Official Title: “Home Automatic External Defibrillator Trial -- HAT”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Study Primary Completion Date: September 2007

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.

Intervention(s) in this Clinical Trial

• Other: Cardiopulmonary Resuscitation
  • Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines
• Device: Automatic External Defibrillation
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.
• Experimental: 2
  • Use of 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 Measures

• All-cause mortality (measured throughout the study)
  • Time Frame: Five interim analyses of the data were performed and reviewed by the DSMB
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Gust H. Bardy Study Chair Seattle Institute for Cardiac Research  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00047411

Study ID Number: 147

ClinicalTrials.gov Identifier: NCT00047411

Health Authority: United States: Federal Government