N/A
Completed N=1,509
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices
Arrhythmias, Cardiac
Source: ClinicalTrials.gov NCT01130896 ↗
Enrolled (actual)
1,509
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Device Malfunction — 24; 52 Participants
Summary
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
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 |
— | — |
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. Informational only — not medical advice.