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Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

Completed
Conditions
Arrhythmias, Cardiac
Registration Number
NCT01130896
Lead Sponsor
Johns Hopkins University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1509
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Device Malfunctionimmediately 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 Safetyassessed 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 Outcome Measures
NameTimeMethod
Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead ImpedanceImmediately post MRI (up to 2 hours)

We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images

Trial Locations

Locations (1)

Johns Hopkins Hospital, Blalcok 5 MRI

🇺🇸

Baltimore, Maryland, United States

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