Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-04-20

Brief Summary

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

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Detailed Description

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Conditions

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Magnetic Resonance Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MRI Scan

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

MRI Scan

Intervention Type RADIATION

MRI scan with Specific Absorption Rate (SAR) limit of 1.5 watts per kilogram of body weight

Interventions

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MRI Scan

MRI scan with Specific Absorption Rate (SAR) limit of 1.5 watts per kilogram of body weight

Intervention Type RADIATION

Other Intervention Names

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Magnetic Resonance Imaging

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No