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Study of the Wearable Defibrillator in Heart-Failure Patients

NCT ID: NCT01326624

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-12-31

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.

Detailed Description

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Conditions

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

Keywords

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heart failure ventricular dysfunction sudden death sudden cardiac arrest ventricular tachycardia ventricular fibrillation wearable defibrillator

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NYHA class III or IV

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)

Intervention Type DEVICE

LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation

left ventricular ejection fraction ≤ 35%

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)

Intervention Type DEVICE

LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation

Awaiting ICD re-implantation

wearable defibrillator (LifeVest)

Intervention Type DEVICE

LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation

Acute myocardial infarction

Patients hospitalized with acute myocardial infarction and Killip Class III/IV.

wearable defibrillator (LifeVest)

Intervention Type DEVICE

LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation

Interventions

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wearable defibrillator (LifeVest)

LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation

Intervention Type DEVICE

Other Intervention Names

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wearable cardioveter defibrillator WCD LifeVest

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Eldar, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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90D0112

Identifier Type: -

Identifier Source: org_study_id