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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01326624
Other study ID # 90D0112
Secondary ID
Status Completed
Phase N/A
First received March 29, 2011
Last updated December 4, 2017
Start date March 2011
Est. completion date December 2017

Study information

Verified date December 2017
Source Zoll Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
Israel Chaim Sheba Medical Center Tel Hashomer
United States University of Rochester Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Defibrillation for life-threatening ventricular tachyarrhythmias 6 months
Primary Assess magnitude and complexity of ventricular and atrial arrhythmias during use 6 months
Secondary Total mortality 6 months and 12 months
Secondary Compliance with wearable defibrillator use 6 months
Secondary Quality of life with a wearable defibrillator 6 months
Secondary Complications (adverse events) with wearable defibrillator use 6 months
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