30 closest matches · ranked by relevance
Safety of a Customized NICU MRI System
Primary: Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam — 0 Adverse Events
NICU MRI
Primary: Number of Participants With Adverse Events as Observed During and After Scanning. — 0 Participants
Magnetic Resonance Imaging
Primary: Number of Participants With Adverse Events as Observed During and After Scanning. — 4 Participants
Neonatal Neuroimaging
Primary: Image Diagnostic Quality for Phase 1 — 24 Participants
Arrhythmias, Cardiac
Primary: Device Malfunction — 24; 52 Participants
Magnetic Resonance Imaging · Cardiac Pacemaker, Artificial
Primary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.0001
Bradycardia
Primary: Freedom From MRI Scan-related Complications — 123 Participants — p=<0.01
Bradycardia · Tachycardia · Heart Failure
Primary: The Occurrence of an MRI-related Event for CIED — 59; 0 Participants — p=0.002
Adverse Effect of MRI on an Implanted Pacemaker Lead · Adverse Effect of MRI on an Implanted Pacemaker
Primary: Freedom From Right Atrial (RA) Lead-related Complications in the Acute Period — 97.2 percentage of subjects
Children Requiring MRI
Primary: Change in Body Temperature in Children Undergoing MRI Under General Anesthesia (GA)and Change in Room Temperature Before and After MRI — 36.7; 36.3; -0.4; 21.1 celsius…
Fetal Arrhythmia · Abnormality in Fetal Heart Rate or Rhythm · Long QT Syndrome
Primary: Percentage of Subjects Experiencing Symptoms — 0; 0 Participants
Magnetic Resonance Imaging
Primary: Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications — 100 percentage of participants
Healthy · Cystic Fibrosis (CF) · Asthma
Primary: Ventilation Defects as Seen on Hyperpolarized Helium-3 MRI — 9; 13; 16 Participants
Subjects With Clinical Indication for PET/CT
Primary: Number Usable PET/MRI Image Sets — 70 Usable image sets
Bradycardia · Slow Heart Beat
Primary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.001
MRI Scans · Magnetic Resonance Imaging · Pacemaker
Primary: Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI — 2 Participants
Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging
Primary: MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate — 100 percentage of participants
Claustrophobia · Complication of Diagnostic Procedure
Primary: Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients) — 10; -3.3 Percentage…
Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Primary: MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate — 100 percentage of participants
Implantable Defibrillator
Primary: MRI-related Events — 147 Participants free of MRI-related events — p=<0.0001
Electromagnetic Interference
Primary: Electromagnetic Interference — 0 participants
Hearing Impairment
Primary: Number of Participants With Skin Erythema After Device Application — 10; 10; 15; 14 Participants
ICD · Tachycardia
Primary: Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System — 177 Participants
Magnetic Resonance Imaging (MRI); Cardiac Pacing
Primary: MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate — 99.5 percentage of participants
Tachycardia
Primary: Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications — 14; 14; 15; 12 Participants
Bradycardia
Primary: Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit — 0 number of MRI related patient adverse ev
Bradycardia · Sinus Node Dysfunction
Primary: Proportion of Participants Without MR Scan-related Complications — 100 Percentage of participants
Magnetic Resonance Imaging (MRI) · Cardiac Pacing
Primary: MRI-related Complication Free Rate — 156 participants — p=<0.0001
Claustrophobia · Complication of Diagnostic Procedure
Primary: Equipment Utilization Q4FY15 = Baseline Quarter (OSU) — 0.83; 0.77 Proportion of completed scans per slots
Cochlear Implant
Primary: Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery — 2 Participants