Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

Mayo Clinic

Status: Completed

Conditions: Magnetic Resonance Imaging

Treatments: Radiation: MRI Scan

Study type: Observational

Funder types: Other

Identifiers

NCT02357082

14-001925

Details and patient eligibility

About

Registry intends to prospectively collect data regarding the safety of magnetic resonance imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter defibrillators.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology
• Male or Female
• 18 years of age or older
• Able to provide informed consent
• Presence of CIED

Exclusion criteria

• Presence of metallic objects that represent a contraindication to MR imaging, including: MRI-unsafe intra-orbital or intra-ocular retained metal fragments, and MRI-unsafe intracranial vascular clips and coils, other MRI-unsafe devices
• Morbid obesity (abdominal diameter greater than 60 centimeters) which results in contact wiht the magnet bore.
• Pregnant at time of scanning Pacemaker or Implanted Cardiac Device that is labeled as MRI-Conditional (approved by the Food and Drug Administration for exposure to MRI)
• Pacemaker dependent and either: 1) device implanted before 2005, or 2) advisory pulse generator that may lower outputs in the setting of radiofrequency currents

Trial design

1,000 participants in 1 patient group

MRI Scan

Description:

Patients with a previously implanted Cardiac Implantable Electronic Device who are undergoing an MRI Scan for clinically indicated, diagnostic purposes.

Treatment:

Radiation: MRI Scan