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

Arrhythmias, Cardiac Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02906189
• Other study ID #: 1608820677
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2016
• Last updated: September 14, 2016
• Start date: September 2016
• Est. completion date: September 2021

Study information

• Verified date: September 2016
• Source: Banner Health
• Contact: Michael Morris, MD
• Phone: 602-839-4850
• Email: michael.morris[@]bannerhealth.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Radiation:
• MRI

Locations

Country	Name	City	State
United States	Banner University Medical Center Phoenix	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Banner Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death during the MRI scan		Immediate	No
Secondary	Decrease in battery voltage >0.04v		6 months	No
Secondary	Change in pacing lead impedance = 50 O		6 months	No
Secondary	Change in high-voltage lead impedance = 3 O		6 months	No
Secondary	Increase in pacing threshold = 0.50 V @ 0.4 ms		6 months	No
Secondary	Decrease in P wave measurement = 50%		6 months	No
Secondary	Decrease in R wave measurement = 25%		6 months	No
Secondary	Generator failure requiring immediate replacement		Immediate	No
Secondary	Lead failure requiring immediate replacement		Immediate	No
Secondary	New onset atrial or ventricular arrhythmia during MRI		Immediate	No
Secondary	Loss of pacemaker capture during MRI		Immediate	No
Secondary	Electrical reset of the device		Immediate	No