Clinical trial NCT06983613: New Onset of Arrhythmia After Patent Foramen Ovale (PFO) Closure
Official title: New Onset of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure - Na Homolce Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Na Homolce Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include patients who have experienced ischemic stroke attributed to patent foramen ovale and for whom percutaneous closure has been recommended.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: New onset of atrial fibrillation after percutaneous patent foramen ovale closure - Na Homolce Hospital
timeFrame: 2025-2028
Secondary outcomes:
measure: Time to first episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia) .
timeFrame: 2025-2028
measure: Number of participants with new stroke or transient ischemic attack during follow up.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
measure: Risk factor at baseline.
timeFrame: 2025-2028
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Nemocnice na Homolce
city: Prague
country: Czechia
facility: Nemocnice na Homolce
Study officials:
References: