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

September 15, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 3 months after enrolment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible participants screened during intervention periods
Time Frame: From enrollment until Day 1
Proportion of eligible participants screened during intervention periods
From enrollment until Day 1
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
From enrollment until Day 1
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
Enrollment to 3 months
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
Enrollment to transthoracic echocardiography, assessed up to 3 months
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
ECHO confirmation to valve clinic referral, an average of 3 months
Diagnostic yield of transthoracic echocardiography
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

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

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAGE-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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