[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591683":3},{"organization":4,"outcomesModule":7,"designInfo":74,"detailedDescription":16,"studyPopulation":77,"armGroups":16,"interventions":16,"overallOfficials":16,"centralContacts":16,"locations":78,"responsibleParty":109,"collaborators":16,"id":111,"slug":16,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":16,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":16,"enrollmentInfo":119,"targetDuration":16,"studyType":122,"phases":16,"briefSummary":123,"conditions":124,"keywords":16,"overallStatus":81,"whyStopped":16,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Na Homolce Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"New 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.","2025-2028",[14,17,19,22,24,26,28,30,32,34,36,38,40,42,44,46,48,50,52,54,56,58,60,62,64,66,68,70,72],{"measure":15,"description":16,"timeFrame":12},"Time to first episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia) .",null,{"measure":18,"description":16,"timeFrame":12},"Number of participants with new stroke or transient ischemic attack during follow up.",{"measure":20,"description":21,"timeFrame":12},"Risk factor at baseline.","Age - in years (at time of the procedure).",{"measure":20,"description":23,"timeFrame":12},"Weight - in kilograms",{"measure":20,"description":25,"timeFrame":12},"Height - in centimetres",{"measure":20,"description":27,"timeFrame":12},"Body mass index (BMI) - in kg\u002Fm2",{"measure":20,"description":29,"timeFrame":12},"Sex - male\u002Ffemale",{"measure":20,"description":31,"timeFrame":12},"CHA₂DS₂-VASc Score for Atrial Fibrillation Stroke Risk",{"measure":20,"description":33,"timeFrame":12},"Risk of Paradoxical Embolism (RoPE) Score - - in points (0-10)",{"measure":20,"description":35,"timeFrame":12},"Number of participants with atrial hypertension",{"measure":20,"description":37,"timeFrame":12},"Number of participants with Diabetes mellitus",{"measure":20,"description":39,"timeFrame":12},"Number of participants with antidiabetic oral drugs",{"measure":20,"description":41,"timeFrame":12},"Number of participants taking insulin",{"measure":20,"description":43,"timeFrame":12},"Number of participants with hypercholesterolemia",{"measure":20,"description":45,"timeFrame":12},"Number of participants actively smoking",{"measure":20,"description":47,"timeFrame":12},"Number of participants formerly smoking",{"measure":20,"description":49,"timeFrame":12},"Number of participants with peripheral embolism",{"measure":20,"description":51,"timeFrame":12},"Number of participants with deep vein thrombosis",{"measure":20,"description":53,"timeFrame":12},"Number of participants with coronary artery disease",{"measure":20,"description":55,"timeFrame":12},"Left Atrial Volume Index in echocardiography - ml\u002Fm2",{"measure":20,"description":57,"timeFrame":12},"Right Atrial Volume Index in echocardiography - ml\u002Fm2 or right atrial width\u002Flenght in apical 4 chamber view in mm",{"measure":20,"description":59,"timeFrame":12},"Left ventricle ejection fraction in %",{"measure":20,"description":61,"timeFrame":12},"Left ventricle end-diastolic diameter - in mm",{"measure":20,"description":63,"timeFrame":12},"Number of participants with presence of atrial septal aneurysm (assessed on preclosure echocardiography) defined as a septum mobility ≥10 mm from midline",{"measure":20,"description":65,"timeFrame":12},"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",{"measure":20,"description":67,"timeFrame":12},"Length of patent foramen ovale (PFO) canal - measured on transoesophageal echocardiography during the procedure in millimetres",{"measure":20,"description":69,"timeFrame":12},"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",{"measure":20,"description":71,"timeFrame":12},"Invasive pressure measurement in right and left atrium - during the patent foramen ovale (PFO) closure procedure in mmHg",{"measure":20,"description":73,"timeFrame":12},"Type and size of occluder",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":75,"timePerspective":76,"maskingInfo":16},"COHORT","PROSPECTIVE","The study will include patients who have experienced ischemic stroke attributed to patent foramen ovale and for whom percutaneous closure has been recommended.",[79,100],{"facility":80,"status":81,"city":82,"state":16,"zip":83,"country":84,"countryCode":16,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Nemocnice na Homolce","RECRUITING","Prague","15030","Czechia",{"type":86,"coordinates":87},"Point",[88,89],14.42076,50.08804,{"lat":89,"lon":88},[92,97],{"name":93,"role":94,"phone":95,"phoneExt":16,"email":96},"Martina Podolec, MD","CONTACT","00420778710680","martina.podolec@homolka.cz",{"name":98,"role":94,"phone":95,"phoneExt":16,"email":99},"Martin Mates, assoc. prof.","martin.mates@homolka.cz",{"facility":80,"status":81,"city":82,"state":16,"zip":83,"country":84,"countryCode":16,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},{"type":86,"coordinates":102},[88,89],{"lat":89,"lon":88},[105,107],{"name":93,"role":94,"phone":106,"phoneExt":16,"email":96},"+420778710680",{"name":108,"role":94,"phone":106,"phoneExt":16,"email":99},"Martin Mates, assoc.prof",{"type":110,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100591683",false,"NCT06983613","New Onset of Arrhythmia After Patent Foramen Ovale (PFO) Closure","New Onset of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure - Na Homolce Hospital","Inclusion Criteria:\n\n* 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.\n* Age \\> 18 years.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients with a known history of atrial fibrillation, atrial flutter, or atrial tachycardia.","ALL","18 Years",{"count":120,"type":121},150,"ESTIMATED","OBSERVATIONAL","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.\n\nHowever, 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.\n\nIn 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.",[125],"Cardiovascular Diseases","2025-05-14",{"date":128,"type":129},"2025-05-21","ACTUAL",{"date":131,"type":129},"2025-01-15",{"date":133,"type":121},"2028-12-31",{"name":5,"class":6},2]