30 closest matches · ranked by relevance
Arrhythmias, Cardiac
Primary: Device Malfunction — 24; 52 Participants
Magnetic Resonance Imaging
Primary: Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications — 100 percentage of 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
Tachycardia
Primary: Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications — 14; 14; 15; 12 Participants
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
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Primary: Conversion of Induced Ventricular Fibrillation — 52 Participants
Implantable Defibrillator
Primary: MRI-related Events — 147 Participants free of MRI-related events — p=<0.0001
MRI Scans · Magnetic Resonance Imaging · Pacemaker
Primary: Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI — 2 Participants
Bradycardia
Primary: Freedom From MRI Scan-related Complications — 123 Participants — p=<0.01
Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging
Primary: MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate — 100 percentage of participants
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
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
Bradycardia · Slow Heart Beat
Primary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.001
Tachycardia · Ventricular Arrythmia
Primary: Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation — 18 Participants
Implantable Cardioverter-Defibrillators
Primary: Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. — 1 Participants
Implantable Defibrillator User
Primary: Number of Participants With MRI Scan Related Complications — 0 Participants
Cardiac Pacemaker, Artificial
Primary: Implant Success — 75.36 % of subjects with successful implant
Ventricular Tachyarrhythmias
Primary: Number of Participants With a Successful Induced Ventricular Fibrillation Conversion — 6 Participants
Cardiomyopathy
Primary: Change in Left Ventricular Ejection Fraction — 10.6 percentage of LVEF
Electromagnetic Interference
Primary: Electromagnetic Interference — 0 participants
Cardiomyopathies
Primary: Referral for Implantable Cardioverter Defibrillator — 11; 1 participants
Tachycardia · Ventricular Arrythmia
Primary: Safety Outcome - Freedom From Major Complications Related to the EV ICD System and/or Procedure at 2 Weeks Post-implant — 13 Participants
Telemedicine · Heart Failure · Defibrillators
Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants
Arrhythmia
Primary: The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free — 100 percentage of participants
Bradycardia · Tachycardia · Heart Failure
Primary: The Occurrence of an MRI-related Event for CIED — 59; 0 Participants — p=0.002
Magnetic Resonance Imaging (MRI) · Cardiac Pacing
Primary: MRI-related Complication Free Rate — 156 participants — p=<0.0001
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
TTR Cardiac Amyloidosis
Primary: Sudden Death — 0 Participants
Primary Prevention of Sudden Cardiac Arrest
Primary: Inappropriate ICD Therapy — 105; 21; 26 participants — p=<0.001