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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Death during the MRI scan | Immediate |
| Measure | Description | 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 |
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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).
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Patients with non-MRI conditional pacemakers and ICDs referred for clinically indicated MRI scans.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Morris, MD | Contact | 602-839-4850 | michael.morris@bannerhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Morris, MD | Banner University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Phoenix | Recruiting | Phoenix | Arizona | 85004 | United States |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |