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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02906189
Other study ID # 1608820677
Secondary ID
Status Recruiting
Phase N/A
First received September 3, 2016
Last updated September 14, 2016
Start date September 2016
Est. completion date September 2021

Study information

Verified date September 2016
Source Banner Health
Contact Michael Morris, MD
Phone 602-839-4850
Email michael.morris@bannerhealth.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Radiation:
MRI


Locations

Country Name City State
United States Banner University Medical Center Phoenix Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Banner Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death during the MRI scan Immediate No
Secondary Decrease in battery voltage >0.04v 6 months No
Secondary Change in pacing lead impedance = 50 O 6 months No
Secondary Change in high-voltage lead impedance = 3 O 6 months No
Secondary Increase in pacing threshold = 0.50 V @ 0.4 ms 6 months No
Secondary Decrease in P wave measurement = 50% 6 months No
Secondary Decrease in R wave measurement = 25% 6 months No
Secondary Generator failure requiring immediate replacement Immediate No
Secondary Lead failure requiring immediate replacement Immediate No
Secondary New onset atrial or ventricular arrhythmia during MRI Immediate No
Secondary Loss of pacemaker capture during MRI Immediate No
Secondary Electrical reset of the device Immediate No
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