[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621990":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":11,"locations":20,"responsibleParty":38,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"Patients with ILR",null,[12,17],{"name":13,"role":14,"phone":15,"phoneExt":10,"email":16},"Lauge Klement Moltke Østergaard, MD PhD","CONTACT","0045 35454295","lauge.klement.moltke.oestergaard.02@regionh.dk",{"name":18,"role":14,"phone":10,"phoneExt":10,"email":19},"Jeppe Petersen, MD","jeppe.kjaergaard.petersen@regionh.dk",[21],{"facility":22,"status":10,"city":23,"state":10,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Rigshospitalet","Copenhagen","2100","Denmark","DK",{"type":28,"coordinates":29},"Point",[30,31],12.56553,55.67594,{"lat":31,"lon":30},[34],{"name":35,"role":14,"phone":36,"phoneExt":10,"email":37},"Larsen","35450922","lesli.hingstrup.larsen@regionh.dk",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Lauge Østergaard","PRospective cohort study for the Identification of Subclinical atrial fibrillation In patients with significant primary Mitral valve regurgitation","100621990","study-for-the-identification-of-subclinical-atrial-fibrillation-in-patients-with-significant-primary-mitral-regurgitation-100621990",false,"NCT07377799","Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Regurgitation","PRospective Cohort Study for the Identification of Subclinical Atrial Fibrillation In Patients With Significant Primary Mitral Valve Regurgitation","PRIME-LOOP","Inclusion Criteria:\n\n* Asymptomatic\u002Fmildly symptomatic\\*, significant primary MR\\*\\*\n* LVEF ≥60%\n* Native mitral valve\n* Age ≥18 years old\n\nExclusion Criteria:\n\n* Prior diagnosis of AF\n* Prescence of cardiac pacemaker, ICD, cardiac resynchronization device, loop recorder, or a clinical indication for loop recorder\n* LVESD ≥ 40 mm\n* Planned for mitral valve surgery\n* Life expectancy \\\u003C 1 year\n* Pregnancy or lactating","ALL","18 Years",{"count":53,"type":54},100,"ESTIMATED","OBSERVATIONAL","The PRIME-LOOP study is a prospective cohort investigating the burden of atrial fibrillation (AF) and subclinical AF in patients with moderate-severe or severe primary mitral regurgitation (MR). The study will use long-term cardiac monitoring with an implantable loop recorder (ILR) for up to three years to identify the burden of AF. Further, the study aims to examine the associated risk of adverse events among patients with detected AF as compared with patients without AF. Only patients with no or mild symptoms related to MR and without a class I indication for surgical intervention will be included. The study aims to include 100 patients.\n\nPatients will be screened from the PRIME cohort - a prospective cohort of patients with primary MR in East Denmark.",[58,59],"Mitral Regurgitation","Atrial Fibrillation (AF)",[61,62,63,64],"degenerative mitral regurgitation","asymptomatic","atrial fibrillation","subclinical atrial fibrillation","NOT_YET_RECRUITING","2026-01-29",{"date":68,"type":69},"2026-02-02","ACTUAL",{"date":71,"type":54},"2026-02-01",{"date":73,"type":54},"2031-02-01",{"name":5,"class":6},1]