| CTRI Number |
CTRI/2020/02/023576 [Registered on: 25/02/2020] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Wearable external loop recorder for continuous cardiac monitoring |
|
Scientific Title of Study
|
A pilot prospective study to evaluate Electrocardiogram (ECG) signal acquisition and functionality of newly developed External Cardiac Monitoring (ECM) prototype |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.0 dated 01 October 2019 |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Sr Director Clinical and Medical Affairs Asia Region Led Market |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 6th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Sr Director Clinical and Medical Affairs Asia Region Led Market |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 6th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Vinay Rajan |
| Designation |
Sr Director Clinical and Medical Affairs Asia Region Led Market |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 6th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9619332703 |
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| India Medtronic Pvt Ltd
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093 |
|
Primary Sponsor
Modification(s)
|
| Name |
India Medtronic Pvt Ltd |
| Address |
Solitaire Corporate Park, Bldg No. 12, 6th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
|
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Daljeet Kaur |
AIG Hospital |
Room No 830
Survey No 136, Plot No 2/3/4/5, 1, Mindspace Rd, Gachibowli, Hyderabad, Telangana 500032
Hyderabad
TELANGANA |
8978428938
drdaljeetsaggu@gmail.com |
| Dr Praveen Sreekumar |
Aster Medicity |
Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala
682027, India
Ernakulam
KERALA |
9995805278
praveen_sreekumar2004@yahoo.com |
| Dr Ajay Naik |
Care Institute of Medical Sciences and Research |
Near Shukan Mall, Off. Science City Road, Sola,
Ahmedabad, Gujarat-380060, India
Ahmadabad
GUJARAT |
7927712771
ajay.naik@cims.me |
| Dr Nagamalesh U M |
M S Ramaiah Medical College and Hospitals, |
New BEL Road, MSRIT Post, MS Ramaiah Nagar, Bangalore, Karnataka – 560054
Bangalore
KARNATAKA |
8022183070
nmalesh@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee of Care Institute Of Medical Science |
Approved |
| Ethics Committee, MS Ramaiah Medical College and Hospital |
Approved |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee Aster Medcity |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Above 18 years of age
2) Patients with the previous history of cardiovascular disease
3) Patients with a previous history of cardiovascular disease (or) suspected (or) increased risk of cardiac arrhythmia in the setting of unexplained syncope, cryptogenic stroke or with transient symptoms of dizziness, palpitations, or chest pain
4) Enroll only In-patients who can complete for the Group A study
5) The subject is willing to sign the Informed consent form
|
|
| ExclusionCriteria |
| Details |
1) Patients implanted with Cardiac Implantable Electronic Device (CIED) (e.g., IPG, ICD, CRT, etc.)
2) Any high-risk patient who is already implanted or needs an implant with other life sustaining equipment during the course of study, that may interfere with the function of Cardilinq External Cardiac Monitor(ECM) prototype should be excluded as per physician discretion
3) Patients with a history of sweat allergy
4) Patients with prior evidence of skin irritation or symptoms of skin infection OR wound at any point where the ZephyrTM Bioharness chest strap will contact the subject
5) Female patients who are pregnant and breastfeeding
6) Not willing to consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the study to evaluate the quality of the ECG signal acquisition to assess the incidence of cardiac arrhythmia during short-term (up to 24hrs) and long-term monitoring (for 3 months), via Group A and Group B studies respectively. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To assess the patient comfort level and compliance with the prototype use while being continuously monitored for 3 months.
- To assess the functionality of the prototype in acquiring ECG data for a period of 3 Months.
|
3 Months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/02/2020 |
| 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
Modification(s)
|
Years="5"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cardiac arrhythmias such as
Atrial Fibrillation (AF) and sinus node disease usually can be silent,
intermittent and asymptomatic in
nature. The current recommended practice of 24 hours
Electrocardiogram (ECG)
recording could miss significant arrhythmia requiring therapeutic intervention
. This results in low diagnostic
yield and inferior clinical outcome for the patient. An extended
Continuous Cardiac Monitoring
(CCM) duration can improve diagnostic yield for diseases with
intermittent symptoms or
asymptomatic arrhythmias (syncope, palpitations or unexplained stroke) and
can provide a clear picture to
the severity for diseases such as atrial fibrillation to help in the guidance
of
appropriate medical management.
|