The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- PFO closure 6 months post procedure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
PFO closure 6 months post procedure
Time Frame: 6 months
Secondary Outcomes
- 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)