[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626540":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":51,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":30,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":80,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Gottsegen National Cardiovascular Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MAD-ILR","EXPERIMENTAL","Patients with mitral annular disjunction, confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium, undergoing loop recorder implantation.",[13],"Device: loop recorder implantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","loop recorder implantation","During the operation, a small incision is made in the chest with local anesthesia and the implantation is performed in a pacemaker operating room, following the rules of sepsis\u002Fantisepsis. The surgical suture is used to close the wound. The healing time is about 10 days, during which time a covering bandage is needed. During the operation we use absorbable sutures, no suture removal is necessary. After implantation, the patient's lifestyle is not restricted. Avoidance of strong magnetic fields, which may result in noise recording, is necessary. The procedure is performed as an outpatient surgery and patients are discharged to their homes on the day of the procedure.",[9],[21],"ILR implantation",[23],{"name":24,"affiliation":5,"role":25},"Attila Kardos, MD PhD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+36703388864",null,"attila.kardos@gokvi.hu",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Sara Mladoniczky, MD","+36301550424","sara.mladoniczky@gokvi.hu",[37],{"facility":5,"status":38,"city":39,"state":30,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Budapest","1096","Hungary","HU",{"type":44,"coordinates":45},"Point",[46,47],19.04045,47.49835,{"lat":47,"lon":46},[50],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"type":52,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[54],{"name":55,"class":56},"Biotronik SE & Co. KG","INDUSTRY","100626540","loop-recorder-implantation-in-patients-with-mitral-annular-disjunction-100626540",false,"NCT07436962","Loop Recorder Implantation in Patients With Mitral Annular Disjunction","ILR MAD IIT","Inclusion Criteria:\n\n* age between 18 and 60 years\n* patient not incapacitated\n* mitral annular disjunction confirmed by echocardiography\n* MR scan confirmed late-type gadolinium enhancement in the myocardium\n\nExclusion Criteria:\n\n* lack of informed consent\n* age under 18 years\n* limited capability\n* guardianship\n* active infection\n* cancer\n* previous ICD implantation\n* indication for ICD or ILR implantation based on current recommendation","ALL","18 Years","60 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of clinical trial is to prospectively collect data to investigate the prevalence of arrhythmia in young patients diagnosed with mitral annular disjunction who have no indication for implantable cardioverter defibrillator (ICD) or implantable loop recorder (ILR) implantation according to the current guideline. The study population is young (age 18-60), the participating patients have mitral annular disjunction confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium. This patient population has an increased risk of ventricular arrhythmias and sudden cardiac death. The investigators plan to implant 20 BioMonitor IIIm ILRs over a year in patients with mild or uncertain symptoms (dizziness, palpitations) and no malignant arrhythmias.\n\nAims of the study:\n\n1. Screening of asymptomatic patients with MAD for arrhythmia.\n2. In case of symptoms, to prove or exclude the underlying arrhythmia.\n\nBioMonitor IIIm ILR implantation is planned in the following patient population:\n\n1. Inclusion of 20 patients with mitral annular disjunction confirmed by echocardiography and late gadolinium enhancement in the myocardium by MRI.\n2. Only patients who do not meet the current indication for ICD or ILR implantation based on the current recommendation will be included in the study.",[75,76,77,78,79],"Mitral Annular Disjunction","Mitral Valve","Arrhythmia Ventricular","Sudden Cardiac Death Due to Cardiac Arrhythmia","Loop Recorder",[81,82,83,84,85,86],"mitral annular disjunction","MAD","sudden cardiac death","loop recorder","ventricular arrhythmia","mitral valve","2026-02-27",{"date":89,"type":90},"2026-03-02","ACTUAL",{"date":92,"type":90},"2025-12-05",{"date":94,"type":69},"2030-02",{"name":5,"class":6},1]