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OpenTrials
Completed

NCT Number: NCT00047411

Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest

To compare home use of an automatic external defibrillator (AED) to the use of local emergency medical system in treating survivors of sudden cardiac arrest.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seattle Institute for Cardiac Research

Seattle, Washington, 98103, United States

About this study

BACKGROUND:

Sudden cardiac arrest (SCA) occurs every two minutes throughout the United States, with more than 70 percent occuring at home. Because survival falls 10 percent per minute over the first ten minutes, it is imperative to defibrillate as soon as possible. Public efforts cannot provide defibrillation fast enough in most cases. Physicians believe the initial shock is best done using readily available AEDs by family members who are only seconds from their loved one.

DESIGN NARRATIVE:

This study tests the central hypothesis that providing an AED for home use will improve survival beyond that achieved from the typical response to sudden cardiac arrest. An estimated 7,000 people who have had an anterior myocardial infarction will be randomly assigned to one of two groups: 1) a standard response to sudden cardiac arrest, entailing calling an emergency medical service (EMS) system and performing CPR, or 2) the addition of a home AED to the standard response. The standard response will be augmented and standardized by the provision of a video on how to respond to sudden cardiac arrest and how to perform CPR. The goal for the standard response will be immediate notification of EMS and prompt CPR. The goal for the AED group will be to shock the cardiac arrest victim up to three times immediately, if indicated by the AED, and call EMS and perform CPR as soon as possible and preferably within two minutes of collapse. Participants will be enrolled for more than two years and followed for an additional two years. The study will be performed at 200 cardiology clinics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of anterior myocardial infarction
  • Live-in spouse or companion willing to administer CPR or AED therapy plus CPR

Exclusion criteria

  • Existing implantable cardiac defibrillator or AED
  • Current candidate for an implantable cardiac defibrillator
  • Current "Do Not Resuscitate" orders

Treatment and study plan

cardiopulmonary resuscitation

Other

Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines

Automatic External Defibrillation

Device

Use the AED first, in accordance with published guidelines for AED use, followed by a call to EMS and perform CPR as in the control group.

Primary outcomes

  1. All-cause mortality (measured throughout the study)

    Time frame: Five interim analyses of the data were performed and reviewed by the DSMB

Secondary outcomes

  1. Survival in the home from cardiac arrest and survival with AED use.

    Time frame: Five interim analyses of the data were performed and reviewed by the DSMB

  2. Quality of life of the participants and their spouses (measured throughout the study)

    Time frame: Five interim analyses of the data were performed and reviewed by the DSMB

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Collaborators

  • Laerdal Medical
  • Philips Medical Systems

Registry information

Official study title

Home Automatic External Defibrillator Trial -- HAT

Acronym: HAT

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Oct 4, 2002
Registry last updated
Mar 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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