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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326624
First Posted: March 31, 2011
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zoll Medical Corporation
  Purpose
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.

Condition Intervention
Heart Failure Ventricular Dysfunction Sudden Death Sudden Cardiac Arrest Ventricular Tachycardia Ventricular Fibrillation Device: wearable defibrillator (LifeVest)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Wearable Defibrillator In Heart-Failure Patients

Resource links provided by NLM:


Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • Defibrillation for life-threatening ventricular tachyarrhythmias [ Time Frame: 6 months ]
  • Assess magnitude and complexity of ventricular and atrial arrhythmias during use [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Total mortality [ Time Frame: 6 months and 12 months ]
  • Compliance with wearable defibrillator use [ Time Frame: 6 months ]
  • Quality of life with a wearable defibrillator [ Time Frame: 6 months ]
  • Complications (adverse events) with wearable defibrillator use [ Time Frame: 6 months ]

Estimated Enrollment: 25
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • wearable cardioveter defibrillator
  • WCD
  • 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.
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
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:
  • wearable cardioveter defibrillator
  • WCD
  • LifeVest
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:
  • wearable cardioveter defibrillator
  • WCD
  • LifeVest

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326624


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14627
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Principal Investigator: Michael Eldar, MD Chaim Sheba Medical Center
  More Information

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT01326624     History of Changes
Other Study ID Numbers: 90D0112
First Submitted: March 29, 2011
First Posted: March 31, 2011
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Zoll Medical Corporation:
heart failure
ventricular dysfunction
sudden death
sudden cardiac arrest
ventricular tachycardia
ventricular fibrillation
wearable defibrillator

Additional relevant MeSH terms:
Heart Failure
Heart Arrest
Tachycardia
Ventricular Dysfunction
Tachycardia, Ventricular
Ventricular Fibrillation
Death, Sudden
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Death