CompletedNot Applicable

SJM MRI Diagnostic Imaging Registry (IDE)

United States189 participantsStarted 2016-06

Plain-language summary

This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT current generation device listed in the study protocol and any market-released pacing or defibrillation lead.
✓. Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.
✓. Patient has a clinical indication for a non-thoracic MRI scan, where MRI is the imaging modality of choice that will give adequate results to manage the patient.
✓. Patient is scheduled for a non-thoracic MRI scan up to 1.5T.
✓. Patient has a pacemaker, ICD, or CRT device implanted pectorally.
✓. Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures.
✓. Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion criteria

✕. Patient has an ICD/CRT-D and is pacemaker dependent
✕. Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads
✕. Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)
✕. High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)
✕. Patient has a device generator battery voltage at elective replacement interval (ERI)
✕. Patient has another existing active implanted medical device (e.g. neurostimulator, infusion pump, etc.) that has MR labeling that will not allow the MRI scans to be completed.
✕. Patient has other non-MRI compatible device or material implanted
✕. Patient has a lead extender, adaptor, or capped/abandoned lead

What they're measuring

The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.

Timeframe: 1 month

The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.

Timeframe: 1 month

Trial details

NCT IDNCT02807948

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-31

Results submitted2019-08-07

View on ClinicalTrials.gov More Cardiac Arrhythmia trials