A Feasibility study of 50 patients with symptomatic Patent ForamenOvale (PFO) undergoing closure of the defect using the Coherex FlatStent Patent Foramen Ovale (PFO) Closure System to evaluate the Safety and Efficacy of the device.

Coherex Medical Inc.0 个研究点目标入组 50 人开始时间: 2007年12月5日最近更新: 2020年1月13日

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•Patients between 18 and 65 years of age with a Patent Foramen Ovale and a clinical indication for closure of the PFO by percutaneous methods.

•Candidates will be excluded from the study if ANY of the following conditions apply:
•1.Patients with a contraindication and/or allergy to aspirin, Clopidrogel, Nitinol, Dacron polyurethane, nickel, stainless steel or other stent materials.
•2.Patients allergic to intravenous (IV) contrast and any combination of drug allergies that would preclude adequate antiplatelet or alternative anticoagulant therapy.
•2.Patients who have extensive congenital cardiac anomalies, which can only be adequately repaired by cardiac surgery.
•3.Patients who have had a major stroke within the past 2 months or a minor stroke within the past two weeks.
•4.Patients who require a trans-septal puncture to access the left atrium.
•5.Patients who had sepsis within one month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
•6.Patients who have demonstrated intracardiac thrombi on echocardiography.
•7.Female patients who may be pregnant.
•8.Patients with any active bacterial infection.
•9.Patients with coronary disease or other structural heart disease.
•10.Patients with known sustained arrhythmia.
•11.Patients with any medical disorder or psychiatric illness that would interfere with the successful completion of the study.
•12. Patients with any untreated medical problems that would interfere with the study.

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