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The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding and is defined as a patent foramen ovale (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a material with superelastic properties, which, in its relaxed state, has the form of a double umbrella. This is a single-center, non-comparative, prospective interventional clinical investigation involving 1 center in Germany to assess the effectiveness, safety and practicability of implantation of the Nit-Occlud PFO® Closure Device.
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Inclusion criteria
Diagnosis of patent foramen ovale (PFO)
Age between 18 and 65 years of both gender
Ability to give written informed consent after being told the potential benefits and risks of entering the trial to understand the planned clinical study and able to participate in all follow-up procedures
Signed informed consent
Presenting with neurological symptoms and at least one of the following clinical circumstances:
PFO defect with or without atrial septal aneurysm of a balloon stretched diameter less than 18 mm. PFO tunnel length less than 10 mm in TEE
Mental and physical ability of patient to follow the protocol according to compliance to time schedule, treatment plan,completion of CRF pages and further study procedures.
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Data sourced from clinicaltrials.gov
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