- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02122549
Hospital Wearable Defibrillator Inpatient Study (HWD)
May 30, 2017 updated by: Zoll Medical Corporation
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States
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Connecticut
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Danbury, Connecticut, United States
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Florida
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Atlantis, Florida, United States
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Jupiter, Florida, United States
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Iowa
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Iowa City, Iowa, United States
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Minnesota
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Saint Paul, Minnesota, United States
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Virginia
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Richmond, Virginia, United States
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Washington
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Seattle, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HWD1000
Subjects using HWD1000
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Wearable cardioverter-defibrillator designed for inpatient use
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.
Time Frame: 24 hours or longer
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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).
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24 hours or longer
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven J Szymkiewicz, MD, Zoll Medical Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
April 17, 2014
First Submitted That Met QC Criteria
April 22, 2014
First Posted (Estimate)
April 24, 2014
Study Record Updates
Last Update Posted (Actual)
May 31, 2017
Last Update Submitted That Met QC Criteria
May 30, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90D0118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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