Trials / Terminated
TerminatedNCT00505570
PRIMA PFO Migraine Trial
Percutaneous Closure of Patent Foramen Ovale In Migraine With Aura - A Randomized Prospective Study (Prima Trial)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 107 (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 migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.
Detailed description
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart which normally closes at or soon after birth) who are randomized to either undergo closure of the patent foramen ovale or continue with standard medical management.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AMPLATZER® PFO Occluder Device | PFO device closure |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-01
- First posted
- 2007-07-23
- Last updated
- 2019-02-04
Locations
17 sites across 4 countries: Canada, Germany, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00505570. Inclusion in this directory is not an endorsement.