Cardiovascular Diseases
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Na Homolce Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for percutaneous closure of patent foramen ovale due to stroke, confirmed through an interdisciplinary meeting between cardiologists and neurologists, in accordance with current guidelines. * Age \> 18 years. * Written informed consent.
Exclusion criteria
* Patients with a known history of atrial fibrillation, atrial flutter, or atrial tachycardia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New onset of atrial fibrillation after percutaneous patent foramen ovale closure - Na Homolce Hospital | 2025-2028 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia) . | 2025-2028 | — |
| Number of participants with new stroke or transient ischemic attack during follow up. | 2025-2028 | — |
| Risk factor at baseline. | 2025-2028 | Age - in years (at time of the procedure). |
Countries
Czechia
Outcome results
None listed