Health TrialsbyHealthPanel

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

ConditionModerate or Severe Aortic Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Proportion of eligible participants screened during intervention periods

Proportion of eligible participants screened during intervention periods

Time frame
From enrollment until Day 1
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunnybrook Health Sciences Centre

Lead sponsor

KMH Cardiology and Diagnostic Centres

Collaborator

Sparrow Acoustics Inc.

Collaborator

Ontario Health

Collaborator

Canadian Cardiovascular Society

Collaborator

Edwards life sciences

Collaborator

Medtronic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: