Recruiting

MRI Safety

Sponsor:

Banner Health

Code:

NCT02906189

Conditions

Arrhythmias, Cardiac

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI

Study Details

Brief summary:

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.

Conditions

Arrhythmias, Cardiac

Study ID

NCT02906189

Start date

Sep, 2016

Status verified date

Sep, 2016

Completion date

Sep, 2021

Anticipated

Primary completion date

Sep, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Interventions

MRI

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Banner University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

More Information

Sponsor

Banner Health

Last update posted

Sep 20, 2016

Last verified

Sep, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Banner Health on 2016-09-20.