NCT00355056

PREMIUM Migraine Trial

Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Migraine Headaches
• Patent Foramen Ovale

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-01-01
• Primary completion: 2015-02-01
• Completion: 2015-12-01
• First posted: 2006-07-21
• Last updated: 2020-07-30
• Results posted: 2020-07-30

Locations

30 sites across 1 country: United States