Back to resultsPFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
Primary Purpose
Patent Foramen Ovale
Status
Suspended
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PFx catheter
Sponsored by
About this trial
This is an interventional treatment trial for Patent Foramen Ovale focused on measuring PFO, Migraine, Stroke, TIA (transient ischemic attack), Decompression Illness
Eligibility Criteria
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.
Sites / Locations
- AZ Middleheim Hospital
- Institut Hospitalier Jacques Carter
- Bichat Hospital
- Cardiovascular Center Frankfurt Sankt katharinen
Outcomes
Primary Outcome Measures
PFO closure 6 months post procedure
Secondary Outcome Measures
PFO closure at 30 days and 12 months post procedure
AE event rates for all subjects
Migraine severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00335296
Brief Title
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
Official Title
The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Suspended
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Cierra
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Foramen Ovale
Keywords
PFO, Migraine, Stroke, TIA (transient ischemic attack), Decompression Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
PFx catheter
Primary Outcome Measure Information:
Title
PFO closure 6 months post procedure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PFO closure at 30 days and 12 months post procedure
Time Frame
30 days, 12 months
Title
AE event rates for all subjects
Time Frame
30 days, 6 and 12 months
Title
Migraine severity
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alec Vahanian, MD
Organizational Affiliation
Bichat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Middleheim Hospital
City
Antwerpen
Country
Belgium
Facility Name
Institut Hospitalier Jacques Carter
City
Massy
Country
France
Facility Name
Bichat Hospital
City
Paris
ZIP/Postal Code
75877
Country
France
Facility Name
Cardiovascular Center Frankfurt Sankt katharinen
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.cierrainc.com/
Description
Related Info
Learn more about this trial
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
We'll reach out to this number within 24 hrs