Heart FailureTRENDSNCT02149290
LifeVest Trends Validation Protocol
An observational study of Heart Failure, run by Zoll Medical Corporation at 21 sites in 3 countries.
Trial summary
This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Trends-equipped LifeVest 4000
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 21 sitesin 3 countries
- Study dates
- Feb 2014to Dec 2017
- Phase
- Observational
- 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
Study population: Patients with heart failure who are being cared for in an outpatient environment
Who may be able to join
- Symptomatic heart failure (i.e., New York Heart Association (NYHA) class II or higher)
- Evidence of a prior Myocardial Infarction (MI) or dilated cardiomyopathy
- Ejection fraction of 35% or less at the start of WCD use
- Anticipated to need a WCD for three months or more
- At least 18 years of age (over the legal age of providing consent)
Who cannot join
- Use of an implantable cardioverter defibrillator (ICD), recent removal of an ICD, or planned use of an ICD within the next three months
- Need for an assistive device for ambulation (wheelchair, walker, or cane)
- Use of a unipolar pacemaker
- Physical or mental conditions that prevent interaction with or wearing of the device
- Advanced directive prohibiting resuscitation
- Pregnancy
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States13 sites
Cardiac Arrhythmia Service
Boca Raton, Florida, 33432
SUNY Downstate
Brooklyn, New York, 11203
CAMC
Charleston, West Virginia, 25304
Erlanger Clinical Research
Chattanooga, Tennessee, 37403
Cardiology Institute of Michigan
Flint, Michigan, 48507
St. Mary's Medical Center
Huntington, West Virginia, 25702
Gwinnett Medical Center
Lawrenceville, Georgia, 30046
Lexington Cardiology Consultants
Lexington, Kentucky, 40503
Methodist Healthcare Foundation
Memphis, Tennessee, 38104
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Orange County Heart Institute
Orange, California, 92868
Swedish Medical Center
Seattle, Washington, 98122
VA Beach General
Virginia Beach, Virginia, 23454
Germany7 sites
Universitats-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79189
Kerckhoff-Klinik
Bad Nauheim
Medizinische Klinik & Poliklinik II - Kardiologie
Bonn, 53105
Klinikum Coburg
Coburg, 96450
St. Vinzenz Hospital
Cologne, 50733
Department für Herzinsuffizienz und Devicetherap
Hamburg
Klinik für Innere Medizin III
Villingen-Schwenningen, 78052
About this study
This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).
Read the detailed description
This is a multi-center validation study of heart failure patients wearing the LifeVest WCD modified to collect data on body position, activity, heart rate, 6-minute walk test, and a health survey in order to evaluate data accuracy and patient interactions with the device.
- Conditions
- Heart Failure
- Being tested
- Trends-equipped LifeVest 4000
- Keywords
- Heart Failure, Six minute walk test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trends-equipped LifeVest 4000Device
LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test
| Study group | Role | What they receive |
|---|---|---|
| Trends-equipped LifeVest 4000 | Subjects using the LifeVest 4000 modified to collect Trends data Receives: Device: Trends-equipped LifeVest 4000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Traveled in Six Minute Walk Test
Relationship of the step count and distance measure of the LifeVest walk test in heart failure patients as compared to distance measure of medically supervised 6-minute walk test. Accuracy of activities, and body position in patients with heart failure as compared to patient diaries of activity and sleeping position.
Measured: Three months
Secondary outcomes (2)
Compliance With Completing 6MWT Through a Wearable Defibrillator.
Observe Compliance with completing weekly 6MWT
Measured: Up to 12-14 Weeks of WCD use
Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.
Observe compliance with answering daily health survey.
Measured: Up to 12-14 Weeks of WCD use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2017
- Study completionDec 2017
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 198 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
- NCT02149290
- Sponsor's protocol ID
- 90D0120
- Acronym
- TRENDS
- Status last verified
- Aug 2020
- First submitted
- 1 May 2014
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LifeVest Trends Validation Protocol
- ClinicalTrials.gov ID
- NCT02149290
- Acronym / sponsor ID
- TRENDS / 90D0120
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Six minute walk test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).
Detailed description
This is a multi-center validation study of heart failure patients wearing the LifeVest WCD modified to collect data on body position, activity, heart rate, 6-minute walk test, and a health survey in order to evaluate data accuracy and patient interactions with the device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trends-equipped LifeVest 4000 | – | Device: Trends-equipped LifeVest 4000Subjects using the LifeVest 4000 modified to collect Trends data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure who are being cared for in an outpatient environment
Key inclusion criteria (5 listed)
- Symptomatic heart failure (i.e., New York Heart Association (NYHA) class II or higher)
- Evidence of a prior Myocardial Infarction (MI) or dilated cardiomyopathy
- Ejection fraction of 35% or less at the start of WCD use
- Anticipated to need a WCD for three months or more
- At least 18 years of age (over the legal age of providing consent)
Key exclusion criteria (6 listed)
- Use of an implantable cardioverter defibrillator (ICD), recent removal of an ICD, or planned use of an ICD within the next three months
- Need for an assistive device for ambulation (wheelchair, walker, or cane)
- Use of a unipolar pacemaker
- Physical or mental conditions that prevent interaction with or wearing of the device
- Advanced directive prohibiting resuscitation
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 |
|---|---|---|
| Trends-equipped LifeVest 4000LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test | Device | Trends-equipped LifeVest 4000 |
Primary outcome
Distance Traveled in Six Minute Walk Test
Time frame: Three months
Relationship of the step count and distance measure of the LifeVest walk test in heart failure patients as compared to distance measure of medically supervised 6-minute walk test. Accuracy of activities, and body position in patients with heart failure as compared to patient diaries of activity and sleeping position.
2 secondary outcomes
Compliance With Completing 6MWT Through a Wearable Defibrillator.
Time frame: Up to 12-14 Weeks of WCD use
Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.
Time frame: Up to 12-14 Weeks of WCD use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Zoll Medical Corporation at 21 sites in 3 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 5 inclusion and 6 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Austria. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2020). 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?
Distance Traveled in Six Minute Walk Test (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 31 Aug 2020.