Safety and efficacy of Cardi-O-fix occluder for percutaneous closure of a patent foramen ovale: A single-center prospective study.

Medicine (Baltimore) · 2017 · PMC5411222 · PMID 28383438

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did not reach statistical significanceno p-value reported

Meanwhile, in the RESPECT study, PFO closure was shown to reduce the recurrence risk of stroke by 63.4% according to the prespecified per-protocol analysis and by 72.7% by the as-treated analysis ( P < 0.05), but the reduction did not reach statistical significance in the intention-to-treat (ITT) analysis.

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