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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients implanted with remote monitoring compatible CIEDs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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