University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices (CDMR)

A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).

Study Overview

• Status: Completed
• Conditions: MRI; Pacemaker; Defibrillator
• Intervention / Treatment: Other: MRI

Detailed Description

Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30901
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who require MR imaging in the presence of a pacemaker or ICD

Description

Inclusion Criteria:

• Male or female 18 years or older
• Informed consent can be provided by patient or medical power of attorney
• Presence of implanted pacemaker or ICD
• MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
• Non-cardiac/non-thoracic MRI ordered

Exclusion Criteria:

• Presence of metallic objects that represent a contraindication to MR imaging
• Morbid obesity which results in body contact with the magnet façade
• Pacemaker or ICD generator implanted prior to 2002
• ICD patients who are pacing dependent
• Pregnancy
• Device generator at ERI (elective replacement interval)
• Presence of other active implanted medical device
• Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
• Presence of implanted cardiac device in the abdominal position
• Pacemaker or ICD that is labeled as MRI-Conditional by the FDA
• Pacemaker or ICD implanted less than 6 weeks prior to MRI scan

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Battery voltage	Change in voltage > 0.04 V	Immediate
Pacing lead impedance	Change in impedance > 50 Ohms	Immediate
Shock impedance	Change in impedance > 3 Ohms	Immediate
P wave amplitude	Decrease in amplitude > 50%	Immediate
R wave amplitude	Decrease in amplitude > 25%	Immediate
Pacing lead threshold	Threshold increase > 0.5 V at a fixed pulse width of 0.4ms	Immediate
Adverse event	An adverse clinical event	Immediate

Collaborators and Investigators

• Sponsor: University Health Care System, Augusta, Georgia
• Investigators: Principal Investigator: Patrick M Aquilina, MD, University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IORG0000351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO