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GORE® HELEX® Septal Occluder / GORE® Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study (HLX 06-03)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by W.L.Gore & Associates
Information provided by (Responsible Party):
W.L.Gore & Associates Identifier:
First received: August 19, 2008
Last updated: August 19, 2014
Last verified: August 2014

The primary objective is to determine that patent foramen ovale (PFO) closure with the 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.

Condition Intervention Phase
Transient Ischemic Attack
Device: GORE® HELEX® Septal Occluder / GORE® Septal Occluder
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GORE® HELEX® Septal Occluder / GORE® Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO)

Resource links provided by NLM:

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Freedom from recurrent ischemic stroke or imaging-confirmed TIA through at least 24 months post-randomization. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Adverse events (AEs) directly related to the device, procedure, and/or antiplatelet medical therapy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Efficacy: Assessment of PFO closure in test (device) arm subjects by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 664
Study Start Date: August 2008
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Antiplatelet Medical Therapy alone
Experimental: 2
PFO Closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder Plus Antiplatelet Medical Therapy
Device: GORE® HELEX® Septal Occluder / GORE® Septal Occluder
PFO closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder
Other Names:
  • GORE® HELEX® Septal Occluder
  • GORE® Septal Occluder


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Presence of cryptogenic ischemic stroke or TIA of presumed embolic infarction verified by a neurologist within 180 days prior to randomization
  • Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
  • Absence of an identifiable source of thromboembolism in the systemic circulation
  • No evidence of a hypercoagulable state
  • Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

  • Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, atrial fibrillation/flutter, cardiac prosthetics (valves), mitral valve stenosis, aortic dissection, significant atherosclerosis, vasculitis, pre-existing neurologic disorders, multiple sclerosis, arteriovenous malformations, prior intracranial hemorrhage, severe CNS disease, severe disability related to prior stroke, and autoimmune disorders that would increase the risk of mortality or morbidity above what is typical for the treatment
  • Previous Myocardial Infarction
  • Active infection that cannot be treated successfully prior to randomization
  • Sensitivity or contraindication to all proposed medical treatments
  • Pregnancy or intent on becoming pregnant through 24-months after randomization
  • Indications outside the parameters accepted for placement of the GORE® HELEX® Septal Occluder / GORE® Septal Occluder, including extensive congenital cardiac anomalies and defect diameter estimated to be > 18mm
  • Atrial septal anatomy that is expected to necessitate placement of more than one GORE® HELEX® Septal Occluder / GORE® Septal Occluder
  • Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
  • Note: Additional Exclusion Criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00738894

Contact: Don Tunucci 800-437-8181 ext 45208

United States, Pennsylvania
University of Pennsylvania Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Steven Messe, MD         
Principal Investigator: Steven Messe, MD         
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lars Søndergaard, MD         
Principal Investigator: Lars Søndergaard, MD         
Sponsors and Collaborators
W.L.Gore & Associates
Principal Investigator: Scott E. Kasner, MD, FAHA University of Pennsylvania Medical Center
Principal Investigator: John F. Rhodes, MD Duke University
Principal Investigator: Lars Søndergaard, MD Rigshospitalet, Denmark
Principal Investigator: Lars Thomassen, MD, PhD Haukeland University Hospital - Bergen, Norway
  More Information

Additional Information:
No publications provided

Responsible Party: W.L.Gore & Associates Identifier: NCT00738894     History of Changes
Other Study ID Numbers: HLX 06-03
Study First Received: August 19, 2008
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:
transient ischemic attack
Patent foramen ovale
Septal Occluder
PFO Occluder

Additional relevant MeSH terms:
Cerebral Infarction
Foramen Ovale, Patent
Ischemic Attack, Transient
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial
Nervous System Diseases
Vascular Diseases processed this record on November 23, 2014