NCT04881578

Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Raban Jeger · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the ALFA ROMEO study is to better understand the association between cryptogenic stroke, PFO, PFO closure and AF.

Detailed description

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

Conditions

• Cryptogenic Stroke
• Foramen Ovale, Patent
• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	continuous cardiac monitoring before and after transcatheter PFO closure	Data will be assessed from patients with cryptogenic stroke and planned PFO occlusion who undergo the contemporary ICM protocols to search for silent AF

Timeline

• Start date: 2021-03-31
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2021-05-11
• Last updated: 2025-05-13

Locations

6 sites across 1 country: Switzerland