Tracks new irregular heartbeats after closing a heart hole in stroke patients
Monitors heart rhythm in adults with a heart hole closed after an unexplained stroke.
Plain-language title generated from the registry record
Registry title: New Onset of Arrhythmia After Patent Foramen Ovale (PFO) Closure
Key facts
- Where
- Prague, CzechiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a closure of a patent foramen ovale (PFO, a small hole in the heart) after a stroke. They will be monitored for new atrial fibrillation.
- Age
- Over 18 years
- Sex
- Men and women
- Disease stage
- Stroke with a patent foramen ovale that needs percutaneous closure, confirmed by heart and nerve specialists following current guidelines.
Main reasons for not taking part
- Known history of atrial fibrillation, atrial flutter or atrial tachycardia
Read by machine on 9 November 2026.
Where in Czechia
- Nemocnice Na HomolcePrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Na Homolce Hospital
- Trial code
- NCT06983613
- Record updated
- 21 May 2025
- Original description
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.Read full original descriptionShow less
New Onset of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure - Na Homolce Hospital
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.
Inclusion: 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: Patients with a known history of atrial fibrillation, atrial flutter, or atrial tachycardia.