Clinical trial NCT01326624: Study of the Wearable Defibrillator in Heart-Failure Patients
Official title: Study of the Wearable Defibrillator In Heart-Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Ventricular Dysfunction
Sudden Death
Sudden Cardiac Arrest
Ventricular Tachycardia
Ventricular Fibrillation
Keywords: heart failure
ventricular dysfunction
sudden death
sudden cardiac arrest
ventricular tachycardia
ventricular fibrillation
wearable defibrillator
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Defibrillation for life-threatening ventricular tachyarrhythmias
timeFrame: 6 months
measure: Assess magnitude and complexity of ventricular and atrial arrhythmias during use
timeFrame: 6 months
Secondary outcomes:
measure: Total mortality
timeFrame: 6 months and 12 months
measure: Compliance with wearable defibrillator use
timeFrame: 6 months
measure: Quality of life with a wearable defibrillator
timeFrame: 6 months
measure: Complications (adverse events) with wearable defibrillator use
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Michael Eldar, MD
role: PRINCIPAL_INVESTIGATOR
References: