Heart Septal Defects, Atrial, Migraine Disorders
Conditions
Keywords
Migraine headache, Patent Foramen Ovale, Patent Foramen Ovale Closure
Brief summary
The purpose of this two arm controlled double-blind study is to determine the safety and effectiveness of PFO closure (closing a hole in the wall of the heart) in reducing the frequency of migraine headaches, in patients who experience migraine headaches and have a PFO, compared to medical therapy alone.
Detailed description
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.
Interventions
DEVICEPFO Closure with Premere investigational device.
PFO Closure with Premere investigational device.
Medical management with current medications per standard of care by personal physician.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint 1: Effectiveness | 12 months |
| The primary effectiveness measure is the decrease in the frequency of migraine headaches. | monthly |
| The primary safety endpoint is the rate of major complications | monthly |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint 1: Effect of Aura | on-going |
| Secondary Endpoint 2: Assessment of Procedural Success and Long-Term Device Performance | Five years |
Countries
United States
Outcome results
None listed