None listed
Conditions
Brief summary
The COHEREX-EU Study is a multi-center registry of the first 50 patients to have their Patent Foramen Ovale closed with the Coheres FlatStent Patent Foramen Ovale (PFO) Closure System. This study will demonstrate the safety and efficacy of the Coheres FlatStent Patent Foramen Ovale (PFO) Closure System.
Interventions
The Coherex FlatStent Patent Foramen Ovale (PFO) Closure System is a implant placed percutaneously by an interventional cardioligist into a patent foramen ovale to close the congenital defect. Patients will be observed for 6 months post intervention.
Sponsors
Coherex Medical Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed