[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100309075":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":33,"locations":44,"responsibleParty":171,"collaborators":24,"id":173,"slug":24,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":174,"sex":180,"minAge":181,"maxAge":24,"enrollmentInfo":182,"targetDuration":24,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":24,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"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",[45,60,73,85,97,108,119,137,145,158],{"facility":46,"status":47,"city":48,"state":49,"zip":24,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Mazankowski Alberta Heart Institute","RECRUITING","Edmonton","Alberta","Canada",{"type":52,"coordinates":53},"Point",[54,55],-113.46871,53.55014,{"lat":55,"lon":54},[58],{"name":59,"role":32,"phone":24,"phoneExt":24,"email":24},"Kenneth Quadros, MD",{"facility":61,"status":62,"city":63,"state":64,"zip":24,"country":50,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"New Brunswick Heart Center","NOT_YET_RECRUITING","Saint John","New Brunswick",{"type":52,"coordinates":66},[67,68],-66.05616,45.27076,{"lat":68,"lon":67},[71],{"name":72,"role":32,"phone":24,"phoneExt":24,"email":24},"Satish Toal, MD",{"facility":74,"status":47,"city":75,"state":76,"zip":24,"country":50,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"QEII Health Sciences Center","Halifax","Nova Scotia",{"type":52,"coordinates":78},[79,80],-63.57688,44.64269,{"lat":80,"lon":79},[83],{"name":84,"role":32,"phone":24,"phoneExt":24,"email":24},"Ratika Parkash, MD",{"facility":86,"status":47,"city":87,"state":88,"zip":24,"country":50,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hamilton Health Sciences Corporation","Hamilton","Ontario",{"type":52,"coordinates":90},[91,92],-79.84963,43.25011,{"lat":92,"lon":91},[95],{"name":96,"role":32,"phone":24,"phoneExt":24,"email":24},"Madhu Natarajan, MD",{"facility":98,"status":47,"city":99,"state":88,"zip":24,"country":50,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"London Health Sciences Center (LHSC)","London",{"type":52,"coordinates":101},[102,103],-81.23304,42.98339,{"lat":103,"lon":102},[106],{"name":107,"role":32,"phone":24,"phoneExt":24,"email":24},"Jaimie Manlucu, MD",{"facility":109,"status":47,"city":110,"state":88,"zip":24,"country":50,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"University of Ottawa Heart Institute (UOHI)","Ottawa",{"type":52,"coordinates":112},[113,114],-75.69812,45.41117,{"lat":114,"lon":113},[117],{"name":118,"role":32,"phone":24,"phoneExt":24,"email":24},"Mehrdad Golian, MD",{"facility":5,"status":47,"city":120,"state":121,"zip":122,"country":50,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Montreal","Quebec","H1T1C8",{"type":52,"coordinates":124},[125,126],-73.58781,45.50884,{"lat":126,"lon":125},[129,132,135],{"name":130,"role":36,"phone":37,"phoneExt":38,"email":131},"lena Rivard, MD, MSc","lena.rivard@icm-mhi.org",{"name":133,"role":36,"phone":37,"phoneExt":134,"email":43},"Caroline Girard","4058",{"name":136,"role":32,"phone":24,"phoneExt":24,"email":24},"Lena Rivard, MD",{"facility":138,"status":47,"city":120,"state":121,"zip":24,"country":50,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"CIUSSS du Nord de l'Île de Mtl",{"type":52,"coordinates":140},[125,126],{"lat":126,"lon":125},[143],{"name":144,"role":32,"phone":24,"phoneExt":24,"email":24},"Rémi Kouz, MD",{"facility":146,"status":47,"city":147,"state":148,"zip":149,"country":50,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Centre hospitalier universitaire de Sherbrooke","Sherbrooke","Quebec, Canada","J1J 3H5",{"type":52,"coordinates":151},[152,153],-71.89908,45.40008,{"lat":153,"lon":152},[156],{"name":157,"role":32,"phone":24,"phoneExt":24,"email":24},"Benoît Daneault, MD",{"facility":159,"status":62,"city":160,"state":161,"zip":24,"country":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Centre Hospitalier Universitaire de Nantes","Nantes","Cedex 01","France",{"type":52,"coordinates":164},[165,166],-1.55336,47.21725,{"lat":166,"lon":165},[169],{"name":170,"role":32,"phone":24,"phoneExt":24,"email":24},"Jean-Baptiste Gourraud, MD",{"type":172,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":183,"type":184},250,"ESTIMATED","INTERVENTIONAL",[187],"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).",[190,191],"Left Bundle-Branch Block","Aortic Valve Stenosis","2025-05-05",{"date":194,"type":195},"2025-05-08","ACTUAL",{"date":197,"type":195},"2017-10-15",{"date":199,"type":184},"2026-12",{"name":5,"class":6},10]