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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT01326624
First received: March 29, 2011
Last updated: April 1, 2013
Last verified: April 2013

March 29, 2011
April 1, 2013
March 2011
October 2012   (final data collection date for primary outcome measure)
  • Defibrillation for life-threatening ventricular tachyarrhythmias [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assess magnitude and complexity of ventricular and atrial arrhythmias during use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01326624 on ClinicalTrials.gov Archive Site
  • Total mortality [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Compliance with wearable defibrillator use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life with a wearable defibrillator [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Complications (adverse events) with wearable defibrillator use [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of the Wearable Defibrillator in Heart-Failure Patients
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Heart Failure
  • Ventricular Dysfunction
  • Sudden Death
  • Sudden Cardiac Arrest
  • Ventricular Tachycardia
  • Ventricular Fibrillation
Device: wearable defibrillator (LifeVest)
LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation
Other Names:
  • wearable cardioveter defibrillator
  • WCD
  • LifeVest
  • 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
    Intervention: 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.
    Intervention: Device: wearable defibrillator (LifeVest)
  • Awaiting ICD re-implantation
    Intervention: Device: wearable defibrillator (LifeVest)
  • Acute myocardial infarction
    Patients hospitalized with acute myocardial infarction and Killip Class III/IV.
    Intervention: Device: wearable defibrillator (LifeVest)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
October 2013
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT01326624
90D0112
No
Zoll Medical Corporation
Zoll Medical Corporation
Not Provided
Principal Investigator: Michael Eldar, MD Chaim Sheba Medical Center
Zoll Medical Corporation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP