Actual device PFO closure for Patent Foramen Ovale

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Patent Foramen Ovale+1 MoreActual device PFO closure - Device
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new device to see if it can relieve migraine headaches. The study is comparing the device to a placebo and sham (fake) device.

Eligible Conditions
  • Patent Foramen Ovale
  • Migraine

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: Week 40

30 days post-procedure
Proportion of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure from procedure through 30 days post-procedure
Proportion of subjects with any Serious Adverse Event (SAE) related to the study device or study procedure through 30 days post-procedure
Week 40
Reduction in Migraine Headache Days: mean reduction in the number of migraine headache days per month from baseline to follow-up
Headache
Reduction in Migraine Headache Days: mean reduction in the number of migraine headache days per month from baseline to follow-upheadache days per month from baseline to follow-up

Trial Safety

Trial Design

2 Treatment Groups

Test Arm
1 of 2
Control Arm
1 of 2

Experimental Treatment

Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Actual device PFO closure · Has Placebo Group · N/A

Test ArmExperimental Group · 2 Interventions: Actual device PFO closure, Thienopyridine (clopidogrel or prasugrel) · Intervention Types: Device, Drug
Control ArmShamComparator Group · 2 Interventions: Thienopyridine (clopidogrel or prasugrel), Sham device PFO closure · Intervention Types: Drug, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 40

Who is running the clinical trial?

W.L.Gore & AssociatesLead Sponsor
87 Previous Clinical Trials
23,784 Total Patients Enrolled
Robert Sommer, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
293 Total Patients Enrolled
David Dodick, MDPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
379 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced migraine with or without aura in the past year.
Subjects must agree to continue their preventive medication at current dosage throughout the duration of the study.
You have a minimum age of 18 years.
You have a minimum of one year of migraine symptom duration.
You have had at least one migraine headache day per week for at least three months.

Who else is applying?

What state do they live in?
Iowa50.0%
North Carolina50.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
What site did they apply to?
Mercy One Iowa Heart Center100.0%
How many prior treatments have patients received?
1100.0%