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Randomised controlled trial
Closure of a patent foramen ovale with a device does not offer a greater benefit than medical therapy alone for the prevention of recurrent cerebrovascular events
  1. Heinrich P Mattle,
  2. Marie-Luise Mono
  1. Department of Neurology, Inselspital, Bern, Switzerland
  1. Correspondence to: Professor Heinrich Mattle
    Department of Neurology, Freiburgstrasse, 3010 Bern, Switzerland; heinrich.mattle{at}insel.ch

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Context

Stroke can rarely be caused by paradoxical emboli passing from the right side of the circulatory system to the left side. Case reports have shown that the most common site of right to left shunt is the patent foramen ovale (PFO), and case control studies have shown a higher prevalence of PFO in patients with cryptogenic stroke as compared to stroke victims with a known cause or non-stroke controls. Therefore, the question arises as to whether closure of the PFO is useful in preventing recurrent stroke in patients with cryptogenic stroke and PFO.

Methods

CLOSURE is a multicentre, randomised, open-label trial of PFO closure with STARFlex, a percutaneous device, as compared with medical therapy alone in patients aged 18–60 years …

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