An interventional study of Stethophone in Moderate or Severe Aortic Stenosis, sponsored by Sunnybrook Health Sciences Centre. Not yet recruiting. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Screening
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.
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.
1,891 studies on the registry are indexed under Lymphoma, Follicular; 290 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 48 across 1,503 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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
Time frame: Within 3 months after enrolment.
Proportion of eligible participants screened during intervention periods
Proportion of eligible participants screened during intervention periods
Time frame: From enrollment until Day 1
Distribution of algorithm outputs
Distribution of algorithm outputs as normal, suggestive of aortic stenosis, other murmur detected, or inconclusive
Time frame: 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
Time frame: Enrollment to 3 months
Average time from abnormal screen to echocardiography
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
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
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
Time frame: enrollment to ECHO confirmation or valve clinic referral whichever comes last, an average of 3 months
No study locations are listed for this record.
Plan to share: No — The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 141 non-industry interventional studies with no phase under Lymphoma, Follicular, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 47. This study's planned 15 months is below that.
Counting every sponsor, half of 165 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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