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GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study (HLX 06-03)
This study is ongoing, but not recruiting participants.
Sponsor:
W.L.Gore & Associates
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00738894
First received: August 19, 2008
Last updated: August 15, 2017
Last verified: August 2017
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Purpose
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder / GORE® CARDIOFORM 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.
A co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone
| Condition | Intervention |
|---|---|
| Stroke Transient Ischemic Attack | Device: GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder Other: Antiplatelet Medical Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO) |
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 ]
- Incidence of subjects with new brain infarct or clinical findings of ischemic stroke from screening through 24 months or last follow-up visit, whichever occurs first. [ Time Frame: 24 months ]
Secondary Outcome Measures:
- Safety: Adverse events (AEs) directly related to the device, procedure, and/or antiplatelet medical therapy [ Time Frame: 24 months ]
- Efficacy: Assessment of PFO closure in test (device) arm subjects by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) [ Time Frame: 24 months ]
| Estimated Enrollment: | 664 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | February 2020 |
| Primary Completion Date: | April 24, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Antiplatelet Medical Therapy Alone
|
Other: Antiplatelet Medical Therapy
Investigator's choice of one of three regimen options specified in protocol
Other Names:
|
|
Experimental: 2
PFO Closure with GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder Plus Antiplatelet Medical Therapy
|
Device: GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
Other Names:
Other: Antiplatelet Medical Therapy
Investigator's choice of one of three regimen options specified in protocol
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 central nervous system (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® CARDIOFORM 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 ClinicalTrials.gov identifier: NCT00738894
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738894
Locations
| United States, Pennsylvania | |
| University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark | |
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
| 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
| Responsible Party: | W.L.Gore & Associates |
| ClinicalTrials.gov Identifier: | NCT00738894 History of Changes |
| Other Study ID Numbers: |
HLX 06-03 |
| Study First Received: | August 19, 2008 |
| Last Updated: | August 15, 2017 |
Keywords provided by W.L.Gore & Associates:
|
cryptogenic stroke transient ischemic attack TIA PFO |
Patent foramen ovale HELEX Septal Occluder PFO Occluder |
Additional relevant MeSH terms:
|
Stroke Ischemic Attack, Transient Foramen Ovale, Patent Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
Cardiovascular Diseases Brain Ischemia Heart Septal Defects, Atrial Heart Septal Defects Heart Defects, Congenital Cardiovascular Abnormalities Heart Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on August 23, 2017