Overview

This trial is active, not recruiting.

Conditions heart failure, ventricular dysfunction, sudden death, sudden cardiac arrest, ventricular tachycardia, ventricular fibrillation
Treatment wearable defibrillator (lifevest)
Sponsor Zoll Medical Corporation
Start date March 2011
End date December 2016
Trial size 25 participants
Trial identifier NCT01326624, 90D0112

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
wearable defibrillator (lifevest) wearable cardioveter defibrillator
LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation
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.
wearable defibrillator (lifevest) wearable cardioveter defibrillator
LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation
wearable defibrillator (lifevest) wearable cardioveter defibrillator
LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation
Patients hospitalized with acute myocardial infarction and Killip Class III/IV.
wearable defibrillator (lifevest) wearable cardioveter defibrillator
LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation

Primary Outcomes

Measure
Defibrillation for life-threatening ventricular tachyarrhythmias
time frame: 6 months
Assess magnitude and complexity of ventricular and atrial arrhythmias during use
time frame: 6 months

Secondary Outcomes

Measure
Total mortality
time frame: 6 months and 12 months
Compliance with wearable defibrillator use
time frame: 6 months
Quality of life with a wearable defibrillator
time frame: 6 months
Complications (adverse events) with wearable defibrillator use
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Study of the Wearable Defibrillator In Heart-Failure Patients
Principal investigator Michael Eldar, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Zoll Medical Corporation.