Gore RELIEF Clinical Study

ABOUT MIGRAINE HEADACHES

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What are migraine headaches?

Migraine headaches are a complicated, yet common, neurological/vascular condition that affect millions of people every day.

Migraine headaches can cause the following symptoms:

  • Sharp or throbbing pain in the head or temples
  • Sensations of uncomfortable pressure behind the eyes
  • Nausea
  • Photophobia (sensitivity to light)
  • Audiophobia (sensitivity to sounds)
  • Hyperosmia (sensitivity to smells)
  • Hot flashes and chills
  • Fainting
  • Fatigue
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14 simple questions

Gore RELIEF Clinical Study

How are migraine headaches treated?

Migraine headaches can be treated with two different types of treatment: prophylactic (preventing a migraine from happening at all) or abortive (stopping a migraine headache right as it starts so it doesn’t continue).

There are many different medications that fall into these treatment types and sometimes patients can use both types to manage their migraine headaches. Treating migraine headaches often varies from one migraine sufferer to the next and this may result in trial-error-strategy which can be difficult for patients.

The RELIEF Study is designed to evaluate the safety and effectiveness of Patent Foramen Ovale (PFO) closure with the Gore® CARDIOFORM Septal Occluder (a medical device) for migraine headache reduction for certain migraine patients. The RELIEF Study has been approved by the FDA to investigate if PFO closure with Gore® CARDIOFORM Septal Occluder is safe and more effective at reducing migraine in comparison to a control procedure (one where the device is not implanted), specifically in those migraine patients who have a PFO.


Study participation

If you or a loved one are interested in participating in this study, the following criteria must be met:

  • Be 18 - 55 years of age.
  • Have had one year or more of migraine symptoms that started before the age of 50.
  • Have more than one migraine headache per week on average.
  • Have tried and have had unsatisfactory results with at least two different migraine medications for prevention, which were taken on a regular basis to reduce the overall frequency and/or severity of migraine.

Additional criteria will apply.

See if You Pre-Qualify

14 simple questions

Gore RELIEF Clinical Study