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PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)
This study has suspended participant recruitment.
Sponsor:
Cierra
Information provided by:
Cierra
ClinicalTrials.gov Identifier:
NCT00335296
First received: June 8, 2006
Last updated: December 18, 2007
Last verified: December 2007
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Purpose
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.
| Condition | Intervention |
|---|---|
| Patent Foramen Ovale | Device: PFx catheter |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness |
Resource links provided by NLM:
Further study details as provided by Cierra:
Primary Outcome Measures:
- PFO closure 6 months post procedure [ Time Frame: 6 months ]
Secondary Outcome Measures:
- PFO closure at 30 days and 12 months post procedure [ Time Frame: 30 days, 12 months ]
- AE event rates for all subjects [ Time Frame: 30 days, 6 and 12 months ]
- Migraine severity [ Time Frame: 6 and 12 months ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | December 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335296
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335296
Locations
| Belgium | |
| AZ Middleheim Hospital | |
| Antwerpen, Belgium | |
| France | |
| Institut Hospitalier Jacques Carter | |
| Massy, France | |
| Bichat Hospital | |
| Paris, France, 75877 | |
| Germany | |
| Cardiovascular Center Frankfurt Sankt katharinen | |
| Frankfurt, Germany, 60389 | |
Sponsors and Collaborators
Cierra
Investigators
| Principal Investigator: | Alec Vahanian, MD | Bichat Hospital |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00335296 History of Changes |
| Other Study ID Numbers: |
CA0005/09 |
| Study First Received: | June 8, 2006 |
| Last Updated: | December 18, 2007 |
Keywords provided by Cierra:
|
PFO Migraine Stroke TIA (transient ischemic attack) Decompression Illness |
Additional relevant MeSH terms:
|
Migraine Disorders Ischemic Attack, Transient Foramen Ovale, Patent Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Brain Ischemia |
Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Heart Septal Defects, Atrial Heart Septal Defects Heart Defects, Congenital Cardiovascular Abnormalities Heart Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on July 18, 2017