Embolic stroke of undetermined source (ESUS) accounts for approximately 25% of all ischemic strokes, with patent foramen ovale (PFO) considered a major mechanism behind ESUS. When specific anatomic criteria are met, transcatheter PFO occlusion is regarded as the gold standard for secondary stroke prevention. However, previous studies have shown that percutaneous PFO closure may increase the risk of new-onset atrial fibrillation and atrial flutter (AF), arrhythmias that elevate the risk of embolic stroke. This raises concerns about performing PFO closure. Indeed, the most common clinically significant complication after catheter-based PFO closure is AF. Available data indicates that AF typically occurs in the early period following occluder implantation, with peak incidence around the 14th day post-closure, followed by a decline after the 45th day. Although AF is considered the most frequent adverse complication after percutaneous PFO occlusion, its incidence remains relatively low, ranging from 3% to 7.4%, depending on the method used for arrhythmia screening, though this remains unclear. In this study, investigators will prospectively monitor patients who have experienced ESUS and are indicated for PFO closure. They will be screened for the occurrence of AF following percutaneous PFO closure using a 3-week ECG Holter monitor (from day 7 to day 28 post-closure) and again 1 week (one year post-closure) after the procedure. The study aims to determine the true incidence of new-onset AF following catheter-based PFO occlusion and to identify the risk factors associated with its development.
Study Type
OBSERVATIONAL
Enrollment
150
Nemocnice na Homolce
Prague, Czechia
RECRUITINGNemocnice na Homolce
Prague, Czechia
RECRUITINGNew onset of atrial fibrillation after percutaneous patent foramen ovale closure - Na Homolce Hospital
The primary endpoint - Number of participants with at least 1 episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia), defined as any episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥ 30 seconds recorded on external cardiac monitor (ECG-Holter) during follow-up.
Time frame: 2025-2028
Time to first episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia) .
Time frame: 2025-2028
Number of participants with new stroke or transient ischemic attack during follow up.
Time frame: 2025-2028
Risk factor at baseline.
Age - in years (at time of the procedure).
Time frame: 2025-2028
Risk factor at baseline.
Weight - in kilograms
Time frame: 2025-2028
Risk factor at baseline.
Height - in centimetres
Time frame: 2025-2028
Risk factor at baseline.
Body mass index (BMI) - in kg/m2
Time frame: 2025-2028
Risk factor at baseline.
Sex - male/female
Time frame: 2025-2028
Risk factor at baseline.
CHA₂DS₂-VASc Score for Atrial Fibrillation Stroke Risk
Time frame: 2025-2028
Risk factor at baseline.
Risk of Paradoxical Embolism (RoPE) Score - - in points (0-10)
Time frame: 2025-2028
Risk factor at baseline.
Number of participants with atrial hypertension
Time frame: 2025-2028
Risk factor at baseline.
Number of participants with Diabetes mellitus
Time frame: 2025-2028
Risk factor at baseline.
Number of participants with antidiabetic oral drugs
Time frame: 2025-2028
Risk factor at baseline.
Number of participants taking insulin
Time frame: 2025-2028
Risk factor at baseline.
Number of participants with hypercholesterolemia
Time frame: 2025-2028
Risk factor at baseline.
Number of participants actively smoking
Time frame: 2025-2028
Risk factor at baseline.
Number of participants formerly smoking
Time frame: 2025-2028
Risk factor at baseline.
Number of participants with peripheral embolism
Time frame: 2025-2028
Risk factor at baseline.
Number of participants with deep vein thrombosis
Time frame: 2025-2028
Risk factor at baseline.
Number of participants with coronary artery disease
Time frame: 2025-2028
Risk factor at baseline.
Left Atrial Volume Index in echocardiography - ml/m2
Time frame: 2025-2028
Risk factor at baseline.
Right Atrial Volume Index in echocardiography - ml/m2 or right atrial width/lenght in apical 4 chamber view in mm
Time frame: 2025-2028
Risk factor at baseline.
Left ventricle ejection fraction in %
Time frame: 2025-2028
Risk factor at baseline.
Left ventricle end-diastolic diameter - in mm
Time frame: 2025-2028
Risk factor at baseline.
Number of participants with presence of atrial septal aneurysm (assessed on preclosure echocardiography) defined as a septum mobility ≥10 mm from midline
Time frame: 2025-2028
Risk factor at baseline.
Presence of right to left shunt on pre-closure echocardiography - Small shunt referred to the appearance of 3 to 10 microbubbles, mild shunt referred to the appearance of 11 to 20 microbubbles, and severe shunt referred to the appearance of \>20 microbubbles in the left atrium within 3 cardiac cycles after opacification of the right atrium
Time frame: 2025-2028
Risk factor at baseline.
Length of patent foramen ovale (PFO) canal - measured on transoesophageal echocardiography during the procedure in millimetres
Time frame: 2025-2028
Risk factor at baseline.
Height of patent foramen ovale (PFO) canal - measured on transoesophageal echocardiography during the procedure in millimetres, defined as the distance between the septum primum and septum secundum at maximum opening
Time frame: 2025-2028
Risk factor at baseline.
Invasive pressure measurement in right and left atrium - during the patent foramen ovale (PFO) closure procedure in mmHg
Time frame: 2025-2028
Risk factor at baseline.
Type and size of occluder
Time frame: 2025-2028
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