Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

Completed

• Conditions: Magnetic Resonance Imaging
• Interventions: Radiation: MRI Scan

• Registration Number: NCT02357082
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Study Start: 2016-12
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
P/R Wave Amplitude at Different Timepoints	Baseline, Visit 1, 3 months, 6 months
Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints	Baseline, Visit 1, 3 months, 6 months
Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints	Baseline, Visit 1, 3 months, 6 months

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States