Hospital Wearable Defibrillator Inpatient Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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In-Hospital Cardiac Arrest

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HWD1000

Subjects using HWD1000

Group Type EXPERIMENTAL

HWD1000

Intervention Type DEVICE

Wearable cardioverter-defibrillator designed for inpatient use

Interventions

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HWD1000

Wearable cardioverter-defibrillator designed for inpatient use

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No