Hospital Wearable Defibrillator Inpatient Study

Not Applicable

Completed

• Conditions: In-Hospital Cardiac Arrest
• Interventions: Device: HWD1000

• Registration Number: NCT02122549
• Lead Sponsor: Zoll Medical Corporation

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.

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-24
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-02
• Results First Submitted: 2017-02-07
• Results First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Results First Posted: 2017-05-31
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HWD1000	HWD1000	Subjects using HWD1000

Primary Outcome Measures

Name	Time	Method
Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.	24 hours or longer	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).