University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-03-31

Brief Summary

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A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).

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Detailed Description

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Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.

Conditions

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MRI Pacemaker Defibrillator

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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MRI

MR imaging of patients with implanted cardiac devices

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female 18 years or older
* Informed consent can be provided by patient or medical power of attorney
* Presence of implanted pacemaker or ICD
* MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
* Non-cardiac/non-thoracic MRI ordered

Exclusion Criteria

* Presence of metallic objects that represent a contraindication to MR imaging
* Morbid obesity which results in body contact with the magnet façade
* Pacemaker or ICD generator implanted prior to 2002
* ICD patients who are pacing dependent
* Pregnancy
* Device generator at ERI (elective replacement interval)
* Presence of other active implanted medical device
* Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
* Presence of implanted cardiac device in the abdominal position
* Pacemaker or ICD that is labeled as MRI-Conditional by the FDA
* Pacemaker or ICD implanted less than 6 weeks prior to MRI scan

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes