NCT04898361

PFO Occlusion and Atrial Fibrillation

Electrophysiological and Echocardiographic PREDICTors of Atrial Fibrillation Following Interventional Closure of Patent Foramen Ovale in Cryptogenic Stroke: PREDICT-AF-PFO

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials. The long-term follow-up results of the RESPECT and DEFENSE-PFO trial confirmed these findings. PFO closure is therefore recommended in patient with cryptogenic ischemic stroke and PFO according to the current German interdisciplinary guidelines. It is likely that the number of PFO closure procedures will increase significantly in the near future. However, new onset atrial fibrillation (AF) appears to increase in patients following this procedure. In the REDUCE study, new onset atrial fibrillation was detected in 6.6% patients in the PFO closure group compared with 0.4% in the control group (medical treatment); 59% of these patients were diagnosed within the first two weeks following the procedure and 83% within 45 days, respectively. These results were consistent with the CLOSE study: AF was detected in 4.6% patients in the intervention group vs. 0.9% in the control group. Up until today, markers to identify and quantify the individual risk of AF onset are lacking. Furthermore, under-reporting and under-detection of AF occurrence after PFO closure is likely. This study is designed to to assess the prevalence and and identification of electrophysiological and echocardiographic parameters of new-onset AF.

Conditions

• Atrial Fibrillation New Onset
• Embolic Stroke of Undetermined Source
• Patent Foramen Ovale

Interventions

Type	Name	Description
PROCEDURE	PFO closure	Interventional closure of a patent foramen oval preceded by an electrophysiological study

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-06-01
• Completion: 2022-06-01
• First posted: 2021-05-24
• Last updated: 2021-05-24

Locations

1 site across 1 country: Germany