PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
- Conditions
- Patent Foramen Ovale
- Registration Number
- NCT00335296
- Lead Sponsor
- Cierra
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 100
- 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
• Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method PFO closure 6 months post procedure 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
AZ Middleheim Hospital
🇧🇪Antwerpen, Belgium
Institut Hospitalier Jacques Carter
🇫🇷Massy, France
Cardiovascular Center Frankfurt Sankt katharinen
🇩🇪Frankfurt, Germany
Bichat Hospital
🇫🇷Paris, France