Hospital Wearable Defibrillator Inpatient Study

In-Hospital Cardiac Arrest Clinical Trial

— HWD  

Official title:

Hospital Wearable Defibrillator Inpatient Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122549
• Other study ID #: 90D0118
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: May 30, 2017
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: February 2017
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest
• In-Hospital Cardiac Arrest

Intervention

Device:
• HWD1000
Wearable cardioverter-defibrillator designed for inpatient use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 hours or longer