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Completed

NCT Number: NCT02548819

University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices

A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).

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Key information

Conditions

MRI Defibrillator Pacemaker

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Augusta, Georgia, 30901, United States

About this study

Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female 18 years or older
  • Informed consent can be provided by patient or medical power of attorney
  • Presence of implanted pacemaker or ICD
  • MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
  • Non-cardiac/non-thoracic MRI ordered

Exclusion criteria

  • Presence of metallic objects that represent a contraindication to MR imaging
  • Morbid obesity which results in body contact with the magnet façade
  • Pacemaker or ICD generator implanted prior to 2002
  • ICD patients who are pacing dependent
  • Pregnancy
  • Device generator at ERI (elective replacement interval)
  • Presence of other active implanted medical device
  • Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
  • Presence of implanted cardiac device in the abdominal position
  • Pacemaker or ICD that is labeled as MRI-Conditional by the FDA
  • Pacemaker or ICD implanted less than 6 weeks prior to MRI scan

Treatment and study plan

MRI

Other

MR imaging of patients with implanted cardiac devices

Primary outcomes

  1. Battery voltage

    Time frame: Immediate

    Change in voltage > 0.04 V

  2. Pacing lead impedance

    Time frame: Immediate

    Change in impedance > 50 Ohms

  3. Shock impedance

    Time frame: Immediate

    Change in impedance > 3 Ohms

  4. P wave amplitude

    Time frame: Immediate

    Decrease in amplitude > 50%

  5. R wave amplitude

    Time frame: Immediate

    Decrease in amplitude > 25%

  6. Pacing lead threshold

    Time frame: Immediate

    Threshold increase > 0.5 V at a fixed pulse width of 0.4ms

  7. Adverse event

    Time frame: Immediate

    An adverse clinical event

Sponsors and collaborators

Lead sponsor

University Health Care System, Augusta, Georgia

Other

Registry information

Acronym: CDMR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 14, 2015
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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