Back to resultsPFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness (Paradigm IV)
Primary Purpose
PFO, Stroke, Transient Ischemic Attack
Status
Suspended
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
PFx Closure System
Sponsored by
About this trial
This is an interventional treatment trial for PFO focused on measuring PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 65 years old
PFO with one or more of:
- Cryptogenic stroke,
- TIA or embolism,
- History of severe migraine headaches, or
- History of severe decompression illness.
Exclusion Criteria:
- In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Sites / Locations
- Cardiovascular Center Frankfurt Sankt katharinen
Outcomes
Primary Outcome Measures
PFO closure at 6 months post procedure.
Secondary Outcome Measures
PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00529945
Brief Title
PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness
Acronym
Paradigm IV
Official Title
The Paradigm IV 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
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Cierra
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary object of this study is to demonstrate the continued 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PFO, Stroke, Transient Ischemic Attack, Migraine, Decompression Illness
Keywords
PFO, Stroke, Transient Ischemic Attack, Migraine, 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
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
PFx Closure System
Primary Outcome Measure Information:
Title
PFO closure at 6 months post procedure.
Time Frame
6 months post procedure
Secondary Outcome Measure Information:
Title
PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine.
Time Frame
30 days; 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 18 to 65 years old
PFO with one or more of:
Cryptogenic stroke,
TIA or embolism,
History of severe migraine headaches, or
History of severe decompression illness.
Exclusion Criteria:
In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horst Sievert, MD
Organizational Affiliation
Cardiovascular Center Frankfurt, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Center Frankfurt Sankt katharinen
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness
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