Study of the Wearable Defibrillator in Heart-Failure Patients

NCT01326624 | Completed

• 1 other identifier: 90D0112
• Study Type: observational
• Target: 25
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Defibrillation for life-threatening ventricular tachyarrhythmias

  6 months

• Assess magnitude and complexity of ventricular and atrial arrhythmias during use

  6 months

Secondary Outcomes (4)

• 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

Study Arms (4)

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)

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)

Awaiting ICD re-implantation

Device: wearable defibrillator (LifeVest)

Acute myocardial infarction

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

Device: wearable defibrillator (LifeVest)

Interventions

wearable defibrillator (LifeVest) DEVICE

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

Also known as: wearable cardioveter defibrillator, WCD, LifeVest

Acute myocardial infarction; Awaiting ICD re-implantation; NYHA class III or IV; left ventricular ejection fraction ≤ 35%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (2)

University of Rochester

Rochester, New York, 14627, United States

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction; Death, Sudden; Death, Sudden, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Study Officials

• Michael Eldar, MD

  Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 31, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (1); IL (1)