30 closest matches · ranked by relevance
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 Cardioverter-Defibrillator With Magnetic Resonance Imaging
Primary: MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate — 100 percentage of 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
Primary: Freedom From MRI Scan-related Complications — 123 Participants — p=<0.01
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
Primary: Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications — 100 percentage of participants
Bradycardia · Slow Heart Beat
Primary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.001
ICD · Tachycardia
Primary: Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System — 177 Participants
Arrhythmias, Cardiac
Primary: Device Malfunction — 24; 52 Participants
Bradycardia · Sinus Node Dysfunction
Primary: Proportion of Participants Without MR Scan-related Complications — 100 Percentage of participants
Implantable Defibrillator
Primary: MRI-related Events — 147 Participants free of MRI-related events — p=<0.0001
Magnetic Resonance Imaging (MRI) · Cardiac Pacing
Primary: MRI-related Complication Free Rate — 156 participants — p=<0.0001
Chronic Pain
Primary: The Rate of the MRI Scan-related Adverse Events — 0 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
MRI Scans · Magnetic Resonance Imaging · Pacemaker
Primary: Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI — 2 Participants
Implantable Defibrillator User
Primary: Number of Participants With MRI Scan Related Complications — 0 Participants
Magnetic Resonance Imaging · Cardiac Pacemaker, Artificial
Primary: Magnetic Resonance Imaging (MRI)-Related Complications — 0 participants — p=<0.0001
Bradycardia
Primary: Freedom From RA and RV Lead-related Complications — 97.19; 99.14 percentage of participants
Movement Disorders · Parkinson Disease · Essential Tremor
Primary: Rate of MRI-related Adverse Events — 0 Percentage of participants
Bradycardia · Tachycardia · Heart Failure
Primary: The Occurrence of an MRI-related Event for CIED — 59; 0 Participants — p=0.002
Arhythmia · Atrioventricular Heart-block · Chronic Bundle Branch or Branch Block
Primary: Percentage of Participants Without Complications at MRI Visit + 1 Month. — 100 percentage of paticipants
Electromagnetic Interference
Primary: Electromagnetic Interference — 0 participants
Tachycardia
Primary: Number of Participants With Freedom From Magnetic Resonance Imaging (MRI) Scan Related Complications — 14; 14; 15; 12 Participants
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Primary: Major Complications — 96.0 Kaplan-Meier survival probability (%) — p=<0.0001
Arrhythmia
Primary: The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free — 100 percentage of 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
Heart Failure · Tachyarrhythmia
Primary: Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up — 122 Participants — p=0.05
Heart Failure · Ventricular Arrythmias
Primary: Percentage of Participants Free of System-related Complications at 3-months Post Implant — 93.6 Percentage of Participants
Cardiac Pacemaker, Artificial
Primary: Implant Success — 75.36 % of subjects with successful implant
Tachyarrhythmias
Primary: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. — 0 percentage of patients