Study of the Wearable Defibrillator in Heart-Failure Patients (SWIFT)

Study of the Wearable Defibrillator In Heart-Failure Patients

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Dysfunction; Sudden Death; Sudden Cardiac Arrest
• Intervention / Treatment: Device: wearable defibrillator (LifeVest)

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • Chaim Sheba Medical Center
• United States
  • New York
    • Rochester, New York, United States, 14627
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: WCD; LifeVest; wearable cardioveter defibrillator
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: WCD; LifeVest; wearable cardioveter defibrillator
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: WCD; LifeVest; wearable cardioveter defibrillator
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: WCD; LifeVest; wearable cardioveter defibrillator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Defibrillation for life-threatening ventricular tachyarrhythmias	6 months
Assess magnitude and complexity of ventricular and atrial arrhythmias during use	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Principal Investigator: Michael Eldar, MD, Chaim Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (Estimate): March 31, 2011

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: heart failure; ventricular tachycardia; ventricular fibrillation; ventricular dysfunction; sudden cardiac arrest; sudden death; wearable defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Death; Heart Failure; Heart Arrest; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Ventricular Dysfunction; Death, Sudden, Cardiac; Death, Sudden
• Other Study ID Numbers: 90D0112