Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00047411
Recruitment Status : Completed
First Posted : October 4, 2002
Last Update Posted : March 10, 2008
Sponsor:
Collaborators:
Philips Medical Systems
Laerdal Medical
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE October 3, 2002
First Posted Date  ICMJE October 4, 2002
Last Update Posted Date March 10, 2008
Study Start Date  ICMJE September 2002
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
All-cause mortality (measured throughout the study) [ Time Frame: Five interim analyses of the data were performed and reviewed by the DSMB ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest
Official Title  ICMJE Home Automatic External Defibrillator Trial -- HAT
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Myocardial Infarction
  • Heart Diseases
  • Death, Sudden, Cardiac
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.
    Intervention: Other: Cardiopulmonary Resuscitation
  • 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.
    Intervention: Device: Automatic External Defibrillation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 11, 2006)
7001
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00047411
Other Study ID Numbers  ICMJE 147
U01HL067972 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gust H. Bardy, MD, Seattle Institute for Cardiac Research
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE
  • Philips Medical Systems
  • Laerdal Medical
Investigators  ICMJE
Study Chair: Gust H. Bardy Seattle Institute for Cardiac Research
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date March 2008

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