Study of the Wearable Defibrillator in Heart-Failure Patients

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Wearable Defibrillator In Heart-Failure Patients

Conditions
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Heart Failure, Ventricular Dysfunction, Sudden Death, Sudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
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* Device: wearable defibrillator (LifeVest)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NYHA class III or IV<br>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. Awaiting cardiac transplantation | Device: wearable defibrillator (LifeVest)<br>* LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation<br>* Other names: LifeVest;|
| left ventricular ejection fraction ≤ 35%<br>Patients with left ventricular ejection fraction ≤ 35% and either one of the following: Coronary revascularization within 3 calendar months prior to enrollment. Heart failure of non-ischemic origin diagnosed within 3 calendar months prior to enrollment. | Device: wearable defibrillator (LifeVest)<br>* LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation<br>* Other names: LifeVest;|
| Awaiting ICD re-implantation<br> | Device: wearable defibrillator (LifeVest)<br>* LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation<br>* Other names: LifeVest;|
| Acute myocardial infarction<br>Patients hospitalized with acute myocardial infarction and Killip Class III/IV. | Device: wearable defibrillator (LifeVest)<br>* LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation<br>* Other names: LifeVest;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defibrillation for life-threatening ventricular tachyarrhythmias |  | 6 months | 
| Assess magnitude and complexity of ventricular and atrial arrhythmias during use |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, ventricular dysfunction, sudden death, sudden cardiac arrest, ventricular tachycardia, ventricular fibrillation, wearable defibrillator