Study to Monitor Patients With Pacemakers or ICDs Who Undergo MRI Scans
Completed
Conditions studied: Arrhythmias, Cardiac
In brief
This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over a 60-month period and followed for 12 months, with data collected to evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker programming changes, and possible artifacts created by the pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the safety MRI scanning in this population and improve practice models and protocols in the future.
Key facts
- Study ID
- NCT01999751
- Run by
- Essentia Health
- People needed
- 124
- Starts
- 2012-10-01
- Expected to finish
- 2018-04-11
- Last updated by the study team
- 2018-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Permanent Pacemaker or ICD implanted for at least 6 weeks
- Referred for medically-required MRI scan
- Age greater than or equal to 18 years
You may not qualify if…
- ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm, GDT Prizm-2 and MDT GEM-I series
- Epicardial lead or subcutaneous array
- Device has reached elective replacement indicator (ERI) or end of life (EOL)
- Other usual contraindications to MRI scanning
- Known or suspected lead fracture or abandoned lead
- Pacemaker dependent patients with an ICD that cannot be programmed to asynchronous pacing (DOO/VOO)
- Clinical factors that are deemed by the PI or Sub-I to increase the participant's risk above an acceptable clinical threshold
Where it is running
- St. Mary's Medical Center — Duluth, Minnesota, United States
Full record on ClinicalTrials.gov
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