[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pacemaker-implantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pacemaker-implantation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,61,87],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100616406","study-of-ahre-burden-in-patients-undergoing-bachmann-bundle-area-pacing-and-left-bundle-branch-pacing-100616406",false,"NCT07305194","Study of AHRE Burden in Patients Undergoing Bachmann Bundle Area Pacing and Left Bundle Branch Pacing.","Study of Atrial High-Rate Episode Burden in Patients Undergoing Concurrent Bachmann Bundle Area Pacing and Left Bundle Branch Pacing , Compared With Either Left Bundle Branch Pacing or Conventional Right Ventricular Pacing.","AHRE-BLAST","Inclusion Criteria:\n\n* Adult patients (≥ 18 years) with a clear indication for permanent pacing, according to ESC guidelines \\[15\\] for the management of conduction disturbances (e.g. symptomatic bradycardia, complete atrioventricular block, sinus node dysfunction).\n* Sinus rhythm at the time of implantation, with no documented episodes of atrial fibrillation prior to implantation, either in the medical history or in previous recordings (ECG, Holter, telemetry).\n* Ability to be followed up for at least 24 months after implantation.\n* Provision of written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* History of atrial fibrillation prior to implantation, either permanent or paroxysmal, documented on ECG, Holter, or telemetry.\n* Prior pharmacological or interventional treatment for AF (e.g. antiarrhythmic drugs, catheter ablation).\n* Inability to comply with long-term follow-up or non-adherence to follow-up visits.\n* Contraindications to pacemaker lead placement at the selected sites.\n* Participation in another study that could influence the results.\n* Previous device implantation.","ALL","18 Years",{"count":20,"type":21},460,"ESTIMATED","24 Months","OBSERVATIONAL","This prospective observational study evaluates the burden of Atrial High-Rate Episodes (AHRE) in patients without a prior history of atrial fibrillation who undergo concurrent Bachmann Bundle Area Pacing (BBAP) and Left Bundle Branch Pacing (LBBP). Physiological pacing at these sites aims to improve interatrial conduction and reduce the risk of atrial arrhythmias.\n\nThe study includes a comparative assessment across three patient groups:\n\n1. BBAP + LBBP (physiological pacing group)\n2. Right Atrial Appendage (RAA) pacing + LBBP\n3. Conventional pacing - RAA and Right Ventricular (RV) pacing AHRE burden will be quantified via device diagnostics and remote monitoring at 3, 12 and 24 months post-implantation. Episodes will be classified by duration (0-6 min, 6-24 h, \\>24 h), differentiating subclinical AHRE from clinically documented AF.\n\nSecondary analyses include electrocardiographic changes (P-wave indices), the need for antiarrhythmic therapy, and comprehensive echocardiographic evaluation of atrial function (e.g., LA strain, conduction delays, LAVI).\n\nThe study aims to determine whether physiological pacing (BBAP + LBBP) provides superior protection against AHRE development compared with RAA + LBBP and conventional pacing strategies.",[26,27,28,29,30],"Atrial Arrhythmia","Atrial Fibrillation (AF)","Pacemaker Implantation","Left Bundle Branch Pacing","Conduction System Pacing",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47],"Atrial High-Rate Episodes (AHRE)","Subclinical Atrial Fibrillation","Bachmann Bundle Area Pacing (BBAP)","Left Bundle Branch Pacing (LBBP)","Physiological Pacing","Interatrial Conduction","Atrial Synchrony","P-wave Duration","Atrial Electromechanical Remodeling","Atrial Strain","Left Atrial Reservoir Strain","Inter-atrial Conduction Delay (IACD)","Speckle Tracking Echocardiography","Left Atrial Volume Index (LAVI)","Atrial Arrhythmias","Device-Detected AF","NOT_YET_RECRUITING","2025-12-11",{"date":51,"type":52},"2025-12-26","ACTUAL",{"date":54,"type":21},"2026-01-01",{"date":56,"type":21},"2028-04-14",{"name":58,"class":59},"University Hospital of Patras","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":60},"100611964","cardioneural-temporary-pacing-to-achieve-autonomic-modulation-100611964","NCT07247422","Cardioneural Temporary Pacing to Achieve Autonomic Modulation","Inclusion Criteria:\n\n* Patients with atrial fibrillation or atrial flutter who are having rapid ventricular rate \\>100bpm\n* Patient who cannot take rate control agents, or heart rate control remains unsatisfactory after rate control agents\n\nExclusion Criteria:\n\n* Patients who cannot provide informed consent\n* Patients \\\u003C 18 years old\n* Pregnant patients\n* Illiterate patients","18 Months",{"count":69,"type":21},33,"INTERVENTIONAL",[72],"NA","Atrial fibrillation (AF) is the most common arrhythmia, with a lifetime risk of 1 in 3-5. In cases of rapid ventricular rate, patients often experience low blood pressure, making standard rate and rhythm control medications contraindicated. While cardioversion may be necessary, it is often ineffective in long-standing AF and can lead to left ventricular stunning. This creates a vicious cycle, worsening heart failure and cardiogenic shock.\n\nAV node ablation may be required, but it is irreversible and carries risks, including complications from long-term pacing. Therefore, temporary pacing may be a preferable option to allow for hemodynamic improvement and better ventricular filling.\n\nResearch suggests that parasympathetic fibers innervating the AV node can modulate conduction. Ablation in these fibers has shown promise for treating vagal-mediated syncope, and high-frequency pacing may provide chronic heart rate suppression. Intermittent pacing has also been effective in reducing ventricular rates in atrial fibrillation to prevent inappropriate ICD shock. This may be potentially beneficial for patients with uncontrolled fast AF.\n\nIn a proof-of-concept study with five patients, pacing at 30Hz and 10mA in the coronary sinus resulted in a dose-dependent prolongation of the ventricular cycle length during AF, with stable blood pressure and no discomfort reported. This suggests that pacing these fibers could achieve rate control without the need for medications or AV node ablation, with no complications observed.\n\nThis study aims to evaluate safety and efficacy of temporary cardio-neural pacing (CNP). This is a prospective cohort study involving patients with atrial fibrillation (AF) and rapid ventricular conduction who have failed or are contraindicated for rate control with antiarrhythmic medications. Enrolled patients will be followed up for 1 month.",[75,28],"Temporary Cardio-neural Pacing",[77],"cardio-neural pacing","2025-11-18",{"date":80,"type":52},"2025-11-25",{"date":82,"type":21},"2025-12",{"date":84,"type":21},"2027-11",{"name":86,"class":59},"Chinese University of Hong Kong",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":70,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100569137","efficacy-and-safety-of-leadless-pacemakers-versus-left-bundle-area-pacing---a-preliminary-exploration-100569137","NCT06690333","Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration","COMPAREPACE","Inclusion Criteria:\n\n1. Age \\> 18\n2. Planned for:\n\n   1. permanent pacemaker implantation for AV node disease (first, second or third degree), OR\n   2. post-TAVR patient requiring permanent pacemaker implantation\n3. Preserved ejection fraction \\> 50%\n4. Preserved sinus node function\n5. Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements\n6. Life expectancy \\> 1 year\n7. Female subject of childbearing potential is not pregnant, not breast feeding, does not plan to be pregnant during the course of the study, and agrees to use a highly effective contraceptive method (i.e. IUD, birth control, vasectomized partner, sexual abstinence, etc.) during the course of the study.\n8. Subject has been informed of the nature of the study, agrees to its provision and has provided written informed consent, approved by the IRB\n\nExclusion Criteria:\n\n1. Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation\n2. Anatomical restriction for either MICRA or transvenous pacing such as\n\n   1. Access vein occlusion or thrombosis\n   2. previous radiation therapy at insertion site\n   3. inferior vena cava filter\n3. Endstage renal disease (ESRD)\u002Fon dialysis\n4. Dementia (inability to give consent)\n5. Moderate to Severe or Severe Tricuspid valve regurgitation\n6. Moderate to Severe or Severe Mitral valve regurgitation\n7. History of mitral or tricuspid valve surgery\n8. Preexisting implanted pacemaker or ICD or lead\n9. Subject is allergic to titanium\n10. Life expectancy \\\u003C 1 year\n11. Recurrent or high risk of infections\n12. Active malignancy requiring systemic chemotherapy or local chest radiation\n13. Subject has myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit\n14. CABG, valve surgery or PCI within the last 3 months except TAVR\n15. Other major cardiac surgery within the last 6 months\n16. Persistent and permanent atrial fibrillation diagnosed by a healthcare provider\n17. NYHA class 3 or 4 Heart Failure\n\n    Additional post-TAVR Exclusion Criteria:\n18. Evidence of renal injury (12 hours post-TAVR)\n19. Access site complication(s) post-TAVR\n20. Suspicion of stroke\u002Fcerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 hours post-TAVR\n21. Physician suspicion that ambulation to pre-TAVR activities post-pacemaker implantation would be unattainable\n22. Other post-TAVR complications that in the opinion of the investigator may seriously confound study outcomes",{"count":95,"type":21},75,[72],"This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.",[28,99],"AV Node Disease",[101,102,103,104],"pacemaker","MICRA AV","Leadless pacemaker","left bundle area pacing","RECRUITING","2025-05-26",{"date":108,"type":52},"2025-05-30",{"date":110,"type":52},"2024-11-05",{"date":112,"type":21},"2026-12",{"name":114,"class":59},"NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH",2]