Foramen Ovale, Patent Clinical Trial
Official title:
Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
The primary objective of this study is to demonstrate the safety and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief neurological dysfunction), migraine or decompression illness.
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; we propose to use a non-implantable system to safely effect closure. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
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Recruiting |
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N/A | |
Completed |
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Decompression Sickness in Divers With or Without Patent Foramen Ovale
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Recruiting |
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Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
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Recruiting |
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Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
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Completed |
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Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries
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N/A | |
Recruiting |
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InterSEPT: InāTunnel SeptRx European PFO Trial
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N/A | |
Completed |
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The Effect on EPCs by Successful Cardiac Occlusion Device Implantation
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N/A | |
Completed |
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Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System
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N/A | |
Recruiting |
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Long-term Outcomes After Percutaneous Closure of PFO
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Completed |
NCT02127294 -
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
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N/A | |
Recruiting |
NCT01149447 -
Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale
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N/A | |
Enrolling by invitation |
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Stitch Closure of PFO and Septal Repair (STITCH)
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N/A | |
Suspended |
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NobleStitch EL STITCH Trial is a PFO Comparative Trial
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N/A | |
Recruiting |
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Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder
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N/A | |
Withdrawn |
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Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
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N/A |