Study of the Wearable Defibrillator in Heart-Failure Patients

Heart Failure Clinical Trial

— SWIFT  

Official title:

Study of the Wearable Defibrillator In Heart-Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326624
• Other study ID #: 90D0112
• 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
• 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.

Related Conditions & MeSH terms

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

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