Expanding MRI Access for Patients with New and Existing ICDs and CRT-Ds

Principal Investigator:  Rudolph Evonich, III, MD

Clinical Trials - ENABLE MRI

  • You are being asked to take part in this study because your doctor has determined that, based on your heart condition, you will receive or already have received an implantable defibrillator.   
  • Most patients with an ICD system are not able to have an MRI scan.
  • The study ICD (Boston Scientific ENABLE MRI) is designed to be safe when used during an MRI
  • The purpose of this study is to test the Boston Scientific Enable MRI (ICD) system when patients who have this system have an MRI scan.
  • The defibrillator used in this study is approved for use by the FDA to help treat your irregular heartbeat. This defibrillator has a new feature that blocks interference from an MRI scanner when the defibrillator is placed into “MRI protection mode” This new MRI scan feature is considered “investigational” in the US because it has not been approved by the FDA for patient use.
  • Approximately 60 hospitals and clinics will participate in the United States and around the world.
  • Phase II will start after Phase I is completed. In this phase, the study will only collect data for medically necessary MRI scans.  UPHS-Marquette is only participating in Phase II.
  • Your defibrillator will be implanted at the study site by your doctor using the same techniques and testing that would be used if you were receiving a non-study defibrillator.
  • You will have your device checked before your discharge from the hospital. This is the same even if you were not in the study.
  • You will be followed every 3 months either by remote monitoring or in clinic follow up visits, to monitor your device performance.
  • Yearly visits will be in clinic starting at one year post implant or enrollment (for those with existing devices) and continuing until 3 years post enrollment.