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Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices

This study is currently recruiting participants.
Verified September 2016 by Michael Morris, Banner Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906189
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Morris, Banner Health
  Purpose
The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.

Condition Intervention
Arrhythmias, Cardiac Radiation: MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices

Resource links provided by NLM:


Further study details as provided by Michael Morris, Banner Health:

Primary Outcome Measures:
  • Death during the MRI scan [ Time Frame: Immediate ]

Secondary Outcome Measures:
  • Decrease in battery voltage >0.04v [ Time Frame: 6 months ]
  • Change in pacing lead impedance ≥ 50 Ω [ Time Frame: 6 months ]
  • Change in high-voltage lead impedance ≥ 3 Ω [ Time Frame: 6 months ]
  • Increase in pacing threshold ≥ 0.50 V @ 0.4 ms [ Time Frame: 6 months ]
  • Decrease in P wave measurement ≥ 50% [ Time Frame: 6 months ]
  • Decrease in R wave measurement ≥ 25% [ Time Frame: 6 months ]
  • Generator failure requiring immediate replacement [ Time Frame: Immediate ]
  • Lead failure requiring immediate replacement [ Time Frame: Immediate ]
  • New onset atrial or ventricular arrhythmia during MRI [ Time Frame: Immediate ]
  • Loss of pacemaker capture during MRI [ Time Frame: Immediate ]
  • Electrical reset of the device [ Time Frame: Immediate ]

Estimated Enrollment: 1500
Study Start Date: September 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-MRI conditional pacemakers and ICDs referred for clinically indicated MRI scans.
Criteria

Inclusion Criteria. All patients with non-MRI conditional pacemakers and ICDs between the ages of 18-85 will be eligible to participate. Medical records will be reviewed to confirm the date and make/model of device implanted. Ordering physician discusses the MRI request with radiologist, documenting that there is no appropriate alternate imaging test. Patient must have an appointment with a cardiologist/electrophysiologist prior to MRI. Banner Health policy for standard of care guidelines involving patients receiving MRI's will be followed.

Exclusion Criteria. Patients will be excluded from MRI based on the Department of Radiology protocol. Additional exclusion criteria include: ICD and pacemaker dependent, Pacemaker inserted before 2002, Epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), Patient not awake or unable communicate, Battery voltage at elective replacement interval, implanted non-MRI conditional device (other than pacemaker/ICD).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906189


Contacts
Contact: Michael Morris, MD 602-839-4850 michael.morris@bannerhealth.com

Locations
United States, Arizona
Banner University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85004
Contact: Michael Morris, MD    602-839-4850    michael.morris@bannerhealth.com   
Sponsors and Collaborators
Banner Health
Investigators
Principal Investigator: Michael Morris, MD Banner - University Medical Center Phoenix
  More Information

Responsible Party: Michael Morris, Clinical Assistant Professor, Banner Health
ClinicalTrials.gov Identifier: NCT02906189     History of Changes
Other Study ID Numbers: 1608820677
First Submitted: September 3, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes