Foramen Ovale, Patent Clinical Trial
Official title:
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent ischemic stroke.
To demonstrate non-inferiority of the NobleStitch™ EL with medical management in both safety and effectiveness compared to the FDA-approved Amplatzer occluder with medical management for PFO closure. To demonstrate that the NobleStitch™ EL does not increase the incidence of ischemic stroke compared to published medical management data. ;
Status | Clinical Trial | Phase | |
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Completed |
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Enrolling by invitation |
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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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Completed |
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N/A | |
Recruiting |
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Recruiting |
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Long-term Outcomes After Percutaneous Closure of PFO
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Completed |
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Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
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N/A | |
Recruiting |
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Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale
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N/A | |
Suspended |
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N/A | |
Recruiting |
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N/A | |
Withdrawn |
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N/A |