FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095701 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On: 30/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   AI stethoscope as a bridge between traditional stethoscope and echocardiogram 
Scientific Title of Study   Validation of a triage tool (AI enabled Smart Stethoscope ) for screening heart sounds and murmurs using AiSteth Murmur Analysis Platform (AsMAP)- A cross-sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr Melvin George 
Designation  Head, Centre for Clinical Pharmacology 
Affiliation  SRM Medical College Hospital & Research Centre, 
Address  SRM Medical College Hospital, & Research Centre, Centre for Clinical Pharmacology, 3rd floor, D- Block, SRM Nagar, Potheri, Kattankulathur, Chengalpattu District.

Chennai
TAMIL NADU
603203
India 
Phone  9894133697  
Fax    
Email  head.ccp.ktr.med@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Melvin George 
Designation  Head, Centre for Clinical Pharmacology 
Affiliation  SRM Medical College Hospital & Research Centre, 
Address  SRM Medical College Hospital, & Research Centre, Centre for Clinical Pharmacology, 3rd floor, D- Block, SRM Nagar, Potheri, Kattankulathur, Chengalpattu District.

Chennai
TAMIL NADU
603203
India 
Phone  9894133697  
Fax    
Email  head.ccp.ktr.med@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Melvin George 
Designation  Head, Centre for Clinical Pharmacology 
Affiliation  SRM Medical College Hospital & Research Centre, 
Address  SRM Medical College Hospital, & Research Centre, Centre for Clinical Pharmacology, 3rd floor, D- Block, SRM Nagar, Potheri, Kattankulathur, Chengalpattu District.

Chennai
TAMIL NADU
603203
India 
Phone  9894133697  
Fax    
Email  head.ccp.ktr.med@srmist.edu.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) 
 
Primary Sponsor  
Name  Ai Health Highway India Private Limited 
Address  DSI Innovation campus, Block A, 2nd Floor, Gharebhavipalya, Hongasandra village, Hosur Road, Bangalore - 560068 Karnataka, India  
Type of Sponsor  Other [Medical Device Start Up ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Devapriya Rejeev  Dr Moopens Medical College  Dr Moopens Medical College, Naseera Nagar, Meppadi (P.O) Wayanad, Kerala 673577
Wayanad
KERALA 
9952949842

priya.snid@gmail.com 
Prof Dr Melvin George  SRM Medical College Hospital and Research Centre  SRM Medical College Hospital, & Research Centre, Centre for Clinical Pharmacology, 3rd floor, D- Block, SRM Nagar, Potheri, Kattankulathur- 603203, Chengalpattu District.
Chennai
TAMIL NADU 
9894133697

head.ccp.ktr.med@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
SRM Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Detection of Cardiac Murmurs and Heart Sounds  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Participants who are able and willing to provide informed consent
(or assent with guardian consent in the case of minors)
2.Participants aged above 10 years, including adolescents and adults
(pediatric and adult populations), of any gender. The upper age limit
is set at 80 years.
3.Individuals with a valid echocardiography report within the last 3
months that includes comprehensive parameters (M-mode,
Doppler, and Color Doppler)
4.Individuals willing to undergo echocardiography for the study if
a recent report is not available
5.Participants presenting to OPD or IPD with cardiac complaints or
referred for cardiac evaluation
6.Individuals with clinically suspected heart murmurs or valvular
disease, irrespective of symptom status
7.Individuals with stable hemodynamic status at the time of
auscultation (no acute distress or emergency)
8.Participants whose chest anatomy allows for proper auscultation
(e.g., no obstructing wounds or dressings) 
 
ExclusionCriteria 
Details  1. Presence of implanted cardiac devices (e.g., pacemaker,
implantable cardioverter defibrillators (ICDs), and left ventricular assist devices (LVADs) Cardiac Resynchronization Therapy (CRT), as these can interfere with murmur detection and acoustic
signals
2. Individuals with poor acoustic windows due to significant
obesity, chest wall deformities, or surgical interventions that impair
heart sound acquisition
3. Patients with active pulmonary conditions (e.g., pneumonia,
bronchospasm, pleural effusion) are likely to produce confounding
auscultatory findings
4. Participants with acute cardiovascular emergencies, such as acute
myocardial infarction, cardiac tamponade, or unstable arrhythmias,
were immediate care overrides study participation
5. Individuals with severe psychiatric illness or cognitive
impairment that impairs understanding of consent or compliance
with study procedures
6. Pregnant women in the third trimester, due to altered
hemodynamics that may affect auscultation and signal
interpretation
7. Patients currently undergoing thoracic surgery or intensive care
interventions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity and specificity of AiSteth in detecting cardiac murmurs and heart sounds as compared with comprehensive assessment by a physician, along with echocardiography.  There are no repeated follow ups. It is a single visit cross sectional study.

During the single study visit (about 30 minutes):
- Comprehensive history and physical examination
- Auscultation with conventional stethoscope
- Auscultation with AiSteth® (minimum 30 seconds exposure)
- Echocardiography (if not available within last 3 months, then performed at study site)

All assessments are done on the same day. There is no follow up after this visit.  
 
Secondary Outcome  
Outcome  TimePoints 
Sensitivity and specificity of AiSteth Murmur Analysis Platform’s (AsMAP) algorithms for detecting heart sounds and murmurs as compared with a conventional stethoscope.  During the single study visit (about 30 minutes):
- Conventional stethoscope auscultation  
 
Target Sample Size   Total Sample Size="1400"
Sample Size from India="1400" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Valvular Heart Disease (VHD) is a leading cause of cardiovascular morbidity and mortality worldwide and the resultant disease burden is only projected to increase in the coming decades. The prevalence of rheumatic heart disease, the most common form of valvular heart disease affects approximately 41 million individuals, has been on the rise in developing countries. This trend is likely linked to the growth of the young adult demographic and a reduction in premature mortality, attributed to enhanced access to antibiotics, microbiological diagnostics, and echocardiography. In developed nations, aortic valve stenosis is the most frequently encountered valvular condition, impacting around 9 million people globally, with its prevalence increasing due to an aging population and a higher incidence of atherosclerosis. Aortic regurgitation, which is linked to diastolic hypertension but not systolic hypertension, has similarly seen an uptick in prevalence in developed regions. Mitral regurgitation affects 24 million individuals worldwide, with significant variability across different countries. Primary mitral regurgitation typically results from myxomatous degeneration and mitral valve prolapse, largely influenced by genetic factors, while secondary mitral regurgitation constitutes 65% of cases and arises from dilation and heart failure. Additionally, tricuspid regurgitation has become more common in developed nations, largely due to the increased use of intracardiac pacemakers. Cardiovascular diseases (CVDs) and pathological murmurs are intricately linked, as murmurs often serve as clinical indicators of underlying cardiac abnormalities that can contribute to or signify various cardiovascular conditions. Pathological murmurs result from turbulent blood flow within the heart, which can be caused by structural defects such as valve abnormalities (e.g., stenosis or regurgitation), congenital heart defects, or other cardiac pathologies. These murmurs may be benign or indicative of serious conditions like hypertrophic cardiomyopathy, aortic aneurysms, or infective endocarditis, all of which are associated with increased risk of cardiovascular morbidity and mortality.

The examination of the cardiovascular system and the practice of cardiac auscultation serve as valuable tools in identifying murmurs. Furthermore, cardiac auscultation has proven to be beneficial in identifying valvular diseases in patients who exhibit no symptoms. Utilizing AIenabled stethoscopes presents an innovative approach to enhancing the efficiency and accuracy of pathological murmur detection. In addition, the rural regions of our nation lack sophisticated diagnostic capabilities for detecting cardiovascular diseases. Therefore, employing AI-enabled stethoscopes allows us to conduct screenings for pathological murmurs even by untrained health workers. Additionally, we can facilitate teleconsultations and arrange referrals for necessary follow-ups., enabling timely intervention to mitigate associated risks and improve patient outcomes.
 
Close