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Trial record 67 of 132 for:    "Paroxysmal Ventricular Fibrillation"

Automatic External Defibrillation Monitoring in Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT00382928
Recruitment Status : Completed
First Posted : October 2, 2006
Results First Posted : July 1, 2014
Last Update Posted : July 15, 2015
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
A. Maziar Zafari, Atlanta VA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Death, Sudden, Cardiac
Ventricular Fibrillation
Tachycardia, Ventricular
Intervention Device: Defibrillation of pulseless VT/VF by AECD
Enrollment 192
Recruitment Details One hundred and ninety two patients were recruited in the time period between 10/10/2006 to 7/20/2007 to the telemetry ward of the Atlanta VA Medical Center.
Pre-assignment Details  
Arm/Group Title No Intervention: Standard of Care Group Experimental: AECD Monitoring + Standard of Care Group
Hide Arm/Group Description Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
Period Title: Overall Study
Started 97 95
Completed 97 95
Not Completed 0 0
Arm/Group Title No Intervention: Standard of Care Group Experimental: AECD Monitoring + Standard of Care Group Total
Hide Arm/Group Description Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention. Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital. Total of all reporting groups
Overall Number of Baseline Participants 97 95 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 95 participants 192 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
97
 100.0%
95
 100.0%
192
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 95 participants 192 participants
62  (3.4) 61.7  (3.4) 61.9  (3.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 95 participants 192 participants
Female
3
   3.1%
3
   3.2%
6
   3.1%
Male
94
  96.9%
92
  96.8%
186
  96.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97 participants 95 participants 192 participants
Hispanic 0 2 2
White 53 42 95
Black 44 51 95
Clinical Characteristics of Study Subjects  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97 participants 95 participants 192 participants
History of Heart Failure 20 25 45
New Diagnosis of Heart Failure 4 6 10
Diabetes mellitus 35 46 81
History of Coronary Artery Disease 42 35 77
Hypertension 74 79 153
Hyperlipidemia 53 55 108
EKG on admission  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97 participants 95 participants 192 participants
normal sinus rhythm 81 84 165
Atrial fibrillation/flutter 11 9 20
supraventricular tachycardia 2 0 2
Other 3 2 5
1.Primary Outcome
Title Number of Participants Without Defibrillation
Hide Description 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.
Time Frame 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description

There was only one patient in the Intervention group who received defibrillation.

No patients had CPR or defibrillation in the standard of care group.

Arm/Group Title Experimental: AECD Monitoring + Stand of Care Group No Intervention: Standard of Care Group
Hide Arm/Group Description:
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Overall Number of Participants Analyzed 95 97
Measure Type: Number
Unit of Measure: participants
94 97
2.Secondary Outcome
Title Frequency of Abnormal Rhythms Monitored by the AECD
Hide Description [Not Specified]
Time Frame During the duration of hospital admission on the telemetry ward.
Hide Outcome Measure Data
Hide Analysis Population Description
Only the AECD+Standard of Care Group was monitored in this portion of the study.
Arm/Group Title AECD Monitoring + Standard of Care Group Standard of Care
Hide Arm/Group Description:
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Overall Number of Participants Analyzed 95 0
Measure Type: Number
Unit of Measure: participants
Atrial Fibrillation/Flutter 9
Supraventricular Tachycardia 1
Premature Ventricular Complexes 10
Non-Sustained Ventricular Tachycardia 5
3.Secondary Outcome
Title Survival to Discharge
Hide Description [Not Specified]
Time Frame At discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental: AECD Monitoring + Standard of Care Group No Intervention: Standard of Care
Hide Arm/Group Description:
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Overall Number of Participants Analyzed 95 97
Measure Type: Number
Unit of Measure: participants
95 97
4.Secondary Outcome
Title Cerebral Performance at Discharge
Hide Description

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.

Time Frame At discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 patient in the Intervention group had defibrillation during hospital admission and his CPC was 1.
Arm/Group Title AECD Monitoring + Standard of Care Group Standard of Care Group
Hide Arm/Group Description:
Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: units on a scale: CPC 1
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: AECD Monitoring + Standard of Care Group No Intervention: Standard of Care Group
Hide Arm/Group Description Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital. Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
All-Cause Mortality
Experimental: AECD Monitoring + Standard of Care Group No Intervention: Standard of Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental: AECD Monitoring + Standard of Care Group No Intervention: Standard of Care Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/95 (0.00%)      0/97 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental: AECD Monitoring + Standard of Care Group No Intervention: Standard of Care Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/95 (10.53%)      0/97 (0.00%)    
Cardiac disorders     
False Positive Events in which, the shocks were delivered inappropriately. * [1]  2/95 (2.11%)  2 0/97 (0.00%)  0
Anxiety *  2/95 (2.11%)  2 0/97 (0.00%)  0
Skin irritation by the pads *  2/95 (2.11%)  2 0/97 (0.00%)  0
Alarming of the AECD, as the pads detached from the chest wall during sleep *  4/95 (4.21%)  4 0/97 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
AECD delivered the shock when patient was eating an apple. Discharge was the result of deliberate action of the patient.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. A. Maziar Zafari
Organization: Atlanta Research and Education Foundation
Phone: 404-321-6111 ext 4019
Responsible Party: A. Maziar Zafari, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00382928     History of Changes
Other Study ID Numbers: 1216-2004
First Submitted: September 29, 2006
First Posted: October 2, 2006
Results First Submitted: December 12, 2013
Results First Posted: July 1, 2014
Last Update Posted: July 15, 2015