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CTRI Number  CTRI/2017/05/008447 [Registered on: 02/05/2017] Trial Registered Retrospectively
Last Modified On: 04/05/2018
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Other (Specify) [Medical Device]  
Study Design  Single Arm Study 
Public Title of Study   MRI Scan of patients implanted with MRI conditional Cardiac Rhythm Management system  
Scientific Title of Study   Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRD-869_V. B_18Oct2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumit Anand  
Designation  Senior Manager 
Affiliation  St. Jude Medical India Pvt. Ltd 
Address  Property No. 100 1st Floor Okhla Industrial Estate Phase III New Delhi
Property No. 100 1st Floor Okhla Industrial Estate Phase III New Delhi
New Delhi
DELHI
110020
India 
Phone  911142600161  
Fax  911142600110  
Email  sanand@sjm.com  
 
Details of Contact Person
Scientific Query  
Name  Sumit Anand  
Designation  Senior Manager 
Affiliation  St. Jude Medical India Pvt. Ltd 
Address  Property No. 100 1st Floor Okhla Industrial Estate Phase III New Delhi
Property No. 100 1st Floor Okhla Industrial Estate Phase III New Delhi
New Delhi
DELHI
110020
India 
Phone  911142600161  
Fax  911142600110  
Email  sanand@sjm.com  
 
Details of Contact Person
Public Query  
Name  Sumit Anand  
Designation  Senior Manager 
Affiliation  St. Jude Medical India Pvt. Ltd 
Address  Property No. 100 1st Floor Okhla Industrial Estate Phase III New Delhi
Property No. 100 1st Floor Okhla Industrial Estate Phase III New Delhi
New Delhi
DELHI
110020
India 
Phone  911142600161  
Fax  911142600110  
Email  sanand@sjm.com  
 
Source of Monetary or Material Support  
St. Jude Medical (India) Ltd. 
 
Primary Sponsor  
Name  St Jude Medical India Ltd 
Address  No 1 11 250 A Matarani Sensation Begumpet Hyderabad 500016 India 
Type of Sponsor  Other [Medical Device ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Hong Kong
India
Australia
China
Finland
Hungary
Italy
Poland
Singapore
Slovakia  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A M Karthigesan   Apollo Hospital, Chennai   Dept. of cardiology, No 21 off Greams Road Chennai – 600006, Tamil Nadu (India)
Chennai
TAMIL NADU 		 91-8939177087

drkarthigesan_am@apollohospitals.com 
Dr Calambur Narasimhan  Care Hospital,   Road No. 1, Banjara Hills, Hyderabad – 500 034, Andhra Pradesh
Hyderabad
ANDHRA PRADESH 		 914023300795

calambur@hotmail.com 
Dr Anil Saxena  Fortis Escorts Heart Institute & Research Center  2nd Floor, OPD Building, Dept. of Clinical Research, Okhla Road, New Delhi - 110025
New Delhi
DELHI 		 01147135140

anil.saxena@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, Apollo Hospital Chennai  Approved 
Institutional Ethics Committee, Care Hospital, Hyderabad  Approved 
Institutional Ethics Committee, Fortis Escorts Heart Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients indicated for any one of the following: ICD / CRT-D / Pacemaker ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MRI Scan  Patient undergoes a Thoracic and Head MRI Scan  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Eligible subjects will meet all of the following:
• Are implanted with one of the following SJM device/lead combinations evaluated in this study for at least 60 days (can include patients with an eligible SJM lead for ≥ 60 days OR patients with a new eligible SJM pacemaker, ICD, or CRT device and eligible SJM lead implanted for at least 60 days:
1. Accent MRIâ„¢, Assurity MRIâ„¢, Endurity MRIâ„¢, or Endurity pacemaker with Tendrilâ„¢ STS Model 2088 lead
2. Accent MRIâ„¢, Assurity MRIâ„¢, Endurity MRIâ„¢, or Endurity pacemaker with IsoFlexâ„¢ Optim (Model 1944 or 1948) lead
3. Ellipseâ„¢ VR/DR or Fortify Assura VR/DR ICD with Tendrilâ„¢ STS (Model 2088) or Tendril MRIâ„¢ and Durataâ„¢ or Optisureâ„¢ leads
4. Quadra Assuraâ„¢ CRT-D with Tendrilâ„¢ STS (Model 2088), Durataâ„¢ or Optisureâ„¢, and Quartetâ„¢ Quadripolar leads
• Are implanted with an eligible SJM pacemaker, ICD, or CRT-D device pectorally
• Be willing to undergo an elective MRI scan without sedation. Note: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the subject can communicate with site personnel during the MRI scan
• Be able to provide informed consent for study participation (legal guardian is NOT acceptable)
• Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations  
 
ExclusionCriteria 
Details  Subjects will be excluded if they meet any of the following:
• Have another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
• Have other non-MRI compatible device or material implanted
o NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol
o NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol
o NOTE: Non-removable dental implants may be included
• Have a lead extender, adaptor, or capped/abandoned lead
• Be unable to fit in MRI bore, i.e., subject will come into contact with the magnet façade inside the MRI bore.
• Are currently participating in a clinical investigation that includes an active treatment arm
• Are pregnant or planning to become pregnant during the duration of the study
• Have a life expectancy of less than 3 months due to any condition
• Meet exclusion criteria per local law (e.g. age)  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Freedom from MRI scan-related complications: one month following the MRI scan.  one month post MRI scan 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of subjects with a capture threshold increase of less than 0.5V at 0.5 ms from pre MRI scan to one month post MRI scan   one month post MRI scan 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "135"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2017 
Date of Study Completion (India) 05/10/2017 
Date of First Enrollment (Global)  12/12/2016 
Date of Study Completion (Global) 02/12/2017 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   We will update same once become available.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This is a prospective, multi-center clinical study designed to confirm the safety and effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber ICDs, and CRT-Ds with various leads in an MRI environment. 

Total of 119 subjects enrolled across 14 investigational sites. The total duration of the study is 14 months. All Subjects were followed for 1 month following the MRI scan.  

 
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