CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 230 enrolled
Drug / intervention
Sham Procedure +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00355056
NCT00355056N/ACompleted
CompareCT.gov

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

Abbott Medical Devices·interventional·Posted Jul 21, 2006·Updated Jul 30, 2020

In Brief

A clinical study evaluating Sham Procedure and AMPLATZER PFO Occluder for Migraine Headaches and Patent Foramen Ovale. Completed, enrolled 230 participants across 30 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Headaches, Patent Foramen Ovale
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2006
Enrollment StartJan 1, 2006
Primary CompletionFeb 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 19.9 years ago

Interventions

Sham Procedureother

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.

AMPLATZER PFO Occluderdevice

Patients in this arm will receive the AMPLATZER PFO Occluder device