Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices
- Conditions
- Magnetic Field Exposure
- Interventions
- Other: Initiate ACLS protocol if lethal arrythmia develops
- Registration Number
- NCT03081364
- Lead Sponsor
- Saint Luke's Health System
- Brief Summary
The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac Implanted Electronic Devices)
- Detailed Description
At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely limited data and experience with performing MRIs on patient with abandoned and epicardial leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss this issue with the patient, screen the patient and assess their device beforehand, monitor them during the MRI examination, keep track of pulse sequences used, assess their devices after (and if necessary, resume prior programming before any changes), and to maintain that experience. The objective of this study is to create a protocol for an MRI at the commonly used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or defibrillators and have abandoned or epicardial leads and maintain a registry of participants, devices involved, MRI examinations and pulse sequences used, and to keep records of any follow up events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 532
- Anyone with a cardiac device
- Anyone who cannot consent for themselves or who don't have a durable power of attorney
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Outpatients Initiate ACLS protocol if lethal arrythmia develops MRI; Critical Care Monitoring, Device Programming
- Primary Outcome Measures
Name Time Method Change in blood pressure 3 years Monitored with automatic blood pressure cuff
Change in Thresholds of Pacing Lead 3 years Measured in mA
Change in heart rate 3 years Measured as beats per minute on single-lead heart monitor.
Change in Device Function 3 years Change in lead impedance or sensing
Oxygen Saturation 3 years Percentage of change or no change
Patient Comments 3 years Real-time patient report via intercom during scan of chest symptoms such as burning or aching
Interference Between the Implanted Cardiac Electronic Device and MRI 3 years Measure any change in device battery voltage
Dysrhythmias Noted During Scan 3 years Change in heart rhythm
- Secondary Outcome Measures
Name Time Method