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Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest (HAT)

This study has been completed.
Sponsor:
Collaborators:
Philips Medical Systems
Laerdal Medical
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00047411
First received: October 3, 2002
Last updated: March 6, 2008
Last verified: March 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Death, Sudden, Cardiac
 Other: Cardiopulmonary Resuscitation
Device: Automatic External Defibrillation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Home Automatic External Defibrillator Trial -- HAT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome 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 ] [ 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 ]

Estimated Enrollment: 7001
Study Start Date: September 2002
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.
 Other: Cardiopulmonary Resuscitation
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.
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047411

Locations
United States, Washington
Seattle Institute for Cardiac Research
Seattle, Washington, United States, 98103
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Philips Medical Systems
Laerdal Medical
Investigators
Study Chair: Gust H. Bardy Seattle Institute for Cardiac Research
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gust H. Bardy, MD, Seattle Institute for Cardiac Research
ClinicalTrials.gov Identifier: NCT00047411     History of Changes
Other Study ID Numbers: 147, U01 HL67972
Study First Received: October 3, 2002
Last Updated: March 6, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
CPR, AED

Additional relevant MeSH terms:
Cardiovascular Diseases
Death, Sudden
Heart Diseases
Infarction
Myocardial Infarction
Death, Sudden, Cardiac
Death
 Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases
Heart Arrest

ClinicalTrials.gov processed this record on May 21, 2013