PREMIUM Migraine Trial

Abbott

Status: Completed

Conditions: Migraine Headaches; Patent Foramen Ovale

Treatments: Other: Sham Procedure; Device: AMPLATZER PFO Occluder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00355056

AGA-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 2 patient groups

Medical Management

Sham Comparator group

Description:

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).

Treatment:

Other: Sham Procedure

PFO Closure

Experimental group

Description:

Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and undergo PFO device closure procedure with the AMPLATZER PFO Occluder.

Treatment:

Device: AMPLATZER PFO Occluder