Hospital Wearable Defibrillator Inpatient Study
HWD
1 other identifier
interventional
59
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
May 31, 2017
CompletedMay 31, 2017
February 1, 2017
1.2 years
April 17, 2014
February 7, 2017
May 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
24 hours or longer
Study Arms (1)
HWD1000
EXPERIMENTALSubjects using HWD1000
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Danbury, Connecticut, United States
Unknown Facility
Atlantis, Florida, United States
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Saint Paul, Minnesota, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Results Point of Contact
- Title
- Vice President of Medical Affairs
- Organization
- ZOLL
Study Officials
- PRINCIPAL INVESTIGATOR
Steven J Szymkiewicz, MD
Zoll Medical Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2014
First Posted
April 24, 2014
Study Start
April 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
May 31, 2017
Results First Posted
May 31, 2017
Record last verified: 2017-02