PREMIUM Migraine Trial

Not Applicable

Completed

Conditions: Migraine Headaches
Patent Foramen Ovale

Interventions: Other: Sham Procedure
Device: AMPLATZER PFO Occluder

Registration Number: NCT00355056

Lead Sponsor: Abbott Medical Devices

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 230

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical Management	Sham Procedure	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).
PFO Closure	AMPLATZER PFO Occluder	Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint - Device Related Serious Adverse Event (SAE)	Baseline through 12 months	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.
Primary Efficacy Endpoint - Percentage of Subjects With a 50% Reduction From Baseline in the Monthly Number of Migraine Attacks at 12 Months.	Baseline and months 10-12	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of Device-related Adverse Events	12 months
Change in Mean Migraine Days/Month	Baseline and months 10-12	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.
Long-Term Success	12 months	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.
Change in Migraine Disability Assessment (MIDAS) Score From Baseline to 12-months	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.
Incidence of a 75% Reduction in Migraine Headache Attacks	12 months
Procedural Success	12 months	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.
Incidence of All Adverse Events at 12-months	12 months
Incidence of a 95% Reduction in Migraine Headache Attacks	12-months
Percentage of Subjects With Successful PFO Closure at 12-months	Baseline and month 12	Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade \<= 2

Trial Locations

Locations (30): St. Joseph's Hospital & Medical Center
🇺🇸
Phoenix, Arizona, United States
Inova Healthcare Services
🇺🇸
Falls Church, Virginia, United States
Medical Center of the Rockies
🇺🇸
Fort Collins, Colorado, United States
St. Johns's Mercy Medical Center
🇺🇸
Saint Louis, Missouri, United States
St. Mark's Hospital
🇺🇸
Salt Lake City, Utah, United States
Intermountain Medical Center
🇺🇸
Salt Lake City, Utah, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
St. Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
Alegent Health Bergan Mercy Medical Center
🇺🇸
Omaha, Nebraska, United States
Mercy Hospital of Buffalo
🇺🇸
Buffalo, New York, United States
Pinnacle Health Hospitals
🇺🇸
Harrisburg, Pennsylvania, United States
UCLA School of Medicine
🇺🇸
Los Angeles, California, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
St. Cloud Hospital
🇺🇸
Saint Cloud, Minnesota, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Children's Heart Center Las Vegas
🇺🇸
Las Vegas, Nevada, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Memorial Hospital
🇺🇸
Colorado Springs, Colorado, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
University of Rochester Medical School
🇺🇸
Rochester, New York, United States
The Methodist Hospital
🇺🇸
Houston, Texas, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
Swedish Medical Center
🇺🇸
Englewood, Colorado, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States