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Clinical Trials/NCT01326624
NCT01326624
Completed
Not Applicable

Study of the Wearable Defibrillator In Heart-Failure Patients

Zoll Medical Corporation2 sites in 2 countries25 target enrollmentMarch 2011
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ConditionsHeart FailureVentricular DysfunctionSudden DeathSudden Cardiac ArrestVentricular TachycardiaVentricular Fibrillation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Zoll Medical Corporation
Enrollment
25
Locations
2
Primary Endpoint
Defibrillation for life-threatening ventricular tachyarrhythmias
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
December 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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 Outcomes

  • Complications (adverse events) with wearable defibrillator use(6 months)
  • Total mortality(6 months and 12 months)
  • Compliance with wearable defibrillator use(6 months)
  • Quality of life with a wearable defibrillator(6 months)

Study Sites (2)

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