of symptoms.
- Post-randomization – device patients only:
- The size of the PFO (measured by indentation with a soft balloon) must be amenable to selection of an investigational device as described in the Instructions For Use.
Exclusion criteria
- A contrast valsalva bubble study demonstrating no shunting from right to left through a PFO
- There is a potential source of embolic stroke or TIA other than PFO,
including but not limited to:
- Carotid artery stenosis >50% (or less if stenosis is ulcerated or associated with thrombus);
- >50% intracranial stenosis appropriate to patient’s symptoms;
- Complex aortic arch atheroma exhibiting high-risk features for embolism;
- Aortic arch, carotid artery, or vertebral artery dissection;
- Mitral valve stenosis;
- Aortic stenosis;
- Mitral or aortic valve vegetations;
- Mitral or aortic valve calcified annulus, classified as > 5mm MAC thickness;
- Prosthetic heart valves in any location;
- Left ventricular ejection fraction of < 30% by echocardiography or ventriculography;
- Left ventricular aneurysm;
- Recent anterior wall myocardial infarction within the three month period preceding the neurological event;
- Chronic atrial fibrillation, paroxysmal atrial fibrillation, or flutter defined as a history of > 2 documented episodes lasting more than 30 seconds each and unrelated to a reversible cause (such as acute myocardial infarction, cardiac surgery, myocarditis, hyperthyroidism, or acute pulmonary disease). Patients meeting this definition will be excluded regardless of persistent or paroxysmal nature of the arrhythmia. (ACC/AHA guideline of AF terminology).
- A large, redundant atrial septal aneurysm which cannot, in the judgment of the investigator, be covered by the investigational device without (1) causing the device to interfere with other intracardiac structures, or (2) prohibiting the ability of the operator to adequately deploy the distal/proximal arms in the left/right atrium prior to final placement on the septum.
- Congenital cardiac defects not repaired prior to enrollment, including:
- Atrial septal defect;
- Ventricular septal defect;
- Coarctation of the aorta; or
- Patent ductus arteriosus.
- Thrombus in or occlusion of the venous lumen between the femoral vein access site and the right atrium.
- A previously implanted atrial septal device.
- Echocardiographic evidence of an intra - atrial or ventricular thrombus.
- History of recent (within the past 6 months) or current intravenous drug abuse.
- Known active endocarditis or documented bacteremia.
- Serum creatinine > 2.0 mg/dL.
- Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 4 weeks after discontinuation of antibiotics)
- Women with suspected or known pregnancy.
- Known hypersensitivity or contraindication (i.e., TPA administration within 24 hours) to warfarin treatment.
- A known contraindication to aspirin, heparin, clopidogrel or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- Any medical condition (other than index stroke) requiring anticoagulation with warfarin.
- A platelet count <100,000 cells/mm3 or >700,000 cells/mm3, or a WBC of <3,000 cells/mm3, or a disorder of platelet function such as thrombocytosis.
- Any patient with a coagulopathy (i.e. prothrombin G20210A, protein C, protein S, anti-thrombin III deficiency, factor V leiden deficiency). These tests must be performed before randomization.
- Patients with a moderate or high positive titer, as defined per study site, of antiphospholipid antibodies. Testing for antiphospholipid antibodies to include, at a minimum, lupus anticoagulant and anticardiolipin antibodies. These tests must be performed before randomization.
- Patients with known vasculitis or neurologic disorder including systemic lupus erythematosis, giant cell arteritis, or multiple sclerosis,
- Patients unable to perform a satisfactory valsalva maneuver.
- Patients in whom transesophageal echocardiography is contraindicated.
- Active peptic ulcer or upper GI bleeding within the prior 6 months.
- Concurrent medical condition with a life expectancy of less than 24 months.
- Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- The presence of a permanent pacemaker.
- The presence of an inferior vena cava filter.
- Patients with diabetes mellitus.
- RV muscle failure/pulmonary hypertension
- Severe tricuspid regurgitation
- Suspected/recognized cirrhosis or portal hypertension or known pulmonary AVM’s
For questions or information regarding stroke, the Stanford Stroke Center, or participation in current clinical trials please send e-mail to . (Please note: individual patient treatment advice cannot be given). You can call (650) 723-6469 to make a referral.
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