30 closest matches · ranked by relevance
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
Anxiety · Depression
Primary: Hospital Anxiety and Depression Scale - Depression Scale at Baseline — 4.70; 7.47; 5.35; 4.12 units on a scale
Telemedicine · Heart Failure · Defibrillators
Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants
Heart Failure, Systolic · Heart Failure
Primary: Knowledge About Defibrillation at Baseline — 53.4; 55.4 score on a scale
Implantable Cardioverter-Defibrillators
Primary: Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. — 1 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
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
Tachycardia · Ventricular Arrythmia
Primary: Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation — 18 Participants
Ventricular Tachyarrhythmias
Primary: Number of Participants With a Successful Induced Ventricular Fibrillation Conversion — 6 Participants
Tachycardia, Ventricular
Primary: Percentage of Participants Free of Type I Complications at 180 Days. — 99.0 percentage of participants
Ventricular Tachycardia · Ventricular Fibrillation
Primary: Implant Success Rate at Septal Site — 97; 99 Participants
Ischemic Cardiomyopathy · Nonischemic Cardiomyopathy · Heart Failure
Primary: Number of Patients With Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF) or Death — 174; 198 Participants — p=0.117
Ventricular Tachycardia · Ventricular Fibrillation · Atrial Fibrillation
Primary: Number of Subjects Inappropriately Shocked by Implantable Cardioverter-Defibrillator (ICD) — 1; 1 Participants — p=1.0
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
Sudden Cardiac Death · Heart Failure
Primary: Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients — 14.4 milli volt (mV)
TTR Cardiac Amyloidosis
Primary: Sudden Death — 0 Participants
Heart Failure · Cardiomyopathy
Primary: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. — 450; 213 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…
Tachycardia, Ventricular
Primary: Perioperative S-ICD Complication Free Rate — 983 Participants
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
Cardiomyopathy
Primary: Change in Left Ventricular Ejection Fraction — 10.6 percentage of LVEF
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
Primary Prevention of Sudden Cardiac Arrest
Primary: Inappropriate ICD Therapy — 105; 21; 26 participants — p=<0.001
Tachyarrhythmias
Primary: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. — 0 percentage of patients
Cardiomyopathies · Cardiac Death, Sudden
Primary: Rate of Successful Completion of S-ICD Implantation and Discharge of the Patient on the Same Day the Device is Implanted Using the Analgesia Protocol. — 49 Participants
Cardiomyopathy
Primary: Sustained Ventricular Fibrillation — 38; 35 participants
Heart Failure · Ventricular Arrythmias
Primary: Percentage of Participants Free of System-related Complications at 3-months Post Implant — 93.6 Percentage of Participants
Sudden Cardiac Death · Heart Failure
Primary: Proportion of Patients Saying "Yes" to ICD — 123; 60; 87; 41 Participants
Tachyarrhythmia
Primary: Remote Follow-up as an Alternative to Onsite Visit — 203 Participants