N/A
N=1,509
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Arrhythmias, Cardiac
Bottom Line
View on ClinicalTrials.gov: NCT01130896 ↗Enrolled (actual)
1,509
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Device Malfunction — 24; 52 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Malfunction |
24; 52 | — |
| PRIMARY Patient Safety |
— | — |
| SECONDARY Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance |
— | — |
Summary
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01130896). 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.