[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pacemaker-induced-cardiomyopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pacemaker-induced-cardiomyopathy":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,68,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100634071","comparing-the-effects-of-newer-pacemakers-and-their-effects-on-the-heart-and-valve-function-in-the-short-term-100634071",false,"NCT07534917","Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.","Left Bundle Branch Area Pacing Versus Right Ventricular Leadless Pacing: Acute Effects on Biventricular and Tricuspid Valve Function","LvL-PACE","Inclusion Criteria:\n\n* All patients aged ≥18 referred for a permanent pacemaker at a single centre (Guys and St. Thomas' NHS Foundation Trust, UK) with high degree AV block, including Mobitz II and complete heart block, or scheduled AV node ablation, and LVEF ≥50%.\n\nExclusion Criteria:\n\n* LVEF \\\u003C50%, severe TR, severe RV dysfunction, clinically unstable AV block requiring temporary pacing or isoprenaline infusion, left bundle branch block, previous TV annuloplasty or replacement, aortic valve replacement, life expectancy \\\u003C1 year, end-stage renal failure, contraindication to cardiac MRI, CT or TOE, pregnancy, contraindication to anticoagulation, peripheral vascular disease precluding insertion of femoral catheters and insufficient capacity to consent to the study.","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","OBSERVATIONAL","Conventional pacemakers involve placing a lead through a valve into the bottom right chamber of the heart. Research has shown that this approach is associated with an increased risk of valve dysfunction, mortality, and impairment of cardiac function.\n\nNewer pacemakers, such as leadless pacemakers and pacemakers that engage directly with the heart's native conduction system (known as left bundle branch pacemakers), are increasingly being adopted. However, the impact of these newer pacing technologies on cardiac function and the tricuspid valve, as well as how they compare with each other, remains unclear.\n\nThe investigators aim to study the impact of leadless pacemakers and left bundle branch pacemakers on cardiac function and the tricuspid valve by conducting an acute study in addition to the routine pacemaker implantation procedure for which participants have been referred. Both procedures will be performed during a single session under general anaesthesia. Outcomes from this study will improve understanding of how these pacing technologies affect cardiac and valvular function and how they compare with each other. These findings will help guide decision-making regarding the optimal type of pacemaker to adopt, particularly for patients at greatest risk of developing tricuspid valve dysfunction or impaired cardiac function.",[25,26,27],"Pacemaker-Induced Cardiomyopathy","Tricuspid Regurgitation","Right Ventricular Dysfunction",[29,30,31,32,33],"leadless pacemaker","left bundle branch area pacing","pacemaker-induced cardiomyopathy","tricuspid regurgitation","right ventricular dysfunction","NOT_YET_RECRUITING","2026-06-04",{"date":37,"type":38},"2026-06-08","ACTUAL",{"date":40,"type":21},"2026-07-01",{"date":42,"type":21},"2029-06-01",{"name":44,"class":45},"Guy's and St Thomas' NHS Foundation Trust","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100550592","the-picm-risk-prediction-study---application-of-ai-to-pacing-100550592","NCT06449079","The PICM Risk Prediction Study - Application of AI to Pacing","Predictive Risk Algorithm for Development of Right Ventricular Pacing Induced Cardiomyopathy - a Step Towards Personalized Pacemaker Lead Deployment","Inclusion Criteria:\n\n* All patients who received a pacing device (VVI, DDD, ICD, leadless pacemaker) from the GSTT\u002FRBH\u002FKCH\u002FICH database in the last 10 years (from 01\u002F01\u002F2014)\n* All patients who are \\>18 years old.\n* Male and Female\n\nExclusion Criteria:\n\n* Patients who did not receive a pacing device (VVI, DDD, ICD, leadless pacemaker)\n* All patients \\\u003C18 years old\n* Patients with congenital heart disease\n* Patients who have received artificial heart valves or underwent cardiac bypass surgery\n* Patients who did not have an echocardiogram after receiving a pacing device",{"count":54,"type":21},10000,"Development of pacing induced cardiomyopathy (PICM) is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality. At present a lack of data leads to a failure to identify patients who are at risk of PICM and would benefit from pre-selection to physiological pacing. In the light of the foregoing, there is an urgent need for novel non-invasive detection techniques which would aid risk stratification, offer a better understanding of the prevalence and incidence of PICM in individuals with pacing devices and the contribution of additional risk factors.",[57,25,58],"Heart Failure","Pacemaker Complication","2024-06-05",{"date":61,"type":38},"2024-06-07",{"date":63,"type":21},"2024-07-30",{"date":65,"type":21},"2026-10-30",{"name":44,"class":45},3,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100509241","left-bundle-brancharea-pacing-to-avoid-pacing-induced-cardiomyopathy-100509241","NCT05910866","LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy","LEft Bundle branchArea Pacing to Avoid Pacing-induced CARdiomyopathy: the LEAP-CAR Prospective, Randomized Trial","LEAP-CAR","Inclusion Criteria:\n\n* advanced AVB (frequent 2° degree or 3° degree AVB, atrial fibrillation - AF - with advanced AV block) and preserved or slightly reduced LVEF (\\>45%)\n\nExclusion Criteria:\n\n* LVEF ≤45%\n* signs or symptoms of heart failure at enrollment\n* unstable angina or acute coronary syndrome \\\u003C3 months\n* percutaneous coronary intervention or coronary-artery bypass surgery \\\u003C3 months\n* life expectancy \\\u003C6 months\n* previous hospitalization for heart failure\n* evidence of pulmonary artery hypertension of any origin\n* valvular disease greater than moderate\n* previous heart transplant pregnancy",{"count":77,"type":21},130,"INTERVENTIONAL",[80],"NA","LEAP-CAR will evaluate the benefit of left bundle branch area pacing (LBBAP), comparing to conventional right ventricular pacing (RVP), in preventing pacing-induced cardiomyopathy (PICM) in patients undergoing pacemaker implant for advanced (2° or 3° degree) atrioventricular block, with baseline left ventricular ejection fraction (LVEF) \\>45%.\n\nLEAP-CAR is a randomized, prospective, double blind clinical trial.",[83,57,25,84,85],"Bradycardia","Conduction Block, Atrioventricular","Cardiac Remodeling, Ventricular",[30,87,88,89],"conduction system pacing","physiologic pacing","pacing-induced cardiomyopathy","RECRUITING","2024-01-29",{"date":93,"type":38},"2024-01-30",{"date":95,"type":38},"2023-06-10",{"date":97,"type":21},"2026-06-10",{"name":99,"class":45},"Azienda Ospedaliero Universitaria Maggiore della Carita",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":78,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":100},"100508030","conventional-versus-left-bundle-branch-pacing-in-tavi-100508030","NCT05895097","Conventional Versus Left Bundle Branch Pacing in TAVI","Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation","Inclusion Criteria:\n\n* Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)\n* Left ventricular ejection fraction \\\u003C 50 %.\n\nExclusion Criteria:\n\n* Unsuccessful TAVI procedure with life expectancy \\\u003C 1 year\n* Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)\n* Severe kidney failure (glomerular filtration rate \\\u003C 30 ml\u002Fmin)\n* Previous permanent pacemaker",{"count":109,"type":21},50,[80],"This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF \\\u003C 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (\\\u003C 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).",[113,57,25,114],"Aortic Valve Stenosis","Transcatheter Aortic Valve Implantation",[114,116],"Left bundle branch pacing","2023-06-05",{"date":119,"type":38},"2023-06-08",{"date":121,"type":21},"2023-06-15",{"date":123,"type":21},"2026-06-15",{"name":125,"class":45},"University Medical Centre Ljubljana"]