Patent Foramen Ovale
Conditions
Keywords
PFO, Migraine, Stroke, TIA (transient ischemic attack), Decompression Illness
Brief summary
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.
Detailed description
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.
Interventions
DEVICEPFx catheter
Sponsors
Cierra
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years old * Documented PFO * Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness
Exclusion criteria
• Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFO closure 6 months post procedure | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| PFO closure at 30 days and 12 months post procedure | 30 days, 12 months |
| AE event rates for all subjects | 30 days, 6 and 12 months |
| Migraine severity | 6 and 12 months |
Countries
Belgium, France, Germany
Outcome results
None listed