Hospital Wearable Defibrillator Inpatient Study

Completed · Not applicable

Conditions studied: In-Hospital Cardiac Arrest

In brief

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.

Key facts

Study ID

NCT02122549

Run by

Zoll Medical Corporation

People needed

59

Starts

2014-04-01

Expected to finish

2015-07-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Danbury, Connecticut, United States
• Study site — Atlantis, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Iowa City, Iowa, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Richmond, Virginia, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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