[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hazem Omran\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"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":19,"type":20},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.",[25,26,27,28],"Tricuspid Valve Regurgitation","Pacemaker","ICD","Left Bundle Branch Area Pacing",[30,31,32],"tricuspid regurgitation","lead-related TR","lead-associated TR","RECRUITING","2026-01-14",{"date":36,"type":37},"2026-01-16","ACTUAL",{"date":39,"type":37},"2024-07-19",{"date":41,"type":20},"2027-01-30",{"name":43,"class":44},"Hazem Omran","OTHER",""]