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Hospital Wearable Defibrillator Inpatient Study (HWD)

Primary Purpose

In-Hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HWD1000
Sponsored by
Zoll Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for In-Hospital Cardiac Arrest focused on measuring In-Hospital Cardiac Arrest, Telemetry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period (patients will be monitored using the hospital's telemetry system). Specific inclusion criteria are:

  • Hospitalized patients having continuous independent ECG monitoring.
  • Patients at risk of sudden cardiac arrest during the hospitalization period as determined by the investigating physician.
  • Patient ≥18 years of age (over the legal age of providing consent).

Exclusion Criteria:

  • Patients with an active implantable cardioverter-defibrillator.
  • Patients with an active unipolar pacemaker.
  • Patients with physical or mental conditions preventing them from interacting with or wearing the device as determined by the investigating physician.
  • Patients having an advanced directive prohibiting resuscitation.
  • Patients having bandages or other clinical condition preventing the HWD use.
  • Patients unable to consent.
  • Patients having recently experienced an arrhythmic storm.
  • Patients prone to paroxysmal supraventricular tachycardia.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HWD1000

Arm Description

Subjects using HWD1000

Outcomes

Primary Outcome Measures

Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.
The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).

Secondary Outcome Measures

Full Information

First Posted
April 17, 2014
Last Updated
May 30, 2017
Sponsor
Zoll Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02122549
Brief Title
Hospital Wearable Defibrillator Inpatient Study
Acronym
HWD
Official Title
Hospital Wearable Defibrillator Inpatient Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zoll Medical Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will obtain device-human interaction evaluations for the HWD1000 within the controlled environment of the hospital as well as establish that the safety profile is similar to outpatient wearable cardioverter-defibrillators use.
Detailed Description
A multi-center prospective study of hospitalized patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period, wearing the HWD1000 hospital wearable defibrillator in order to evaluate caregiver and patient interactions with the device. In addition, ECG signal quality will be reviewed to confirm the HWD1000 safety profile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
In-Hospital Cardiac Arrest
Keywords
In-Hospital Cardiac Arrest, Telemetry

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HWD1000
Arm Type
Experimental
Arm Description
Subjects using HWD1000
Intervention Type
Device
Intervention Name(s)
HWD1000
Intervention Description
Wearable cardioverter-defibrillator designed for inpatient use
Primary Outcome Measure Information:
Title
Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.
Description
The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).
Time Frame
24 hours or longer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period (patients will be monitored using the hospital's telemetry system). Specific inclusion criteria are: Hospitalized patients having continuous independent ECG monitoring. Patients at risk of sudden cardiac arrest during the hospitalization period as determined by the investigating physician. Patient ≥18 years of age (over the legal age of providing consent). Exclusion Criteria: Patients with an active implantable cardioverter-defibrillator. Patients with an active unipolar pacemaker. Patients with physical or mental conditions preventing them from interacting with or wearing the device as determined by the investigating physician. Patients having an advanced directive prohibiting resuscitation. Patients having bandages or other clinical condition preventing the HWD use. Patients unable to consent. Patients having recently experienced an arrhythmic storm. Patients prone to paroxysmal supraventricular tachycardia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Szymkiewicz, MD
Organizational Affiliation
Zoll Medical Corporation
Official's Role
Principal Investigator
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Danbury
State/Province
Connecticut
Country
United States
City
Atlantis
State/Province
Florida
Country
United States
City
Jupiter
State/Province
Florida
Country
United States
City
Iowa City
State/Province
Iowa
Country
United States
City
Saint Paul
State/Province
Minnesota
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Hospital Wearable Defibrillator Inpatient Study

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