Heart Failure, Sudden Cardiac Arrest, Sudden Death, Ventricular Dysfunction, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
heart failure, ventricular dysfunction, sudden death, sudden cardiac arrest, ventricular tachycardia, ventricular fibrillation, wearable defibrillator
Brief summary
The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are either not eligible for an implantable defibrillator under current guidelines or are not able to receive the device due to their condition.
Interventions
LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation
Sponsors
Zoll Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with NYHA class III or IV during the past month and one or more of the following: * hospitalization for cardiac decongestion and stabilization, * advanced heart failure receiving intravenous diuretics/inotropics in an outpatient clinic, or * awaiting cardiac transplantation * Patients with left ventricular ejection fraction ≤ 35% and either one of the following: * coronary revascularization within 3 calendar months prior to enrollment, or * heart failure of non-ischemic origin diagnosed within 3 calendar months prior to enrollment. * Patients awaiting ICD re-implantation following device explantation or lead extraction, * Patients hospitalized with acute myocardial infarction and Killip Class III/IV.
Exclusion criteria
* The presence of an implantable cardioverter defibrillator prior to enrollment. * Advanced cerebrovascular disease. * Non-cardiac terminal illness associated with reduced likelihood of survival for the duration of the study. * Use of supplemental oxygen in an outpatient setting requiring an external oxygen tank. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defibrillation for life-threatening ventricular tachyarrhythmias | 6 months |
| Assess magnitude and complexity of ventricular and atrial arrhythmias during use | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Total mortality | 6 months and 12 months |
| Compliance with wearable defibrillator use | 6 months |
| Quality of life with a wearable defibrillator | 6 months |
| Complications (adverse events) with wearable defibrillator use | 6 months |
Countries
Israel, United States
Outcome results
None listed