Study of the Wearable Defibrillator in Heart-Failure Patients

Completed

• Conditions: Ventricular Tachycardia; Sudden Death; Ventricular Fibrillation; Ventricular Dysfunction; Sudden Cardiac Arrest; Heart Failure
• Interventions: Device: wearable defibrillator (LifeVest)

• Registration Number: NCT01326624
• Lead Sponsor: Zoll Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Awaiting ICD re-implantation	wearable defibrillator (LifeVest)	-
NYHA class III or IV	wearable defibrillator (LifeVest)	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
left ventricular ejection fraction ≤ 35%	wearable defibrillator (LifeVest)	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.
Acute myocardial infarction	wearable defibrillator (LifeVest)	Patients hospitalized with acute myocardial infarction and Killip Class III/IV.

Primary Outcome Measures

Name	Time	Method
Defibrillation for life-threatening ventricular tachyarrhythmias	6 months
Assess magnitude and complexity of ventricular and atrial arrhythmias during use	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University of Rochester; 🇺🇸 Rochester, New York, United States

Chaim Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel