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PREMIUM Migraine Trial

NCT00355056 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2020-07-30

Study results available
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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.

Conditions

  • Migraine Headaches
  • Patent Foramen Ovale

Interventions

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Sherman Sorensen, M.D. · Intermountain Medical Center

  • Stephen Silberstein, M.D. · Thomas Jefferson University

  • Jonathan Tobis, M.D. · University of California, Los Angeles

  • Andrew Charles, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2015-02-28
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00355056 on ClinicalTrials.gov