30 closest matches · ranked by relevance
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
Magnetic Resonance Imaging (MRI) · Cardiac Pacing
Primary: MRI-related Complication Free Rate — 156 participants — p=<0.0001
Bradycardia
Primary: Freedom From MRI Scan-related Complications — 123 Participants — p=<0.01
Electromagnetic Interference
Primary: Electromagnetic Interference — 0 participants
Arrhythmias, Cardiac
Primary: Device Malfunction — 24; 52 Participants
Bradycardia
Primary: Freedom From RA and RV Lead-related Complications — 97.19; 99.14 percentage of participants
Bradycardia, Atrial Tachyarrhythmia
Primary: Device Response Assessed by Asynchronous Pacing When Using a Smart Phone — 528; 547 ohms
Bradyarrhythmia
Primary: Ease of Implant — 6.9; 6.3 score on a scale
MRI Scans · Magnetic Resonance Imaging · Pacemaker
Primary: Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI — 2 Participants
Cardiac Pacemaker, Artificial
Primary: Implant Success — 75.36 % of subjects with successful implant
Magnetic Resonance Imaging · Cardiac Pacemaker, Artificial
Primary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.0001
Implantable Defibrillator User
Primary: Number of Participants With MRI Scan Related Complications — 0 Participants
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
Cardiomyopathy · Cardiac Arrhythmia · Heart Failure
Primary: Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure — 29; 29; 8; 8 participants — p=1.0
Magnetic Resonance Imaging
Primary: Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications — 100 percentage of participants
Tachycardia
Primary: Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications — 14; 14; 15; 12 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
Bradycardia · Slow Heart Beat
Primary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.001
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
Implantable Defibrillator
Primary: MRI-related Events — 147 Participants free of MRI-related events — p=<0.0001
Cardiac Arrhythmia
Primary: The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. — 129 MRI Scans
Cardiomyopathy
Primary: Cardiac Ejection Fraction — 64; 66; 65; 62 Percent
ICD · Tachycardia
Primary: Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System — 177 Participants
Bradycardia · Tachycardia · Heart Failure
Primary: The Occurrence of an MRI-related Event for CIED — 59; 0 Participants — p=0.002
Bradycardia · Sinus Node Dysfunction
Primary: Proportion of Participants Without MR Scan-related Complications — 100 Percentage of 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
Heart Failure
Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 participants
Sensory Disorders
Primary: Degree of Discomfort Under Applied Pulsed Magnetic Fields — 0 percentage of subjects with discomfort
Heart Failure · Pacing · Bradycardia
Primary: Model 4965 Complication Free Rate — 98.8 Model 4965 complication free rate
Heart Failure
Primary: Safety (Subjects Without a Model 4396 Lead Related Complication) — 155 participants