CompletedNot Applicable

Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

United States1,000 participantsStarted 2016-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints

Timeframe: Baseline, Visit 1, 3 months, 6 months

Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints

Timeframe: Baseline, Visit 1, 3 months, 6 months

P/R Wave Amplitude at Different Timepoints

Timeframe: Baseline, Visit 1, 3 months, 6 months

Trial details

NCT IDNCT02357082

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-04-20

View on ClinicalTrials.gov More Magnetic Resonance Imaging trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints

Timeframe: Baseline, Visit 1, 3 months, 6 months

Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints

Timeframe: Baseline, Visit 1, 3 months, 6 months

P/R Wave Amplitude at Different Timepoints

Timeframe: Baseline, Visit 1, 3 months, 6 months