30 closest matches · ranked by relevance
Device Replacement · Elective Replacement (ERI) · Device Advisory
Primary: Percentage of Subjects Experiencing a Complication During Generator Replacement Without a Planned Lead Revision or Addition (Straight-forward Device Replacment) or With…
Anxiety · Depression
Primary: Hospital Anxiety and Depression Scale - Depression Scale at Baseline — 4.70; 7.47; 5.35; 4.12 units on a scale
Cardiomyopathies
Primary: Referral for Implantable Cardioverter Defibrillator — 11; 1 participants
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Primary: Conversion of Induced Ventricular Fibrillation — 52 Participants
Heart Failure
Primary: Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil. — 10.4; 12.2 Joules — p=0.103
Implantable Cardioverter-Defibrillators
Primary: Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. — 1 Participants
Electromagnetic Interference
Primary: Electromagnetic Interference — 0 participants
Telemedicine · Heart Failure · Defibrillators
Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 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
Ventricular Arrhythmias
Primary: Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. — 85.7 percentage of success
Ventricular Tachycardia · Ventricular Fibrillation
Primary: Implant Success Rate at Septal Site — 97; 99 Participants
Cardiomyopathy
Primary: Sustained Ventricular Fibrillation — 38; 35 participants
Ventricular Fibrillation · Ventricular Tachycardia
Primary: First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death — 90; 104…
Ventricular Tachycardia · Ventricular Fibrillation · Atrial Fibrillation
Primary: Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) — 1; 1 Participants — p=1.0
Congenital Disorder
Primary: Feasibility of Pacemaker Implant With Total Thoracoscopic Approach to Epicardial Pacing Lead — 100 percentage of particiapants
Ventricular Fibrillation · Ventricular Flutter · Sudden Cardiac Death
Primary: Number of Participants With Severe Intra-operative Complications at ICD Implant and/or Events at Follow up — 18; 16 Participants
Ventricular Fibrillation · Ventricular Tachycardia · Low Cardiac Output
Primary: Percentage of Patients Who Did Not Experience an Inappropriate Shock From Their EMBLEM S-ICD — 95.9 Percentage of participants
Cardiac Implantable Electronic Device Infection
Primary: Major CIED Infection — 0.6; 1.0; 0.7 percentage of Participants — p=0.0023
Heart Failure · Cardiomyopathy
Primary: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. — 450; 213 participants
Sudden Cardiac Arrest · Ventricular Arrythmia
Primary: Time to the First Occurrence of a Ventricular Arrhythmia — 32.5; 18.3 Estimated 24-Month VT-VF Pct of Patients
Ventricular Tachyarrhythmias
Primary: Number of Participants With a Successful Induced Ventricular Fibrillation Conversion — 6 Participants
Tachyarrhythmias · Sudden Cardiac Death · Heart Failure
Primary: Right Ventricle (RV) Bipolar Capture Thresholds — 0.92 Volts
Tachycardia · Ventricular Arrythmia
Primary: Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation — 18 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
Heart Failure
Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 participants
Acute Lung Injury · Sepsis · Infections
Primary: Acute Lung Injury After Cardiac Surgery — 20 participants — p=<0.05
Sick Sinus Syndrome · Complete Heart Block · Syncope
Primary: Number of Patients With a Major Cardiac Implantable Electronic Devices (CIED) Infection — 5; 6 Participants
Heart Failure
Primary: Number of Vectors With Phrenic Nerve Stimulation (PNS) — 181; 189 Number of Pacing vectors with PNS
Cardiomyopathy
Primary: Change in Left Ventricular Ejection Fraction — 10.6 percentage of LVEF
Arrhythmias, Cardiac
Primary: Number of Participants With a Significant Arrhythmia Detected — 0 participants