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We're sorry, but this trial is no longer enrolling volunteers.

ImageReady(TM) MR Conditional Pacing System Clinical Study




Inclusion and Exclusion Criteria

  • Subject must have the ImageReady System as their initial (de novo) pacing system implant
  • Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography
  • Subject is able and willing to undergo an MRI scan without intravenous sedation
  • Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
  • Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

  • Subject has or has had any pacing or ICD system implants
  • Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant
  • Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol
  • Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study
  • Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
  • Subject has a mechanical tricuspid heart valve
  • Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries* that are not in conflict and do not affect the following:
  • Schedule of procedures for the SAMURAI Study (i.e. should not cause additional or missed visits);
  • SAMURAI Study outcome (i.e. involve medications that could affect pacing thresholds);
  • Conduct of the SAMURAI Study per GCP/ ISO 14155:2011/ local regulations
  • Subjects with documented permanent or persistent AF where the physician intends to implant a dual chamber pulse generator (single chamber VVIR pulse generators are acceptable)
  • Subject is currently on the active heart transplant list
  • Subject has documented life expectancy of less than 12 months
  • Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician's discretion)
  • Subjects currently requiring dialysis


  • California

    • USC Medical Center, Los Angeles, California, 90033
    • University of California, San Francisco, San Francisco, California, 94143
  • Arizona

    • Banner Heart Hospital, Mesa, Arizona, 85206
  • Washington

    • University of Washington Medical Center, Seattle, Washington, 98195
  • Montana

    • Billings Clinic, Billings, Montana, 59101
  • Texas

    • Texas Cardiac Arrhythmia Research Foundation, Austin, Texas, 78705
    • Medical City Dallas Hospital, Dallas, Texas, 75230
  • South Dakota

    • Avera Heart Hospital of South Dakota, Sioux Falls, South Dakota, 57108
  • Minnesota

    • United Heart and Vascular Clinic, St Paul, Minnesota, 55102
    • St Mary's Duluth Clinic Regional Heart Center, Duluth, Minnesota, 55805
  • Wisconsin

    • Froedtert Memorial Lutheran Hospital - Medical College of Wisconsin, Milwaukee, Wisconsin, 53226
  • Illinois

    • University of Chicago Hospital, Chicago, Illinois, 60637
  • Georgia

    • Emory University Hospital, Atlanta, Georgia, 30322
  • Malaysia

    • University Malaya Medical Center, Kuala Lumpur, 50603
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