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Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older (SAGE-AS)

15 september 2026 uppdaterad av: Sunnybrook Health Sciences Centre
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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

All 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.

Investigators 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.

Studietyp

Interventionell

Inskrivning (Beräknad)

1000

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  1. Age 70 years or older at the time of consent.
  2. Written informed consent from participant
  3. Receiving care at a participating primary care practice during the study period.

Exclusion Criteria:

  1. Known moderate or severe aortic stenosis before enrolment.
  2. Prior surgical or transcatheter aortic valve replacement.
  3. Any condition that, in the opinion of the investigator or treating clinician, would preclude informed consent or make participation impractical or unsafe.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Undersökning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Intervention
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.
Enhet: 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.
Inget ingripande: Standard of Care
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of new diagnosis of moderate or severe aortic stenosis on transthoracic echo/1000 patients screened of patients over 70 years
Tidsram: Within 3 months after enrolment.
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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of eligible participants screened during intervention periods
Tidsram: From enrollment until Day 1
Proportion of eligible participants screened during intervention periods
From enrollment until Day 1
Distribution of algorithm outputs
Tidsram: From enrollment until Day 1
Distribution of algorithm outputs as normal, suggestive of aortic stenosis, other murmur detected, or inconclusive
From enrollment until Day 1
Proportion completing transthoracic echocardiography after an abnormal or inconclusive result
Tidsram: Enrollment to 3 months
Proportion of participants completing transthoracic echocardiography after an abnormal or inconclusive result
Enrollment to 3 months
Average time from abnormal screen to echocardiography
Tidsram: Enrollment to transthoracic echocardiography, assessed up to 3 months
Average time from abnormal screen to echocardiography
Enrollment to transthoracic echocardiography, assessed up to 3 months
Average time from confirmed diagnosis to referral to valve clinic, where applicable
Tidsram: ECHO confirmation to valve clinic referral, an average of 3 months
Average time from confirmed diagnosis to referral to valve clinic, where applicable
ECHO confirmation to valve clinic referral, an average of 3 months
Diagnostic yield of transthoracic echocardiography
Tidsram: enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months
  1. proportion of completed TTE studies demonstrating moderate or severe aortic stenosis or other clinically significant structural heart disease among all abnormal screening result;
  2. proportion of moderate/severe aortic stenosis with referral to the valve clinic
enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sunnybrook Health Sciences Centre

Samarbetspartners

Medtronic
Canadian Cardiovascular Society
KMH Cardiology and Diagnostic Centres
Ontario Health
Sparrow Acoustics Inc.
Edwards life sciences

Utredare

  • Huvudutredare: Nicolas Bowers, MD MSc FRCPC FACC FSCAI, Sunnybrook Health Sciences Centre

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 december 2027

Avslutad studie (Beräknad)

1 mars 2028

Studieregistreringsdatum

Först inskickad

19 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

15 september 2026

Första postat (Faktisk)

18 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SAGE-AS

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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