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NCT Number: NCT07828730

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Stethophone

Device

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.

Primary outcomes

  1. Number of new diagnosis of moderate or severe aortic stenosis on transthoracic echo/1000 patients screened of patients over 70 years

    Time frame: 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

Secondary outcomes

  1. Proportion of eligible participants screened during intervention periods

    Time frame: From enrollment until Day 1

    Proportion of eligible participants screened during intervention periods

  2. Distribution of algorithm outputs

    Time frame: From enrollment until Day 1

    Distribution of algorithm outputs as normal, suggestive of aortic stenosis, other murmur detected, or inconclusive

  3. Proportion completing transthoracic echocardiography after an abnormal or inconclusive result

    Time frame: Enrollment to 3 months

    Proportion of participants completing transthoracic echocardiography after an abnormal or inconclusive result

  4. Average time from abnormal screen to echocardiography

    Time frame: Enrollment to transthoracic echocardiography, assessed up to 3 months

    Average time from abnormal screen to echocardiography

  5. Average time from confirmed diagnosis to referral to valve clinic, where applicable

    Time frame: ECHO confirmation to valve clinic referral, an average of 3 months

    Average time from confirmed diagnosis to referral to valve clinic, where applicable

  6. Diagnostic yield of transthoracic echocardiography

    Time frame: enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months

    • proportion of completed TTE studies demonstrating moderate or severe aortic stenosis or other clinically significant structural heart disease among all abnormal screening result;
    • proportion of moderate/severe aortic stenosis with referral to the valve clinic

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

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

Registry information

Acronym: SAGE-AS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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