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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02122549
Other study ID # 90D0118
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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