ESCAPE Migraine Trial

Migraine headache is a neurological disorder characterized by chronic and disabling headache.
Approximately 10-12% of humans, comprising some 28 million Americans, suffer from this
disorder. Despite continual advances in medical management of migraine, many sufferers
continue to experience frequent and disabling attacks despite appropriate medical therapy.
Preventative medications, such as anti-epileptic drugs, anti-depressants, and beta-blockers,
while effective for many patients, have side-effect profiles that preclude use in many
patients. In the past decade, there has been growing evidence that patients with migraine,
particularly those with aura, are more likely to have a patent foramen ovale.

A patent foramen ovale (PFO) is a persistent, flap-like opening in the wall of the heart,
between the right and left atrium. Typically, this opening closes shortly after birth,
however, in some people, it remains open.

While there is currently no proof for cause-effect relationship, several recent studies have
confirmed a strong association between the presence of PFO and migraine with aura.

Comparison: This clinical study will compare PFO closure with medical therapy alone for the
treatment of migraine headaches.

Major Inclusion Criteria:

- Patient must be between the ages of 18 and 70;

- Patient must have a migraine history and demonstrate a refractoriness to medical
treatment;

- Patient must have a Patent Foramen Ovale (PFO);

- Patient must be willing and able to give informed consent and complete required
follow-up visits.

Major Exclusion Criteria:

- Patient has any medical condition or receives any medication that would preclude
participation in the trial

- Patient is enrolled or intends to participate in another clinical study (of an
investigational drug or device, new indication for an approved drug or device, or
requirement of additional testing beyond standard clinical practice) during the study
or within four weeks prior to his/her enrollment in the study.

- Patient is pregnant, or intends to become pregnant during the trial period