Hospital Wearable Defibrillator Inpatient Study (HWD)

ZOLL Medical

Status

Completed

Conditions

In-Hospital Cardiac Arrest

Treatments

Device: HWD1000

Study type

Interventional

Funder types

Industry

Identifiers

NCT02122549

90D0118

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.