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This study is ongoing, but not recruiting participants.
Sponsor:
AGA Medical Corporation
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00355056
First received: July 19, 2006
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Headaches Patent Foramen Ovale |
Other: Sham Procedure Device: AMPLATZER PFO Occluder |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management. |
Resource links provided by NLM:
Further study details as provided by AGA Medical Corporation:
Primary Outcome Measures:
- Whether subjects with percutaneous PFO closure experience a reduction in migraine attacks. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in the average number of migraine days; change in MIDAS score; reduction in the number of acute and/or rescue migraine medications; complete closure of the defect; improvement of Quality of Life; Improvement in the BECK Depression Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 230 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sham Comparator: 1 |
Other: Sham Procedure
Sham Procedure
|
|
Experimental: 2
PFO device Closure
|
Device: AMPLATZER PFO Occluder
Patients in this arm will receive the AMPLATZER PFO Occluder device
|
Detailed Description:
The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in patients who are refactory to medical treatment.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects diagnosed as having migraine headaches both with and without aura
- Have a Patent Foramen Ovale (PFO)
- A migraine history and show a refractoriness to medical treatment
- Willing to participate in follow-up visits
Exclusion Criteria:
- Subjects whose primary headaches are other than migraine headaches
- Who overuse migraine treatments
- With a clinical history of stroke or Transient Ischemic Attack (TIA)
- With contraindication to aspirin therapy and Clopidogrel
- Pregnant or desire to become pregnant within the next year
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355056
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| United States, Arizona | |
| St. Joseph's Hospital & Medical Center | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Memorial Hospital | |
| Colorado Springs, Colorado, United States, 80909 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80113 | |
| Medical Center of the Rockies | |
| Fort Collins, Colorado, United States, 80528 | |
| United States, District of Columbia | |
| Washington Hospital Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52240 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70124 | |
| United States, Massachusetts | |
| Tufts Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Abbott Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| St. Cloud Hospital | |
| St. Cloud, Minnesota, United States, 56303 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| St. Johns's Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Alegent Health Bergan Mercy Medical Center | |
| Omaha, Nebraska, United States, 68124 | |
| United States, Nevada | |
| Children's Heart Center Las Vegas | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New York | |
| Mercy Hospital of Buffalo | |
| Buffalo, New York, United States, 14214 | |
| University of Rochester Medical School | |
| Rochester, New York, United States, 14642-8679 | |
| United States, Pennsylvania | |
| Pinnacle Health Hospitals | |
| Harrisburg, Pennsylvania, United States, 17104 | |
| Thomas Jefferson University | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Intermountain Medical Center | |
| Salt Lake City, Utah, United States, 84143 | |
| St. Mark's Hospital | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Virginia | |
| Inova Healthcare Services | |
| Falls Church, Virginia, United States, 22042 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215 | |
Sponsors and Collaborators
AGA Medical Corporation
Investigators
| Principal Investigator: | Sherman Sorensen, M.D. | Intermountain Medical Center |
| Principal Investigator: | Stephen Silberstein, M.D. | Thomas Jefferson University |
| Principal Investigator: | Jonathan Tobis, M.D. | University of California, Los Angeles |
More Information
No publications provided
| Responsible Party: | AGA Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT00355056 History of Changes |
| Other Study ID Numbers: | AGA-010, G050054 |
| Study First Received: | July 19, 2006 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AGA Medical Corporation:
|
Migraine PFO Migraine Headache patent foramen ovale |
Additional relevant MeSH terms:
|
Foramen Ovale, Patent Heart Septal Defects, Atrial Headache Migraine Disorders Heart Septal Defects Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases |
Congenital Abnormalities Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013