Aura, Migraine, Patent Foramen Ovale
Conditions
Keywords
migraine, aura, Patent Foramen Ovale (PFO), cardiac defects, Heart Septal Defects, Atrial, Cephalalgia
Brief summary
The objective of the study is to investigate the safety and effectiveness of PFO closure with the BioSTAR Septal Repair Implant System in a population of patients that have refractory migraine (with aura) and who have failed medications.
Detailed description
During the last five years, transcatheter and surgical closure of PFO in the cyrptogenic stroke and TIA population has grown in frequency world-wide. Observational retrospective reports, from both single and multi-center experiences of over 400 patients, suggest Patent Foramen Ovale (PFO) closure to reduce the risk of recurrent migraine events in these populations may be beneficial, particularly for those patients in the migraine with aura subgroup. Although none of these reports are from prospective, randomized, controlled trials, the reports are compelling enough in their totality to support further investigation of a well defined group in a prospective manner. The patients reported in these studies were brought to PFO closure with no expectation of their procedure having any impact on their migraine. In fact, in many cases, the discovery of a history of migraine was not made until well after the PFO closure procedure. This clinical trial will prospectively compare the safety and effectiveness of PFO closure with the BioSTAR device to a control arm. Patients will be followed one year post-implant.
Interventions
DEVICEBioSTAR Septal Repair Implant System
PFO Closure
PROCEDURESham Procedure
Catheterization
Sponsors
NMT Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* age between 18 and 60. * migraine history prior to age 50 * must meet definition of refractory migraine with aura * must have a Patent Foramen Ovale (PFO) within bubble study specifications. * must provide informed consent. Guardian consent is not accepted. * patient's heart structure and vasculature must be compatible with BioSTAR Septal Repair Implant System. * patient must not be pregnant and agrees not to become pregnant during study participation
Exclusion criteria
* Medical conditions or medications that are not compatible with protocol or that would increase the patient's risk. * patient must not have any cardiac or vascular anomalies, repaired or not, that would be incompatible with the delivery system or device for PFO occlusion. * Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current trial endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Migraine reduction rates during analysis period. | — |
| Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy:Change in number of attacks from baseline period compared to analysis phase. | — |
| Safety: Device success during index procedure without procedural complication. | — |
| Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications. | — |
Countries
United States
Outcome results
None listed