[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656664":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":42,"studyPopulation":34,"armGroups":43,"interventions":54,"overallOfficials":60,"centralContacts":34,"locations":34,"responsibleParty":64,"collaborators":66,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":34,"enrollmentInfo":91,"targetDuration":34,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":102,"whyStopped":34,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":34},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Number of new diagnosis of moderate or severe aortic stenosis on transthoracic echo\u002F1000 patients screened of patients over 70 years","Determine whether Sparrow app based screening increases the number of patients with a new diagnosis of moderate or severe aortic stenosis confirmed by transthoracic echo within 3 months","Within 3 months after enrolment.",[14,17,20,24,27,30],{"measure":15,"description":15,"timeFrame":16},"Proportion of eligible participants screened during intervention periods","From enrollment until Day 1",{"measure":18,"description":19,"timeFrame":16},"Distribution of algorithm outputs","Distribution of algorithm outputs as normal, suggestive of aortic stenosis, other murmur detected, or inconclusive",{"measure":21,"description":22,"timeFrame":23},"Proportion completing transthoracic echocardiography after an abnormal or inconclusive result","Proportion of participants completing transthoracic echocardiography after an abnormal or inconclusive result","Enrollment to 3 months",{"measure":25,"description":25,"timeFrame":26},"Average time from abnormal screen to echocardiography","Enrollment to transthoracic echocardiography, assessed up to 3 months",{"measure":28,"description":28,"timeFrame":29},"Average time from confirmed diagnosis to referral to valve clinic, where applicable","ECHO confirmation to valve clinic referral, an average of 3 months",{"measure":31,"description":32,"timeFrame":33},"Diagnostic yield of transthoracic echocardiography","1. proportion of completed TTE studies demonstrating moderate or severe aortic stenosis or other clinically significant structural heart disease among all abnormal screening result;\n2. proportion of moderate\u002Fsevere aortic stenosis with referral to the valve clinic","enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","CROSSOVER","Every three months a randomly assigned family practice center crosses over to the intervention with a 2 week wash in period.","SCREENING",{"masking":41,"maskingDescription":34,"whoMasked":34},"NONE","This study employs a stepped-wedge cluster randomized design involving four primary care practices affiliated with KMH Cardiology. Each family practice constitutes a single cluster.\n\nAll participating practices will start as usual standard of care. At three-month intervals, one practice will be randomly selected to crossover from usual standard of care (control group) to the intervention group. There will be a 2-week wash in period when a family practice crosses over from control to intervention. This process will continue until all practices have implemented the intervention, resulting in full intervention by 15 months.\n\nInvestigators hypothesize that the Sparrow screening pathway will result in a higher proportion of patients with a positive echo for moderate or severe aortic stenosis than usual care without protocol driven screening.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Intervention","ACTIVE_COMPARATOR","During intervention periods, trained clinic personnel will obtain heart sound recordings at three standard chest positions using the Stethophone application, with at least 30 seconds of recording at each position.",[49],"Device: Stethophone",{"label":51,"type":52,"description":53,"interventionNames":34},"Standard of Care","NO_INTERVENTION","No study procedures. Patients will be consented for obtaining data related to ECHO confirmation for of moderate or severe aortic stenosis (if applicable) followed by referral for valve clinic assessment (if need be) for the duration of this study.",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":34},"DEVICE","Stethophone","The device is a FDA \\& HC approved mobile application, the Stethophone (developed by Sparrow BioAcoustics), that transforms a smartphone into a digital stethoscope and analytic tool able to identify murmurs that may indicate aortic stenosis.",[45],[61],{"name":62,"affiliation":5,"role":63},"Nicolas Bowers, MD MSc FRCPC FACC FSCAI","PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[67,69,72,75,77,79],{"name":68,"class":6},"KMH Cardiology and Diagnostic Centres",{"name":70,"class":71},"Sparrow Acoustics Inc.","INDUSTRY",{"name":73,"class":74},"Ontario Health","UNKNOWN",{"name":76,"class":6},"Canadian Cardiovascular Society",{"name":78,"class":74},"Edwards life sciences",{"name":80,"class":71},"Medtronic","100656664","sparrow-app-guided-evaluation-sage-vanguard-trial-for-aortic-stenosis-in-adults-aged-seventy-and-older-100656664",false,"NCT07828730","Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older","SAGE-AS","Inclusion Criteria:\n\n1. Age 70 years or older at the time of consent.\n2. Written informed consent from participant\n3. Receiving care at a participating primary care practice during the study period.\n\nExclusion Criteria:\n\n1. Known moderate or severe aortic stenosis before enrolment.\n2. Prior surgical or transcatheter aortic valve replacement.\n3. Any condition that, in the opinion of the investigator or treating clinician, would preclude informed consent or make participation impractical or unsafe.",true,"ALL","70 Years",{"count":92,"type":93},1000,"ESTIMATED","INTERVENTIONAL",[96],"NA","The purpose of this research is to look at an approved intervention (Stethophone application) to obtain additional information about improving detection of moderate or severe aortic stenosis when compared with usual standard of care.",[99],"Moderate or Severe Aortic Stenosis",[101],"moderate or severe aortic stenosis","NOT_YET_RECRUITING","2026-09-15",{"date":105,"type":106},"2026-09-18","ACTUAL",{"date":108,"type":93},"2026-09",{"date":110,"type":93},"2028-03",{"name":5,"class":6}]