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RecruitingACTRN12607000623493

COHEREX-EU:A Multi-Center Study to Evaluate the Safety and Efficacy of the Coherex FlatStent Patent Foramen Ovale(PFO) Closure System

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.

Sponsor

Coherex Medical Inc.

Enrollment

50 participants

Start Date

Oct 1, 2007

Study Type

Interventional

Conditions

Symptomatic 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.

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria1

  • 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 Criteria14

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

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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. Patien

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.

Locations(2)

Germany

New Zealand

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ACTRN12607000623493