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

ZOLL Medical

Status: Completed

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

Treatments: Device: wearable defibrillator (LifeVest)

Study type: Observational

Funder types: Industry

Identifiers

NCT01326624

90D0112

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

25 participants in 4 patient groups

NYHA class III or IV

Description:

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

Treatment:

Device: wearable defibrillator (LifeVest)

left ventricular ejection fraction ≤ 35%

Description:

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.

Treatment:

Device: wearable defibrillator (LifeVest)

Awaiting ICD re-implantation

Treatment:

Device: wearable defibrillator (LifeVest)

Acute myocardial infarction

Description:

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

Treatment:

Device: wearable defibrillator (LifeVest)