Principal Investigator: Rodney Badger
Keywords: Heart , PFO , Occluder Department: Cardiovascular Medicine
IRB Number: 00055748 Co Investigator: Brigham Smith
Specialty: Cardiology, Neurology
Sub Specialties: Interventional Cardiology, Stroke
Recruitment Status: Completed

Contact Information

Renee Neuharth

Brief Summary

Demonstrate that patent foramen ovale (PFO) closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.


Detailed Description

HLX 06-03 is a prospective, randomized, multicenter, multinational clinical trial. Approximately 664 subjects will be randomized to either the test or control arm using a 2:1 randomization scheme. A maximum of fifty (50) Investigational Sites in the United States and European Countries will participate in the study with no per-site subject limit. The anticipated accrual rate is approximately 15 subjects per month for a total accrual period of approximately 44-48 months. Randomized subjects will be followed for 60 months with follow-up evaluations at 1, 6, 12, 18, 24, 36, 48, and 60 months.

Inclusion Criteria

The criteria listed below shall be used to determine whether a patient is eligible for entry into the trial.  The patient must meet all inclusion criteria to be enrolled in the study.  In other words, all inclusion criteria must be answered “yes” for the patient to be eligible for the study.

  1. Patient has had a cryptogenic, ischemic stroke, or transient ischemic attack (TIA), of presumed embolic etiology, verified by a neurologist within 180 days prior to randomization, meeting either criteria a or b:

(a) Patient has a diagnosis of ischemic stroke (clinical symptoms persisting ≥24 hours). 


(b) Patient has a diagnosis of TIA (clinical symptoms persisting <24 hours) and has MRI evidence of infarction. For MRI-incompatible patients (i.e., patients that are claustrophobic and/or have implants that are contraindicated for MR) a CT scan of the brain will be accepted.

  1. Patient is diagnosed with a patent foramen ovale (PFO), confirmation of which is achieved by transesophageal echocardiography (TEE) with bubble study demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
  2. There is an absence of an identifiable source of thromboembolism in the systemic arterial circulation.
  3. Patient is at least 18 years and less than 60 years of age (subjects cannot have reached their 60th birthday prior to randomization/enrollment).
  4. Patient has vascular imaging that rules out other potential sources of cerebral thromboembolism (e.g., dissection of the aorta or neck vessels, carotid stenosis > 50% and/or presence of ulcerated plaques, or intracranial stenosis > 50%).
  5. Patient has no evidence of hypercoagulable state which requires anticoagulation therapy.  This determination will be based on the evaluation of, at a minimum: platelet count, Prothrombin Time (PT) or International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT), and Antiphospholipid Antibodies.  All test results are to be evaluated based on the laboratory normals established at the institution.  Patients requiring anticoagulation for Antiphospholipid Antibodies are excluded.  A thorough history of thromboembolic events in first degree family members must be obtained for all patients.  For patients who have a first degree family member with such an event prior to age 55, or whose family history is unknown, the following additional tests are required and must be interpreted as normal:  Factor V Leiden mutation, Prothrombin Gene G20210A mutation, protein C, protein S, and Antithrombin III.
  6. Patient is willing and capable of complying with the study protocol requirements, including the specified follow-up period, and can be contacted by telephone.
  7. Patient or patient’s legal representative (or person designated acceptable under local Ethics Committee requirements) is willing to provide written informed consent prior to enrollment in study.

Exclusion Criteria

All exclusion criteria must be answered “no” for subject inclusion in the study.

  1. Patient has a life expectancy of less than one year.
  2. Patient is experiencing severe disability, defined as modified Rankin Scale (mRS) score greater than or equal to 3, at the time of randomization.
  3. Patient has neurological deficits not due to stroke that may affect the patient’s neurologic assessments.
  4. Patient has other potential source(s) of cardio-embolism, for example: atrial fibrillation (AFib) or atrial flutter (AFlu), prosthetic heart valve, severe native valve disease, left ventricular ejection fraction of <40%, severe ventricular wall motion abnormalities (akinesis, severe hypokinesis), intracardiac thrombus, mitral valve stenosis, prior cardiac surgery, other major congenital cardiac abnormality.
  5. Patient has had a prior myocardial infarction.
  6. Patient has uncontrolled diabetes mellitus at the time of randomization, in the opinion of the investigator.
  7. Patient has pulmonary hypertension (mean pulmonary artery pressure >25 mmHg).
  8. Patient has uncontrolled systemic hypertension at the time of screening, in the opinion of the investigator. 
  9. Patient presented with a lacunar stroke syndrome (e.g., small deep infarction <1.5 cm in diameter and/or a typical lacunar syndrome such as pure motor hemiparesis, pure sensory stroke, clumsy hand-dysarthria syndrome, or ataxic-hemiparesis syndrome).
  10. Patient has intracranial pathology that makes the patient inappropriate for study participation based on discretion of the Investigator (e.g., brain tumor other than meningioma, arterio-venous malformation (AVM) or cerebral hemorrhage, cerebral venous sinus thrombosis on CT or MRI, or cerebral aneurysm > 7 mm).
  11. Patient has active autoimmune disease (e.g., lupus erythrematosus disseminata, rheumatoid arthritis, polyarteritis nodosa, primary cerebral vasculitis).
  12. Patient has active infection that cannot be treated successfully prior to randomization.
  13. Patient abuses alcohol and/or drugs [e.g., on average >5 units or drinks (60 grams) of alcohol/day] or abuses alcohol and/or drugs in the opinion of the Investigator.
  14. Patient is pregnant, lactating, or intent on becoming pregnant through 24-months after randomization.
  15. Patient has contraindication to study medications, including antiplatelet therapy.
  16. Patient requires chronic anticoagulation therapy that cannot be discontinued prior to randomization, in the opinion of the Investigator. Testing for prothrombotic disorders may be performed at the discretion of the treating physicians but is not required for this study.
  17. Patient is currently participating in another clinical device or drug trial that has not completed its primary endpoint or that will clinically confound the current study endpoints or does not permit subjects to participate in other studies.  Typically, subjects that are involved in the long-term surveillance phase of a clinical study are eligible.
  18. Patient has other anatomic or co-morbid conditions that could, in the Investigator’s opinion, limit the patient’s ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
  19. Patient has a known sensitivity to contrast media that cannot be controlled adequately with pre-medication.
  20. Patient has had any major surgical procedure within 30 days preceding randomization.
  21. Patient plans to have a major elective surgical procedure within 30 days after randomization or within 30 days of a PFO closure procedure.
  22. Patient has the need for any concomitant procedure, based on the results of the screening evaluations, during the PFO closure procedure that may confound detection of device-related adverse events.
  23. In the opinion of the Investigator, patient has anatomic criteria identified during the screening evaluation and/or the screening transesophageal echocardiogram (TEE) that are unfavorable for successful placement of the GORE® HELEX® Septal Occluder / GORE® Septal Occluder or the patient has contraindications for device placement, which may include:
  • Inability to accommodate a 10 Fr delivery catheter
  • The need for trans-septal puncture
  • Requires placement of more than one GORE HELEX Septal Occluder
  • PFO estimated to be too large for successful device placement
  • Device would impinge on cardiac structure(s)
  • Anatomy would likely prevent discs from apposing the septal tissue.