Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

Magnetic Resonance Imaging Clinical Trial

Official title:

Mayo Clinic Cardiac Implantable Electronic Device (CIED) Magnetic Resonance Imaging (MRI) Registry; Determining the Risks of of MRI in the Presence of Cardiac Implantable Electronic Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02357082
• Other study ID #: 14-001925
• Status: Completed
• Start date: December 2016
• Est. completion date: April 20, 2022

Study information

• Verified date: June 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 20, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints		Baseline, Visit 1, 3 months, 6 months
Primary	Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints		Baseline, Visit 1, 3 months, 6 months
Primary	P/R Wave Amplitude at Different Timepoints		Baseline, Visit 1, 3 months, 6 months

External Links

•   Mayo Clinic Clinical Trials