The aim of the ALFA ROMEO study is to better understand the association between cryptogenic stroke, PFO, PFO closure and AF.
For patients with cryptogenic stroke and PFO, a better understanding of the exact incidence of new-onset AF before and after PFO closure, its occurrence during follow-up, its persistence or reversibility and its prognostic impact is critical: If only a PFO, but no AF is available, then PFO closure followed by a limited duration of antiplatelet therapy is indicated. If on the other hand side a PFO and AF is found, lifelong therapeutic anticoagulation is mandatory. By using the contemporary ICM protocols to search for silent AF in patients with cryptogenic stroke and a PFO for 3 months before PFO closure, ALFA ROMEO will help to understand the relationship of silent and previously undetected AF in the setting of PFO and investigate the true incidence of new-onset AF and its temporal course after effective PFO closure. Our findings will have the potential to impact on the future diagnostic and therapeutic management of patients with cryptogenic stroke and a PFO
Study Type
OBSERVATIONAL
Enrollment
200
Data will be assessed from patients with cryptogenic stroke and planned PFO occlusion who undergo the contemporary ICM protocols to search for silent AF
Stadtspital Triemli
Zurich, Canton of Zurich, Switzerland
University Hospital Basel, Heart Center
Basel, Switzerland
University Hospital Bern Inselspital Cardiology
Bern, Switzerland
Cantonal Hospital St.Gallen Cardiology
Sankt Gallen, Switzerland
incidence of first AF within 12 months after percutaneous PFO occlusion
to assess the incidence of first AF within 12 months after percutaneous PFO closure with a prespecified landmark analysis after 3 months to differentiate potentially device related AF (months 0-3) from likely intrinsic AF (months 4-12)
Time frame: 12 months
Incidence of first AF within 3 months of continuous rhythm monitoring before the intended percutaneous PFO closure procedure
to assess the incidence of first AF within 3 months of continuous rhythm monitoring before PFo closure
Time frame: 3 months
Overall incidence of first AF from ICM-implantation to ICM-explantation or 36 months post implantation (if ICM remains in situ) excluding a blanking period of the first 3 months after PFO closure
To assess the overall incidence of first AF from ICM-implantation to ICM-explantation or 36 months post implantation
Time frame: 36 months
Differences in the primary endpoint according to the grade of the PFO
To assess the differences in the primary endpoint according to the grade of the PFO
Time frame: 12 months
Incidence of recurrent clinical embolic events such as cryptogenic strokes or systemic embolism including pulmonary embolism (with the use of the TOAST classification algorithm)
To assess the incidence of recurrent clinical embolic events
Time frame: 36 months
AF burden, defined as proportion of follow-up time with documented AF at different time points
To assess the AF burden
Time frame: 36 months
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Bürgerspital Solothurn Cardiology
Solothurn, Switzerland
University Hospital Zürich Cardiology
Zurich, Switzerland
Incidence of major bleeding (BARC 3 to 5)
To assess the incidence of major bleeding
Time frame: 36 months
Incidence of any death and cardiovascular death at different timepoints
To assess the incicence of any death and cardiovascular death at diefferent timepoints
Time frame: 36 months
Device related events
To assess device related events
Time frame: 36 months