ACTRN12607000623493
Recruiting
Not Applicable
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.
ConditionsSymptomatic Patent Foramen OvaleThe Coheres FlatStent Patemnt Foramen Oveale (PFO) Closure System will be implanted when closure of a Patent Foramen Ovale is clinically indicated. Each patient who receives an implant will be followed for six months after the the FlatStent is implanted. Enrollment will continue for six months or until 50 patients have been enrolled.Cardiovascular - Other cardiovascular diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Symptomatic Patent Foramen Ovale
- Sponsor
- Coherex Medical Inc.
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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