The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
230
Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.
Patients in this arm will receive the AMPLATZER PFO Occluder device
Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.
A 50% reduction from the monthly number of migraine attacks during the 60-day baseline phase to the monthly number of migraine attacks during month ten through the twelfth month in the treatment phase (device group versus sham group).
Time frame: Baseline and months 10-12
Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)
Number of subjects who experience a device-related major adverse event (DRMAE) through 12-months of follow-up. This endpoint was analyzed using an as-treated cohort that consists of all enrolled subjects who received the device (randomized and Optional PFO Closure group) and who had follow-up sufficient to adequately assess the DRMAE rate.
Time frame: Baseline through 12 months
Change in Mean Migraine Days/Month
Change in the number of migraine days is calculated by the difference in the mean number of migraine days between the baseline assessment period and the treatment phase (months 10-12 post-procedure) for the respective randomization groups.
Time frame: Baseline and months 10-12
Percentage of Subjects With Successful PFO Closure at 12-months
Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade \<= 2
Time frame: Baseline and month 12
Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months
The MIDAS questionnaire measure the impact of headaches on daily living. A total score of 0-5 equals little to no disability, 6-10 equals mild disability, 11-20 equals moderate disability, and a score 21 or greater equals severe disability. The maximum possible score is 276.
Time frame: 12 months
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St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
UCLA School of Medicine
Los Angeles, California, United States
Memorial Hospital
Colorado Springs, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Medical Center of the Rockies
Fort Collins, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
...and 20 more locations
Incidence of a 75% Reduction in Migraine Headache Attacks
Time frame: 12 months
Procedural Success
Procedural success is calculated by the percent of device group subjects who were implanted with the study device and experienced no serious device or procedure-related adverse events.
Time frame: 12 months
Long-Term Success
Percent of PFO closure group subjects who were implanted with the study device, experienced no serious device or procedure-related adverse events and have a core-lab adjudicated TCD Grade at Valsalva ≤ 2 at 1-year.
Time frame: 12 months
Incidence of All Adverse Events at 12-months
Time frame: 12 months
Incidence of Device-related Adverse Events
Time frame: 12 months
Incidence of a 95% Reduction in Migraine Headache Attacks
Time frame: 12-months