[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100309075":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":33,"locations":44,"responsibleParty":173,"collaborators":24,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":177,"sex":183,"minAge":184,"maxAge":24,"enrollmentInfo":185,"targetDuration":24,"studyType":188,"phases":189,"briefSummary":191,"conditions":192,"keywords":24,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Montreal Heart Institute","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"EP-based approach\u002Fpacemaker implant","Subjects will undergo an EP study prior to hospital discharge and will receive a pacemaker implantation if the HV interval is ≥65 msec.\n\nIn the case where the electrical slowdown is not confirmed by the electrophysiological study, the participant will not have a pacemaker implantation.",[12],"Device: Pacemaker implant",{"label":14,"type":6,"description":15,"interventionNames":16},"Compared transcutaneous cardiac monitor","Subjects will undergo a minimum of 72 hour ECG monitoring in hospital and receive transcutaneous monitoring prior to hospital discharge for a duration of 30 days.",[17],"Device: Transcutaneous cardiac monitor",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Pacemaker implant","Patient will be in the electrophysiology laboratory. The doctor will freeze the groin area and a medication may be given to help the patient relax. A catheter will be inserted into the groin up to the heart and the heart's electrical system will be recorded.",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Transcutaneous cardiac monitor","Transcutaneous cardiac patches will allow continuous electrocardiographic monitoring for a 30-day period. For the first randomized patients at the Montreal Heart Institute, Icentia was used and then was changed to a m-Health® device which allows continuous cardiac monitoring. The PocketECG from m-Health® is attached to 3 electrodes on the chest and contains a SIM card that transmits to a server located in Burlington, Ontario .The COME-TAVI coordinating center and the associated site will be informed rapidly of any events that occur . These events include:\n\nVentricular fibrillation; Sustained ventricular tachycardia Any RR interval \\>5 sec; Third-degree AV block or Mobitz 2 AV block;",[14],[30],{"name":31,"affiliation":5,"role":32},"Léna Rivard, MD, MSC","PRINCIPAL_INVESTIGATOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Léna Rivard, MD, MSc","CONTACT","514-376-3330","2120","lena.rivard@umontreal.ca",{"name":41,"role":36,"phone":37,"phoneExt":42,"email":43},"Caroline Girard, EP Prof.","2905","caroline.girard@icm-mhi.org",[45,61,74,86,98,109,120,138,146,159],{"facility":46,"status":47,"city":48,"state":49,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Mazankowski Alberta Heart Institute","RECRUITING","Edmonton","Alberta","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-113.46871,53.55014,{"lat":56,"lon":55},[59],{"name":60,"role":32,"phone":24,"phoneExt":24,"email":24},"Kenneth Quadros, MD",{"facility":62,"status":63,"city":64,"state":65,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"New Brunswick Heart Center","NOT_YET_RECRUITING","Saint John","New Brunswick",{"type":53,"coordinates":67},[68,69],-66.05616,45.27076,{"lat":69,"lon":68},[72],{"name":73,"role":32,"phone":24,"phoneExt":24,"email":24},"Satish Toal, MD",{"facility":75,"status":47,"city":76,"state":77,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"QEII Health Sciences Center","Halifax","Nova Scotia",{"type":53,"coordinates":79},[80,81],-63.57688,44.64269,{"lat":81,"lon":80},[84],{"name":85,"role":32,"phone":24,"phoneExt":24,"email":24},"Ratika Parkash, MD",{"facility":87,"status":47,"city":88,"state":89,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Hamilton Health Sciences Corporation","Hamilton","Ontario",{"type":53,"coordinates":91},[92,93],-79.84963,43.25011,{"lat":93,"lon":92},[96],{"name":97,"role":32,"phone":24,"phoneExt":24,"email":24},"Madhu Natarajan, MD",{"facility":99,"status":47,"city":100,"state":89,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"London Health Sciences Center (LHSC)","London",{"type":53,"coordinates":102},[103,104],-81.23304,42.98339,{"lat":104,"lon":103},[107],{"name":108,"role":32,"phone":24,"phoneExt":24,"email":24},"Jaimie Manlucu, MD",{"facility":110,"status":47,"city":111,"state":89,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"University of Ottawa Heart Institute (UOHI)","Ottawa",{"type":53,"coordinates":113},[114,115],-75.69812,45.41117,{"lat":115,"lon":114},[118],{"name":119,"role":32,"phone":24,"phoneExt":24,"email":24},"Mehrdad Golian, MD",{"facility":5,"status":47,"city":121,"state":122,"zip":123,"country":50,"countryCode":51,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Montreal","Quebec","H1T1C8",{"type":53,"coordinates":125},[126,127],-73.58781,45.50884,{"lat":127,"lon":126},[130,133,136],{"name":131,"role":36,"phone":37,"phoneExt":38,"email":132},"lena Rivard, MD, MSc","lena.rivard@icm-mhi.org",{"name":134,"role":36,"phone":37,"phoneExt":135,"email":43},"Caroline Girard","4058",{"name":137,"role":32,"phone":24,"phoneExt":24,"email":24},"Lena Rivard, MD",{"facility":139,"status":47,"city":121,"state":122,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"CIUSSS du Nord de l'Île de Mtl",{"type":53,"coordinates":141},[126,127],{"lat":127,"lon":126},[144],{"name":145,"role":32,"phone":24,"phoneExt":24,"email":24},"Rémi Kouz, MD",{"facility":147,"status":47,"city":148,"state":149,"zip":150,"country":50,"countryCode":51,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Centre hospitalier universitaire de Sherbrooke","Sherbrooke","Quebec, Canada","J1J 3H5",{"type":53,"coordinates":152},[153,154],-71.89908,45.40008,{"lat":154,"lon":153},[157],{"name":158,"role":32,"phone":24,"phoneExt":24,"email":24},"Benoît Daneault, MD",{"facility":160,"status":63,"city":161,"state":162,"zip":24,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Centre Hospitalier Universitaire de Nantes","Nantes","Cedex 01","France","FR",{"type":53,"coordinates":166},[167,168],-1.55336,47.21725,{"lat":168,"lon":167},[171],{"name":172,"role":32,"phone":24,"phoneExt":24,"email":24},"Jean-Baptiste Gourraud, MD",{"type":174,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100309075","clinical-monitoring-strategy-versus-electrophysiology-guided-algorithmic-approach-with-a-new-lbbb-after-tavi-100309075",false,"NCT03303612","Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach With a New LBBB After TAVI","Comparison of a Clinical Monitoring Strategy Versus Electrophysiology-guided Algorithmic Approach in Patients With a New Left Bundle Branch Block After Transcatheter Aortic Valve Implantation (TAVI) a Bayesian Randomized Trial (COME-TAVI)","COME-TAVI","Inclusion Criteria:\n\n* Age ≥18 years\n* Informed consent to participate\n* Persistent new-onset LBBB after TAVI implantation (i.e. present at day 2)\n\nExclusion Criteria:\n\n* Prior pacemaker or implantable cardioverter-defibrillator\n* Pre-existing right bundle branch block (RBBB) or LBBB (i.e., prior to TAVI)\n* Class I or IIA indication for PPM implantation according to management guidelines","ALL","18 Years",{"count":186,"type":187},250,"ESTIMATED","INTERVENTIONAL",[190],"NA","The primary hypothesis of the proposed study is that an electrophysiology-based algorithmic approach is superior to standard clinical follow-up with 30-day monitoring in reducing the combined endpoint of syncope, hospitalization, and death in patients in patients with new of left bundle branch block following transcatheter aortic valve implantation (TAVI).",[193,194],"Left Bundle-Branch Block","Aortic Valve Stenosis","2025-05-05",{"date":197,"type":198},"2025-05-08","ACTUAL",{"date":200,"type":198},"2017-10-15",{"date":202,"type":187},"2026-12",{"name":5,"class":6},10]