Arrhythmias, Cardiac
Conditions
Keywords
MRI, pacemakers, Defibrillator
Brief summary
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
Detailed description
This prospective cohort study to use an established MRI device safety protocol to decrease the risk of clinically indicated MR imaging in patients with implantable cardiac devices. All devices will undergo a complete interrogation and testing of thresholds, sensing, battery voltage and impedances prior to and following imaging. Pre-MRI, devices will be programmed to setting that will ensure MRI safety. During imaging, patients will blood pressure, heart rate and O2 sat level will be monitored continuously.
Interventions
None listed
Sponsors
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with an emergent or absolute need for MR imaging and PPM or certain ICD's
Exclusion criteria
* Pacemaker dependent patients with ICD's * Patients with other contraindication to MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Malfunction | immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months) | Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline |
| Patient Safety | assessed during MRI and immediate post MRI (up to 2 hours) | Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance | Immediately post MRI (up to 2 hours) | We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI and Cardiac Devices Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD | 1,509 |
| Total | 1,509 |
Baseline characteristics
| Characteristic | MRI and Cardiac Devices |
|---|---|
| Age, Continuous | 69.3 years |
| Region of Enrollment United States | 1509 participants |
| Sex: Female, Male Female | 548 Participants |
| Sex: Female, Male Male | 961 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,509 |
| other Total, other adverse events | 8 / 1,509 |
| serious Total, serious adverse events | 0 / 1,509 |
Outcome results
Primary
Device Malfunction
Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline
Time frame: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MRI and Cardiac Devices | Device Malfunction | immediately post MRI (up to 2 hours) | 24 Participants |
| MRI and Cardiac Devices | Device Malfunction | Long-term follow-up (up to 6 months) | 52 Participants |
Primary
Patient Safety
Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)
Time frame: assessed during MRI and immediate post MRI (up to 2 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI and Cardiac Devices | Patient Safety | 0 Participants |
Secondary
Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance
We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images
Time frame: Immediately post MRI (up to 2 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI and Cardiac Devices | Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance | 0 Participants |