Study Results
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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COMPLETED
12 participants
OBSERVATIONAL
2016-08-31
2018-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Subjects undergoing high quality MRI Scans
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject is willing and able to undergo study requirements
Exclusion Criteria
* Subject has any magnetizable foreign object (e.g. jewelry) which cannot be removed for the duration of the study
* Subject is claustrophobic
* Subject is unable to stand without assistance
* Subject requires sedation for MRI scans
* Subject is implanted with non-Magnetic Resonance conditional or other medical device:
* Non-MRI conditional pacemaker, Implantable Cardiac Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or an implantable hemodynamic monitor
* Metal clips (i.e. brain aneurysm clip)
* Artificial heart valve
* Implanted neural stimulator
* Gastric capsule camera
* Swan Ganz catheter
* Stent
* Inferior Vena Cava (IVC) filter
* Orthopedic implant
* Eye prosthesis
* Vascular access port
* Penile prosthesis
* Intrauterine device
* Subject has a cochlear implant, middle ear prosthesis, or has had ear surgery
* Subject has ocular foreign bodies (i.e. metal shavings)
* Subject has any type of device held in place by a magnet (i.e. dentures)
* Subject has an insulin pump
* Subject has metal shrapnel
* Subject is pregnant or lactating
* Subject has magnetizable implant
* Subject requires legally authorized representative to sign Patient Informed Consent (PIC)/ Informed Consent (IC) form
* Subject has other contraindication for an MRI scan as defined by the study site
18 Years
ALL
Yes
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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MRI HB
Identifier Type: -
Identifier Source: org_study_id
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