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.
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
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
59
Wearable cardioverter-defibrillator designed for inpatient use
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Danbury, Connecticut, United States
Unnamed facility
Atlantis, Florida, United States
Unnamed facility
Jupiter, Florida, United States
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).
Time frame: 24 hours or longer
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Unnamed facility
Iowa City, Iowa, United States
Unnamed facility
Saint Paul, Minnesota, United States
Unnamed facility
Richmond, Virginia, United States
Unnamed facility
Seattle, Washington, United States