Cardiac Arrhythmia
Conditions
Keywords
MRI Scan, pacemakers, ICD, CRT
Brief summary
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.
Detailed description
This study will be performed as part of a regulated, prospective, non-randomized, multi-center clinical study. Subjects will be enrolled, undergo a clinically-indicated MRI scan, and have an assessment of adverse events, device measurements, and clinical utility of the MRI scan images.
Interventions
DEVICEPacemaker, ICD, or CRT device
MRI Scans on SJM device implanted subjects for clinical purpose
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT current generation device listed in the study protocol and any market-released pacing or defibrillation lead. 2. Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI. 3. Patient has a clinical indication for a non-thoracic MRI scan, where MRI is the imaging modality of choice that will give adequate results to manage the patient. 4. Patient is scheduled for a non-thoracic MRI scan up to 1.5T. 5. Patient has a pacemaker, ICD, or CRT device implanted pectorally. 6. Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures. 7. Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion criteria
1. Patient has an ICD/CRT-D and is pacemaker dependent 2. Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads 3. Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms) 4. High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms) 5. Patient has a device generator battery voltage at elective replacement interval (ERI) 6. Patient has another existing active implanted medical device (e.g. neurostimulator, infusion pump, etc.) that has MR labeling that will not allow the MRI scans to be completed. 7. Patient has other non-MRI compatible device or material implanted NOTE: * MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol * MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol * Non-removable dental implants may be included 8. Patient has a lead extender, adaptor, or capped/abandoned lead 9. Patient is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. | 1 month | Based on the ability of the radiologist to read and provide a diagnosis/report. |
| The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. | 1 month | Based on the ability of the radiologist to read and provide a diagnosis/report. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pacemaker, ICD, or CRT Device Patients Subjects who need a non-thoracic clinically indicated scan
Pacemaker, ICD, or CRT device: MRI Scans on SJM device implanted subjects for clinical purpose | 189 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Pacemaker, ICD, or CRT Device Patients |
|---|---|
| Age, Continuous | 70.7 years STANDARD_DEVIATION 12 |
| Arrhythmia History Atrial Arrhythmia | 94 Participants |
| Arrhythmia History No Arrhythmia History | 69 Participants |
| Arrhythmia History Ventricular Arrhythmia | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 174 Participants |
| Region of Enrollment United States | 189 participants |
| Sex: Female, Male Female | 63 Participants |
| Sex: Female, Male Male | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 189 |
| other Total, other adverse events | 4 / 189 |
| serious Total, serious adverse events | 0 / 189 |
Outcome results
Primary
The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Based on the ability of the radiologist to read and provide a diagnosis/report.
Time frame: 1 month
Population: Proportion of MRI scans from ICDs or CRT-Ds providing sufficient image quality for diagnostic interpretation
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Pacemaker or CRT-P Device Patients | The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. | 56 MRI Scans |
Primary
The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Based on the ability of the radiologist to read and provide a diagnosis/report.
Time frame: 1 month
Population: Proportion of MRI scans from CRT-Ps or Pacemakers providing sufficient image quality for diagnostic interpretation
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Pacemaker or CRT-P Device Patients | The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. | 129 MRI Scans |