Primary and secondary endpoints of the PFO-AF study
| Primary endpoints | Secondary endpoints |
| Any episode of AF or atrial tachycardia/flutter lasting at least 30 s, and recorded on the ICM, during the 2 months following percutaneous PFO closure | Any episode of AF or atrial tachycardia/flutter lasting at least 30 s, and recorded on the ICM, during the 2 months prior to, and up to 2 years after percutaneous PFO closure |
| And/or any episode of AF or atrial tachycardia/flutter documented by ECG during the 2 months following percutaneous PFO closure | And/or any episode of AF or atrial tachycardia/flutter documented by ECG during the 2 months prior to, and up to 2 years after percutaneous PFO closure |
| Burden of AF (expressed in days, hours and min), as recorded in the ICM, during the 2 months prior to, and up to 2, 12 and 24 months after percutaneous PFO closure | |
| Plasma levels of MR-proANP as assayed in peripheral venous blood drawn prior to PFO closure | |
| Ischaemic or haemorrhagic stroke, peripheral emboli documented on imaging (CT or MRI), major or minor bleeding according to the ISTH classification, and up to 2 years after percutaneous PFO closure |
AF, atrial fibrillation; ICM, implanted cardiac monitor; ISTH, International Society on Thrombosis and Haemostasis; MR-proANP, midregional proatrial natriuretic peptide; PFO, patent foramen ovale.