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

University Health Care System, Augusta, Georgia

Status: Completed

Conditions: MRI; Pacemaker; Defibrillator

Treatments: Other: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT02548819

IORG0000351

Details and patient eligibility

About

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).

Full description

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

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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