Heart FailureSWIFTNCT01326624
Study of the Wearable Defibrillator in Heart-Failure Patients
An observational study of Heart Failure and Ventricular Dysfunction, run by Zoll Medical Corporation at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are either not eligible for an implantable defibrillator under current guidelines or are not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ventricular Dysfunction, Sudden Death
- What is being tested?
- wearable defibrillator (LifeVest)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2011to Dec 2017
- 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 with left ventricular dysfunction or advanced heart failure symptoms (New York Heart Association functional Class III/IV), who have a high-risk for sudden cardiac death, but are not eligible for an implantable defibrillator or are not able to receive one due to their condition.
Who may be able to join
- Patients with NYHA class III or IV during the past month and one or more of the following:
- hospitalization for cardiac decongestion and stabilization,
- advanced heart failure receiving intravenous diuretics/inotropics in an outpatient clinic, or
- awaiting cardiac transplantation
- Patients with left ventricular ejection fraction ≤ 35% and either one of the following:
- coronary revascularization within 3 calendar months prior to enrollment, or
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- heart failure of non-ischemic origin diagnosed within 3 calendar months prior to enrollment.
- Patients awaiting ICD re-implantation following device explantation or lead extraction,
- Patients hospitalized with acute myocardial infarction and Killip Class III/IV.
Who cannot join
- The presence of an implantable cardioverter defibrillator prior to enrollment.
- Advanced cerebrovascular disease.
- Non-cardiac terminal illness associated with reduced likelihood of survival for the duration of the study.
- Use of supplemental oxygen in an outpatient setting requiring an external oxygen tank.
- Pregnancy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Study of the Wearable Defibrillator In Heart-Failure Patients
The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are either not eligible for an implantable defibrillator under current guidelines or are not able to receive the device due to their condition.
- Conditions
- Heart Failure, Ventricular Dysfunction, Sudden Death, Sudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- wearable defibrillator (LifeVest)
- Keywords
- heart failure, ventricular dysfunction, sudden death, sudden cardiac arrest, ventricular tachycardia, ventricular fibrillation, wearable defibrillator
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Death, Sudden, Death, Sudden, Cardiac, Tachycardia, Ventricular, Ventricular Fibrillation
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 wearable cardioveter defibrillator, WCD, LifeVest
LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation
| Study group | Role | What they receive |
|---|---|---|
| NYHA class III or IV | Patients with NYHA class III or IV during the past month and one or more of the following:
* Hospitalization for cardiac decongestion and stabilization.
* Advanced heart failure receiving intravenous diuretics/inotropics in an outpatient clinic.
* Awaiting cardiac transplantation Receives: Device: wearable defibrillator (LifeVest) | |
| left ventricular ejection fraction ≤ 35% | Patients with left ventricular ejection fraction ≤ 35% and either one of the following:
* Coronary revascularization within 3 calendar months prior to enrollment.
* Heart failure of non-ischemic origin diagnosed within 3 calendar months prior to enrollment. Receives: Device: wearable defibrillator (LifeVest) | |
| Awaiting ICD re-implantation | Not described Receives: Device: wearable defibrillator (LifeVest) | |
| Acute myocardial infarction | Patients hospitalized with acute myocardial infarction and Killip Class III/IV. Receives: Device: wearable defibrillator (LifeVest) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defibrillation for life-threatening ventricular tachyarrhythmias
Measured: 6 months
Assess magnitude and complexity of ventricular and atrial arrhythmias during use
Measured: 6 months
Secondary outcomes (4)
Total mortality
Measured: 6 months and 12 months
Compliance with wearable defibrillator use
Measured: 6 months
Quality of life with a wearable defibrillator
Measured: 6 months
Complications (adverse events) with wearable defibrillator use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Eldar, MD, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326624
- Sponsor's protocol ID
- 90D0112
- Acronym
- SWIFT
- Status last verified
- Dec 2017
- First submitted
- 29 Mar 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
- Study of the Wearable Defibrillator In Heart-Failure Patients
- ClinicalTrials.gov ID
- NCT01326624
- Acronym / sponsor ID
- SWIFT / 90D0112
- Conditions
- Heart Failure, Ventricular Dysfunction, Sudden Death, Sudden Cardiac Arrest, Ventricular Tachycardia, Ventricular Fibrillation
- Keywords
- heart failure, ventricular dysfunction, sudden death, sudden cardiac arrest, ventricular tachycardia, ventricular fibrillation, wearable defibrillator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Mar 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.
The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are either not eligible for an implantable defibrillator under current guidelines or are not able to receive the device due to their condition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NYHA class III or IV | – | Device: wearable defibrillator (LifeVest)Patients with NYHA class III or IV during the past month and one or more of the following: * Hospitalization for cardiac decongestion and stabilization. * Advanced heart failure receiving intravenous diuretics/inotropics in an outpatient clinic. * Awaiting cardiac transplantation |
| left ventricular ejection fraction ≤ 35% | – | Device: wearable defibrillator (LifeVest)Patients with left ventricular ejection fraction ≤ 35% and either one of the following: * Coronary revascularization within 3 calendar months prior to enrollment. * Heart failure of non-ischemic origin diagnosed within 3 calendar months prior to enrollment. |
| Awaiting ICD re-implantation | – | Device: wearable defibrillator (LifeVest) |
| Acute myocardial infarction | – | Device: wearable defibrillator (LifeVest)Patients hospitalized with acute myocardial infarction and Killip Class III/IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with left ventricular dysfunction or advanced heart failure symptoms (New York Heart Association functional Class III/IV), who have a high-risk for sudden cardiac death, but are not eligible for an implantable defibrillator or are not able to receive one due to their condition.
Key inclusion criteria (9 listed)
- Patients with NYHA class III or IV during the past month and one or more of the following:
- Patients with left ventricular ejection fraction ≤ 35% and either one of the following:
- Patients awaiting ICD re-implantation following device explantation or lead extraction,
- Patients hospitalized with acute myocardial infarction and Killip Class III/IV.
Key exclusion criteria (5 listed)
- The presence of an implantable cardioverter defibrillator prior to enrollment.
- Advanced cerebrovascular disease.
- Non-cardiac terminal illness associated with reduced likelihood of survival for the duration of the study.
- Use of supplemental oxygen in an outpatient setting requiring an external oxygen tank.
- Pregnancy.
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: wearable cardioveter defibrillator, WCD, LifeVestLifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation | Device | Acute myocardial infarction, Awaiting ICD re-implantation, NYHA class III or IV, left ventricular ejection fraction ≤ 35% |
Primary outcome
Defibrillation for life-threatening ventricular tachyarrhythmias
Time frame: 6 months
Assess magnitude and complexity of ventricular and atrial arrhythmias during use
Time frame: 6 months
4 secondary outcomes
Total mortality
Time frame: 6 months and 12 months
Compliance with wearable defibrillator use
Time frame: 6 months
Quality of life with a wearable defibrillator
Time frame: 6 months
Complications (adverse events) with wearable defibrillator use
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Michael Eldar, MD principal investigator
Chaim Sheba Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Ventricular Dysfunction, run by Zoll Medical Corporation at 2 sites in 2 countries.
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 9 inclusion and 5 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 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 2 sites in United States, Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Defibrillation for life-threatening ventricular tachyarrhythmias (time frame: 6 months). The study lists 2 primary outcomes in all. 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.