| CTRI Number |
CTRI/2017/05/008511 [Registered on: 08/05/2017] Trial Registered Prospectively |
| Last Modified On: |
06/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Usefullness and safety of Remote monitoring of pacemakers in India |
|
Scientific Title of Study
|
A Multicentre Registry on Remote monitoring of Cardiac Implantable Electronic Devices – Analysis of Feasibility and Efficacy in Indian population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ulhas M Pandurangi |
| Designation |
Project Owner |
| Affiliation |
The Madras Medical Mission |
| Address |
No:4A, Dr. JJ Nagar,
Mogappair
Chennai 600037 No:4A, Dr. JJ Nagar,
Mogappair
Chennai 600037 Chennai TAMIL NADU 600037 India |
| Phone |
9841273868 |
| Fax |
|
| Email |
epulhas@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ulhas M Pandurangi |
| Designation |
Project Owner |
| Affiliation |
The Madras Medical Mission |
| Address |
No:4A, Dr. JJ Nagar,
Mogappair
Chennai 600037 No:4A, Dr. JJ Nagar,
Mogappair
Chennai 600037 Chennai TAMIL NADU 600037 India |
| Phone |
9841273868 |
| Fax |
|
| Email |
epulhas@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ulhas M Pandurangi |
| Designation |
Project Owner |
| Affiliation |
The Madras Medical Mission |
| Address |
No:4A, Dr. JJ Nagar,
Mogappair
Chennai 600037 No:4A, Dr. JJ Nagar,
Mogappair
Chennai 600037 Chennai TAMIL NADU 600037 India |
| Phone |
9841273868 |
| Fax |
|
| Email |
epulhas@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Madras Medical Mission
4A, Dr. JJ Nagar, Mogappair,
Chennai 600037 |
|
|
Primary Sponsor
|
| Name |
The Madras Medical Mission |
| Address |
No:4A, Dr. JJ Nagar,
Mogappair
Chennai 600037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aftab Khan |
Apollo Gleneagles Hospital, Kolkata, |
58 Canal Circular Road, Kolkata-700054 Kolkata WEST BENGAL |
9051024522
Cardiokhan@gmail.com |
| Dr Subash Chandra |
BL KAPOOR superspeciality hospital |
PUSA ROAD, NEW DELHI-110005 Central DELHI |
9810075983
Subhash.chandra@blkhospital.com |
| Dr Ajay Naik |
Care Institute of Medical Sciences |
Nr. Shukan Mall, Off Science City Road, Sola Ahmedabad, Gujarat, 380060
Ahmadabad
GUJARAT Ahmadabad GUJARAT |
7930101166-67
ajay.naik@cims.me |
| DR JOHN ROSHAN |
Christian Medical College Hospital |
IDA Scudder Rd, Vellore, Tamil Nadu 632004 Vellore TAMIL NADU |
9443312680
johnroshanjacob@gmail.com |
| Dr Aparna Jaswal |
Fortis Escorts Heart Institute |
Okhla Main Road, Okhla, Delhi- 110025
South
DELHI South DELHI |
911141628426
aparnajaswal@hotmail.com |
| Dr Viveka kumar |
MAX SUPERSPECIALITY HOSPITAL |
NO.2, PRESS ENCLAVE ROAD, SAKET, Delhi-110017 Central DELHI |
9871201190
Viveka.kumar@maxhealthcare.com |
| Dr Animesh Mishra |
NEIGRIHMS |
DEPARTMENT OF CARDIOLOGY
NEIGRIHMS, MAWDIANGDIANG,SHILONG, MEGHALAYA Chennai TAMIL NADU |
9436114330
animesh.shillong@gmail.com |
| Dr Anoop Gupta |
Sterling Hospitals |
Sterling Hospital Road, Memnagar
Ahmadabad
GUJARAT 380060 Ahmadabad GUJARAT |
91-79-40011111
anoopgupta@msn.com |
| Dr Jayakeerthi Rao |
Sunshine Hospital |
Penderghast Road, Opposite Parsi Dharamsala, Behind Paradise Hotel, Secunderabad, Telangana 500003 Hyderabad ANDHRA PRADESH |
9880110011
jayakeerthiy@gmail.com |
| Dr Ulhas M Pandurangi |
The Madras Medical Mission |
4A, Dr. JJ Nagar, Mogappair, Chennai 600037 Chennai TAMIL NADU |
9884671892
epulhas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| AARCE |
Submittted/Under Review |
| Ethics Committee of CIMS |
Submittted/Under Review |
| Institution ethics committee, Max Superspeciality hospital |
Submittted/Under Review |
| Institution ethics committee, NEIGRIHMS |
Submittted/Under Review |
| Institutional Ethics Committee, Apollo Gleneagles Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, The Madras Medical Mission |
Approved |
| Institutional ethics commmittee, Sunshine Hospitals |
Submittted/Under Review |
| Institutional Review Board, Christian Medical College, Vellore |
Submittted/Under Review |
| Sterling Hospital Ethics Committee |
Submittted/Under Review |
| The Independent Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients implanted with remote monitoring compatible CIEDs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who are implanted with any one of the following CIEDs (irrespective of age of implant) that are compatible to Home Monitoring® who are willing to acquire the remote monitoring unit and willing to provide consent shall be enrolled into the registry.
•Single / Dual Chamber Pacemaker
•Single / Dual Chamber AICD
•Cardiac Resynchronization Therapy Pacemaker (CRT-P)
•Cardiac Resynchronization therapy Defibrillator (CRT-D)
|
|
| ExclusionCriteria |
| Details |
•Patients who cannot provide consent or unwilling to acquire Home monitoring® |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
safety and feasibility.
The utility of remote monitoring in terms of early identification of device related malfunctions
Benefits of early device optimization with daily transmissions from CardioMessenger® Smart.
Avoidance of hospital device interrogation visits with daily transmissions from CardioMessenger® Smart.
|
end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Technical difficulties
Remote monitoring unit related malfunctions
The acceptance and satisfaction by patients and physicians
Battery consumption and success rate of daily remote monitoring transmissions
|
end of study |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/06/2017 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary objective: · To evaluate the feasibility and safety of remote monitoring in Indian population · To identify the utility of remote monitoring in terms of early identification of device related malfunctions with daily transmissions from CardioMessenger® Smart · To analyze the benefits of remote monitoring resulting in early device optimization with daily transmissions from CardioMessenger® Smart · To analyze the influence of remote monitoring in avoiding in hospital device interrogation visits with daily transmissions from CardioMessenger® Smart Secondary objective: To identify the technical difficulties involved in remote monitoring in India · To identify the remote monitoring unit related malfunctions · To evaluate the acceptance of remote monitoring technology in all patients who undergo CIEDs and also evaluate the satisfaction of the patients and the physician by obtaining feedback at the end of the registry. · To evaluate the battery consumption and success rate of daily remote monitoring transmissions Procedural Description: All the patients implanted with CIEDs (irrespective of age of implant) that are compatible with Home Monitoring® who are willing to acquire the remote monitoring unit and willing to provide consent shall be enrolled into the registry. The initial acceptance to remote monitoring technology is analyzed. Upon enrolment onto the registry, the clinical data, implantation details and device data at the time of implant and/or prior to discharge is documented. The first remote monitoring transmission is performed in the hospital on the day of enrolment. The routine pacemaker clinic follow up is avoided. The patient would be called to the pacemaker clinic only if reprogramming of the device is warranted. The clinical evaluation is as per the discretion of the treating investigator and the frequency of visits and their clinical details are documented. The remote monitoring transmissions are automatic and are transmitted every day by 2:00am. The data is analysed based on the alerts received from the Home Monitoring® service centre. The parameters to be monitored and the severity of alerts from the device needs to be programmed as specified in the protocol at the time of enrolment. The decision made by the treating physician on treatment for each alert received for every patient is documented. In case of an event requiring medical/device optimization, the event is expected to be documented and reported on the same day. All the data documented will be collected in paper CRF. |