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

Completed

• Conditions: Defibrillator; Pacemaker; MRI

• Registration Number: NCT02548819
• Lead Sponsor: University Health Care System, Augusta, Georgia

Brief Summary

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).

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Augusta, Georgia, United States