NCT02122549

Hospital Wearable Defibrillator Inpatient Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• In-Hospital Cardiac Arrest

Interventions

Type	Name	Description
DEVICE	HWD1000	Wearable cardioverter-defibrillator designed for inpatient use

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-04-24
• Last updated: 2017-05-31
• Results posted: 2017-05-31

Locations

8 sites across 1 country: United States