Study of the Wearable Defibrillator in Heart-Failure Patients - Full Text View

Sponsor:	Zoll Medical Corporation
Information provided by (Responsible Party):	Zoll Medical Corporation
ClinicalTrials.gov Identifier:	NCT01326624

Purpose

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.

Condition	Intervention
Heart Failure Ventricular Dysfunction Sudden Death Sudden Cardiac Arrest Ventricular Tachycardia Ventricular Fibrillation	Device: wearable defibrillator (LifeVest)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Study of the Wearable Defibrillator In Heart-Failure Patients

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Cardiac Arrest Heart Failure

U.S. FDA Resources

Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:

Defibrillation for life-threatening ventricular tachyarrhythmias [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Assess magnitude and complexity of ventricular and atrial arrhythmias during use [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total mortality [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
Compliance with wearable defibrillator use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Quality of life with a wearable defibrillator [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complications (adverse events) with wearable defibrillator use [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	March 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	Device: wearable defibrillator (LifeVest) LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation Other Names: wearable cardioveter defibrillator WCD LifeVest
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.	Device: wearable defibrillator (LifeVest) LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation Other Names: wearable cardioveter defibrillator WCD LifeVest
Awaiting ICD re-implantation	Device: wearable defibrillator (LifeVest) LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation Other Names: wearable cardioveter defibrillator WCD LifeVest
Acute myocardial infarction Patients hospitalized with acute myocardial infarction and Killip Class III/IV.	Device: wearable defibrillator (LifeVest) LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation Other Names: wearable cardioveter defibrillator WCD LifeVest

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients with left ventricular dysfunction or advanced heart failure symptoms (New York Heart Association functional Class III/IV), who have a high-risk for sudden cardiac death, but are not eligible for an implantable defibrillator or are not able to receive one due to their condition.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326624

Locations

Israel
Chaim Sheba Medical Center	Recruiting
Tel Hashomer, Israel, 52621
Contact: Ilan Goldenberg, MD (585) 273-1875 Ilan.Goldenberg@heart.rochester.edu
Principal Investigator: Michael Eldar, MD

Sponsors and Collaborators

Zoll Medical Corporation

Investigators

Principal Investigator:

Michael Eldar, MD

Chaim Sheba Medical Center

More Information

No publications provided

Responsible Party:	Zoll Medical Corporation
ClinicalTrials.gov Identifier:	NCT01326624 History of Changes
Other Study ID Numbers:	90D0112
Study First Received:	March 29, 2011
Last Updated:	October 3, 2011
Health Authority:	Israel: Ministry of Health

Keywords provided by Zoll Medical Corporation:

heart failure
ventricular dysfunction
sudden death
sudden cardiac arrest

ventricular tachycardia
ventricular fibrillation
wearable defibrillator

Additional relevant MeSH terms:

Death
Death, Sudden
Heart Arrest
Heart Failure
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular

Ventricular Dysfunction
Death, Sudden, Cardiac
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 23, 2012