An interventional study of Sham Procedure and AMPLATZER PFO Occluder in Migraine Headaches and Patent Foramen Ovale, sponsored by Abbott Medical Devices. Completed at 30 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 230 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: Sham Procedure
Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.
Device: AMPLATZER PFO Occluder
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
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
Change in Beck Depression Inventory (BDI) Scale
The difference in BDI between baseline and 12-months for the respective randomization groups. The highest possible score of the BDI is 63, which represents extreme depression. The lowest possible score is 0, which represents no depression.
Time frame: 12 months
| Milestone | Sham Procedure | Patent Foramen Ovale (PFO) Device Closure |
|---|---|---|
| Started | 107 | 123 |
| Completed | 103 | 117 |
| Not completed | 4 | 6 |
| Withdrew: Early termination | 4 | 6 |
| Milestone | Sham Procedure | Patent Foramen Ovale (PFO) Device Closure |
|---|---|---|
| Started | 0 | 87 |
| Completed | 0 | 84 |
| Not completed | 0 | 3 |
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).
| percentage of subjects | Sham Procedure | PFO Device Closure |
|---|---|---|
| Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months. | 32 | 38 |
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.
| percentage of participants | PFO Device Closure |
|---|---|
| Primary Safety Endpoint - Device Related Serious Adverse Event (SAE) | 0.49 (0.01 to 2.69) |
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.
| Migraine days per month | Sham Procedure | PFO Device Closure |
|---|---|---|
| Change in Mean Migraine Days/Month | 2.0 ± 5.0 | 3.4 ± 4.4 |
Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade \<= 2
| percentage of participants | PFO Closure |
|---|---|
| Percentage of Subjects With Successful PFO Closure at 12-months | 82.7 (74 to 89) |
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.
| units on a scale | Sham Procedure | PFO Device Closure |
|---|---|---|
| Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months | -17 ± 36 | -22.6 ± 32.9 |
| percentage of participants | Sham Procedure | PFO Device Closure |
|---|---|---|
| Incidence of a 75% Reduction in Migraine Headache Attacks | 16.5 | 20.5 |
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.
| percentage of participants | PFO Closure |
|---|---|
| Procedural Success | 94.3 (88.6 to 97.7) |
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.
| percentage of participants | PFO Closure |
|---|---|
| Long-Term Success | 80.8 (71.9 to 87.8) |
| participants | Sham Procedure | PFO Device Closure |
|---|---|---|
| Incidence of All Adverse Events at 12-months | 93 | 105 |
| percentage of participants | PFO Closure |
|---|---|
| Incidence of Device-related Adverse Events | 31.7 (23.6 to 40.7) |
| percentage of participants | Sham Procedure | PFO Device Closure |
|---|---|---|
| Incidence of a 95% Reduction in Migraine Headache Attacks | 0.97 | 8.55 |
The difference in BDI between baseline and 12-months for the respective randomization groups. The highest possible score of the BDI is 63, which represents extreme depression. The lowest possible score is 0, which represents no depression.
| units on a scale | Sham Procedure | PFO Device Closure |
|---|---|---|
| Change in Beck Depression Inventory (BDI) Scale | -0.3 ± 7.1 | -2.1 ± 6.5 |
The term "majority" in "majority of migraine attacks included aura" was defined by the Neurologist (\>50%) at the time of randomization based on a review of the subject's study baseline headache diary and medical history.
| percentage of subjects | PFO Device Closure | Sham Procedure |
|---|---|---|
| Responder Rate for Subjects in Whom Majority of Attacks Were With Aura | 48.7 | 22.5 |
Complete Cessation of Migraine Attacks, baseline diary compared to months 10-12
| percentage of subjects | PFO Device Closure | Sham Procedure |
|---|---|---|
| Percentage of Subjects With Migraine With Aura Determined to Have a Complete Cessation of Migraine Attacks According to the International Headache Society (IHS) | 10.8 | 1.5 |
Collected over All adverse events were collected from the time of signing informed consent until the 12-month follow-up visit. After the 12-month follow-up visit, serious adverse events and/or device-related events were collected until completion of study requirements.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PFO Device Closure | — | 1/123 (0.8%) | 119/123 (96.7%) |
| Sham Procedure | — | 0/107 (0%) | 103/107 (96.3%) |
| Optional PFO Closure | — | 0/87 (0%) | 68/87 (78.2%) |
| Event | PFO Device Closure | Sham Procedure | Optional PFO Closure |
|---|---|---|---|
| Transient atrial fibrillation after device placementCardiac disorders | 1/123 | 0/107 | 0/87 |
| Event | PFO Device Closure | Sham Procedure | Optional PFO Closure |
|---|---|---|---|
| Common cold/Upper Respiratory Tract InfectionInfections and infestations | 29/123 | 28/107 | 3/87 |
| Bruise/Purpura SimplexGeneral disorders | 20/123 | 27/107 | 10/87 |
| PalpitationsCardiac disorders | 30/123 | 16/107 | 12/87 |
| SinusitisGeneral disorders | 29/123 | 23/107 | 7/87 |
| Chest PainGeneral disorders | 22/123 | 13/107 | 13/87 |
| Vascular Access Site Complication PainVascular disorders | 22/123 | 12/107 | 9/87 |
| Musculoskeletal PainGeneral disorders | 21/123 | 9/107 | 0/87 |
| Abdominal PainGastrointestinal disorders | 17/123 | 14/107 | 1/87 |
| Urinary Tract InfectionInfections and infestations | 16/123 | 13/107 | 4/87 |
| Vascular Access Site Complication HematomaVascular disorders | 8/123 | 12/107 | 6/87 |
| Age, Continuous(years) | Sham Procedure | PFO Device Closure | Total |
|---|---|---|---|
| Mean | 43.72 ± 10.16 | 42.75 ± 10.27 | 43.20 ± 10.20 |
| Sex: Female, Male(Participants) | Sham Procedure | PFO Device Closure | Total |
|---|---|---|---|
| Female | 95 | 110 | 205 |
| Male | 12 | 13 | 25 |
| Region of Enrollment(participants) | Sham Procedure | PFO Device Closure | Total |
|---|---|---|---|
| United States | 107 | 123 | 230 |
| International Classification of Headache Disorders (ICH)(participants) | Sham Procedure | PFO Device Closure | Total |
|---|---|---|---|
| Migraine with Aura (ICH) | 71 | 80 | 151 |
| Migraine without Aura (ICH) | 83 | 102 | 185 |
| Migraine with and without Aura | 47 | 58 | 105 |
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