Arrhythmias, Cardiac
Conditions
Brief 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.
Interventions
RADIATIONMRI
Sponsors
Banner Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death during the MRI scan | Immediate |
Secondary
| Measure | Time frame |
|---|---|
| Loss of pacemaker capture during MRI | Immediate |
| Electrical reset of the device | Immediate |
| 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 |
| New onset atrial or ventricular arrhythmia during MRI | Immediate |
| 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 |
| Increase in pacing threshold ≥ 0.50 V @ 0.4 ms | 6 months |
Countries
United States
Contacts
Primary ContactMichael Morris, MD
Outcome results
None listed