Magnetic Resonance Imaging of Human Biometrics (MRI HB)

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

Study Overview

• Status: Completed
• Conditions: Volunteers

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll up to 30 subjects at up to 5 study sites in the US.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects undergoing high quality MRI Scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Collect High Quality MRI Data	Approximately 6 Weeks

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 6, 2017
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: MRI HB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO