30 closest matches · ranked by relevance
Sick Sinus Syndrome · Complete Heart Block · Syncope
Primary: Number of Patients With a Major Cardiac Implantable Electronic Devices (CIED) Infection — 5; 6 Participants
Cardiac Implantable Electronic Device Infection
Primary: Major CIED Infection — 0.6; 1.0; 0.7 percentage of Participants — p=0.0023
Telemedicine · Heart Failure · Defibrillators
Primary: Percentage of Participants With Interventional Procedures Successfully Completed — 10; 20 Participants
CIED Related Infection
Primary: 12 Month Kaplan-Meier Estimate of Major CIED Infection Rate — 0.7; 1.2 Percentage of subjects — p=0.0406
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Primary: Conversion of Induced Ventricular Fibrillation — 52 Participants
Infections · Wounds and Injuries
Primary: Pocket Hematoma, Moderate-Severe — 2; 2 participants
Arrhythmias, Cardiac
Primary: Device Malfunction — 24; 52 Participants
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…
Cardiomyopathies
Primary: Referral for Implantable Cardioverter Defibrillator — 11; 1 participants
Physical Activity · Aging · Cardiac Disease
Primary: Non-elective Hospital Admissions — 2; 3; 31; 104 Participants
Heart Failure · Cardiomyopathy
Primary: Overall Death Rate and Cause Specific Death Rate During Three Years Post Implant. — 450; 213 participants
TTR Cardiac Amyloidosis
Primary: Sudden Death — 0 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
Tachycardia · Ventricular Arrythmia
Primary: Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation — 18 Participants
Ventricular Tachycardia · Ventricular Fibrillation
Primary: Implant Success Rate at Septal Site — 97; 99 Participants
Cardiac Surgery · Sternal Wound Infection
Primary: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 — 63; 65 Participants
Cardiac Disease · Heart Failure · Coronary Artery Disease
Primary: Number of Participants With Major Infection Post Procedure — 2; 0; 0 Participants
Tachyarrhythmias · Syncope
Primary: Sensitivity for R Waves During In-Clinic Recordings at Rest — 100 percentage of recordings
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
Acute Myocardial Infarction · Coronary Artery Disease · Acute Coronary Syndrome
Primary: Number of Participants Readmitted Within 30-days Post Hospital Discharge — 13; 145 Participants — p=0.018
Tachycardia, Ventricular
Primary: Perioperative S-ICD Complication Free Rate — 983 Participants
Heart Failure
Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 participants
Arrhythmias, Cardiac
Primary: Procedure-related Complications Rate Requiring Resolution by Surgical Intervention — 2 participants
Device Malfunction · ICD · Pacemaker Lead Dysfunction
Primary: IVUS Grades — 1.33; 1; 1.57; 1.44 Grade — p=0.2201
Heart Failure, Systolic · Heart Failure
Primary: Knowledge About Defibrillation at Baseline — 53.4; 55.4 score on a scale
Electromagnetic Interference
Primary: Electromagnetic Interference — 0 participants
Tachycardia, Ventricular
Primary: Percentage of Participants Free of Type I Complications at 180 Days. — 99.0 percentage of participants
Tachyarrhythmias
Primary: Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant. — 0 percentage of patients
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)