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Brief description/objective

Atrial fibrillation before and after patent foramen ovale closure study

This is a prospective, multicenter, single-arm, observational study assessing the incidence, predictors and prognostic impact of AF occurring before (monitoring phase A) or after (monitoring phase B) transcatheter PFO closure using an ICM device to continuously monitor heart rhythm.

The primary objective of the ALFA ROMEO study is to assess the incidence of first AF within 12 months after percutaneous PFO closure in patients with a history of systemic embolization, i.e.,
cryptogenic stroke or acute peripheral arterial closures, and a concomitant PFO (Monitoring Phase B), with a prespecified landmark analysis after 3 months to differentiate potentially device
related AF (months 0-3) from likely intrinsic A (months 4-12).