Abstract
The patent foramen ovale and cryptogenic embolism (PC) trial was designed in 1999 as the first randomized clinical trial comparing the efficacy of percutaneous device closure of patent foramen ovale (PFO) with medical treatment in preventing recurrent events among patients with cryptogenic embolism. The PC Trial is an investigator initiated trial which originally sought to include any commercially available device in the closure group, but soon came to the conclusion, that device related differences may affect their individual performance regarding closure rates and thrombus formation and hence the clinical outcome. Therefore the purpose of the study was modified to comparing the efficacy of percutaneous PFO closure using one device only, the Amplatzer PFO Occluder (previously AGA Medical Corporation, Golden Valley, MN, USA, currently St. Jude Medical Corporation, Plymouth, MN, USA), with medical treatment in patients with presumed paradoxical embolism in a prospective, randomized trial. Accordingly, the device manufacturer sponsored the study by an unrestricted educational grant, with no involvement in study design, conduct, or publication. The study results were published in the March 21, 2013 issue of the New England Journal of Medicine.
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Khattab, A.A., Meier, B. (2015). The PC Trial: An Effective Treatment Not Demonstrating Effective Power. In: Amin, Z., Tobis, J., Sievert, H., Carroll, J. (eds) Patent Foramen Ovale. Springer, London. https://doi.org/10.1007/978-1-4471-4987-3_24
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