NCT02906189
Unknown
Not Applicable
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
ConditionsArrhythmias, Cardiac
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmias, Cardiac
- Sponsor
- Banner Health
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Death during the MRI scan
- Last Updated
- 9 years ago
Overview
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.
Investigators
Michael Morris
Clinical Assistant Professor
Banner Health
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Death during the MRI scan
Time Frame: Immediate
Secondary Outcomes
- Decrease in battery voltage >0.04v(6 months)
- Change in pacing lead impedance ≥ 50 Ω(6 months)
- Change in high-voltage lead impedance ≥ 3 Ω(6 months)
- Increase in pacing threshold ≥ 0.50 V @ 0.4 ms(6 months)
- Decrease in P wave measurement ≥ 50%(6 months)
- Decrease in R wave measurement ≥ 25%(6 months)
- Generator failure requiring immediate replacement(Immediate)
- Lead failure requiring immediate replacement(Immediate)
- New onset atrial or ventricular arrhythmia during MRI(Immediate)
- Loss of pacemaker capture during MRI(Immediate)
- Electrical reset of the device(Immediate)
Study Sites (1)
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