Death, Sudden, CardiacPhase 1NCT00382928
Automatic External Defibrillation Monitoring in Cardiac Arrest
A Phase 1 study testing Defibrillation of pulseless VT/VF by AECD in people with Death, Sudden, Cardiac and Ventricular Fibrillation, run by Foundation for Atlanta Veterans Education and Research, Inc. at 1 site in United States.
Trial summary
We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments being constant including cardiopulmonary resuscitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Ventricular
- What is being tested?
- Defibrillation of pulseless VT/VF by AECD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients admitted to telemetry ward and emergency department
- Age > 18 years.
Who cannot join
- Pregnant women
- Patients with R wave less than 0.5 millivolts.
- Patients with functioning Internal Cardiac Device.
- Patients with cardiac pacemakers if oversensing by AECD is demonstrated (double counting of pacer spikes).
- Patients with visible chest lesions that would prevent AECD pad placement.
- Patients who are designated Do Not Resuscitate.
Show all 9Show fewer
- Right bundle branch block.
- Patients with Parkinson's disease.
- Patients with seizure disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Veterans Adminstration Medical Center
Decatur, Georgia, 30033
About this study
We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments being constant including cardiopulmonary resuscitation.
We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic technology used in AECDs will further increase the rate of survival in patients with cardiac arrest through rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation initiated by healthcare providers.
Read the detailed description
Cardiac arrest (CA) is defined as the sudden cessation of effective cardiac pumping function as a result of either ventricular asystole (inactivity of the heart) or pulseless ventricular tachycardia/ventricular fibrillation (VT/VF). Pulseless ventricular tachycardia/ventricular fibrillation is an abnormal electrical activity of the ventricles of the heart. Rapid diagnosis and treatment are essential because first, more than a few minutes of total CA results in permanent damage to the brain due to lack of oxygen, and second, the success of resuscitative measures is related to the rapidity with which they are instituted following arrest. For a person in VT/VF the probability of successful defibrillation and subsequent survival to hospital discharge is directly and negatively related to the interval between onset of VT/VF and delivery of first shock.
Comparison: By using AECDs we will evaluate if an automatic, rapid, accurate and specific diagnostic technology will further increase the rate of survival in patients with VT/VF by rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation (CPR) with conventional defibrillators initiated by healthcare providers. This trial will be a randomized, controlled trial and will test if AECDs can improve outcome measures when compared to traditional responses.
Conventional defibrillators are manually operated defibrillators that have to be attached to the patient and operated by a healthcare provider or layperson. In contrast, the purpose of AECDs is to automatically detect life-threatening arrhythmias and deliver external shocks according to a programmable prescription for hospitalized patients, who may be at transient risk for the development of life-threatening arrhythmias. AECDs immediately and automatically monitor, detect and treat cardiac arrhythmias with no human intervention. The AECD proposed to be utilized in this trial, PowerHeart CRM, a product of Cardiac Science, Inc, has been evaluated in the hospital setting to assess safety and efficacy, and has been approved by the FDA to be prophylactically attached to hospital patients and provide automatic defibrillation therapy without human intervention.
All patients admitted to the telemetry unit will be asked to volunteer for this study. Up to 3,000 patients will be asked to volunteer in this study during their stay in the telemetry unit. This study will evaluate if there is a way to improve survival in CA by comparing two groups
Group 1: This group includes patients admitted to telemetry unit who will undergo standard measures of CPR in case cardiac arrest is suspected.
Group 2: This group includes patients admitted to telemetry unit who will have an AECD attached to the chest wall and who will also undergo standard measures of CPR in case of cardiac arrest.
- Being tested
- Defibrillation of pulseless VT/VF by AECD
- Keywords
- Randomized Controlled Trials, Defibrillators, Medical Devices
- Medical subject headings
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defibrillation of pulseless VT/VF by AECDDevice
In case of cardiac arrest caused by shockable rhythms the automatic external cardioverter defibrillator (AECD) will automatically deliver defibrillation. Automated External Cardioverter Defibrillator (AECD; The PowerHeart CRM, Cardiac Science Inc., Seattle, WA) is a device attached to the chest wall by pads, monitors the electrocardiogram, and is capable of automatically delivering electric countershock to appropriate rhythms without operator intervention. The device will deliver only one shock of 150 Joules for pulseless ventricular tachycardia and ventricular fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | No intervention | Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention |
| AECD Monitoring + Standard of Care Group | Experimental | Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital. Defibrillation of pulseless VT/VF by AECD. Receives: Device: Defibrillation of pulseless VT/VF by AECD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Without Defibrillation
Time to defibrillation: interval between onset of VT/VF and delivery of first shock. Expected time to defibrillation for AECD group: 30±30 seconds; expected time to defibrillation for Standard of Care group: 180±180.
Measured: 10 minutes
Secondary outcomes (3)
Frequency of Abnormal Rhythms Monitored by the AECD
Measured: During the duration of hospital admission on the telemetry ward.
Survival to Discharge
Measured: At discharge
Cerebral Performance at Discharge
Cerebral Performance Categories/CPC scale:
CPC 1: Good cerebral performance - conscious, alert, able to work, might have mild neurologic or psychological deficit.
CPC 2: Moderate cerebral disability - conscious, sufficient cerebral function for independent activities of daily life. Able to work in sheltered environment.
CPC 3: Severe cerebral disability - conscious, dependent on others for daily support because of impaired brain function. Ranges from ambulatory state to severe dementia or paralysis.
CPC 4: Coma or vegetative state - any degree of coma without the presence of all brain death criteria. Unawareness, even if appears awake (vegetative state) without interaction with environment; may have spontaneous eye opening and sleep/awake cycles. Cerebral unresponsiveness.
CPC 5: Brain death - apnea, areflexia, electroencephalogram (EEG) silence, etc.
Measured: At discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Death, Sudden, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, A. Maziar Zafari, Atlanta VA Medical Center
- Investigators
- A. Maziar Zafari, M.D., Ph.D, Principal investigator, Division of Cardiology, Atlanta Veterans Adminstration Medical Center/ Emory University, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382928
- Sponsor's protocol ID
- 1216-2004
- Status last verified
- Jun 2015
- First submitted
- 29 Sep 2006
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ali B, Bloom H, Veledar E, House D, Norvel R, Dudley SC, Zafari AM. Automated external cardioversion defibrillation monitoring in cardiac arrest: a randomized trial. Trials. 2008 Jun 11;9:36. doi: 10.1186/1745-6215-9-36.
PubMed 18547438
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic External Defibrillation Monitoring in Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00382928
- Acronym / sponsor ID
- 1216-2004
- Keywords
- Randomized Controlled Trials, Defibrillators, Medical Devices
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Foundation for Atlanta Veterans Education and Research, Inc.University, hospital or other
- Collaborators
- Emory University
- Study start
- Oct 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Oct 2006 (estimated)
- Results
- Posted 1 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to randomize automatic external cardioverter/defibrillators (AECD) in patients who are at high risk for life-threatening abnormal heart rhythms (arrhythmias) and are admitted to the telemetry ward, all other treatments being constant including cardiopulmonary resuscitation.
We hypothesize that the automatic, rapid, accurate and specific diagnostic and therapeutic technology used in AECDs will further increase the rate of survival in patients with cardiac arrest through rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation initiated by healthcare providers.
Detailed description
Cardiac arrest (CA) is defined as the sudden cessation of effective cardiac pumping function as a result of either ventricular asystole (inactivity of the heart) or pulseless ventricular tachycardia/ventricular fibrillation (VT/VF). Pulseless ventricular tachycardia/ventricular fibrillation is an abnormal electrical activity of the ventricles of the heart. Rapid diagnosis and treatment are essential because first, more than a few minutes of total CA results in permanent damage to the brain due to lack of oxygen, and second, the success of resuscitative measures is related to the rapidity with which they are instituted following arrest. For a person in VT/VF the probability of successful defibrillation and subsequent survival to hospital discharge is directly and negatively related to the interval between onset of VT/VF and delivery of first shock.
Comparison: By using AECDs we will evaluate if an automatic, rapid, accurate and specific diagnostic technology will further increase the rate of survival in patients with VT/VF by rapid and automatic defibrillation, independent of operator initiation, as compared to standard cardiopulmonary resuscitation (CPR) with conventional defibrillators initiated by healthcare providers. This trial will be a randomized, controlled trial and will test if AECDs can improve outcome measures when compared to traditional responses.
Conventional defibrillators are manually operated defibrillators that have to be attached to the patient and operated by a healthcare provider or layperson. In contrast, the purpose of AECDs is to automatically detect life-threatening arrhythmias and deliver external shocks according to a programmable prescription for hospitalized patients, who may be at transient risk for the development of life-threatening arrhythmias. AECDs immediately and automatically monitor, detect and treat cardiac arrhythmias with no human intervention. The AECD proposed to be utilized in this trial, PowerHeart CRM, a product of Cardiac Science, Inc, has been evaluated in the hospital setting to assess safety and efficacy, and has been approved by the FDA to be prophylactically attached to hospital patients and provide automatic defibrillation therapy without human intervention.
All patients admitted to the telemetry unit will be asked to volunteer for this study. Up to 3,000 patients will be asked to volunteer in this study during their stay in the telemetry unit. This study will evaluate if there is a way to improve survival in CA by comparing two groups
Group 1: This group includes patients admitted to telemetry unit who will undergo standard measures of CPR in case cardiac arrest is suspected.
Group 2: This group includes patients admitted to telemetry unit who will have an AECD attached to the chest wall and who will also undergo standard measures of CPR in case of cardiac arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | No intervention | –Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention |
| AECD Monitoring + Standard of Care Group | Experimental | Device: Defibrillation of pulseless VT/VF by AECDPatients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital. Defibrillation of pulseless VT/VF by AECD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted to telemetry ward and emergency department
- Age > 18 years.
Key exclusion criteria (9 listed)
- Pregnant women
- Patients with R wave less than 0.5 millivolts.
- Patients with functioning Internal Cardiac Device.
- Patients with cardiac pacemakers if oversensing by AECD is demonstrated (double counting of pacer spikes).
- Patients with visible chest lesions that would prevent AECD pad placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defibrillation of pulseless VT/VF by AECDIn case of cardiac arrest caused by shockable rhythms the automatic external cardioverter defibrillator (AECD) will automatically deliver defibrillation. Automated External Cardioverter Defibrillator (AECD; The PowerHeart CRM, Cardiac Science Inc., Seattle, WA) is a device attached to the chest wall by pads, monitors the electrocardiogram, and is capable of automatically delivering electric countershock to appropriate rhythms without operator intervention. The device will deliver only one shock of 150 Joules for pulseless ventricular tachycardia and ventricular fibrillation. | Device | AECD Monitoring + Standard of Care Group |
Primary outcome
Number of Participants Without Defibrillation
Time frame: 10 minutes
Time to defibrillation: interval between onset of VT/VF and delivery of first shock. Expected time to defibrillation for AECD group: 30±30 seconds; expected time to defibrillation for Standard of Care group: 180±180.
3 secondary outcomes
Frequency of Abnormal Rhythms Monitored by the AECD
Time frame: During the duration of hospital admission on the telemetry ward.
Survival to Discharge
Time frame: At discharge
Cerebral Performance at Discharge
Time frame: At discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 18547438Ali B, Bloom H, Veledar E, House D, Norvel R, Dudley SC, Zafari AM. Automated external cardioversion defibrillation monitoring in cardiac arrest: a randomized trial. Trials. 2008 Jun 11;9:36. doi: 10.1186/1745-6215-9-36.
- Click here for detailed information about this study: Automated external cardioversion defibrillation monitoring in cardiac arrest: a randomized trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Maziar Zafari, M.D., Ph.D principal investigator
Division of Cardiology, Atlanta Veterans Adminstration Medical Center/ Emory University, Decatur, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Defibrillation of pulseless VT/VF by AECD in people with Death, Sudden, Cardiac and Ventricular Fibrillation, run by Foundation for Atlanta Veterans Education and Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Without Defibrillation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00382928, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.