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

• Conditions: Arrhythmias, Cardiac

• Registration Number: NCT02906189
• Lead Sponsor: Banner Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-03
• Study First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Study First Posted: 2016-09-20
• Last Update Posted: 2016-09-20
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death during the MRI scan	Immediate

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Banner University Medical Center Phoenix; 🇺🇸 Phoenix, Arizona, United States