Sudden Cardiac DeathNCT01448005
LifeVest Post-CABG Registry
An observational study of Sudden Cardiac Death and Ventricular Fibrillation, run by Zoll Medical Corporation at 5 sites in United States.
Trial summary
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia
- What is being tested?
- wearable defibrillator (LifeVest)
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2011to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients who have undergone CABG surgery during current hospitalization and have an ejection fraction ≤ 35% following the surgery.
Who may be able to join
- Patients who have undergone CABG surgery during current hospitalization
- Patients who have an ejection fraction ≤ 35% following the surgery.
- Patients who have dilated cardiomyopathy or prior myocardial infarction.
- Patients who are prescribed a wearable defibrillator following surgery.
- Patient who are at least 18 years old.
Who cannot join
- Patients who have an active ICD.
- Patients who have an active unipolar pacemaker.
- Patients having a chest circumference over 56 inches or under 26 inches.
- Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.
- Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.
- Patients participating in another clinical study with mortality as the primary endpoint.
- Patients unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, dextrocardia, etc.).
- Patients who have decided to forgo resuscitation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Saint Joseph's Health System, Inc.
Atlanta, Georgia, 30342
Texas Heart Institute, St. Luke's Episcopal Hospital
Houston, Texas, 77030
Chippenham Johnston-Willis Medical Center
Richmond, Virginia, 23225
Sutter Heart and Vascular Institute
Sacramento, California, 95819
Washington Adventist Hospital
Takoma Park, Maryland, 20912
About this study
Official title: Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.
- Conditions
- Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Dysfunction, Myocardial Ischemia
- Being tested
- wearable defibrillator (LifeVest)
- Keywords
- Coronary Artery Bypass Grafting, Resuscitation, Sudden Cardiac Death, Ventricular Dysfunction
- Medical subject headings
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Ventricular, Ventricular Dysfunction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable defibrillator (LifeVest)Device
Also called LifeVest, wearable cardioverter defibrillator, wearable automatic external defibrillator
A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.
| Study group | Role | What they receive |
|---|---|---|
| wearable defibrillator use | subjects will use a wearable defibrillator Receives: Device: wearable defibrillator (LifeVest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who experience sudden cardiac death
Measured: three months
Secondary outcomes (3)
number of patients who experience inappropriate shocks
Measured: three months
hours per day of wearable defibrillator use
Measured: three months
number of patients who experience sudden cardiac arrest
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2014
- Study completionOct 2014
Why it stopped: Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven J Szymkiewicz, MD, Study director, Zoll Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448005
- Sponsor's protocol ID
- 90D0107
- Status last verified
- Dec 2017
- First submitted
- 4 Oct 2011
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Release Registry of Wearable Defibrillator Use in Patients With Ventricular Dysfunction Following CABG Surgery
- ClinicalTrials.gov ID
- NCT01448005
- Acronym / sponsor ID
- 90D0107
- Conditions
- Sudden Cardiac Death, Ventricular Fibrillation, Ventricular Tachycardia, Ventricular Dysfunction, Myocardial Ischemia
- Keywords
- Coronary Artery Bypass Grafting, Resuscitation, Sudden Cardiac Death, Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center prospective registry of patients with an ejection fraction (EF) ≤ 35% following coronary artery bypass graft (CABG) surgery in order to test the hypothesis that wearable defibrillators (WD) will decrease overall mortality after discharge by decreasing arrhythmic death in this select population with high risk for sudden cardiac death (SCD). This is a pilot project to determine the feasibility of a larger-scale study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wearable defibrillator use | – | Device: wearable defibrillator (LifeVest)subjects will use a wearable defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone CABG surgery during current hospitalization and have an ejection fraction ≤ 35% following the surgery.
Key inclusion criteria (5 listed)
- Patients who have undergone CABG surgery during current hospitalization
- Patients who have an ejection fraction ≤ 35% following the surgery.
- Patients who have dilated cardiomyopathy or prior myocardial infarction.
- Patients who are prescribed a wearable defibrillator following surgery.
- Patient who are at least 18 years old.
Key exclusion criteria (8 listed)
- Patients who have an active ICD.
- Patients who have an active unipolar pacemaker.
- Patients having a chest circumference over 56 inches or under 26 inches.
- Patients who are unable to consent or unwilling to wear the WCD after discharge or who do not agree to be contacted at 90 days.
- Patients with a mental, visual, physical or auditory deficit that could impair their ability to properly interact with a wearable defibrillator.
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 |
|---|---|---|
| wearable defibrillator (LifeVest)Also: LifeVest, wearable cardioverter defibrillator, wearable automatic external defibrillatorA wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention. | Device | wearable defibrillator use |
Primary outcome
number of patients who experience sudden cardiac death
Time frame: three months
3 secondary outcomes
number of patients who experience inappropriate shocks
Time frame: three months
hours per day of wearable defibrillator use
Time frame: three months
number of patients who experience sudden cardiac arrest
Time frame: three months
Results and safety
The study was stopped early (reason given: Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
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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.
Steven J Szymkiewicz, MD study director
Zoll Medical Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death and Ventricular Fibrillation, run by Zoll Medical Corporation at 5 sites 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
Are results available for this study?
The study was stopped early (reason given: Enrollment). Results are not available in the source record.
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 patients who experience sudden cardiac death (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2017.