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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
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: March 2011
Estimated Study Completion Date: October 2013
Primary Completion Date: October 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT01326624     History of Changes
Other Study ID Numbers: 90D0112
Study First Received: March 29, 2011
Last Updated: April 1, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013