[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leadless-pacemaker\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leadless-pacemaker":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,70,102,124],{"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":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100601153","aveir-leadless-pacemaker-japan-pms-100601153","NCT07106788","Aveir Leadless Pacemaker Japan PMS","Aveir Leadless Pacemaker Japan Post Marketing Surveillance","Inclusion Criteria:\n\n* Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system\n* Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study\n* Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system\n\nExclusion Criteria:\n\n* N\u002FA",{"count":53,"type":20},304,"3 Years","OBSERVATIONAL","The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.",[26],[31,59],"AVEIR","2026-05-11",{"date":62,"type":36},"2026-05-13",{"date":64,"type":36},"2025-05-26",{"date":66,"type":20},"2029-11",{"name":68,"class":43},"Abbott Medical Devices",14,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100611865","leadless-pacemaker-registry-outcomes-and-follow-up-from-the-university-hospital-of-st-plten-100611865","NCT07246135","Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten","Leadless Pacemaker Registry","LPR","Inclusion Criteria:\n\n* Patients undergoing implantation of a leadless pacemaker at the University Hospital of St. Pölten\n* Patients who previously received a leadless pacemaker between June 2015 and the start of the registry (retrospective inclusion).\n* Age ≥ 18 years.\n* Written informed consent provided by the patient.\n\nExclusion Criteria:\n\n* Patients who decline or are unable to provide informed consent.\n* Patients in whom a conventional transvenous pacemaker is implanted (i.e., not leadless).\n* Any condition that, in the opinion of the treating physician, precludes participation in the registry.",{"count":79,"type":20},700,"The registry for leadless pacemakers will collect and annually analyze the data of all leadless pacemaker implantations at the University Hospital St. Pölten, including demographic information, indications, procedural details, acute, medium- and long-term complications during follow-up. Due to the partially novel nature of the signals (atrial mechanical sensing markers) and the lack of long-term experience to date, data on these aspects will also be collected and analyzed.\n\nThis is a single-center, prospective and retrospective registry that includes all patients receiving a leadless pacing device, as well as all patients who received a leadless pacing device between January 2021 and the start of the registry. All patients undergoing implantation of a leadless pacemaker will be invited to participate in the registry. For patients to be included retrospectively, participation in the registry will be offered at the time of their next routine follow-up visit.\n\nThe indication for leadless pacing will be determined by the physician responsible for the patient. Enrollment in the registry will in no case alter or influence the treatment the patient receives. Data collection will take place at the time of implantation and continuously during follow-up over the entire study period. Pacemaker-related data may be obtained either in person or via remote monitoring.",[82,26,83,84],"Pacemaker","Cardiac Pacing, Artificial","Registries",[86,26,82,87,88,89,90,27],"Registry","Cardiac Pacing","Pacemaker Complication","Leadless Pacemaker Outcomes","Heart Conduction System Disease","2025-11-17",{"date":93,"type":36},"2025-11-24",{"date":95,"type":36},"2015-06-18",{"date":97,"type":20},"2035-01",{"name":99,"class":100},"Karl Landsteiner University of Health Sciences","OTHER",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":55,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":101},"100570101","combined-leadless-pacemaker-and-left-atrial-appendage-occlusion-registry-100570101","NCT06702865","Combined Leadless Pacemaker and Left Atrial Appendage Occlusion Registry","Inclusion Criteria:\n\n1. Age \\> 18-year-old\n2. Patients satisfying guideline Class I or Class II indication for pacemaker 6,7\n3. Patients with atrial fibrillation\n4. Patient deemed indicated for left atrial appendage occlusion after a shared decision making between physician and patient\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Expected life expectancy \\\u003C1 year\n3. Patients with known mitral stenosis\n4. LVEF \\\u003C30%\n5. Severe mitral regurgitation",{"count":109,"type":20},47,"1 Year","Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in selected patients. Implantation is performed with a large caliber delivery catheter. Care must be taken in introducing the delivery catheter into the patient's venous system. Implantation in patients with small body habitus demands extra caution to avoid vascular injury and cardiac perforation. Negotiating the large caliber delivery catheter into the desired implant position may also be more difficult in small right ventricles. In a previous report of Micra leadless pacemakers, it was found that low BMI was associated with poor efficacy and safety.\n\nThe Aveir leadless pacemaker is a new leadless pacemaker that has obtained FDA approval and is commercially available in Hong Kong. It features a screw-in fixation mechanism, in contrast to the passive fixation of Micra. Most of its efficacy and safety data comes from a Western population. It would be important to study its efficacy and safety in an Asian population, who tend to have smaller body builds, hence more prone to complications.\n\nIn recent papers regarding the Micra leadless pacemaker, it was found that tricuspid regurgitation (TR) could be a result, especially if the implant was too close to the tricuspid valve. Given the almost 50% longer device dimension of the Aveir VR compared with the Micra leadless pacemaker (38mm vs 26mm), it is expected that the device mechanical interaction with tricuspid valve dysfunction can be more common. In the smaller hearts of an Asian population, it would be important to study the TR progression after device implantation.\n\nAbout half of the patients implanted with leadless pacemakers were having concomitant atrial fibrillation and thus were at risk for thromboembolic events. Left atrial appendage occlusion was an effective procedure for stroke prevention in patients with atrial fibrillation. Because one patient often has indication for both LAAO and leadless pacemaker, combining them into the same procedure is appealing. The combined procedure can be performed with one single access. The imaging used to guide LAAO implantation can also be used to guide leadless pacemaker implantation to improve the procedure safety.\n\nThis study is a prospective observational study. Patients indicated for combined leadless pacemaker and left atrial appendage occlusion will be enrolled. Patients would fulfill guideline Class I and Class II indication for leadless pacemaker. The decision for left atrial appendage occlusion will be a shared decision-making process between the physician and patient. The consideration is usually based on patient's bleeding risk, tolerability for oral anticoagulation and patient preference.",[26,113],"Left Atrial Appendage Occlusion","NOT_YET_RECRUITING","2024-11-20",{"date":117,"type":36},"2024-11-25",{"date":119,"type":20},"2024-11",{"date":121,"type":20},"2027-12",{"name":123,"class":100},"Chinese University of Hong Kong",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":101},"100569282","leadless-pacemaker-implantation-positions-and-its-relationship-with-procedure-efficacy-and-complication-100569282","NCT06692218","Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication","Inclusion Criteria:\n\n* Patients who will implant leadless pacemaker or already implanted leadless pacemaker since 1 Jan 2015\n* Patients with ability to provide informed consent\n\nExclusion Criteria:\n\n* Patients who cannot provide informed consent\n* Patient \\< 18 years old\n* Pregnant patients",{"count":131,"type":20},196,[23],"Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right ventricle, bypassing many of the weaknesses of transvenous pacemakers. Traditionally leadless pacemakers have been implanted in the right ventricular (RV) septum to prevent cardiac perforation, and much emphasis is placed during implantation to ensure a septal implant. However, in Asians with smaller heart sizes, septal implantation may be unfeasible. Cases of RV free wall implant have been achieved without any complications. This study aims to examine patients previously implanted with LP and determine their final attachment location. If a substantial portion of complication-free patients had RV free wall implants, then it can be argued the additional effort to ensure a septal implant is unnecessary. Additionally, intraoperative data, such as the intracardiac electrogram, may contain parameters correlated with implant position. This study also aims to study this correlation to guide future implant procedures.\n\nThis is a prospective-retrospective cohort study. Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. The attachment of the leadless pacemaker to the RV will be adjudicated from the CT. The patients' pre-operative laboratory tests, baseline demographics, medical history, LP electrical data and pre- and post-operative medication regiment will be collected retrospectively from their medical records in the Hospital Authority's Clinical Management System (CMS) and Clinical Data Analysis and Reporting System (CDARS).",[26],[136],"Leadless pacemaker","2024-11-14",{"date":139,"type":36},"2024-11-18",{"date":141,"type":36},"2024-08-05",{"date":143,"type":20},"2025-09-30",{"name":123,"class":100}]