Moderate or Severe Aortic StenosisSAGE-ASNCT07828730
Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older
A study testing Stethophone in people with Moderate or Severe Aortic Stenosis, run by Sunnybrook Health Sciences Centre.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moderate or Severe Aortic Stenosis
- What is being tested?
- Stethophone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Moderate or Severe Aortic Stenosis
- Being tested
- Stethophone
- Keywords
- moderate or severe aortic stenosis
- Medical subject headings
- Lymphoma, Follicular, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StethophoneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Stethophone |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new diagnosis of moderate or severe aortic stenosis on transthoracic echo/1000 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
Measured: Within 3 months after enrolment.
Secondary outcomes (6)
Proportion of eligible participants screened during intervention periods
Proportion of eligible participants screened during intervention periods
Measured: From enrollment until Day 1
Distribution of algorithm outputs
Distribution of algorithm outputs as normal, suggestive of aortic stenosis, other murmur detected, or inconclusive
Measured: From enrollment until Day 1
Proportion completing transthoracic echocardiography after an abnormal or inconclusive result
Proportion of participants completing transthoracic echocardiography after an abnormal or inconclusive result
Measured: Enrollment to 3 months
Average time from abnormal screen to echocardiography
Average time from abnormal screen to echocardiography
Measured: Enrollment to transthoracic echocardiography, assessed up to 3 months
Average time from confirmed diagnosis to referral to valve clinic, where applicable
Average time from confirmed diagnosis to referral to valve clinic, where applicable
Measured: ECHO confirmation to valve clinic referral, an average of 3 months
Diagnostic yield of transthoracic echocardiography
- 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
Measured: enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate or Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Every three months a randomly assigned family practice center crosses over to the intervention with a 2 week wash in period.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- KMH Cardiology and Diagnostic Centres, Sparrow Acoustics Inc., Ontario Health, Canadian Cardiovascular Society, Edwards life sciences, Medtronic
- Responsible party
- Sponsor
- Investigators
- Nicolas Bowers, MD MSc FRCPC FACC FSCAI, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828730
- Sponsor's protocol ID
- SAGE-AS
- Acronym
- SAGE-AS
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older
- ClinicalTrials.gov ID
- NCT07828730
- Acronym / sponsor ID
- SAGE-AS / SAGE-AS
- Conditions
- Moderate or Severe Aortic Stenosis
- Keywords
- moderate or severe aortic stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- KMH Cardiology and Diagnostic Centres, Sparrow Acoustics Inc., Ontario Health, Canadian Cardiovascular Society, Edwards life sciences, Medtronic
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Every three months a randomly assigned family practice center crosses over to the intervention with a 2 week wash in period.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: StethophoneDuring 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. |
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StethophoneThe 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. | Device | Intervention |
Primary outcome
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
6 secondary outcomes
Proportion of eligible participants screened during intervention periods
Time frame: From enrollment until Day 1
Distribution of algorithm outputs
Time frame: From enrollment until Day 1
Proportion completing transthoracic echocardiography after an abnormal or inconclusive result
Time frame: 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 confirmed diagnosis to referral to valve clinic, where applicable
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.
Related trials for Moderate or Severe Aortic Stenosis
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Recruiting
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Bowers, MD MSc FRCPC FACC FSCAI principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Stethophone in people with Moderate or Severe Aortic Stenosis, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.