| CTRI Number |
CTRI/2024/04/065617 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Study Comparing Two Heart Monitoring Devices |
|
Scientific Title of Study
|
A prospective, open label, pilot study to compare ECG electrical signals of
EG Holter PX3.0 with Bittium Faros 360 (3 channel lead-set with 5
electrodes) ECG Holter to evaluate equivalence via analysis using FDA
approved Bittium software without intended use in arrythmia(s) treatment |
| 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 Pradeep Kumar K |
| Designation |
Professor and HOD of Cardiology |
| Affiliation |
|
| Address |
Room No 410, Fourth Floor, Division of Interventional Cardiology, Department of Cardiology, SIMSRC, 15, Hesarghatta Rd, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
|
| Fax |
|
| Email |
doctorpradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Chandradhara |
| Designation |
Chief Executive Officer-Clinical or Contract Research Organization |
| Affiliation |
|
| Address |
BioAgile Therapeutics Pvt Ltd
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road,
RMV 2nd Stage, Bengaluru, Karnataka 560094
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Chandradhara |
| Designation |
Chief Executive Officer-Clinical or Contract Research Organization |
| Affiliation |
|
| Address |
BioAgile Therapeutics Pvt Ltd
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road,
RMV 2nd Stage, Bengaluru, Karnataka 560094
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
|
Source of Monetary or Material Support
|
| Nitto Denko Asia Technical Centre Pte Ltd, 3, Biopolis Drive, #03-17/18, Synapse, Singapore |
|
|
Primary Sponsor
|
| Name |
Nitto Denko Asia Technical Centre Pte Ltd, |
| Address |
3, Biopolis Drive, #03-17/18, Synapse, Singapore |
| Type of Sponsor |
Other [Medical Device Compnay] |
|
|
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 Pradeep Kumar K |
Sapthagiri Institute of Medical Sciences and Research Centre |
Room No 410, Fourth Floor, Division of Interventional Cardiology, Department of Cardiology, SIMSRC, 15, Hesarghatta Rd, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA |
9738620216
doctorpradeep@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences & Research Centre IEC |
Approved |
| SRI JAYADEVA 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 |
| Comparator Agent |
Bittium Faros 360 |
3 channel lead-set with 5 electrodes |
| Intervention |
EG Holter PX3.0 |
Patch type electrocardiograph |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subjects judged by PI with cardiac arrhythmia(s); Inclusion Criteria based on clinical symptoms
1.Unexplained syncope
2.Recurrent palpitation
3.Mitral valve prolapse with palpitations
4.IHD with severe LV dysfunction
5.Suspected Prinz metal angina
6.COPD patients with palpitations
Inclusion criteria on documented arrhythmias
1.Atrial fibrillation (paroxysmal or chronic)
2.Ventricular Tachycardia (sustained or non sustained)
3.Bundle branch block.
4.Supra ventricular Tachycardias including WPW
syndrome.
5.Frequent ventricular premature contractions or atrial premature contractions
6.Sinus Bradycardia
7.Sick sinus syndrome
8.First degree or second degree or suspected
intermittent third degree atrio ventricular blocks.
9.After initial catheter ablation treatment for atrial fibrillation.
10.Persons with a history of cerebral infarction or transient ischemic attack (TIA)
11.Willing to give written informed consent and adhere to all the requirements of this protocol. |
|
| ExclusionCriteria |
| Details |
Subjects with any of the following will be excluded
from the participation/enrollment in the clinical trial:
1.As per under use medical device instruction of use.
2.Pregnant and lactating female.
3.Subjects who are chronic smokers and alcoholics
4.Subject having known derma allergy.
5.Any other as adjudicated by PI
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the equivalence of ECG electrical signals of EG Holter PX3.0 with Bittium Faros 360 |
Baseline to 24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient experiences; Effect on skin and Ease of use |
At 24 Hours; 48 Hours and at 72 Hours |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
29/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Traditional ECG recordings involve placing electrodes on specific locations on the chest, which
can be cumbersome and limit patient mobility. Ambulatory ECG monitoring, also known as Holter
monitoring, addresses this limitation by allowing for continuous ECG recording over an extended
period, typically 24 to 72 hours, allowing the patient to undergo its daily routine activities.
This study aims to compare the signal quality and performance of a novel ECG Holter device, the
EG Holter PX3.0, against a well-established and FDA-approved device, the Bittium Faros 360.
In response to the challenge associated with the conventional ECG monitoring, there is a growing
need for alternative monitoring options that address issues of inconvenience and restricted patient
activity. If demonstrated to be comparable to current devices, the EG Holter PX3.0 may provide
patients undergoing Holter monitoring with a more pleasant and convenient option. Since the EG
Holter PX3.0 (assessment of a novel Japanese technology) is a relatively new gadget, it is necessary
to assess how well it performs in comparison to the industry standard, the Bittium Faros 360. Data
collection as results of this study on analysis can help with future research and development
activities connected to the EG Holter PX3.0 and its possible uses in arrhythmia management, even
if the study does not intend to use the collected data for arrhythmia diagnosis or treatment. |