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

Completed

Conditions: patients indicated for any one of the following: ICD / CRT-D / Pacemaker

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Eligible subjects will meet all of the following: â€¢ 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 â‰¥ 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 â€¢ Are implanted with an eligible SJM pacemaker, ICD, or CRT-D device pectorally â€¢ 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 â€¢ Be able to provide informed consent for study participation (legal guardian is NOT acceptable) â€¢ 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: â€¢ 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.
â€¢ 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 â€¢ Have a lead extender, adaptor, or capped/abandoned lead â€¢ Be unable to fit in MRI bore, i.e., subject will come into contact with the magnet faÃ§ade inside the MRI bore.
â€¢ Are currently participating in a clinical investigation that includes an active treatment arm â€¢ Are pregnant or planning to become pregnant during the duration of the study â€¢ Have a life expectancy of less than 3 months due to any condition â€¢ Meet exclusion criteria per local law (e.g. age).

Primary Outcome Measures

Name	Time	Method
Freedom from MRI scan-related complications: one month following the MRI scan.	one month post MRI scan

Secondary Outcome Measures

Name	Time	Method
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

Locations (3): Apollo Hospital, Chennai
🇮🇳
Chennai, TAMIL NADU, India
Care Hospital,
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Fortis Escorts Heart Institute & Research Center
🇮🇳
Delhi, DELHI, India
Apollo Hospital, Chennai
🇮🇳Chennai, TAMIL NADU, India
Dr A M Karthigesan
Principal investigator
91-8939177087
drkarthigesan_am@apollohospitals.com