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Sponsored by: |
St. Jude Medical |
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Information provided by: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00267371 |
The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone.
Condition | Intervention | Phase |
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Migraine Disorders Heart Septal Defects, Atrial |
Device: PFO Closure Device: Sham procedure. |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Septal Closure of Atrial PFO on Events of Migraine With Premere: ESCAPE Migraine Trial |
Estimated Enrollment: | 492 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Test Arm: Active Comparator
PFO Closure with investigational device.
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Device: PFO Closure
Trans-catheter closure of PFO with the Premere Device
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Control Arm: Sham Comparator
Patients in the control group arm will not receive the medical device and will continue medical management.
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Device: Sham procedure.
Right heart catheritization procedure, PFO assessment and randomization are blinded. Control arm patients continue use of preventive medications.
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Migraine headache is a neurological disorder characterized by chronic and disabling headache. Approximately 10-12% of humans, comprising some 28 million Americans, suffer from this disorder. Despite continual advances in medical management of migraine, many sufferers continue to experience frequent and disabling attacks despite appropriate medical therapy. Preventative medications, such as anti-epileptic drugs, anti-depressants, and beta-blockers, while effective for many patients, have side-effect profiles that preclude use in many patients. In the past decade, there has been growing evidence that patients with migraine, particularly those with aura, are more likely to have a patent foramen ovale.
A patent foramen ovale (PFO) is a persistent, flap-like opening in the wall of the heart, between the right and left atrium. Typically, this opening closes shortly after birth, however, in some people, it remains open.
While there is currently no proof for cause-effect relationship, several recent studies have confirmed a strong association between the presence of PFO and migraine with aura.
Comparison: This clinical study will compare PFO closure with medical therapy alone for the treatment of migraine headaches.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Major Inclusion Criteria:
Major Exclusion Criteria:
Principal Investigator: | Robert Sommer, MD | Columbia University Medical Center |
Principal Investigator: | David Dodick, MD | Mayo Clinic Scottsdale |
Responsible Party: | St. Jude Medical ( St. Jude Medical Cardiovascular Division ) |
Study ID Numbers: | 1202-001, IDE G050112 |
Study First Received: | December 16, 2005 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00267371 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Migraine headache Patent Foramen Ovale Patent Foramen Ovale Closure |
Heart Septal Defects Heart Diseases Cardiovascular Abnormalities Central Nervous System Diseases Headache Disorders, Primary Brain Diseases Heart Septal Defects, Atrial |
Headache Disorders Migraine Disorders Foramen Ovale, Patent Headache Congenital Heart Septum Defect Congenital Abnormalities Heart Defects, Congenital |
Heart Septal Defects Heart Diseases Cardiovascular Abnormalities Nervous System Diseases Central Nervous System Diseases Headache Disorders, Primary Brain Diseases |
Heart Septal Defects, Atrial Headache Disorders Migraine Disorders Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |