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CTRI Number  CTRI/2013/10/004057 [Registered on: 10/10/2013] Trial Registered Prospectively
Last Modified On: 11/03/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Monitoring in Dialysis study 
Scientific Title of Study   Monitoring in Dialysis Clinical Study India 
Trial Acronym  MID Study 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
Version 2.0, 07 October 2013  Protocol Number 
Version 3.0, 10 March 2014  Protocol Number 
Version 4.0, 09 May 2014  Protocol Number 
Version 5.0, 21-July-2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Rajesh Radhakrishnan 
Designation  Clinical Research Director 
Affiliation  India Medtronic Pvt. Ltd. 
Address  ndia Medtronic Pvt. Ltd. 1241, Solitaire Corporate Park, Building No 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E)

Mumbai
MAHARASHTRA
400093
India 
Phone    
Fax    
Email  rajesh.radhakrishnan@medtronic.com  
 
Details of Contact Person
Public Query  
Name  Rajesh Radhakrishnan 
Designation  Clinical Research Director 
Affiliation  India Medtronic Pvt. Ltd. 
Address  India Medtronic Pvt. Ltd. 1241, Solitaire Corporate Park, Building No 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E)

Mumbai
MAHARASHTRA
400093
India 
Phone    
Fax    
Email  rajesh.radhakrishnan@medtronic.com  
 
Source of Monetary or Material Support  
India Medtronic Pvt. Ltd. 
 
Primary Sponsor  
Name  India Medtronic Pvt Ltd 
Address  1241, Solitaire Corporate Park, Building No 12, 4th Floor, Andheri-Ghatkopar Link Road, Andheri (E) Mumbai MH 400093 India 
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K C Prakash  Apollo Hospital, Chennai  No. 21, Greams Lane, Off. Greams Road, Chennai-600 006
Chennai
TAMIL NADU 		 9884333934

Kcprk55@gmail.com 
Dr Vikranth Reddy  CARE Hospital  Banjara Hills, Road No. 01, Hyderabad - 500034
Hyderabad
ANDHRA PRADESH 		 91-9849122585

vikranthreddy@yahoo.com 
Dr SC Tiwari  Fortis Escorts Heart Institute and Research Centre  Okhla Road, New Delhi – 110025
New Delhi
DELHI 		 9810517781

sctiwari@hotmail.com 
Dr S C Tiwari  Fortis Flt. Lt. Rajan Dhall Hospital  Fortis Flt Lt Rajan Dhall Hospital,  B-1, Aruna Asaf Ali Marg, Sector B,  Vasant Kunj,  New Delhi 110070
North
DELHI 		 9810517781

sctiwari@hotmail.com 
Dr Saurabh Pokhariyal  Fortis Memorial Research Insitute  Fortis Memorial Research Institute, Sector 44, Gurgaon 122002 Haryana
Gurgaon
HARYANA 		 09811695298

saurabh.pokhariyal@fortishealthcare.com 
Dr Sanjiv Jasuja  Indraprastha Apollo Hospitals, Delhi  Sarita Vihar, Delhi - Mathura Road, New Delhi - 110076
New Delhi
DELHI 		 91-9811-111-455

sanjivjasuja@yahoo.com 
Dr Vijay Kher  Medanta - The Medicity  Sector - 38, Gurgaon, Haryana - 122001
Gurgaon
HARYANA 		 91-9811054118

vijay.kher@medanta.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Central Ethics Commitee, Apollo Hospital Group - Chennai  Approved 
Ethics Committee for Research-Fortis Vasantkunj  Approved 
Ethics committee on Clinical Trials, Indraprastha Apollo, Delhi  Approved 
Institutional Ethics Committee - Fortis Memorial Research Institute  Submittted/Under Review 
Institutional ethics committee of CARE forundation  Approved 
Medanta Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Patients on hemodialysis at least thrice-weekly,subjects with glomerular filtration rate less than (eGFR)15 mL/min/1.73m2 who will begin hemodialysis within two months of the Reveal® XT implant.,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Reveal XT Insertable Cardiac Monitor and Reveal LINQTM Implantable ICM  The Medtronic Reveal XT Model 9529 is a leadless, implantable, battery-powered, magnetic resonance (MR) conditional, monitoring and data storage device. It continuously monitors the patient’s subcutaneous ECG and The Medtronic Reveal LINQTM Model LNQ11 is a leadless, implantable, battery-powered, magnetic resonance (MR) conditional, monitoring and data storage device. It does not provide therapy but does continuously monitor the patient’s subcutaneous ECG. 
 
Inclusion Criteria
Modification(s)  
Age From  21.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  • Subject is 21 years of age or older
• Subject is willing to be implanted with the Reveal® ICM
• Subject has been diagnosed with ESRD and on hemodialysis at least three times per week
OR has an estimated glomerular filtration rate (eGFR) of < 15 mL/min/1.73m2 and is
expected to begin hemodialysis within 2 months of the Reveal® ICM implant, in the
opinion of the investigator
• Subject is willing and able to comply with the protocol, including sending data to the
Medtronic CareLink® Network using a CareLink® Monitor as requested 
 
ExclusionCriteria 
Details  • Subject is currently enrolled in an interventional study that may interfere with the
Monitoring in Dialysis protocol. Enrollment into another observational study is permitted
• Subject not suitable for Reveal® ICM implantation (e.g., severe cachexia, dermatologic
conditions of the skin, or major medical or social conditions expected to reduce survival to
6 months), in the opinion of the investigator
• Subject with an existing hemodialysis catheter that exits the left chest wall below the
clavicle and may interfere with the Reveal® ICM implantation site, in the opinion of the
investigator
• Subject with a recent infection defined as 1) bacteremia within 60 days OR 2) (nonbacteremic)
infection within 14 days
• Subject has end-stage liver failure, as determined by the investigator
• Subject has had thoracic surgery within the past 6 months
• Subject has an existing pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac
resynchronization devices
• Subject who is scheduled for renal transplantation or will likely be transplanted within 6 months, in the opinion of the investigator
• Subject that is currently on home hemodialysis, is scheduled to transition to home
hemodialysis or to peritoneal dialysis within 6 months, in the opinion of the investigator 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
The primary objective of this study is to estimate the proportion of hemodialysis subjects
experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous
cardiac monitoring with an implanted Medtronic Reveal® ICM device. 		 within 6 months after first dialysis session post device- implant 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To characterize the rate of device and procedure related adverse events (AEs) associated
with the use of the Reveal® XT in ESRD patients.
2) To document the nature and timing of health-related events (such as hospitalization,
hyper or hypovolemia, worsening heart failure, sudden cardiac death, etc.) and
treatment associated with ESRD and other conditions occurring in the implanted
patients. 		 As mentioned above 
 
Target Sample Size
Modification(s)  		 Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial
Modification(s)  		 N/A 
Date of First Enrollment (India)
Modification(s)  		 28/11/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   publication plan will be developed which may describe, but not limited to, committee member criteria and management of publications. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The purpose of this study is to characterize and estimate the occurrence of arrhythmic events in

hemodialysis patients through extended continuous cardiac monitoring using Medtronic’s Reveal® XT

Insertable Cardiac Monitor (ICM) system. Additionally, the study will explore the correlation of

arrhythmias recorded by the Reveal® XT with specific ESRD treatment characteristics, including preand

post-dialysis serum electrolyte changes, variations in dialysis session parameters, and changes in

background medications. Finally, this study will explore patterns of arrhythmic events detected by

the Reveal® XT which may be predictive of hospitalizations or severe cardiovascular events (e.g.,

sudden cardiac death, stroke, acute myocardial infarction, onset or worsening of congestive heart

failure, etc.).

The proposed study is an interventional post-market release study.

Subjects selected to participate in the study include those who are diagnosed with ESRD and are

currently on hemodialysis at least thrice-weekly or those subjects with an estimated glomerular

filtration rate (eGFR) <15 mL/min/1.73m2 who will begin hemodialysis within two months of the

Reveal® XT implant.

 
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