[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619239":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":33,"responsibleParty":52,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Clinic for General and Interventional Cardiology\u002FAngiology, Herz- und Diabeteszentrum NRW","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Pacemaker-standard",null,"Only pacemaker with standard positioning (no ICD leads, no LBBaP)",{"label":13,"type":10,"description":14,"interventionNames":10},"ICD","any ICD leads through tricuspid valve",{"label":16,"type":10,"description":17,"interventionNames":10},"LBBaP","Left bundle branch area pacing leads",[19],{"name":20,"affiliation":21,"role":22},"Hazem Omran, MD","Herz- und Diabeteszentrum NRW","PRINCIPAL_INVESTIGATOR",[24,28],{"name":20,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","+49 5731 970","homran@hdz-nrw.de",{"name":29,"role":25,"phone":30,"phoneExt":31,"email":32},"Lena Riemke-Maw, BSc","+49 5731 97","1258","lriemke-maw@hdz-nrw.de",[34],{"facility":21,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Bad Oeynhausen","North Rhine-Westphalia","32545","Germany","DE",{"type":42,"coordinates":43},"Point",[44,45],8.80365,52.20699,{"lat":45,"lon":44},[48,50,51],{"name":20,"role":25,"phone":49,"phoneExt":10,"email":27},"+49 5731 972",{"name":29,"role":25,"phone":26,"phoneExt":10,"email":32},{"name":20,"role":22,"phone":10,"phoneExt":10,"email":10},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Hazem Omran","Attending Physician","100619239","prospective-study-of-lead-associated-tricuspid-regurgitation-in-patients-undergoing-new-transvalvular-lead-insertion-100619239",false,"NCT07342036","Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion","LITR","Inclusion Criteria:\n\n* medically indicated for pacemaker, ICD- or CRT implantation\n* No previous diagnosis of severe tricuspid regurgitation on enrollment\n* No existing transvalvular device (must be first implantation)\n* No other diagnosed severe valvular heart disease\n* Not previous diagnosis with pre-capillary pulmonary hypertension\n* No previous diagnosis of structural disease of the right ventricle (i.e. ACM, cardiac sarcoidosis, carcinoid...)\n\nExclusion Criteria:\n\n* Patients unable to give consent\n* Under the age of 18 years\n* Relevant pre-capillary pulmonary hypertension according to decision of the heart-team (sPAP echo \\>70 mmHg)\n* Severe tricuspid valve regurgitation (Grade 3 or worse) on enrollment\n* Patients who have undergone Lead-explantation\n* Exisiting valvular heart disease requiring treatment according to the decision of the heart-team. These patients may be enrolled in the study following treatment.\n* Previous tricuspid valve surgery\n* Patients with congenital heart disease (i.e. tetralogy of fallot, Ebstein's anomaly,...)\n* Pregnant or breastfeeding women\n* Life expectancy \\\u003C 12 months","ALL","18 Years",{"count":66,"type":67},200,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead. To collect this data, a transthoracic echocardiogram (TTE) with 3D imaging of the tricuspid valve (TV) will be performed before and after pacemaker implantation, with particular emphasis on assessing the tricuspid valve. Additionally, routine follow-up visits will be conducted at 6 and 12 months post-intervention, during which a TTE, ECG, NT-proBNP measurement, and pacemaker check will be performed.",[72,73,13,74],"Tricuspid Valve Regurgitation","Pacemaker","Left Bundle Branch Area Pacing",[76,77,78],"tricuspid regurgitation","lead-related TR","lead-associated TR","2026-01-14",{"date":81,"type":82},"2026-01-16","ACTUAL",{"date":84,"type":82},"2024-07-19",{"date":86,"type":67},"2027-01-30",{"name":54,"class":6},1]