GORE HELEX™ Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - Full Text View

Purpose

The primary objective is to determine that patent foramen ovale (PFO) closure with the GORE HELEX 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
Stroke Transient Ischemic Attack	Device: GORE HELEX™ Septal Occluder	Phase III

MedlinePlus related topics:

Transient Ischemic Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	GORE HELEX™ 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, imaging-confirmed TIA, or death due to stroke through 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:	August 2015
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Antiplatelet Medical Therapy alone
2: Experimental PFO Closure Plus Antiplatelet Medical Therapy	Device: GORE HELEX™ Septal Occluder PFO closure with GORE HELEX™ Septal Occluder

Eligibility

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

Criteria

Inclusion Criteria:

Presence of cryptogenic ischemic stroke or TIA with MRI (or CT) evidence of a presumably 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 to become pregnant during study period
Indications outside the parameters accepted for placement of the GORE HELEX 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
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

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 - Copenhagen, Denmark

Principal Investigator:	Lars Thomassen, MD, PhD	Haukeland University Hospital - Bergen, Norway

More Information

Responsible Party:	W.L. Gore & Associates, Inc. ( Donald Harkness / Clinical Affairs Leader )
Study ID Numbers:	HLX 06-03
First Received:	August 19, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00738894
Health Authority:	United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:

cryptogenic

stroke

transient ischemic attack

TIA

PFO

Patent foramen ovale

Study placed in the following topic categories:

Ischemic Attack, Transient

Heart Septal Defects

Heart Diseases

Cardiovascular Abnormalities

Cerebral Infarction

Stroke

Vascular Diseases

Central Nervous System Diseases

Ischemia

Brain Diseases

Cerebrovascular Disorders

Recurrence

Heart Septal Defects, Atrial

Congenital heart septum defect

Foramen Ovale, Patent

Brain Ischemia

Brain Infarction

Congenital Abnormalities

Infarction

Heart Defects, Congenital

Additional relevant MeSH terms:

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	W.L.Gore & Associates
Information provided by:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00738894