Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)

Johns Hopkins University1 site in 1 country1,509 target enrollmentMay 2003

ConditionsArrhythmias, Cardiac

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arrhythmias, Cardiac
Sponsor: Johns Hopkins University
Enrollment: 1509
Locations: 1
Primary Endpoint: Device Malfunction
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

January 22, 2015

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Device Malfunction

Time Frame: immediately 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 Safety

Time Frame: assessed 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)