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OpenTrials
Completed

NCT Number: NCT02942667

Magnetic Resonance Imaging of Human Biometrics

The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Winston-Salem, North Carolina, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is at least 18 years of age
  • Subject is willing and able to undergo study requirements

Exclusion criteria

  • Subject has a medical condition that precludes the subject from participation
  • 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

Treatment and study plan

Primary outcomes

  1. Collect High Quality MRI Data

    Time frame: Approximately 6 Weeks

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: MRI HB

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 24, 2016
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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