N/A
Completed N=262
Registry of Patients for MRI With Non-MRI Conditional Pacemakers and ICD Non-MRI Conditional Pacemakers and ICD
MRI Scans · Magnetic Resonance Imaging · Pacemaker · Implantable Cardioverter Defibrillator
Source: ClinicalTrials.gov NCT02318550 ↗
Enrolled (actual)
262
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI — 2 Participants
Summary
The purpose of the registry is to accumulate pre-and post-scan device interrogation data for the purpose of determining the risk of MRI for patients with implantable devices.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI |
2 | — |
| PRIMARY Number of Participants With Potentially Lethal/Previously Non-diagnosed Arrhythmias During MRI |
— | — |
| PRIMARY Number of Participants With Spontaneous and Unanticipated Pacing Rate Change |
— | — |
| PRIMARY Number of Participants With Power on Reset of Pacemaker or ICD |
— | — |
| PRIMARY Number of Participants With MRI Related Device Malfunction/Failure |
— | — |
| PRIMARY Number of Participants With Serious Injury/Death Related to MRI Device Malfunction/Failure |
— | — |
| PRIMARY Number of MRI Scans With Post-MRI Device Parameter Change: Greater Than 50 Ohm Change in Atrial or Ventricular (RV and/or LV) Lead Impedance |
19 | — |
| PRIMARY Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than 5 Ohm Change in High Voltage Lead Impedance |
1 | — |
| PRIMARY Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than 50% Decrease in Atrial or Ventricular (RV and/or LV) Sensing Threshold |
— | — |
| PRIMARY Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than or Equal to a 1 Volt Increase in Atrial or Ventricular (RV and/or LV) Pacing Threshold |
— | — |
Eligibility Criteria
- Patient has a non-MRI conditional permanently implanted pacemaker or ICD implanted after 2001
- Patient has a strong clinical indication for MRI where MRI is the diagnostic modality of choice for specific disease state without acceptable alternative imaging technologies as determined by the ordering physician and a radiologist
- Patient is at least 18 years of age
- Patient is willing and able to sign study informed consent and HIPAA authorization
Exclusion Criteria
- Non-device related contraindication for MRI (such as implanted metallic objects, claustrophobia, morbid obesity)
- Presence of capped/abandoned/epicardial leads or subcutaneous coil
- Pregnancy
- Device generator at elective replacement interval
- Abdominal device implant
Data sourced from ClinicalTrials.gov (NCT02318550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.