Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03012568
• Date of registration: 05/01/2017
• Prospective Registration: No
• Primary sponsor: Abbott Medical Devices
• Public title: Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems ASSUREMRI
• Scientific title: ASSURE MRI Study - Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
• Date of first enrolment: November 10, 2016
• Target sample size: 119
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03012568
• Study type: Observational

Countries of recruitment

Australia, India

Contacts

• Name: Grant Kim
• Affiliation: Abbott Medical Devices

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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, Implantable
Cardioverter-Defibrillators (ICD), or Cardiac Resynchronization Therapy Defibrillators
(CRT-D) 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:

- 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

- 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

- 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: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tachycardia

Bradycardia

Intervention(s)

Device: SJM Implantable cardiac devices

Primary Outcome(s)

Safety Endpoint: Freedom from MRI scan-related complications [Time Frame: One month following the MRI scan.]

Secondary ID(s)

SJM-CIP-10137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors