[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545215":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":11,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"14 day monitoring","EXPERIMENTAL",null,[13],"Diagnostic Test: 14-day rhythm monitoring",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DIAGNOSTIC_TEST","14-day rhythm monitoring","Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Bert Vandenberk, MD PhD","CONTACT","+3216338686","vandenberkbert@gmail.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"UZ Leuven","RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":36,"coordinates":37},"Point",[38,39],4.70093,50.87959,{"lat":39,"lon":38},[42,45],{"name":43,"role":23,"phone":11,"phoneExt":11,"email":44},"Bert Vandenberk, MD, PhD","bert.vandenberk@uzleuven.be",{"name":22,"role":46,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100545215","arrhythmic-mitral-valve-prolapse-detection-using-long-term-ambulatory-rhythm-monitoring-100545215",false,"NCT06378996","Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring","Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study","ALARM-PILOT","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI\n* New York Heart association classification ≥3 for cohort 3 and classification 1 or 2 for cohorts 1 and 2\n* Willing and able to provide signed written informed consent\n* No contra-indication for long-term monitoring (known allergy to adhesives)\n\nExclusion Criteria:\n\n* Prior cardiac surgery, including previous mitral valve intervention\n* Prior endovascular mitral valve repair (MitraClip)\n* Previous catheter ablation of ventricular arrhythmias\n* Patients not in sinus rhythm\n* Patients on anti-arrhythmic drugs but betablockers\n* Known alternative arrhythmic substrate, for example previous myocardial infarction\n* Known allergy to adhesives","ALL","18 Years",{"count":60,"type":61},60,"ESTIMATED","INTERVENTIONAL",[64],"NA","Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.\n\nCurrently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).\n\nThis pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry.",[67,68],"Mitral Valve Prolapse","Ventricular Arrythmia","2026-04-28",{"date":71,"type":72},"2026-05-05","ACTUAL",{"date":74,"type":72},"2024-05-01",{"date":76,"type":61},"2026-06",{"name":5,"class":6},1]