[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602042":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":173,"collaborators":175,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":190,"maxAge":20,"enrollmentInfo":191,"targetDuration":20,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":203,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},{"fullName":5,"class":6},"Biotronik, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Non randomized arm","OTHER","Single Arm",[13],"Device: LivIQ Leadless Pacemaker System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","LivIQ Leadless Pacemaker System","Patients will receive a single-chamber leadless pacemaker system, with the device implanted directly into the right ventricle.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Samuel Asirvatham, MD","Mayo Clinic","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Jennifer Alkire Project Manager","CONTACT","800-547-0394","US-BIO-LivIQ@biotronik.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Andreas Peth Clinical Project Manager","+49 30 68905 1288","BIO-LivIQ@biotronik.com",[37,51,60,70,80,92,102,113,122,131,140,152,162],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":20},"Trinity Health Ann Arbor Hospital","RECRUITING","Ypsilanti","Michigan","48197","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-83.61299,42.24115,{"lat":49,"lon":48},{"facility":52,"status":39,"city":53,"state":53,"zip":54,"country":43,"countryCode":44,"cosmosGeoPoint":55,"geoPoint":59,"contacts":20},"NY Presbyterian Weill Cornell Medicine","New York","10021",{"type":46,"coordinates":56},[57,58],-74.00597,40.71427,{"lat":58,"lon":57},{"facility":61,"status":39,"city":62,"state":63,"zip":64,"country":43,"countryCode":44,"cosmosGeoPoint":65,"geoPoint":69,"contacts":20},"Wake Forest University Health","Winston-Salem","North Carolina","27157",{"type":46,"coordinates":66},[67,68],-80.24422,36.09986,{"lat":68,"lon":67},{"facility":71,"status":39,"city":72,"state":73,"zip":74,"country":43,"countryCode":44,"cosmosGeoPoint":75,"geoPoint":79,"contacts":20},"UVA Health University Medical Center","Charlottesville","Virginia","22903",{"type":46,"coordinates":76},[77,78],-78.47668,38.02931,{"lat":78,"lon":77},{"facility":81,"status":39,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":20},"Princess Alexandra Hospital","Woolloongabba","Queensland","4102","Australia","AU",{"type":46,"coordinates":88},[89,90],153.03655,-27.48855,{"lat":90,"lon":89},{"facility":93,"status":39,"city":94,"state":95,"zip":96,"country":85,"countryCode":86,"cosmosGeoPoint":97,"geoPoint":101,"contacts":20},"Victorian Heart Hospital","Clayton","Victoria","3168",{"type":46,"coordinates":98},[99,100],145.11667,-37.91667,{"lat":100,"lon":99},{"facility":103,"status":39,"city":104,"state":20,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":20},"AZ Sint-Jan","Bruges","8000","Belgium","BE",{"type":46,"coordinates":109},[110,111],3.22424,51.20892,{"lat":111,"lon":110},{"facility":114,"status":39,"city":115,"state":20,"zip":116,"country":106,"countryCode":107,"cosmosGeoPoint":117,"geoPoint":121,"contacts":20},"Jessa Ziekenhuis","Hasselt","3500",{"type":46,"coordinates":118},[119,120],5.33781,50.93106,{"lat":120,"lon":119},{"facility":123,"status":39,"city":124,"state":20,"zip":125,"country":106,"countryCode":107,"cosmosGeoPoint":126,"geoPoint":130,"contacts":20},"UZ Leuven Gasthuisberg","Leuven","3000",{"type":46,"coordinates":127},[128,129],4.70093,50.87959,{"lat":129,"lon":128},{"facility":132,"status":39,"city":133,"state":20,"zip":134,"country":106,"countryCode":107,"cosmosGeoPoint":135,"geoPoint":139,"contacts":20},"CHR de la Citadelle - Liège","Liège","4000",{"type":46,"coordinates":136},[137,138],5.56749,50.63373,{"lat":138,"lon":137},{"facility":141,"status":39,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":20},"Kokura Memorial Hospital","Kitakyushu","Fukuoka","802-8555","Japan","JP",{"type":46,"coordinates":148},[149,150],130.85034,33.85181,{"lat":150,"lon":149},{"facility":153,"status":39,"city":154,"state":155,"zip":156,"country":145,"countryCode":146,"cosmosGeoPoint":157,"geoPoint":161,"contacts":20},"National Cerebral and Cardiovascular Center Hospital","Suita","Osaka","564-8565",{"type":46,"coordinates":158},[159,160],135.51567,34.76143,{"lat":160,"lon":159},{"facility":163,"status":39,"city":164,"state":20,"zip":165,"country":166,"countryCode":167,"cosmosGeoPoint":168,"geoPoint":172,"contacts":20},"HagaZiekenhuis van Den Haag - Leyweg","The Hague","2545","Netherlands","NL",{"type":46,"coordinates":169},[170,171],4.29861,52.07667,{"lat":171,"lon":170},{"type":174,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[176,178,180],{"name":177,"class":6},"Biotronik SE & Co. KG",{"name":179,"class":6},"Biotronik Japan, Inc.",{"name":181,"class":6},"Biotronik Australia Pty Ltd.","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":192,"type":193},325,"ESTIMATED","INTERVENTIONAL",[196],"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.",[199,200,201,202],"Leadless Pacemaker","Bradycardia","AV Block","Cardiac Rhythm Disorder",[204],"leadless pacemaker","2026-06-17",{"date":207,"type":208},"2026-06-18","ACTUAL",{"date":210,"type":208},"2026-03-16",{"date":212,"type":193},"2028-04",{"name":5,"class":6},13]