[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"av-block\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:av-block":240},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,73,105,138,163,191,212],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100602042","biotronik-investigation-of-the-liviq-leadless-pacemaker-system-100602042",false,"NCT07118358","BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System","BIO-LivIQ","Inclusion criteria:\n\n1. Class I or Class II indication for ventricular pacing (VVI\u002FVDD) according to applicable guidelines\n2. Age is greater than or equal to 18 years at time of consent\n3. Able to understand the nature of the study and provide written informed consent\n4. Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up\n\nExclusion criteria:\n\n1. AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met\n2. Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle\n3. Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement\n4. Intolerance of dexamethasone acetate\n5. Other implanted devices that, in the judgement of the implanting physician, could interfere (mechanically or electrically) with the leadless pacemaker or with the implant procedure\n6. Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body\n7. Prior leadless pacemaker implant attempt\n8. Existing transvenous or leadless pacemaker, transvenous or subcutaneous ICD, or CRT device or previous extraction in which transvenous leads (full or partial) were left in the heart Note: Exception given to use temporary transvenous pacemakers\n9. CIED device extraction within the previous 72 hours or signs of active infection after CIED extraction Note: Patients with extraction due to potential systemic infection must have a blood culture. A blood culture is considered negative if there is no growth within 72 hours prior to the LivIQ implant.\n10. Planned ICD or CRT device implant\n11. Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment\n12. Life expectancy of less than 12 months\n13. Unable to tolerate an urgent sternotomy\n14. Planned right-sided heart intervention within 30 days after implant Note: Exception given to AV nodal ablations when performed by an implanting investigator once early safety phase objectives are met\n15. Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD)\n16. Participation or plan to participate in any other potentially confounding investigational drug or device trial, or any other clinical trial that may interfere with this study's treatment or protocol during the duration of the study Note: Co-enrollment in concurrent trials is only allowed when documented prior approval is obtained from BIOTRONIK\n17. Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans)\n18. Pregnant or plan to become pregnant during the duration of the study\n\nAVS Sub-Study Inclusion Criteria:\n\nAfter consenting to the main study, patients potentially eligible for the AVS Sub-Study must meet these additional criteria:\n\n1. Willing and able to perform the requested procedures for the AVS assessments\n2. Current or history of AV block Note: This includes patients with any degree or type of AV block, irrespective of related symptoms and relevance of the AV block for the underlying pacemaker indication\n\nAVS Sub-Study Exclusion Criteria:\n\nAfter consenting to the main study, patients potentially eligible for the AVS Sub-Study must not meet the following criterion:\n\n1\\. Permanent AF","ALL","18 Years",{"count":19,"type":20},325,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI\u002FVDD) according to applicable guidelines. An integrated atrioventricular synchrony sub-study (AVS) is specifically designed to evaluate the AVS performance of the LivIQ system.",[26,27,28,29],"Leadless Pacemaker","Bradycardia","AV Block","Cardiac Rhythm Disorder",[31],"leadless pacemaker","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":36},"2026-03-16",{"date":40,"type":20},"2028-04",{"name":42,"class":43},"Biotronik, Inc.","INDUSTRY",13,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100531262","randomized-study-of-physiological-vs-right-ventricular-pacing-in-patients-with-normal-ventricular-function-post-tavi-100531262","NCT06197503","Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI","Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)","PHYSTAVIII","Inclusion Criteria:\n\n* Successful implantation of TAVI according to VARC-3 criteria.\n* Indication of cardiac pacing due to AV block according to ESC Guidelines.\n* LVEF\\> 50%.\n* The patient must indicate their acceptance to participate in the study by signing an informed consent document.\n\nExclusion Criteria:\n\n* Ventricular dysfunction: LVEF \\\u003C50%.\n* Transapical TAVI.\n* Participating currently in a clinical investigation that includes an active treatment.\n* Patients with left bundle branch block but without indication of pacing (AV block).\n* Life expectancy \\\u003C12 months.",{"count":54,"type":20},48,[23],"Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.",[58,59,60,28,61],"Transcatheter Aortic Valve Implantation","Physiological Pacing","Right Ventricular Pacing","Preserved Left Ventricular Systolic Function","2026-03-30",{"date":64,"type":36},"2026-03-31",{"date":66,"type":36},"2023-11-30",{"date":68,"type":20},"2026-12-15",{"name":70,"class":71},"Hospital Clinic of Barcelona","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":4},"100629048","alps-single-chamber-new-device-study-100629048","NCT07469579","ALPs Single ChambEr New Device Study","Early Feasibility Study of the Single Chamber ALPS Leadless Pacemaker System in Patients With Bradycardia","ASCEND","Inclusion Criteria:\n\n1. Male or female, ≥ 18 years of age at enrolment\n2. Subject who has a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC\u002FAHA\u002FHRS\u002FEHRA guidelines:\n\n   1. Paroxysmal or permanent high-grade AV block in the presence of Atrial Fibrillation (AF)\n   2. Paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.\n   3. Symptomatic bradycardia-tachycardia syndrome or Sinus Node Dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.\n3. Subject able and willing to undergo the study requirements and is expected to be geographically stable for the duration of the follow-up.\n4. Subject with a life expectancy of more than 24 months.\n5. Subject is able and willing to use the Home Monitor.\n6. Written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure.\n\nExclusion Criteria:\n\n1. Subject who is entirely pacemaker dependent (escape rhythm \\\u003C30 bpm).\n2. Subject has an existing or prior pacemaker, ICD, or CRT device implant.\n3. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.\n4. Subject had recent cardiovascular or peripheral vascular surgery within 30 days prior to enrollment\n5. Subject with current implantation of a neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.\n6. Subject with a prior intervention of the tricuspid valve, implanted vena cava filter that cannot be crossed, or left ventricular assist device (LVAD).\n7. Subject who is morbidly obese (BMI \\> 40).\n8. Subject who has a below normal BMI (BMI\\\u003C18).\n9. Subject whose femoral venous anatomy is unable to accommodate a 24 French introducer sheath or an implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.\n10. Subject with ventricular dysfunction and LVEF ≤ 50\n11. Subject who is considered as unable to tolerate an urgent sternotomy.\n12. Subject with a known intolerance to Titanium, titanium nitride, parylene C, PEEK, platinum-iridium alloy, heparin, or sensitivity to contrast media.\n13. Subject for whom a single dose of 1.0 mg dexamethasone acetate may be contraindicated.\n14. Subject with a life expectancy of less than 24 months.\n15. Subject with significant co-morbid conditions or other conditions which, at the discretion of the PI, are deemed to prohibit study entry\n16. Subject who is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Cairdac study manager.\n17. Pregnant woman, or woman of childbearing potential and who is not on a reliable form of birth control.\n18. Subject with exclusion criteria required by local law (e.g. age, breast feeding, etc.).",{"count":82,"type":20},15,[23],"Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.",[86,87,27,28,88],"Brady-tachy Syndrome","Brady Arrythmia","Atrial Fibrillation (Paroxysmal)",[31,90,91,92,93,94,95],"leadless cardiac pacemaker","bradycardia","brady-tachy syndrome","AV block","Atrial Fibrilation","leadless pacing system","NOT_YET_RECRUITING",{"date":98,"type":36},"2026-03-18",{"date":100,"type":20},"2026-06",{"date":102,"type":20},"2028-12",{"name":104,"class":71},"Cairdac SA",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":78,"acronym":79,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":84,"conditions":114,"keywords":116,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":137,"locationsCount":4},"100628461","alps-single-chamber-new-device-100628461","NCT07461935","ALPs Single ChambEr New Device","Inclusion Criteria:\n\n1. Male or female, ≥ 18 years of age at enrolment\n2. Subject who has a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC\u002FAHA\u002FHRS\u002FEHRA guidelines:\n\n   * Paroxysmal or permanent high-grade AV block in the presence of Atrial Fibrillation (AF)\n   * Paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.\n   * Symptomatic bradycardia-tachycardia syndrome or Sinus Node Dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.\n3. Subject able and willing to undergo the study requirements and is expected to be geographically stable for the duration of the follow-up.\n4. Subject with a life expectancy of more than 24 months.\n5. Subject is able and willing to use the Home Monitor.\n6. Written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure.\n\nExclusion Criteria:\n\n1. Subject who is entirely pacemaker dependent (escape rhythm \\\u003C30 bpm).\n2. Subject has an existing or prior pacemaker, ICD, or CRT device implant.\n3. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.\n4. Subject had recent cardiovascular or peripheral vascular surgery within 30 days prior to enrollment\n5. Subject with current implantation of a neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.\n6. Subject with a prior intervention of the tricuspid valve, implanted vena cava filter that cannot be crossed, or left ventricular assist device (LVAD).\n7. Subject who is morbidly obese (BMI \\> 40).\n8. Subject who has a below normal BMI (BMI\\\u003C18).\n9. Subject whose femoral venous anatomy is unable to accommodate a 24 French introducer sheath or an implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.\n10. Subject with ventricular dysfunction and LVEF ≤ 50\n11. Subject who is considered as unable to tolerate an urgent sternotomy.\n12. Subject with a known intolerance to Titanium, titanium nitride, parylene C, PEEK, platinum-iridium alloy, heparin, or sensitivity to contrast media.\n13. Subject for whom a single dose of 1.0 mg dexamethasone acetate may be contraindicated.\n14. Subject with a life expectancy of less than 24 months.\n15. Subject with significant co-morbid conditions or other conditions which, at the discretion of the PI, are deemed to prohibit study entry\n16. Subject who is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented preapproval is obtained from the Cairdac study manager.\n17. Pregnant woman, or woman of childbearing potential and who is not on a reliable form of birth control.\n18. Subject with exclusion criteria required by local law (e.g. age, breast feeding, etc.).",{"count":112,"type":20},10,[23],[27,86,28,115],"Atrial Fibrillation (AF)",[31,117,27,118,93,119,120,90,95,121,122,123,124,125,126,127,128,129,130,131],"ventricular leadless pacemaker","Brady-tachy syndrome","Atrial Fibrillation","pacemaker","delivering leadless system","permanent leadless pacemaker","single chamber leadless pacemaker","single chamber leadless pacing therapy","VVI","autonomous leadless pacing system","piezoelectric energy harvester","VOO","home monitor","home monitoring","remote monitoring","2026-03-09",{"date":134,"type":36},"2026-03-10",{"date":100,"type":20},{"date":102,"type":20},{"name":104,"class":71},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":159,"leadSponsor":161,"locationsCount":72},"100620352","efficacy-and-safety-of-micra-av2-transcatheter-pacing-system-100620352","NCT07356505","Efficacy and Safety of Micra AV2 Transcatheter Pacing System","EMAV2","Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n3. Participant will be implanted with a Micra AV2 for an approved indication for use\n4. Participant with a history of any type of high-degree AV block\n5. Participant is willing and able to comply the study protocol\n\nExclusion Criteria:\n\n-1. Subject implanted with a Micra AV2 on a non-permanent basis (e.g. CIED infection) 2. Subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to Micra AV2 implant procedure) 3. Subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study.\n\n4\\. Subject meets any exclusion criteria required by local law (age or other)",{"count":146,"type":20},150,[23],"A third generation, Micra AV2 is now available and proposes increased automaticity and improved AV synchrony algorithms based on computing model. The new algorithms permit the delivery of AV synchronous pacing, improving the automatic AV synchrony at faster heart rates between 80-100 bpm with a maximal upper tracking rate limit of 135 bpm (previously 115-120 bpm in the Micra AV1). Micra AV2 presents also a potential extended longevity of 15.6 years (increased by \\> 44% in comparison of Micra AV1). Up to now, no clinical study has evaluated the efficacy and safety of Micra AV2 in a real-world setting.\n\nThe focus of this study is to characterize chronic ambulatory AV synchrony in patients with high degree AV block and normal sinus rhythm implanted with a Micra AV2 as primary objective to evaluate AV synchrony during exercise as secondary objective.",[150,151,28],"AV Block Complete","AV Block-2Nd Degree-Type 1",[31,153,154],"Micra AV","AV synchrony","2026-01-12",{"date":157,"type":36},"2026-01-21",{"date":155,"type":36},{"date":160,"type":20},"2029-01-31",{"name":162,"class":71},"Universitaire Ziekenhuizen KU Leuven",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100489249","left-vs-left-randomized-clinical-trial-100489249","NCT05650658","Left vs Left Randomized Clinical Trial","Cardiac Resynchronization Therapy Using His\u002FLeft Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF)≤50% and With Either a Wide QRS Complex (>130 ms) or With\u002FAnticipated >40% Pacing Randomized Clinical Trial","Inclusion Criteria:\n\n* Men and women 18 years of age or older.\n* A LVEF ≤ 50% within 6 months prior to enrollment.\n* Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing \\>40% OR device in place with right ventricular pacing \\> 40%.\n* Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as permitted by the participant clinical status and co-morbidities prior to implantation procedure.\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.\n* Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months.\n* Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.\n* Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and\u002For stent angioplasty) within the past three (3) months prior to enrollment.\n* Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).\n* Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.\n* Expected to receive left ventricular assist device or heart transplantation within 6 months.\n* Participants with primary severe valvular disease (e.g., aortic stenosis).\n* Have a life expectancy of less than 12 months.\n* Participants with irreversible brain damage from preexisting cerebral disease.\n* Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and\u002For diphenhydramine.\n* Participants participating in any other interventional cardiovascular clinical trial.\n* Participants who would be unable to comply with the study's follow-up visit schedule; or\n* Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.",{"count":171,"type":20},2136,[23],"The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with\u002Fanticipated \\>40% pacing who are already receiving current standard heart failure pharmacological therapy.",[175,176,28,177,178,179,180],"Heart Failure","Heart Failure With Reduced Ejection Fraction","LBBB","RBBB","Intraventricular Conduction Delay","Pacing-Induced Cardiomyopathy","2025-09-28",{"date":183,"type":36},"2025-10-02",{"date":185,"type":36},"2023-09-13",{"date":187,"type":20},"2029-06-30",{"name":189,"class":71},"Baylor College of Medicine",71,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100580886","synchrony-in-cardiac-conduction-assessing-the-effects-of-pacing-on-cardiac-performance-through-magnetic-resonance-imaging-and-advanced-ecg-imaging-100580886","NCT06843135","Synchrony in Cardiac Conduction: Assessing the Effects of Pacing on Cardiac Performance Through Magnetic Resonance Imaging and Advanced ECG-imaging","HARMONY","Inclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age ≥ 18 years\n* Patients with a left ventricular ejection fraction of ≥35%\n* Patients with an indication for ventricular pacing and high-degree atrioventricular block where the degree of anticipated RV pacing is \\>20% including:\n* Third degree AV block\n* Symptomatic or asymptomatic second-degree AV block\n* High degree AV block\n* Pace and ablate (AV-node ablation)\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* CRT indication (patients with heart failure (NYHA \\>1) in sinus rhythm with left ventricular ejection fraction (LVEF) \\\u003C35%, QRS duration \\>150 ms, and left bundle branch block (LBBB) QRS morphology despite optimised medical therapy)\n* Inability to undergo CMR (i.e. severe claustrophobia or MRI contraindications)\n* Life expectancy \\\u003C12 months\n* Indication for an implantable cardioverter defibrillator\n* Presence of severe valve disease or mechanical valves\n* Any prior attempt at implantation of an ICD, CRT, CSP\n* Permanent AF with rapid ventricular response, unless pace and ablate",{"count":199,"type":20},88,[23],"Rationale Right ventricular pacing (RVP) is an established and effective therapy for patients with atrioventricular (AV) block. However, frequent RVP has been associated with left ventricular (LV) dyssynchrony and may progess heart failure. Conduction system pacing (CSP), a recently introduced alternative to RVP, aims to preserve physiological ventricular activation by engaging the heart's native conduction system. CSP includes diverse pacing approaches such as selective or non-selective His-bundle pacing, selective left bundle pacing, and LV-septal pacing, each with varying levels of fidelity in reproducing normal conduction. The mechanical impact of these distinct CSP strategies on left and right ventricular (RV) performance remains poorly understood.\n\nCardiac magnetic resonance imaging (CMR), a non-invasive and highly accurate tool for assessing cardiac structure and function, is uniquely positioned to elucidate the effects of CSP and RVP on cardiac performance. This trial aims to evaluate the comparative mechanical effects of these pacing strategies, potentially identifying the optimal approach for improving outcomes in patients with AV block.\n\nObjective To investigate and compare the effects of CSP and RVP on cardiac performance, as assessed by CMR and electrocardiographic imaging (ECG-imaging).\n\nMain Trial Endpoints The primary endpoints are measures of LV and RV performance assessed via CMR, including: ventricular volumes, ejection fraction (EF), and myocardial strain\n\nSecondary Trial Endpoints\n\nSecondary endpoints include:\n\nSafety and Feasibility:\n\n* Adverse events (e.g., troponin release, lead displacement, arrhythmias, heart failure).\n* Technical feasibility (e.g., ease of device implantation, ability to maintain proper pacing).\n\nElectrophysiological Assessment:\n\n* Degree of selectivity in engaging the native conduction system.\n* Ventricular activation times as assessed by ECG-imaging.\n\nTrial Design This is a randomized, controlled, single blind, two-center crossover trial. Participants will undergo CSP and RVP in a randomized sequence, each for six months. CMR and ECG-imaging will be performed at 6 months (end of the first pacing phase) and 12 months (end of the second pacing phase).\n\nTrial Population The trial will enroll 88 patients with a normal of at most mildly reduced ejection fraction and an indication for ventricular pacing.\n\nInterventions Participants will undergo CMR and ECG-imaging at 6 months and 12 months.\n\nEthical Considerations This trial is designed to advance understanding of the mechanical and clinical effects of CSP relative to RVP in patients with AV block. The anticipated benefits include improved cardiac performance and enhanced quality of life. The primary burden to participants is the requirement for an additional CMR scan, which may be perceived as inconvenient or even stressful. The trial minimizes risk by utilizing established clinical procedures and closely monitoring participants for adverse events.",[175,28],"2025-02-18",{"date":205,"type":36},"2025-02-24",{"date":207,"type":20},"2025-03-01",{"date":209,"type":20},"2028-03-01",{"name":211,"class":71},"Amsterdam UMC, location VUmc",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":221,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":72},"100570470","left-septal-pacing-or-left-bundle-branch-pacing-to-avoid-left-ventricle-systolic-dysfunction-100570470","NCT06707662","Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction","Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators","STAY II","Inclusion Criteria:\n\n1. Age of 18 years or more.\n2. Preserved or mild deteriorated LVEF (Simpson \\>40%) assessed by a recent (\\\u003C1 month before implantation) transthoracic echocardiography.\n3. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\\>80%).\n4. Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.\n\nExclusion Criteria:\n\n1. Patients with indication for implantable cardioverter defibrillator device.\n2. Patients with indication for a CRT device, with LVEF \\\u003C40%.\n3. Patients with previous severe LVD (Simpson LVEF \\\u003C30%) and a recovered LVEF.\n4. History of myocardial infarction\u002Frevascularization or cardiac surgery within 6 months before randomization.\n5. Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.",{"count":146,"type":20},[23],"Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial).\n\nCriteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.",[28],[225,226,227,228,229,230],"Conduction System Pacing","Left bundle branch area pacing","Right ventricle apical pacing","Left septum pacing","Left ventricle ejection fraction","Heart failure","2025-02-10",{"date":233,"type":36},"2025-02-11",{"date":235,"type":36},"2025-01-01",{"date":237,"type":20},"2026-12-01",{"name":239,"class":71},"Parc de Salut Mar","AV-Block"]