PREMIUM Migraine Trial

Patent Foramen Ovale Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355056
• Other study ID #: AGA-010
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Est. completion date: December 2015

Study information

• Verified date: July 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Headache
• Migraine Disorders
• Migraine Headaches
• Patent Foramen Ovale

Intervention

Other:
• 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). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.

Device:
• AMPLATZER PFO Occluder
Patients in this arm will receive the AMPLATZER PFO Occluder device

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months
Primary	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).	Baseline and months 10-12
Primary	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.	Baseline through 12 months
Secondary	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.	Baseline and months 10-12
Secondary	Percentage of Subjects With Successful PFO Closure at 12-months	Successful Closure by Core Lab Adjudicated Transcranial Doppler (TCD) Grade <= 2	Baseline and month 12
Secondary	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.	12 months
Secondary	Incidence of a 75% Reduction in Migraine Headache Attacks		12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Incidence of All Adverse Events at 12-months		12 months
Secondary	Incidence of Device-related Adverse Events		12 months
Secondary	Incidence of a 95% Reduction in Migraine Headache Attacks		12-months