Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest (HAT)
Home Automatic External Defibrillator Trial -- HAT
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98103
- Seattle Institute for Cardiac Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
All-cause mortality (measured throughout the study)
Time Frame: Five interim analyses of the data were performed and reviewed by the DSMB
|
Five interim analyses of the data were performed and reviewed by the DSMB
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Five interim analyses of the data were performed and reviewed by the DSMB
|
|
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
|
Five interim analyses of the data were performed and reviewed by the DSMB
|
Collaborators and Investigators
Investigators
- Study Chair: Gust H. Bardy, Seattle Institute for Cardiac Research
Publications and helpful links
General Publications
- Mark DB, Anstrom KJ, McNulty SE, Flaker GC, Tonkin AM, Smith WM, Toff WD, Dorian P, Clapp-Channing NE, Anderson J, Johnson G, Schron EB, Poole JE, Lee KL, Bardy GH. Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT). Am Heart J. 2010 Apr;159(4):627-634.e7. doi: 10.1016/j.ahj.2010.01.013.
- 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. doi: 10.1056/NEJMoa0801651. Epub 2008 Apr 1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 147
- U01HL067972 (U.S. NIH Grant/Contract)
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