A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging (ASIA MRI ICD)

To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.

Study Overview

• Status: Completed
• Conditions: Tachycardia; ICD
• Intervention / Treatment: Radiation: Thoracic MRI Scan

Detailed Description

This clinical investigation is a prospective, multicenter, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Post Graduate Institute of Medical Education & Research
  • Delhi, India, 110005
    • BLK Super Speciality Hospital
  • Delhi, India, 110017
    • MAX Super Specialty Hospital
  • Delhi, India, 110017
    • Pushpawati Singhania Research Institute
  • Delhi, India
    • Apollo Gleneagles Hospital
  • Delhi, India
    • Batra Hospital & Medical Research Centre
  • Delhi, India
    • Fortis Flt. Lt. Rajan Dhall Hospital
  • Delhi, India
    • National Heart Institute
  • Gurgaon, India, 122001
    • Medanta Medicity Hospital
  • Hyderabad, India, 500034
    • Care hospital
  • Mumbai, India, 400051
    • Asian Heart Institute
  • New Delhi, India
    • Escorts Heart Institute and Research Centre
  • Pune, India, 411001
    • Ruby Hall Clinic
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Medanta-The Medicity
• Korea, Republic of
  • Cheonan, Korea, Republic of
    • Dankook University Hospital
  • Seongnam-si, Korea, Republic of
    • CHA Bundang Medical Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Seoul St. Mary Hospital
• Malaysia
  • Kajang, Malaysia
    • Hospital Serdang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 60 days
2. Subject is willing to undergo an elective MRI scan without sedation 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
3. Subject's ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms
4. Subject's ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is stable > 4mV
5. Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
6. Subject is willing and able to comply with the prescribed follow-up tests and procedures
7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form)

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 < 60 days of the enrollment visit
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
6. Subject has a lead extender, adaptor, or capped/abandoned lead
7. Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM.
8. Subject is pregnant or planning to become pregnant during the duration of the subject's participation in the study
9. Subject has a life expectancy of less than 12 months due to any condition
10. Subject has exclusion criteria required by local law (e.g., age)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic MRI Scan with 1.5 Tesla MRI; Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.	Radiation: Thoracic MRI Scan; The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.
Experimental: Thoracic MRI Scan with 3 Tesla MRI; Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 3T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.	Radiation: Thoracic MRI Scan; The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System	*A complication is a serious adverse device effect (SADE) that requires an invasive intervention or leads to death. The primary endpoint analysis will be performed for each study phase separately.	from MRI scan visit to 1 month post-MRI scan visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Average Specific Absorption Rate (SAR)	The average Specific Absorption Rate (SAR) during the MRI scan	MRI scan visit
Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System	This proportion was calculated as the number of subjects who had high voltage leads with capture threshold increases of ≤ 0.5V @ 0.5 ms from pre MRI scan testing to 1-month post MRI scan testing divided by total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre-MRI scan and 1-month post MRI scan capture threshold measurements available.	from MRI scan visit to 1-month post MRI scan visit
Proportion of SJM High Voltage Lead Implanted With SJM MR Conditional ICD With Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1 Month Post-MRI Scan Testing	This proportion was calculated as the number of subjects who had high voltage leads with sensing amplitude decrease of ≤ 50% from pre MRI scan testing to 1 month post MRI scan testing divided by the total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available.	from pre MRI scan to 1-month post MRI scan
The Peak Specific Absorption Rate (SAR) During the MRI Scan	The peak Specific Absorption Rate (SAR) during the MRI scan	MRI Scan Visit
The Mean MRI Visit Duration in the MRI Lab	The mean MRI visit duration in the MRI lab	MRI Visit
Total MRI Scan Duration in MRI Laboratory	Total MRI scan duration in MRI laboratory	MRI Visit

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Grant Kim, St. Jude Medical, Inc.

Publications and helpful links

General Publications

• Tarlochan Singh Kler, Praveen Chandra, Chandrakant Chavan, Rajesh Vijayvergiya, Subhash Chandra, Anoop Gupta, Sridevi Chennapragada, Joung Bo Young, Mona Bhatia, Choi Eue Keun, Vanita Arora, Tom Devasia, Upendra Kaul, Sumit Anand, Kartikeya Bhargava. Initial experience of thoracic Magnetic Resonance Imaging (MRI) scanning in Asian patients implanted the Ellipse MR Conditional ICD System - The ASIA MRI ICD Study. APHRS 2017; Abstract no. 40528.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): March 23, 2020
• Study Completion (Actual): March 23, 2020

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimated): August 24, 2016

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: ICD; tachycardia; Thoracic MRI Scan
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: SJM-CIP-10163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED