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Clinical Trial Details (PDF Generation Date :- Thu, 26 Aug 2021 01 PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 14:08:32 GMT) CTRI Number CTRI/2016/12/007612 [Registered on: 23/12/2016] - Trial Registered Retrospectively Last Modified On 25/09/2019 Post Graduate Thesis No Type of Trial PMS Type of Study Medical Device Study Design Other Public Title of Study MRI Scans in patients implanted with MRI conditional ICD Scientific Title of A post-market clinical evaluation of St. Jude Medical™ MR Conditional ICD System on patients Study undergoing Magnetic Resonance Imaging Secondary IDs if Any Secondary ID Identifier The CRD_889_V B_04 Dec 2017 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Tarlochan Singh Kler Trial Coordinator (multi-center study) Designation Executive Director Affiliation Fortis Escorts Heart Institute & Research Center Address Fortis Escorts Heart Institute & Research Center Okhla Road South DELHI 110025 India Phone 01147135000 Fax 911141628431 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Sumit Anand PhD Query) Designation Senior Manager Affiliation St. Jude Medical Pvt. Ltd Address Property No. 100 1st Floor Okhla Industrial Estate Phase III New Delhi South DELHI 110020 India Phone 01142600161 Fax 01142600110 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Sumit Anand PhD Designation Senior Manager Affiliation St. Jude Medical Pvt. Ltd Address Property No. 100 1st Floor Okhla Industrial Estate Phase III New Delhi South DELHI 110020 India Phone 01142600161 Fax 01142600110 page 1 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > St. Jude Medical (Hong Kong) Ltd. Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Malaysia Republic of Korea Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Debasis Ghosh Apollo Gleneagles 1st Floor, Clinical Trial 91-9831034078 hospital & Research Dept, 58 canal circular road [email protected] Kolkata- 700054, west Bengal, India Kolkata WEST BENGAL Dr Santosh Kumar Dora Asian Heart Institute, G / N Block, Bandra 9920069719 Mumbai Kurla Complex, Bandra East, Mumbai, [email protected] Maharashtra 400051, India Mumbai MAHARASHTRA Dr Upendra Kaul Batra Hospital & 1, Tughlakabad 919811150518 Medical Research Institutional Area, Centre Mehrauli Badarpur [email protected] Road, Near Saket m Metro Station New Delhi DELHI Dr Subhash Chandra BLK Super Speciality Dept. of Cardiology, 91-1130653932 Hospital Pusa Road, Rajinder Nagar, New Delhi, Delhi subhash.chandra@blkh 110005 ospital.com New Delhi DELHI Dr Chennapragada Care Hospital Dept. of Cardiology, 91-9866101054 sridevi Road No. 1, Banjara Hills, [email protected] Huderabad-500034, m Andhra Pradesh, India Hyderabad ANDHRA PRADESH Dr Ajay Naik Care Institute of Near Shukan Mall, Off 917927712777 Medical Sciences Science City Road, Sola, Ahmedabad, [email protected] Gujarat, India 380060 page 2 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Ahmadabad GUJARAT Dr Aparna Jaswal Fortis Escorts Heart Okhla Road, New Delhi 01147135000 Institute 110 025, India South aparnajaswal@hotmail. DELHI com Dr Upendra Kaul Fortis Flt. Lt. Rajan Sector B, Pocket 1, 9811150518 Dhall Hospital, Delhi Aruna Asaf Ali Marg,Vasant Kunj, New [email protected] Delhi, Delhi 110070, m India New Delhi DELHI Dr Vanita Arora Max Super Specialty Dept. of Cardiology, 1, 91-9871879994 Hospital 2, Press Enclave Road, Mandir Marg, Saket, vanita.arora@maxhealt Delhi 110017 hcare.com New Delhi DELHI Dr Balbir Singh Medanta Medicity 4 Floor, Dept. of EP & 919811102598 Hospital Intervention Cardiology, edanta-The Medicity, Balbir.Singh@Medanta. Sector 38, Gurgaon, org Haryana, 122001 Gurgaon HARYANA Dr Praveen Chandra Medanta-The Medicity Medanta-The Medicity, 91-9810125370 Sector 38, Gurgaon, Haryana, 122001 Praveen.chandra@med Gurgaon anta.org HARYANA Dr Kapil Kumawat Narayana Institute of 258/A, Bommasandra 9694094523 Cardiac Sciences, Industrial Area Hosur Bommasandra Road, Anekal Taluk, drkapilkumawat@yahoo Bangalore, .com KARNATAKA 560099 Bangalore KARNATAKA Dr Vinod Sharma National Heart Institute Ground Floor, OPD 919810131739 Building, National Heart Institute, 49-50, [email protected] Community Centre, East of Kailash, New Delhi, India New Delhi DELHI Dr Rajesh Vijayvergiya Post Graduate Institute Department of 91-9815221856 of Medical Education & Cardiology, 3rd Floor C Research Block, Advance Cardiac rajeshvijay999@hotmail Center, Post Graduate .com Institute of Medical Education & Research, Chandigarh 160012, India Chandigarh CHANDIGARH Dr T S Kler Pushpawati Singhania 1st Floor, Dept. of 9810081850 Research Institute Cardiology, Pushpawati Singhania Research [email protected] page 3 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Institute , Press Enclave Marg, New Delhi 110017 New Delhi DELHI Dr Chandrakant Ruby Hall Clinic Dept. of Cardiology, 40, 91-9823503077 Chavan Sassoon Road, Pune-411001, cbchavan19740210@y Maharashtra, India ahoo.com Pune MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Dr. B. L. Kapur Approved 17/12/2016 No Memoprial Hospital, Ethics Committee, BLK Hospital Ethics Committee of Approved 18/12/2018 No Care Institute of Medical Sciences Institutional Ethics Not Applicable No Date Specified No Committee, AIIMS, Delhi Institutional Ethics Approved 01/02/2018 No Committee, Apollo Gleneagles Hospital Institutional Ethics Approved 22/12/2017 No Committee, Asian Heart Institute Mumbai Institutional Ethics Approved 17/02/2018 No Committee, Care Hospital, Hyderabad Institutional Ethics Approved 12/04/2018 No Committee, Fortis Escorts Heart Institute Institutional Ethics Approved 22/03/2018 No Committee, Fortis Flt. Lt. Rajan Dhall Hospital Institutional Ethics Approved 22/03/2017 No Committee, Max Super Speciality Hospital, Delhi Institutional Ethics Approved 26/12/2017 No Committee, National Heart Institute Institutional Ethics Approved 19/04/2018 No Committee, PGIMER Chandigarh Institutional Ethics Approved 28/10/2016 No Committee, Ruby Hall Clinic Medanta Institutional Approved 05/01/2018 No Ethics Committee Medanta Institutional Approved 05/01/2018 No Ethics Committee Narayana Health Approved 24/05/2019 No page 4 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in Medical Ethics Committee, Bangalore Pushpawati Singhania Approved 14/12/2017 No Research Institute Ethics Committee Scientific Research & Approved 14/12/2017 No Ethics Review Committee, Batra Hospital Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Patient implanted with MRI conditional ICD of St. Jude Medical Intervention / Type Name Details Comparator Agent Intervention MRI Scan Patient undergoes a Thoracic MRI Scan Comparator Agent Nil Nil Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 80.00 Year(s) Gender Both Details To participate in this clinical investigation, the subject must meet all of the following inclusion criteria: <br/> 1. Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 60 days<br/> 2. Subject is willing to undergo an elective MRI scan without sedation<br/> NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan<br/> 3. Subject’s ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms<br/> 4. Subject’s ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is stable > 4mV<br/> 5. Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)<br/> 6. Subject is willing and able to comply with the prescribed follow-up tests and procedures<br/> 7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form) Exclusion Criteria Exclusion Criteria Details To participate in this clinical investigation, the subject must meet none of the following exclusion criteria: 1. Subject is pacemaker dependent 2. Subject has a non SJM MRI compatible endocardial lead implanted or capped 3. Subject has 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. 4. Subject has a high voltage lead revision incidence 5. Subject has other non-MRI compatible device or material implanted 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 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 NOTE: Non-removable dental implants may be included page 5 / 7 PDF of Trial CTRI Website URL - http://ctri.nic.in 6. Subject has a lead extender, adaptor, or capped/abandoned lead 7.
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