Magnetic Resonance Imaging of Human Biometrics

Completed

• Conditions: Volunteers

• Registration Number: NCT02942667
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-30
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Primary Completion: 2017-12-06
• Status Verified: 2018-02
• Study Completion: 2018-02-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect High Quality MRI Data	Approximately 6 Weeks