Heart Failure
Conditions
Keywords
Heart Failure, Six minute walk test
Brief 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).
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.
Interventions
DEVICETrends-equipped LifeVest 4000
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
Sponsors
Zoll Medical Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Traveled in Six Minute Walk Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With Completing 6MWT Through a Wearable Defibrillator. | Up to 12-14 Weeks of WCD use | Observe Compliance with completing weekly 6MWT |
| Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator. | Up to 12-14 Weeks of WCD use | Observe compliance with answering daily health survey. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Interactions With the Wearable Defibrillator | Three months | Compliance with WCD use during the study period, and patient-device interactions during a ventricular arrhythmia, if any should occur during the study period. |
Countries
Austria, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trends-equipped LifeVest 4000 Subjects using the LifeVest 4000 modified to collect Trends data
Trends-equipped LifeVest 4000: 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 | 198 |
| Total | 198 |
Baseline characteristics
| Characteristic | Trends-equipped LifeVest 4000 | — |
|---|---|---|
| Age, Continuous | 57 Years STANDARD_DEVIATION 12 | — |
| Baseline Left Ventricular Ejection Fraction | 23 Ejection Fraction Percentage STANDARD_DEVIATION 7 | — |
| New York Heart Association Classification Class I | 0 Participants | — |
| New York Heart Association Classification Class II | 102 Participants | — |
| New York Heart Association Classification Class III | 83 Participants | — |
| New York Heart Association Classification Class IV | 11 Participants | — |
| New York Heart Association Classification Not Reported | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Austria | 27 participants | — |
| Region of Enrollment Germany | 90 participants | — |
| Region of Enrollment United States | 81 participants | — |
| Sex: Female, Male Female | 47 Participants | — |
| Sex: Female, Male Male | 151 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 198 |
| other Total, other adverse events | 0 / 198 |
| serious Total, serious adverse events | 5 / 198 |
Outcome results
Primary
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.
Time frame: Three months
Population: All participants that had at least one recorded in-clinic 6MWT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinician Guided 6MWT | Distance Traveled in Six Minute Walk Test | 306 meters | Standard Deviation 100 |
| WCD Guided 6MWT | Distance Traveled in Six Minute Walk Test | 296 meters | Standard Deviation 100 |
Secondary
Compliance With Completing 6MWT Through a Wearable Defibrillator.
Observe Compliance with completing weekly 6MWT
Time frame: Up to 12-14 Weeks of WCD use
Population: All participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinician Guided 6MWT | Compliance With Completing 6MWT Through a Wearable Defibrillator. | 79 % of participants completing >= 1 6MWT |
Secondary
Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.
Observe compliance with answering daily health survey.
Time frame: Up to 12-14 Weeks of WCD use
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinician Guided 6MWT | Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator. | 93 % of participants completing >= 1 survey |
Other Pre-specified
Patient Interactions With the Wearable Defibrillator
Compliance with WCD use during the study period, and patient-device interactions during a ventricular arrhythmia, if any should occur during the study period.
Time frame: Three months
Population: All participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clinician Guided 6MWT | Patient Interactions With the Wearable Defibrillator | 78 Days worn |