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Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest (HAT)
This study has been completed.
Study NCT00047411   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: October 3, 2002   Last Updated: March 6, 2008   History of Changes

October 3, 2002
March 6, 2008
September 2002
September 2007   (final data collection date for primary outcome measure)
All-cause mortality (measured throughout the study) [ Time Frame: Five interim analyses of the data were performed and reviewed by the DSMB ] [ Designated as safety issue: Yes ]
All-cause mortality (measured throughout the study)
Complete list of historical versions of study NCT00047411 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]
  • Survival free from post-arrest neurological impairments
  • Quality of life of the participants and their spouses (measured throughout the study)
 
Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest
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.

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.

Phase III
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Cardiovascular Diseases
  • Myocardial Infarction
  • Heart Diseases
  • Death, Sudden, Cardiac
  • Other: Cardiopulmonary Resuscitation
  • Device: Automatic External Defibrillation
  • Active Comparator: Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.
  • Experimental: 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.
Bardy GH, Lee KL, Mark DB, Poole JE, Toff WD, Tonkin AM, Smith W, Dorian P, Packer DL, White RD, Longstreth WT Jr, Anderson J, Johnson G, Bischoff E, Yallop JJ, McNulty S, Ray LD, Clapp-Channing NE, Rosenberg Y, Schron EB; HAT Investigators. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. 2008 Apr 24;358(17):1793-804. Epub 2008 Apr 1.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
7001
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00047411
Gust H. Bardy, MD, Seattle Institute for Cardiac Research
147, U01 HL67972
National Heart, Lung, and Blood Institute (NHLBI)
  • Philips Medical Systems
  • Laerdal Medical
Study Chair: Gust H. Bardy Seattle Institute for Cardiac Research
National Heart, Lung, and Blood Institute (NHLBI)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP