NCT00047411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,001

participants targeted

Target at P75+ for phase_3 cardiovascular-diseases

Timeline
Completed

Started Sep 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2002

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 10, 2008

Status Verified

March 1, 2008

Enrollment Period

5 years

First QC Date

October 3, 2002

Last Update Submit

March 6, 2008

Conditions

Cardiovascular DiseasesMyocardial InfarctionHeart DiseasesDeath, Sudden, Cardiac

Keywords

CPR, AED

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality (measured throughout the study)

    Five interim analyses of the data were performed and reviewed by the DSMB

Secondary Outcomes (2)

  • Survival in the home from cardiac arrest and survival with AED use.

    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)

    Five interim analyses of the data were performed and reviewed by the DSMB

Study Arms (2)

1

ACTIVE COMPARATOR

Intervention: Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines.

Other: Cardiopulmonary Resuscitation

2

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.

Device: Automatic External Defibrillation

Interventions

Cardiopulmonary ResuscitationOTHER

Immediate notification of EMS by telephone and prompt initiation of CPR, in accordance with published Basic Life Support guidelines

1
Automatic External DefibrillationDEVICE

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of anterior myocardial infarction
  • Live-in spouse or companion willing to administer CPR or AED therapy plus CPR

You may not qualify if:

  • Existing implantable cardiac defibrillator or AED
  • Current candidate for an implantable cardiac defibrillator
  • Current "Do Not Resuscitate" orders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Institute for Cardiac Research

Seattle, Washington, 98103, United States

Location

Related Publications (2)

  • 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.

    PMID: 20362722DERIVED

  • 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.

    PMID: 18381485DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial InfarctionHeart DiseasesDeath, Sudden, Cardiac

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHeart ArrestDeath, SuddenDeath

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Study Officials

  • Gust H. Bardy

    Seattle Institute for Cardiac Research

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 3, 2002

First Posted

October 4, 2002

Study Start

September 1, 2002

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

March 10, 2008

Record last verified: 2008-03

Locations

US(1)