| CTRI Number |
CTRI/2026/04/108963 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Monitoring Heart Rhythm Using a Wearable ECG Device for Early Arrhythmia Detectio |
|
Scientific Title of Study
|
CARDIO SENSE Wearable ECG Monitor for Early Detection of Cardiac Arrhythmias . |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gulipalli Pallavi |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College & Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital Saveetha Nagar , Thandalam , Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8500295909 |
| Fax |
|
| Email |
pallavigulipalli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Kannan |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College & Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital Saveetha Nagar , Thandalam , Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9710071284 |
| Fax |
|
| Email |
endork@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Gulipalli Pallavi |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College & Hospital |
| Address |
Department of General Medicine, Saveetha Medical College and Hospital Saveetha Nagar , Thandalam , Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8500295909 |
| Fax |
|
| Email |
pallavigulipalli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical college and hospital , Saveetha Nagar , Thandalam, Chennai , Tamil Nadu , India , PIN code: 602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai, Tamil Nadu , 602105 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gulipalli Pallavi |
Saveetha Medical College and Hospital |
Department of General Medicine, Room no-1 , Thandalam
Chennai
TAMIL NADU |
8500295900
pallavigulipalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CARDIO SENSE wearable ECG monitoring system |
The CARDIO SENSE wearable ECG monitoring system is a non-invasive, ambulatory electrocardiographic monitoring device used for continuous cardiac rhythm surveillance. The device is applied externally and records ECG signals continuously for a duration of 7–14 days.
It incorporates AI-assisted algorithms for automated detection of cardiac arrhythmias and enables prolonged monitoring, thereby improving the likelihood of identifying intermittent or asymptomatic arrhythmias. Data obtained from the device are stored and analyzed for the presence of rhythm abnormalities.
The device will be applied once and worn continuously during the monitoring period, with removal at the end of the study duration or earlier if clinically indicated. |
| Comparator Agent |
Conventional ECG monitoring (12-lead ECG ± 24-hour Holter monitoring) |
Conventional ECG monitoring includes a standard 12-lead electrocardiogram (ECG) performed at rest, with or without 24-hour ambulatory Holter monitoring, as per routine clinical practice.
The 12-lead ECG provides a point-in-time assessment of cardiac electrical activity, while Holter monitoring allows short-duration continuous recording (typically 24 hours). This approach represents the current standard diagnostic method for the evaluation and detection of cardiac arrhythmias.
Monitoring will be performed once or as clinically indicated during the study period. However, due to its limited duration, this method may have lower sensitivity for detecting intermittent or asymptomatic arrhythmias compared to prolonged continuous monitoring. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Population with suspected or confirmed intermittent arrhythmias e.g., palpitations, syncope, post-stroke AF screening |
|
| ExclusionCriteria |
| Details |
Dermatologic conditions precluding electrode placement.Implanted devices causing uninterpretable noise (if not filtered).Hemodynamic instability requiring continuous bedside monitoring only |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity and specificity of the CARDIO SENSE wearable ECG monitor in detecting cardiac arrhythmias compared to standard Holter ECG |
Assessed from baseline to 24–48 hours of continuous monitoring |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first arrhythmia detection, participant compliance (% wear time), ECG data quality (interpretable vs artifact), and any clinical actions triggered by the findings. |
collected daily during monitoring and assessed at end of monitoring period. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/04/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The CARDIO SENSE study aims to evaluate the effectiveness of a wearable ECG monitoring systemdesigned to continuously record cardiac electrical activity and early detect cardiac arrhythmias in adult participants. This non-invasive wearable device continuously collects high-fidelity ECG signals and related vital data to identify clinically significant arrhythmias such as atrial fibrillation, bradycardia, tachycardia, and other rhythm disturbances. The system integrates real-time data acquisition with automated analysis to alert clinicians and participants promptly upon detection of arrhythmic events. The study will assess the diagnostic accuracy of the wearable monitor compared with standard clinical ECG/Holter monitoring, and determine its feasibility for long-term ambulatory cardiac surveillance to support early intervention and improved clinical outcomes. |