Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices

The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.

Study Overview

• Status: Unknown
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Radiation: MRI

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Banner University Medical Center Phoenix
      • Contact: Michael Morris, MD; Phone Number: 602-839-4850; Email: michael.morris@bannerhealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-MRI conditional pacemakers and ICDs referred for clinically indicated MRI scans.

Description

Inclusion Criteria. All patients with non-MRI conditional pacemakers and ICDs between the ages of 18-85 will be eligible to participate. Medical records will be reviewed to confirm the date and make/model of device implanted. Ordering physician discusses the MRI request with radiologist, documenting that there is no appropriate alternate imaging test. Patient must have an appointment with a cardiologist/electrophysiologist prior to MRI. Banner Health policy for standard of care guidelines involving patients receiving MRI's will be followed.

Exclusion Criteria. Patients will be excluded from MRI based on the Department of Radiology protocol. Additional exclusion criteria include: ICD and pacemaker dependent, Pacemaker inserted before 2002, Epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), Patient not awake or unable communicate, Battery voltage at elective replacement interval, implanted non-MRI conditional device (other than pacemaker/ICD).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death during the MRI scan	Immediate

Secondary Outcome Measures

Outcome Measure	Time Frame
Decrease in battery voltage >0.04v	6 months
Change in pacing lead impedance ≥ 50 Ω	6 months
Change in high-voltage lead impedance ≥ 3 Ω	6 months
Increase in pacing threshold ≥ 0.50 V @ 0.4 ms	6 months
Decrease in P wave measurement ≥ 50%	6 months
Decrease in R wave measurement ≥ 25%	6 months
Generator failure requiring immediate replacement	Immediate
Lead failure requiring immediate replacement	Immediate
New onset atrial or ventricular arrhythmia during MRI	Immediate
Loss of pacemaker capture during MRI	Immediate
Electrical reset of the device	Immediate

Collaborators and Investigators

• Sponsor: Banner Health
• Investigators: Principal Investigator: Michael Morris, MD, Banner University Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: September 3, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 1608820677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO