- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02906189
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Michael Morris, MD
- Phone Number: 602-839-4850
- Email: michael.morris@bannerhealth.com
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- Banner University Medical Center Phoenix
-
Contact:
- Michael Morris, MD
- Phone Number: 602-839-4850
- Email: michael.morris@bannerhealth.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death during the MRI scan
Time Frame: Immediate
|
Immediate
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in battery voltage >0.04v
Time Frame: 6 months
|
6 months
|
Change in pacing lead impedance ≥ 50 Ω
Time Frame: 6 months
|
6 months
|
Change in high-voltage lead impedance ≥ 3 Ω
Time Frame: 6 months
|
6 months
|
Increase in pacing threshold ≥ 0.50 V @ 0.4 ms
Time Frame: 6 months
|
6 months
|
Decrease in P wave measurement ≥ 50%
Time Frame: 6 months
|
6 months
|
Decrease in R wave measurement ≥ 25%
Time Frame: 6 months
|
6 months
|
Generator failure requiring immediate replacement
Time Frame: Immediate
|
Immediate
|
Lead failure requiring immediate replacement
Time Frame: Immediate
|
Immediate
|
New onset atrial or ventricular arrhythmia during MRI
Time Frame: Immediate
|
Immediate
|
Loss of pacemaker capture during MRI
Time Frame: Immediate
|
Immediate
|
Electrical reset of the device
Time Frame: Immediate
|
Immediate
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Morris, MD, Banner University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1608820677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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