[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656783":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":16,"studyPopulation":17,"armGroups":18,"interventions":24,"overallOfficials":13,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":13,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":13,"maxAge":13,"enrollmentInfo":63,"targetDuration":13,"studyType":66,"phases":13,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":38,"whyStopped":13,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Occurence and Number of Severe Ventricular Arrhythmias in participants","Occurence and number of severe ventricular arrhythmias, defined as ventricullar fibrillation, sustained ventricular tachycardia, aborted cardiac arrest or appropriate implantable cardioverter-defibrillator (ICD) therapy, occuring more than 1 month after baseline.","From >6 months after baseline until the end of available follow-up, minimum follow-up 6 months",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":6,"maskingInfo":13},"COHORT","Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.\n\nThe aim of this study is to develop and validate a risk prediction model for severe ventricular arrhythmias in patients with AMVP, with the goal of improving individualized risk stratification and identying patients who may warrant consideration for ICD therapy.\n\nThis is a retrospective, multicenter longitudinal cohort study of patients with mitral valve prolapse and ventricular arrhythmias. Baseline characteristics are defined based on the clinical status at the index event and during the subsequent six months. Clinical events occurring six months or more after the index event are considered follow-up events.","Mitral Valve Prolapse with Ventricular Arrhythmias",[19],{"label":20,"type":13,"description":21,"interventionNames":22},"Patients with Mitral Valve Prolapse and Ventricular Arrhythmias","Patients with mitral valve prolapse and ventricular arrhythmias will be included in the study cohort. Clinical, echocardiographic, arrhythmic and other cardiac imaging variables will be evaluated in relation to the occurence of life-threatening ventricular arrhythmias. No study-specific intervention is performed.",[23],"Other: Risk prediction model",[25],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":13},"Risk prediction model","A multivariable risk prediction model will be developed and validated to estimate the individual risk of severe ventricular arrhythmias in patients with mitral valve prolapse. The model will be based on clinical, electrocardiographic, arrhythmic, echocardiographic and CMR variables. The risk prediction model is evaluated as part of this observational study and does not constitute a study-specific therapeutic or diagnostic intervention.",[20],[30],{"name":31,"role":32,"phone":33,"phoneExt":13,"email":34},"Kristina Hermann Haugaa, Professor, MD, PhD","CONTACT","+47 23070000","mvp-risk@ous-hf.no",[36],{"facility":37,"status":38,"city":39,"state":13,"zip":13,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Rikshospitalet, Oslo University Hospital","RECRUITING","Oslo","Norway","NO",{"type":43,"coordinates":44},"Point",[45,46],10.74609,59.91273,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":13,"email":34},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Kristina Hermann Haugaa","Professor, MD, PhD","100656783","mitral-valve-prolapse-arrhythmic-risk-100656783",false,"NCT07830888","Mitral Valve Prolapse Arrhythmic Risk","Development and Validation of Risk Prediction Model for Severe Ventricular Arrhythmias in Patients With Mitral Valve Prolapse","MVP-Risk","Inclusion Criteria:\n\n* MVP according to the ESC definition AND\n* Arrhythmic burden of:\n* A total PVC burden ≥ 0,5 % per day OR\n* Documentation of NSVT on any modality OR\n* More severe ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest) that occurred \\>1 month after the beginning of follow up.\n\nAND\n\n\\- Follow up \\>6 months\n\nExclusion Criteria:\n\n* VT\u002FVF as the initial presentation without prior cardiac evaluation (ECG, echo, Holter)\n* History of myocardial infarction\n* Obstructive coronary diseases - ≥50 % stenosis that was not treated\n* History of coronary artery bypass surgery\n* Significant valve disease other than MVP - rheumatic heart disease, severe aortic stenosis\n* LGE suggestive of probable myocarditis as the etiology.\n* Primary inherited arrhythmia - Brugada syndrome, short QT, long QT, CPVT\n* Carrier of disease causing mutation known to be associated with arrhythmia even when phenotype is negative (e.g. Lamin A\u002FC)\n* Sustained ventricular arrhythmia clearly caused by a reversable cause","ALL",{"count":64,"type":65},500,"ESTIMATED","OBSERVATIONAL","Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.",[69,70],"Mitral Valve Prolapse","Ventricular Arrhythmias and Cardiac Arrest",[72,73,69,74,75],"Arrhythmic Mitral Valve Prolapse","Implantable cardioverter defibrillator","Ventricular Arrhythmias","Sudden Cardiac Death","2026-09-24",{"date":78,"type":79},"2026-09-29","ACTUAL",{"date":81,"type":79},"2026-08-07",{"date":83,"type":65},"2035-09",{"name":5,"class":6},1]