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CTRI Number  CTRI/2025/02/081461 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Wireless Patch Holter Monitor for Heart Rhythm Tracking: A Validation Study 
Scientific Title of Study   Comparison of Holter Monitors and Wireless Patch Devices in Cardiac patients: Validation of Wireless Patch Device 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhanu Duggal 
Designation  Professor and Head  
Affiliation  All India Institute of Medical Sciences 
Address  Department of Cardiology, AIIMS Rishikesh, Virbhadra Road, Shivaji Nagar Rishikesh, Uttarakhand.

Dehradun
UTTARANCHAL
249203
India 
Phone  9869418148  
Fax    
Email  nitin@sunfox.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhanu Duggal 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Cardiology, AIIMS Rishikesh, Virbhadra Road, Shivaji Nagar Rishikesh, Uttarakhand.

Dehradun
UTTARANCHAL
249203
India 
Phone  9869418148  
Fax    
Email  nitin@sunfox.in  
 
Details of Contact Person
Public Query  
Name  Dr Bhanu Duggal 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Cardiology, AIIMS Rishikesh, Virbhadra Road, Shivaji Nagar Rishikesh, Uttarakhand.

Dehradun
UTTARANCHAL
249203
India 
Phone  9869418148  
Fax    
Email  nitin@sunfox.in  
 
Source of Monetary or Material Support  
Sunfox Technologies Private Limited, 112, Dharampur Rd, Nehru Colony, Dharampur, Dehradun, Uttarakhand, India 248001 
 
Primary Sponsor  
Name  Sunfox Technologies Private Limited 
Address  112, Dharampur Rd, Nehru Colony, Dharampur, Dehradun, Uttarakhand 248001 
Type of Sponsor  Other [Medical Device manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhanu Duggal  All India Institute of Medical Sciences, Department of Cardiology  Department of cardiology, virbhadra road, Shivaji Nagar, Rishikesh, uttarakhand, 249203
Dehradun
UTTARANCHAL 		 7319893219

ghanshyam04t@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I491||Atrial premature depolarization. Ayurveda Condition: HRUDROGAH, (2) ICD-10 Condition:I499||Cardiac arrhythmia, unspecified. Ayurveda Condition: HRUDROGAH, (3) ICD-10 Condition:I482||Chronic atrial fibrillation. Ayurveda Condition: HRUDROGAH, (4) ICD-10 Condition:I447||Left bundle-branch block, unspecified. Ayurveda Condition: HRUDROGAH, (5) ICD-10 Condition:I443||Other and unspecified atrioventricular block. Ayurveda Condition: HRUDROGAH, (6) ICD-10 Condition:I498||Other specified cardiac arrhythmias. Ayurveda Condition: HRUDROGAH, (7) ICD-10 Condition:I480||Paroxysmal atrial fibrillation. Ayurveda Condition: HRUDROGAH, (8) ICD-10 Condition:I479||Paroxysmal tachycardia, unspecified. Ayurveda Condition: HRUDROGAH, (9) ICD-10 Condition:I481||Persistent atrial fibrillation. Ayurveda Condition: HRUDROGAH, (10) ICD-10 Condition:I470||Re-entry ventricular arrhythmia. Ayurveda Condition: HRUDROGAH, (11) ICD-10 Condition:I471||Supraventricular tachycardia. Ayurveda Condition: HRUDROGAH, (12) ICD-10 Condition:I489||Unspecified atrial fibrillation and atrial flutter. Ayurveda Condition: HRUDROGAH, (13) ICD-10 Condition:I472||Ventricular tachycardia. Ayurveda Condition: HRUDROGAH,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Patients with a history of cardiac symptomssuch as chest pain, lightheadedness, or breathlessness and those recommended for ambulatory ECG monitoring. 
 
ExclusionCriteria 
Details  Patients with significant skin conditions where device adhesion may be problematic.
Patients unable to comply with study protocols. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare the ability of wireless patch devices and Holter monitors to accurately detect and diagnose cardiac arrhythmias and other ECG abnormalities.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Analyse the correlation between ECG data from wireless patch devices and Holter monitors.  1 year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/03/2025 
Date of Study Completion (India) 13/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   This single-center, comparative, observational study at AIIMS Rishikesh aims to evaluate the diagnostic accuracy and overall reliability of a wireless patch device compared to a traditional Holter monitor for continuous cardiac monitoring. Fifty adult patients (above 20 years) with a history of cardiac symptoms and indications for ambulatory ECG monitoring will be enrolled. Following informed consent, participants will simultaneously wear both devices for a 24-hour period. Data from each device will be collected, analyzed, and compared in terms of arrhythmia detection rates, signal quality, patient comfort, and technical feasibility. The study will also incorporate patient feedback on ease of use and adherence. Statistical analysis will include constructing a confusion matrix and calculating sensitivity, specificity, positive predictive value, and negative predictive value. By comparing accuracy, usability, and compliance between the two devices, the research seeks to validate the wireless patch as a reliable alternative to the Holter monitor for extended cardiac monitoring in clinical practice. 
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