[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-bundle-branch-block\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-bundle-branch-block":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,43,69,106,136,158,181,204,232,255,282,311,369],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100637765","machine-learning-for-diagnosis-of-occlusive-mi-in-lbbb-patients-100637765",false,"NCT07620119","Machine Learning for Diagnosis of Occlusive MI in LBBB Patients","Development of a Machine Learning Model for the Diagnosis of Occlusive Myocardial Infarction in the Setting of Left Bundle Branch Block","AI-LBBB","Inclusion Criteria:\n\n* Patients aged 18 years and older who present to the emergency department. Patients presenting with acute ischemic chest pain or clinical ischemia-equivalent symptoms (such as acute dyspnea, unexplained diaphoresis, or syncope).\n\nPatients with a confirmed Left Bundle Branch Block (LBBB) on their initial 12-lead electrocardiogram (ECG), which can be either newly developed or known\u002Fchronic.\n\nPatients who undergo invasive coronary angiography during their index hospital admission.\n\nPatients or their legally authorized representatives who provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients under the age of 18. Pregnant or lactating women. Patients with poor-quality or uninterpretable digital ECG recordings due to severe artifact, missing leads, or technical errors.\n\nPatients who develop cardiopulmonary arrest before an initial diagnostic 12-lead ECG can be obtained in the emergency department.\n\nPatients transferred from another healthcare facility who have already undergone coronary angiography or revascularization.\n\nPatients who decline to participate or refuse to provide written informed consent.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","OBSERVATIONAL","This study investigates a new way to diagnose severe heart attacks in patients who have a specific electrical heart pattern called a Left Bundle Branch Block (LBBB). When patients present to the emergency department with chest pain, doctors routinely perform an electrocardiogram (ECG) to check for a heart attack. However, the presence of an LBBB can alter the heart's electrical signals on the ECG, effectively masking or hiding the typical signs of an ongoing acute coronary occlusion (a completely blocked artery). This making it highly challenging for emergency physicians to make an accurate and rapid diagnosis.\n\nThe primary purpose of this prospective and observational research is to develop and evaluate an artificial intelligence\u002Fmachine learning (ML) model that can analyze digital 12-lead ECG signals to accurately predict a true blocked coronary artery in patients with LBBB. The machine learning model will analyze raw digital ECG waveforms to detect subtle, microscopic patterns that might be missed by the human eye.\n\nTo confirm the accuracy of the model, its predictions will be compared directly with invasive coronary angiography results, which is the gold standard reference method used to visualize blocked vessels. Additionally, the study aims to evaluate if the model can differentiate between a true heart attack caused by a blocked artery (Type 1 MI) and other non-occlusive conditions that cause elevated heart enzymes (Type 2 MI). Ultimately, the investigators intend to determine whether integrating this machine learning tool into emergency care can safely reduce the rate of unnecessary emergency invasive procedures for patients who do not have a true coronary blockage.",[25,26,27,28,29],"Acute Myocardial Infarction (AMI)","Left Bundle Branch Block","Coronary Occlusion\u002FThrombosis","Chest Pain","Myocardial Infarction","RECRUITING","2026-05-22",{"date":33,"type":34},"2026-06-02","ACTUAL",{"date":36,"type":21},"2026-06-01",{"date":38,"type":21},"2027-01-31",{"name":40,"class":41},"Konya City Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100507205","left-bundle-branch-area-mapping-for-conduction-system-pacing-100507205","NCT05884359","Left Bundle Branch Area Mapping for Conduction System Pacing","Inclusion Criteria:\n\n* 30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation.\n\nExclusion Criteria:\n\n* Recent MI-less than 3 months\n* Recent Percutaneous Coronary Revascularization-less than 2 weeks\n* Recent Open-Heart Procedures (CABG, Valvular procedures, etc.)-less than 1 month\n* Patients who are acutely ill and unstable, from the investigator's perspective, but require an urgent permanent pacemaker","88 Years",{"count":51,"type":21},30,"This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.",[54,55],"Left Bundle-Branch Block","Pacemaker DDD",[57,58,59],"left bundle branch block","pacemaker","physiologic stimulation","2025-12-09",{"date":62,"type":34},"2025-12-17",{"date":64,"type":34},"2023-06-01",{"date":66,"type":21},"2026-12",{"name":68,"class":41},"Steward St. Elizabeth's Medical Center of Boston, Inc.",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":42},"100498344","conventional-biventricular-versus-left-bundle-branch-pacing-on-outcomes-in-heart-failure-patients-100498344","NCT05769036","Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients","Randomized Study of Integrated Evaluation of Conventional Biventricular and Left Bundle Branch Pacing Therapy Effect on Left Ventricular Remodeling and Clinical Outcomes in Patients With Chronic Heart Failure With Reduced Ejection Fraction","RECOVER-HF","Inclusion criteria:\n\n1. The patient is willing and able to comply with the protocol and has provided written informed consent;\n2. Male or female patients aged 18 to 80 years;\n3. Patients with ischemic or non-ischemic cardiomyopathy;\n4. Symptomatic HF for at least 3 months prior to enrollment in the study;\n5. New York Heart Association (NYHA) functional class HF ≥ II;\n6. Patients with HF in sinus rhythm (SR) with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with LBBB morphology;\n7. Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration 130-149 ms with LBBB morphology;\n8. Patients with HF in SR with LVEF ≤ 35% (measured in the last 6 weeks prior to enrollment), QRS duration ≥150 ms with non-LBBB morphology;\n9. Patients with symptomatic persistent or permanent atrial fibrillation, HF with LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) and an uncontrolled heart rate who are candidates for atrioventricular junction ablation (irrespective of QRS duration);\n10. Patients with HF, LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) and indications for continuous ventricular pacing due to bradycardia;\n11. Patients who have received a conventional pacemaker or an implanted cardioverter-defibrillator and who subsequently develop symptomatic HF with LVEF \\\u003C 40% (measured in the last 6 weeks prior to enrollment) despite optimal medical therapy, and who have a significant proportion of right ventricle pacing;\n12. Optimal HF medical therapy.\n\nExclusion criteria:\n\n1. Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;\n2. Acute myocardial infarction within 3 months prior to enrollment;\n3. Acute coronary syndrome;\n4. Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);\n5. Patients listed for heart transplant;\n6. Patients with implanted cardiac assist device;\n7. Acute myocarditis;\n8. Infiltrative myocardial disease;\n9. Hypertrophic cardiomyopathy;\n10. Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;\n11. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;\n12. Mental or physical inability to participate in the study;\n13. Patients unable or unwilling to cooperate within the study protocol;\n14. Patients with rheumatic heart disease;\n15. Mechanic tricuspid valve patients;\n16. Patients with any serious medical condition that could interfere with this study;\n17. Enrollment in another investigational drug or device study;\n18. Patients not available for follow-up;\n19. Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml\u002Fmin\u002F1.73 m2);\n20. Life expectancy ≤ 12 months;\n21. Participation in another telemonitoring concept.","80 Years",{"count":79,"type":21},60,"INTERVENTIONAL",[82],"NA","Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of cardioresynchronization device using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Subsequently, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has showed greater improvement in hemodynamic parameters than with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to biventricular CRT. This method has become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS duration. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP in patients with CRT indications. However, it is not enough data about CRT with LBBP effectiveness in LV remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP compared with conventional biventricular CRT will significantly improve the clinical outcomes and reverse LV remodeling in patients with chronic HF with reduced LV ejection fraction and reduce the number of non-responders to conventional CRT.",[85,54,86,87,88,89,90],"Heart Failure","Ischemic Cardiomyopathy","Non-ischemic Dilated Cardiomyopathy","Left Ventricular Dysfunction","Left Ventricular Dyssynchrony","Left Ventricle Remodeling",[92,93,94,95,96],"Cardiac Resynchronization Therapy","Biventricular Pacing","Left Bundle Branch Pacing","Speckle Tracking Echocardiography","Biomarker of Fibrosis and Remodeling","2025-09-03",{"date":99,"type":34},"2025-09-10",{"date":101,"type":34},"2023-10-01",{"date":103,"type":21},"2028-09-01",{"name":105,"class":41},"Tomsk National Research Medical Center of the Russian Academy of Sciences",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":80,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":42},"100597365","uhf-ecg-in-lbbb-and-response-to-crt-prediction-100597365","NCT07057544","UHF ECG in LBBB and Response to CRT Prediction","The Role of Ultra-high-frequency ECG in the Localization of Left Ventricular Conduction Disorders and Prediction of Response to Resynchronization Therapy","UHF BLOCK","Inclusion Criteria:\n\n* HF due to ischemic or non-ischemic cardiomyopathy\n* known coronary angiography\n* NYHA II-IV\n* LVEF ≤40%\n* non-RBBB QRSd lasting \\>130 ms (by automated measurement)\n* proximal LBBB proved by an invasive EP study or non-invasive dyssynchrony assessment in case such a method is confirmed to be non-inferior to an invasive EP study during the project\n\nExclusion Criteria:\n\n* Age ˂18 years\n* heart failure from reversible causes\n* Moderate to severe aortic stenosis\n* pregnancy\n* active myocarditis\n* hypertrophic cardiomyopathy\n* cardiac valve surgery in the last three months\n* myocardial infarction, PCI, or CABG in the last three months\n* severe valvular disease requiring intervention\n* severe atherosclerotic disease of the aorta and\u002For femoral arteries\n* life expectancy ˂1 year\n* known medical condition or contraindication causing potential complications for EP study",{"count":115,"type":21},200,[82],"The main objective of the project is to demonstrate that in patients with heart failure and QRS complex of nonRBBB morphology lasting over 130 ms, UHF-ECG can differentiate patients with trueLBBB from IVCD better than existing approaches based on the assessment of QRS complex morphology and duration from 12-lead ECG.\n\nAnother goal of the proposed study is to demonstrate that trueLBBB patients will benefit more from CRT using left bundle branch pacing than from CRT using biventricular pacing.\n\nThe final aim of the project is to demonstrate that the echocardiographic and clinical response in patients with intraventricular conduction disturbance will be dependent on the degree of reduction in ventricular dyssynchrony after CRT.",[26,119,93,120],"Left Bundle Branch Area Pacing","Intraventricular Conduction Delay",[57,122,123,124,125],"resynchronization therapy","intraventricular conduction delay","left bundle branch pacing","biventricular pacing","2025-07-09",{"date":128,"type":34},"2025-07-14",{"date":130,"type":34},"2024-05-01",{"date":132,"type":21},"2027-12-31",{"name":134,"class":135},"Faculty Hospital Kralovske Vinohrady","OTHER_GOV",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":80,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":42},"100527524","management-of-patients-with-new-left-bundle-branch-block-after-transcatheter-aortic-valve-implantation-100527524","NCT06148883","Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation","Comparison of Early Ambulatory Monitoring Strategy Versus Electrophysiological Study Approach in the Management of Patients With New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation","MONITORTAVI","Inclusion Criteria:\n\nPatients who are 18 years or older and undergo Transcatheter Aortic Valve Implantation :\n\n1. Presenting with New Onset Persistent Left Bundle Branch Block, defined as a new Left Bundle Branch Block \\>150 ms that persists at least two days after Transcatheter Aortic Valve Implantation and is stable\n2. With an anticipated life expectancy \\>1 year\n3. Who consent to participate to the study\n\nExclusion Criteria:\n\n1. During in-hospital Electrocardiogram monitoring period, immediately after Transcatheter Aortic Valve Implantation and before inclusion:\n\n   * Documented high grade Atrio Ventricular block (Atrio Ventricular block of a degree higher than Mobitz I)\n   * Persistent PR interval prolongation \\> 240 ms\n   * Occurrence of syncope or sudden cardiac death,\n   * Identification of any indisputable criteria for Pacemaker implantation\n   * Definitive Pacemaker implantation\n2. Prior Pacemaker or Implantable Cardiac defibrillator\n3. Indication for Cardiac Resynchronization Therapy or Implantable cardiac defibrillator\n4. Pre-existing Left Bundle Branch Block or Right Bundle Branch Block\n5. Pre-existing PR interval prolongation \\> 240 ms\n6. Severe or moderate dementia, evaluated before Transcatheter Aortic Valve Implantation, defined as a Mini Mental State Examination \\\u003C 15\n7. Pregnancy or breastfeeding patient\n8. No affiliation to a social security scheme\n9. Adult under legal protection (trusteeship, guardianship).",{"count":145,"type":21},360,[82],"The purpose of this study is to show that Electrocardiogram Ambulatory Monitoring-guided strategy is superior to ElectroPhysiological Study on the rate of alive patients with an appropriate Pacemaker implantation\u002Fnon-implantation, at 12 months after randomization, in patients with New Onset Persistent Left Bundle Branch Block after Transcatheter Aortic Valve Implantation.",[54],"2025-06-27",{"date":151,"type":34},"2025-07-01",{"date":153,"type":34},"2024-11-12",{"date":155,"type":21},"2027-05",{"name":157,"class":41},"Assistance Publique Hopitaux De Marseille",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":42},"100482642","absolute-coronary-flow-in-patients-with-heart-failure-with-reduced-ejection-fraction-and-left-bundle-branch-block-with-cardiac-resynchronization-therapy-100482642","NCT05564689","Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy","FLOW-LBBB","Inclusion Criteria:\n\n* Age \\> 18\n* QRS ≥ 150 ms before implantation\n* Heart failure because of dilated cardiomypathy\n* Sinus rhythm\n* Stable medical therapy\n* LBBB\n* CRT device\n\nExclusion Criteria:\n\n* eGFR \\\u003C 30 ml\u002Fmin\n* Severe valvular heart disease\n* Permanent atrial fibrillation or atrial flutter\n* Prior PCI or CABG\n* Prior myocardial infarction\n* Heart failure due to ischemic heart disease\n* Other type of device (pacemaker, ICD)\n* Not able to give informed consent\n* Does not understand Danish",{"count":79,"type":21},"Cardiac resynchronization therapy (CRT) is an effective therapeutic strategy in patients with symptomatic heart failure (HF) patients with LVEF of ≤35% and left bundle branch block (LBBB). However, approximately one-third of CRT-recipients do not improve after therapy (non-responders), despite meeting the required criteria.\n\nPrevious studies have documented that the positive respons to CRT is related to the delayed electrical activation of the left ventricle in patients with LBBB. It has also been illustrated that non-ischemic CRT-candidates with LBBB demonstrate lower regional myocardial blood flow and metabolism in the septum. Additionally, it has been suggested that LBBB can lead to impaired coronary blood flow in the left anterior descending artery (LAD). This observation is based on an echocardiography-based study, that showed that the percentage of diastolic flow duration (%DD) in LAD was shorter in patients with LBBB compared to the control-group and patients with right-ventricular pacing.\n\nIt has been demonstrated that CRT has positive effects on septal myocardial perfusion in patients with HF and LBBB. The dominant hypothesis explaining this phenomenon is built on improved septal myocardial work after CRT-implantation, which leads to increased myocardial energy and therefore increased myocardial perfusion. In contrast, it has been suggested that due to re-established synchronous left ventricular electrical activation, CRT reduces the septal intramyocardial pressure in early diastole, leading to a relatively longer antegrade flow duration in LAD. Therefore, the aim of the study is to evaluate the effect of CRT on coronary blood flow in LAD in patients with non-ischemic HF and LBBB.\n\nThe investigators hypothesize that increased LV-function after CRT not only is due to resynchronized LV ejection and filling, but also improved coronary flow.\n\nThe study aims to enroll 60 patients with heart failure due to non-ischemic dilated cardiomyopathy, LBBB, with or without CRT. All patients meeting the criteria will be recruited from the outpatient clinic at the Department of Cardiology, Aalborg University Hospital.\n\nInvasive flow measurements in the LAD, including fractional flow reserve (FFR), absolute coronary flow and -reserve will be conducted with the CRT on and off, respectively.",[54,85,92,168],"Dilated Cardiomyopathy",[170,171],"absolute coronary flow","fractional flow reserve","2025-06-16",{"date":174,"type":34},"2025-06-18",{"date":176,"type":34},"2022-09-29",{"date":178,"type":21},"2026-09-30",{"name":180,"class":41},"Ashkan Eftekhari",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":80,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":201,"locationsCount":203},"100309075","clinical-monitoring-strategy-versus-electrophysiology-guided-algorithmic-approach-with-a-new-lbbb-after-tavi-100309075","NCT03303612","Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI","Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)","COME-TAVI","Inclusion Criteria:\n\n* Age ≥18 years\n* Informed consent to participate\n* Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)\n\nExclusion Criteria:\n\n* Prior pacemaker or implantable cardioverter-defibrillator\n* Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)\n* Class I or IIA indication for PPM implantation according to management guidelines",{"count":190,"type":21},250,[82],"The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).",[54,194],"Aortic Valve Stenosis","2025-05-05",{"date":197,"type":34},"2025-05-08",{"date":199,"type":34},"2017-10-15",{"date":66,"type":21},{"name":202,"class":41},"Montreal Heart Institute",10,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":80,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":223,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":42},"100574658","phase-4-early-effect-of-glucocorticoid-on-incidence-of-persistent-left-bundle-branch-block-lbbb-post-tavr-eagle-tavr-trial-100574658","NCT06762145","EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR (EAGLE-TAVR Trial)","EArly Effect of Glucocorticoid on Incidence of Persistent Left BundlE Branch Block (LBBB) Post-TAVR","EAGLE-TAVR","Inclusion Criteria:\n\n1. Age ≥ 65 years\n2. Selected to undergo transfemoral TAVR based on heart team decision\n\nExclusion Criteria:\n\n1. Allergic to Methylprednisolone\n2. Patients with a prior pacemaker or high degree atrioventricular block\n3. Septicemia\n4. Life expectancy \\\u003C 1 year irrespective of heart disease (Cancer, severe liver disease, severe renal disease, severe pulmonary, et al)\n5. Inability to provide written informed consent\n6. Participation in another clinical trial with an active intervention\n7. Patients on prior chronic treatment with glucocorticoids (both oral, inhaled, or intravenous, but topical and ophthalmic administration is allowed)\n8. Gastrointestinal bleeding\n9. Acute myocardial infarction within 1 month\n10. Intracardiac thrombus or vegetation","65 Years",{"count":115,"type":21},[215],"PHASE4","Transcatheter aortic valve replacement (TAVR) has become an established alternative for the treatment of severe symptomatic aortic stenosis irrespective of surgical risk. The development of new-onset left bundle branch block (LBBB) is the most common complication, which impairs outcomes after TAVR.\n\nGlucocorticoid has been proven safe and effective in arrythmia after cardiac surgery. The anti-inflammatory effect of glucocorticoid may alleviate the occurrence of LBBB and thus the prognosis.\n\nEAGLE-TAVR is a multi-center, randomized, double blind, placebo-controlled trial. A total of 200 patients selected to undergo TAVR will be randomized in a 1:1 ratio to the treatment with intravenous Methylprednisolone 1mg\u002Fkg\u002Fday or placebo for 3 days started from the day of the procedure.\n\nAccording to the definition of the Valve Academic Research Consortium 3, persistent LBBB is defined as present LBBB at discharge or \\>7 days post-TAVR. The primary endpoint is the occurrence of new-onset LBBB at 30 days post TAVR.",[218,26],"Transcatheter Aortic Valve Replacemen",[220,221,222],"TAVR","LBBB","Glucocorticoid","NOT_YET_RECRUITING","2025-01-01",{"date":226,"type":34},"2025-01-07",{"date":224,"type":21},{"date":229,"type":21},"2025-07-31",{"name":231,"class":41},"Xiao-dong Zhuang",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":240,"targetDuration":4,"studyType":80,"phases":241,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":254,"locationsCount":42},"100497721","left-bundle-branch-pacing-on-outcomes-and-ventricular-remodeling-in-biventricular-crt-nonresponders-100497721","NCT05760924","Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders","Randomized Trial of Left Bundle Branch Pacing Effect on Clinical Outcomes and Left Ventricular Remodeling in Patients With Nonresponse to Biventricular Cardiac Resynchronization Therapy","RESCUE","Inclusion criteria:\n\n1. The patient is willing and able to comply with the protocol and has provided written informed consent;\n2. Male or female patients aged 18 to 80 years;\n3. Patients with ischemic or non-ischemic cardiomyopathy;\n4. Symptomatic HF for at least 3 months prior to enrollment in the study;\n5. New York Heart Association (NYHA) functional class HF ≥ II;\n6. Patients who are non-responders to biventricular CRT with HF, reduced LVEF and CRT-D replacement or one of the CRT-D leads replacement indications (without LVEF increase ≥ 5% and\u002For without a left ventricle end-systolic volume decrease ≥ 15% after CRT-D implantation at least 1 year old);\n7. Optimal HF medical therapy.\n\nExclusion criteria:\n\n1. Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;\n2. Acute myocardial infarction within 3 months prior to enrollment;\n3. Acute coronary syndrome;\n4. Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);\n5. Patients listed for heart transplant;\n6. Patients with implanted cardiac assist device;\n7. Acute myocarditis;\n8. Infiltrative myocardial disease;\n9. Hypertrophic cardiomyopathy;\n10. Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;\n11. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;\n12. Mental or physical inability to participate in the study;\n13. Patients unable or unwilling to cooperate within the study protocol;\n14. Patients with rheumatic heart disease;\n15. Mechanic tricuspid valve patients;\n16. Patients with any serious medical condition that could interfere with this study;\n17. Enrollment in another investigational drug or device study;\n18. Patients not available for follow-up;\n19. Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml\u002Fmin\u002F1.73 m2);\n20. Life expectancy ≤ 12 months;\n21. Participation in another telemonitoring concept.",{"count":51,"type":21},[82],"Heart failure (HF) is the most common nosology encountered in clinical practice. Its incidence and prevalence increase exponentially with increasing age and it is associated with the increased mortality, more frequent hospitalization and decreased quality of life. An initial approach to the treatment of HF patients with reduced left ventricular (LV) systolic function and left bundle branch block (LBBB) was implantation of device for cardiac resynchronization therapy using biventricular pacing. This has resulted in long-term clinical benefits such as improved quality of life, increased functional capacity, reduced HF hospitalizations and overall mortality. However, conventional cardiac resynchronization therapy (CRT) is effective in only 70% of patients. And the remaining 30% of patients are non-responders to conventional CRT. Cardiac conduction system pacing is currently a promising technique for these patients. Particularly, His bundle pacing (HBP) has been developed to achieve the same results. According to other studies HBP has shown greater improvement in hemodynamic parameters comparing with conventional biventricular CRT. But, nevertheless, there are significant clinical troubles with HBP, especially high pacing threshold. In this regard, in 2017, the left bundle branch pacing (LBBP) was developed, which demonstrated clinical advantages compared to conventional biventricular CRT. Also, since 2019, left bundle branch pacing-optimized CRT (LBBPO CRT) has been used in clinical practice. These methods have become an alternative to HBP due to the stimulation of LBB outside the blocking site, a stable pacing threshold and a narrow QRS complex duration on electrocardiogram. A series of case reports and observational studies have demonstrated the efficacy and safety of LBBP and LBBPO CRT in patients with CRT indications. However, it is not enough data about impact of CRT with LBBP and combined CRT with LBBP and LV pacing on myocardial remodeling, reducing mortality and complications. According to our hypothesis, CRT with LBBP and combined CRT with LBBP and LV pacing compared with conventional biventricular pacing will significantly improve the clinical outcomes and reverse myocardial remodeling in patients who are non-responders to biventricular CRT with HF, reduced LV ejection fraction and with indications to CRT devices with defibrillator function (CRT-D) or one of the CRT-D leads replacement.",[85,54,86,87,88,90],[92,93,94,95,96,245,246,247],"Combined Left Bundle Branch and Left Ventricular Pacing","CRT Non-responder","CRT Responder","2024-11-20",{"date":250,"type":34},"2024-11-22",{"date":252,"type":34},"2024-11-01",{"date":103,"type":21},{"name":105,"class":41},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":80,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":5},"100464389","cardiac-resynchronization-therapy-delivery-guided-non-invasive-electrical-and-venous-anatomy-assessment-100464389","NCT05327062","Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment","CRT-DRIVE: Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment","CRT-DRIVE","Eligible subjects shall meet all following criteria:\n\n* Appropriately signed and dated informed consent.\n* Age ≥18 years at time of consent.\n* CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA\u002FACC\u002FHFSA guidelines (COR I).\n* Sinus rhythm\n* QRS duration ≥130 ms\n* Left bundle branch block\n* Left ventricular ejection fraction ≤35%\n* Symptomatic heart failure NYHA class ≥ II\n* Documented stable medical treatment for at least 6 months\n* No cardiovascular intervention during the last 6 month\n\nExclusion Criteria are:\n\n* History of persistent or permanent atrial fibrillation\n* Previous pacemaker or ICD implantation\n* Indication to pacing due to bradycardia\n* Patients considered for His bundle pacing or cardiac conduction pacing\n* Patients with unstable angina\n* Subject experienced a recent myocardial infarction, within 40 days prior to enrollment\n* Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment\n* Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year\n* Subject is implanted with a left ventricular assist device\n* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure\n* Subject has severe aortic stenosis (with a valve area of \\\u003C1.0 cm2 or significant valve disease expected to be operated within study period)\n* Subject has congenital heart disease\n* Subject has a mechanical right-sided heart valve\n* Subject has a life expectancy of less than one year in the opinion of the investigator\n* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control\n* Subject is enrolled in one or more concurrent studies that would confound the results of this study\n* Patients who have contraindications to CT scanning.\n* Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 \\\u003C 40 ml\u002Fmin\u002F1.73m2",{"count":264,"type":21},150,[82],"The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from 3D activation sequence from ECG, and coronary venous anatomy from cardiac computed tomography. This CRT-roadmap will be used to guide LV lead placement to a coronary vein in an electrically late-activated region.\n\nStudy Hypothesis: At least 75% of patients undergoing a CRT implantation guided by non-invasive electrical and venous anatomy assessment (XSPLINE technology) will show a reduction of left ventricular end-systolic volume of 15% or more at 6-month evaluation.",[92,268,54],"Chronic Heart Failure",[270,271],"Non-invasive activation mapping","Coronary Sinus","2024-10-22",{"date":274,"type":34},"2024-10-24",{"date":276,"type":34},"2023-03-06",{"date":278,"type":21},"2025-09",{"name":280,"class":281},"XSpline S.p.A.","INDUSTRY",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":291,"studyType":22,"phases":4,"briefSummary":292,"conditions":293,"keywords":298,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":42},"100394507","pacing-to-maintain-physiologic-ventricular-activation-100394507","NCT04416958","Pacing to Maintain Physiologic Ventricular Activation","Pacing for Cardiac Resynchronisation Using the Intrinsic Conduction System to Maintain Physiologic Ventricular Activation","Pace-Conduct","Inclusion Criteria:\n\n* Pacemaker or ICD Implantation aiming to avoid pacing induced ventricular dyssynchrony according to current guidelines\n* age \\>= 18 years\n\nExclusion Criteria:\n\n* no informed consent for the procedure given\n* no follow-up data",{"count":115,"type":21},"1 Year","Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest guidelines. However, compared to conventional device implantation, cardiac resynchronization, His bundle pacing and left bundle area pacing remain demanding procedures in the individual case. Goal of the single center observational \"Pace conduct\" study is to evaluate implantation success, safety and outcome of pacing methods that maintain physiologic ventricular activation.",[55,294,295,296,54,297],"His Bundle Pacing","LBB Area Pacing","Pacing-Induced Cardiomyopathy","ICD",[299,300,301],"His bundle pacing","LBB area pacing","cardiac resynchronisation therapy","2024-10-11",{"date":304,"type":34},"2024-10-15",{"date":306,"type":34},"2018-01-01",{"date":308,"type":21},"2030-12-31",{"name":310,"class":41},"Klinikum-Fuerth",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":321,"conditions":322,"keywords":347,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"100541040","contemporary-cardiac-stimulation-in-clinical-practice-left-biventricular-right-and-conduction-system-pacing-100541040","NCT06324682","ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing","Evaluation of conTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing","TREEBEARD","Inclusion Criteria:\n\n* Indication for cardiac stimulation\n* Having performed the implantation of a device for cardiac stimulation\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Pregnancy status;",{"count":320,"type":21},8400,"The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.\n\nParticipants \\[patients over 18 years old with an indication to receive a definitive pacemaker\u002Fintracardiac defibrillator implant\\] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches.",[323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,54,338,339,340,341,342,343,344,345,346],"Arrhythmias, Cardiac","Atrioventricular Block","Reduced Systolic Function","Atrial Fibrillation","Bradyarrhythmia","Ventricular Tachycardia","Ventricular Dysfunction","Ventricular Fibrillation","Ventricular Arrythmia","Atrioventricular Nodal Disease","Atrioventricular Conduction Defects","Atrioventricular Block Complete","Atrioventricular Block Incomplete","Atrioventricular Junctional Rhythm","Bundle-Branch Block","Heart Failure, Systolic","Block;Atrioventricular","Block; Arrhythmic","Block; Mobitz","Block, Heart","Block, Fascicular","Block Branch Bundle Left","Heart Failure，Congestive","Heart Arrhythmia",[348,349,324,327,329,350,351,352,353,354,355,356,357,334,358,331,330,328],"Pace maker (PM)","Implantable cardioverter defibrillator (ICD)","Cardiac Resynchronization therapy","Conduction System Pacing","His Pacing","Left bundle branch area pacing (LBBAP)","CRT","CSP","Primary prevention","Secondary prevention","Heart failure","2024-03-19",{"date":361,"type":34},"2024-03-22",{"date":363,"type":34},"2023-01-01",{"date":365,"type":21},"2034-12-31",{"name":367,"class":41},"University Hospital of Ferrara",31,{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":377,"enrollmentInfo":378,"targetDuration":380,"studyType":22,"phases":4,"briefSummary":381,"conditions":382,"keywords":383,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":42},"100385035","prediction-of-outcome-by-echocardiography-in-left-bundle-branch-block-100385035","NCT04293471","Prediction of Outcome by Echocardiography in Left Bundle Branch Block","Prediction of Heart-failure and Mortality by Echocardiographic Parameters and Machine Learning in Individuals With Left Bundle Branch Block","EchoLBBB","Inclusion Criteria:\n\n* QRS complex \\>130 ms and R-wave duration in\n* V6 \\>70 ms\n* ventricular pacing\\>50%\n* Previously implanted cardiac resynchronisation therapy (CRT)\n\nExclusion Criteria:\n\n* Typical right bundle branch block.\n* No ability to give informed consent,\n* non-cardiovascular co-mobidities with reduced life-expectancy \\\u003C 1 year\n* patients with complex congenital heart disease.","100 Years",{"count":379,"type":21},2000,"15 Years","Patients with left bundle branch block have an increased risk for the development of heart-failure and death. However, risk factors for unfavorable outcomes are still poorly defined. This study aims to identify echocardiographic parameters and ECG characteristics by machine learning in order to develop individual risk assessment",[54],[384,385,386,387],"Left bundle branch block","strain-imaging","myocardial work assessment","machine learning","2022-05-18",{"date":390,"type":34},"2022-05-24",{"date":392,"type":34},"2021-04-15",{"date":394,"type":21},"2036-12-31",{"name":396,"class":41},"University Hospital of North Norway"]