Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

NCT02357082 | Completed FDA Device

• 1 other identifier: 14-001925
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

• 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

• P/R Wave Amplitude at Different Timepoints

  Baseline, Visit 1, 3 months, 6 months

Study Arms (1)

MRI Scan

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

Radiation: MRI Scan

Interventions

MRI Scan RADIATION

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

Also known as: Magnetic Resonance Imaging

MRI Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Mayo Clinic who have a previously implanted CIED and are scheduled for a clinically-indicated MRI will be included in the registry.

You may qualify if:

• 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
• years of age or older
• Able to provide informed consent
• Presence of CIED

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Paul A Friedman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: February 6, 2015
• Study Start: December 1, 2016
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)