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OpenTrials
Completed

NCT Number: NCT01326624

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Arrest Sudden Death Tachycardia Tachycardia, Ventricular Ventricular Dysfunction Ventricular Fibrillation Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chaim Sheba Medical Center, Tel Litwinsky, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

wearable defibrillator (LifeVest)

Device

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

Other names: wearable cardioveter defibrillator, WCD, LifeVest

Primary outcomes

  1. Defibrillation for life-threatening ventricular tachyarrhythmias

    Time frame: 6 months

  2. Assess magnitude and complexity of ventricular and atrial arrhythmias during use

    Time frame: 6 months

Secondary outcomes

  1. Total mortality

    Time frame: 6 months and 12 months

  2. Compliance with wearable defibrillator use

    Time frame: 6 months

  3. Quality of life with a wearable defibrillator

    Time frame: 6 months

  4. Complications (adverse events) with wearable defibrillator use

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Acronym: SWIFT

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2011
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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