[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-bundle-branch-area-pacing\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-bundle-branch-area-pacing":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,54,77,101,128,154,179,204,235,256],{"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":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100609654","left-bundle-branch-area-pacing-lbbap-pmcf-study-100609654",false,"NCT07217392","Left Bundle Branch Area Pacing (LBBAP) PMCF Study","LBBAP PMCF","Inclusion Criteria:\n\n1. Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area\n2. Are ≥ 18 years of age or age of legal consent, whichever age is greater.\n3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.\n4. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB\u002FEC.\n\nExclusion Criteria:\n\n1. Patient meets a standard contraindication for lead implant including:\n\n   1. the presence of tricuspid atresia\n   2. patients with mechanical tricuspid valves\n   3. patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate\n2. Patient is currently implanted with a pacemaker, ICD, or CRT-D\u002FP device\n3. Patient has had a previous unsuccessful attempt to place a lead in the LBB area\n4. Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant\n5. Patient is expected to receive a heart transplant within 6 months\n6. Patient life expectancy less than 6 months\n7. Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder\n8. Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study\n9. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.\n10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this study is to evaluate the safety and effectiveness of LBBA pacing\u002Fsensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.",[26,27,28,29,30,31,32],"Bradycardia","Right Ventricular Pacing","Heart Failure","Atrial Fibrillation (AF)","Cardiac Disease","Left Bundle Branch Area Pacing","Conduction System Pacing",[34,35,36,37,38,39,40],"Right ventricular pacing","cardiac disease","heart failure","atrial fibrillation","bradycardia","left bundle branch area pacing","conduction system pacing","RECRUITING","2026-04-22",{"date":44,"type":45},"2026-04-24","ACTUAL",{"date":47,"type":45},"2025-07-24",{"date":49,"type":20},"2027-04-30",{"name":51,"class":52},"Abbott Medical Devices","INDUSTRY",13,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100619283","safety-and-performances-of-the-linea-cardiac-pacing-lead-optimized-for-the-implantation-in-interventricular-septum-100619283","NCT07342608","Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum","STARLIGHT","Inclusion criteria (phase I and II):\n\n* Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)\n* Patient planned for a de novo implantation of an ALIZEA, BOREA or CELEA Single Chamber (SR) or Dual Chamber (DR) pacemaker from MicroPort CRM\n* Patient planned for a catheter-guided ventricular pacing lead implantation in the interventricular septum area\n* Patient's pacemaker with the remote monitoring functions accepted by the patient and planned to be activated\n\nExclusion criteria (phase I and II):\n\n* Patient planned for a device upgrade, or a device or a lead replacement\n* Patient with a congenital heart disease, hypertrophic cardiomyopathy or infiltrative cardiomyopathy\n* Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%\n* Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)\n* Patient having a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient for whom a single dose of steroid eluted by the pacing lead (e.g., dexamethasone sodium phosphate) is contraindicated, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)\n* Patient with a life expectancy of less than 2 years\n* Minor age patient (i.e. under 18 years of age)\n* Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation\n* Non-menopausal women",{"count":62,"type":20},450,[23],"The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.",[26,31,66],"Left Bundle Branch Pacing","NOT_YET_RECRUITING","2026-02-13",{"date":70,"type":45},"2026-02-17",{"date":72,"type":20},"2026-03-31",{"date":74,"type":20},"2030-04-30",{"name":76,"class":52},"MicroPort CRM",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":85,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100624215","feasibility-and-outcomes-registry-of-lumenless-defibrillation-leads-for-conduction-system-pacing-100624215","NCT07406737","Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing","FORGE CSP","Inclusion Criteria:\n\n* age \\> 18-year-old\n* indication for CRT according to current ESC\u002FEHRA guidelines\n* first-line LBBAP ICD lead implantation attempted\n* national insurance coverage\n\nExclusion Criteria:\n\n* pregnancy",{"count":19,"type":20},"12 Months","OBSERVATIONAL","The recent development and market introduction of small diameter implantable defibrillation leads able to deliver left bundle branch area pacing (LBBAP) has opened the possibility of achieving cardiac resynchronization therapy (CRT) using a single- or dual-chamber implantable-cardioverter defibrillator (ICD). This approach may reduce the number of intracardiac leads required and, consequently, has the potential to lower both procedural and long-term complication rates. However, the integration of these leads into currently recommended CRT strategies remains hypothetical. The FORGE CSP registry will prospectively enroll patients with an indication for CRT in whom implantation of a LBBAP ICD lead is attempted.",[89,31],"Cardiac Resynchronization Therapy","2026-02-06",{"date":92,"type":45},"2026-02-12",{"date":94,"type":20},"2026-05-01",{"date":96,"type":20},"2027-09-01",{"name":98,"class":99},"University Hospital, Caen","OTHER",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":109,"studyType":86,"phases":4,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":100},"100619239","prospective-study-of-lead-associated-tricuspid-regurgitation-in-patients-undergoing-new-transvalvular-lead-insertion-100619239","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",{"count":19,"type":20},"1 Year","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.",[112,113,114,31],"Tricuspid Valve Regurgitation","Pacemaker","ICD",[116,117,118],"tricuspid regurgitation","lead-related TR","lead-associated TR","2026-01-14",{"date":121,"type":45},"2026-01-16",{"date":123,"type":45},"2024-07-19",{"date":125,"type":20},"2027-01-30",{"name":127,"class":99},"Hazem Omran",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100484236","preventive-effect-of-left-bundle-branch-area-pacing-versus-right-ventricular-pacing-on-all-cause-death-heart-failure-progression-and-ventricular-dyssynchrony-in-patients-with-substantial-ventricular-pacing-protect-sync-multicenter-prospective-randomized-controlled-trial-100484236","NCT05585411","PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n1. At least 19 years old and willing and capable to give informed consent\n2. Patients who is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.\n\n3 Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (\\>40%) is anticipated\n\nExclusion criteria:\n\n1. Incapacitated or unable to read or write\n2. Patient who is an indication of ICD or CRT\n3. History of prosthetic valve surgery on tricuspid valve\n4. Prior myocardial infarction including ventricular septum\n5. Life expectancy \\\u003C 12 months due to any condition\n6. Unavailable for at least 24 months of follow-up visits\n7. Pregnant or breastfeeding at the time of signing consent\n8. Prior Heart transplant surgery\n9. Persistent Left Superior Vena Cava (PLSVC)","19 Years",{"count":62,"type":20},[23],"PROTECT-SYNC study is a multicenter, randomized, controlled trial. A total of 7 medical centers across Republic of Korea will enroll 450 patients during 2 years of enrollment period, and followed for 2 years of follow-up period. The purpose of this study to compare the clinical outcomes of Left Bundle Branch Area Pacing (LBBAP) compared to Right Ventricular Pacing (RVP) in bradyarrhythmia patients who require high burden of ventricular pacing (\\>40%).",[139,140,31],"Bradyarrhythmia","Atrioventricular Block",[142,27,28,143],"Left Bundle Branch Area pacing","Atrioventricular block","2025-12-30",{"date":146,"type":45},"2026-01-05",{"date":148,"type":45},"2022-11-01",{"date":150,"type":20},"2026-11-01",{"name":152,"class":99},"Yonsei University",8,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":177,"locationsCount":178},"100612471","left-bundle-branch-area-pacing-lbbap-monitoring-assistant-evaluation-of-portable-ecg-solution-100612471","NCT07254013","Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution","LBBOT","Inclusion Criteria:\n\n* Subject with indication for LBBAP using an Electrophysiology ECG monitoring system (EP System) as part of pacemaker or CRT-P or CRT-D implant procedure (de novo implant, device revision or upgrade including LOT-CRT)\n* Subject signed and dated the ICF\n\nExclusion Criteria:\n\n* Incapacitated subject or under guardianship\n* inability to understand the purpose of the study\n* Minor subjects\n* Non menopausal women\n* Patients implanted with other electrically active non cardiac devices.",true,{"count":163,"type":20},55,[23],"To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead in interventricular septum area",[26,31,167,168],"Cardiac Resynchronisation Therapy (CRT)","ECG",[170],"LBBAP ECG MONITORING ASSISTANT","2025-11-27",{"date":173,"type":45},"2025-12-05",{"date":175,"type":45},"2025-11-14",{"date":72,"type":20},{"name":76,"class":52},4,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100501937","physiological-vs-right-ventricular-pacing-outcome-trial-evaluated-for-bradycardia-treatment-protect-hf-100501937","NCT05815745","\"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment\" (PROTECT-HF)","Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment","PROTECT-HF","We will recruit patients who are referred for clinically indicated pacemaker implantation\n\nInclusion Criteria:\n\n1\\. Adults aged over 18 with left ventricular ejection fraction \\>35% and one or more of the following guideline based ventricular pacing indications:\n\n1. Permanent or intermittent 3rd degree AV block\n2. Permanent or intermittent Mobitz type II AV block\n3. First Degree AV block with a pacing indication\n4. Slow chronic Atrial Fibrillation or Proposed AV node ablation\n5. Bifascicular block with a pacing indication\n6. Trifascicular block with a pacing indication\n7. Wenckebach with a pacing indication\n\nExclusion Criteria:\n\n1. Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.\n2. Pregnant women.\n3. Unable to provide informed consent.\n4. Those with comorbidity leading to a life expectancy \\\u003C1year.",{"count":188,"type":20},2600,[23],"The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients.\n\nPatients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient.\n\nRecruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis.\n\n2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover.\n\n500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).",[26,192,27,193,31],"Pacing","His Bundle Pacing","2025-11-21",{"date":196,"type":45},"2025-11-28",{"date":198,"type":45},"2023-06-05",{"date":200,"type":20},"2029-12-04",{"name":202,"class":99},"Imperial College London",45,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":219,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":100},"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":19,"type":20},[23],"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.",[216,31,217,218],"Left Bundle Branch Block","Biventricular Pacing","Intraventricular Conduction Delay",[220,221,222,223,224],"left bundle branch block","resynchronization therapy","intraventricular conduction delay","left bundle branch pacing","biventricular pacing","2025-07-09",{"date":227,"type":45},"2025-07-14",{"date":229,"type":45},"2024-05-01",{"date":231,"type":20},"2027-12-31",{"name":233,"class":234},"Faculty Hospital Kralovske Vinohrady","OTHER_GOV",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},"100550958","safety-and-performance-evaluation-of-a-new-catheter-range-for-lead-implantation-at-interventricular-septum-100550958","NCT06453850","Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum","POLARIS","Inclusion criteria (phase I):\n\n* Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)\n* Patient planned for a de novo implantation of any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker\n* Patient planned for a catheter-guided implantation in the interventricular septum area\n* Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter\n* Patient reviewed, signed and dated the Informed Consent Form (ICF)\n\nInclusion criteria (phase II):\n\n* Patient indicated for cardiac pacing or CRT according to the most recent guidelines from the ESC\n* Patient planned for a de novo implantation of any SR or DR CE marked pacemaker, or any CE marked CRT-D\n* Patient planned for a catheter-guided implantation in the interventricular septum area\n* Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter\n* Patient reviewed, signed and dated the ICF\n\nExclusion criteria (phase I):\n\n* Patient planned for a device upgrade, or a device or a lead replacement\n* Patient with a congenital heart disease\n* Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy\n* Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%\n* Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)\n* Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)\n* Minor age patient (i.e. under 18 years of age)\n* Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation\n* Non-menopausal women\n\nExclusion criteria (phase II):\n\n* Patient planned for a device upgrade, or a device or a lead replacement\n* Patient with a congenital heart disease\n* Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy\n* Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)\n* Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)\n* Minor age patient (i.e. under 18 years of age)\n* Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation\n* Non-menopausal women",{"count":243,"type":20},216,[23],"The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.",[26,89,31],"2025-03-03",{"date":249,"type":45},"2025-03-06",{"date":251,"type":45},"2025-02-14",{"date":253,"type":20},"2026-12",{"name":76,"class":52},3,{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":100},"100517918","the-impact-of-lbbap-vs-rvp-on-the-incidence-of-new-onset-atrial-fibrillation-in-patients-with-atrioventricular-block-100517918","NCT06023784","The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block","The Impact of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients aged 18-85;\n* AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)\\> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP\\>40%; (d) symptomatic first degree AV block and PR interval on ECG \\> 300ms;\n* Signed informed consent;\n\nExclusion Criteria:\n\n* Baseline echocardiographic assessment of patients with impaired LV function (LVEF\\\u003C50%);\n* Patients with the history of atrial fibrillation;\n* Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;\n* Pacemaker replacement without new implanted ventricular electrodes;\n* Surgery is required within 1 year due to severe structural heart disease;\n* Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc);\n* AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.","85 Years",{"count":265,"type":20},530,[23],"This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block.",[31,27,140,269],"Atrial Fibrillation","2023-09-03",{"date":272,"type":45},"2023-09-05",{"date":274,"type":20},"2023-09-30",{"date":276,"type":20},"2030-12-31",{"name":278,"class":99},"Peking Union Medical College Hospital"]