MRI Scan of patients implanted with MRI conditional Cardiac Rhythm Management system

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/05/008447
• Date of registration: 02-05-2017
• Prospective Registration: No
• Primary sponsor: St Jude Medical India Ltd
• Public title: MRI Scan of patients implanted with MRI conditional Cardiac Rhythm Management system
• Scientific title: Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems
• Date of first enrolment: 20-01-2017
• Target sample size: 88
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15979
• Study type: PMS
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

Australia, China, Finland, Hong Kong, Hungary, India, Italy, Poland, Singapore, Slovakia

Contacts

• Name: Sumit Anand
• Affiliation: St. Jude Medical India Pvt. Ltd

• Name: Sumit Anand
• Affiliation: St. Jude Medical India Pvt. Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 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 MRI•, Assurity MRI•, Endurity MRI•, or Endurity pacemaker with Tendril• STS Model 2088 lead

2. Accent MRI•, Assurity MRI•, Endurity MRI•, or Endurity pacemaker with IsoFlex• Optim (Model 1944 or 1948) lead

3. Ellipse• VR/DR or Fortify Assura VR/DR ICD with Tendril• STS (Model 2088) or Tendril MRI• and Durata• or Optisure• leads

4. Quadra Assura• CRT-D with Tendril• STS (Model 2088), Durata• or Optisure•, and Quartet• 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
Exclusion criteria: 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)

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- patients indicated for any one of the following: ICD / CRT-D / Pacemaker

Intervention(s)

Intervention1: MRI Scan: Patient undergoes a Thoracic and Head MRI Scan
Control Intervention1: Nil: Nil

Primary Outcome(s)

Freedom from MRI scan-related complications: one month following the MRI scan.Timepoint: one month post MRI scan

Secondary Outcome(s)

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 scanTimepoint: one month post MRI scan

Secondary ID(s)

CRD-869_V. B_18Oct2016

Source(s) of Monetary Support

St. Jude Medical (India) Ltd.

Ethics review

Status: Approved
Approval date: 15/10/2016
Contact:

Institutional Ethics Committee, Care Hospital, Hyderabad

Status: Approved
Approval date: 30/11/2016
Contact:

Institutional Ethics Committee, Fortis Escorts Heart Institute

Status: Approved
Approval date: 31/12/2016
Contact:

Institutional Ethics Committee, Apollo Hospital Chennai

Results

• Date Completed: 05/10/2017