InterSEPT: In-Tunnel SeptRx European PFO Trial

Exclusion Criteria

• •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure
• •Other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.)
• •Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, Nitinol, and/or contrast sensitivity that cannot be adequately pre-medicated
• •Currently participating in another investigational study, or participation in another clinical trial in the previous 3 months
• •PFO flat width \<4mm or \>14mm to begin the trial. PFO flat width \<4mm or \>19mm when the second size device is ready
• •PFO length \<4mm or \>20mm
• •Active endocarditis, active bacterial infection, or other infection producing bacteremia or sepsis
• •History of chronic or sustained arrhythmia
• •Congenital or structural heart disease other than PFO
• •Thrombus at the intended site of implant or documented venous thrombosis in venous access
• •Severe pulmonary hypertension
• •Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
• •Acute appendicitis
• •Confinement to bed (increased risk for clot formation)
• •Prior cardiac surgery, including implantation of active cardiac devices