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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trends-equipped LifeVest 4000 | Subjects using the LifeVest 4000 modified to collect Trends data |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trends-equipped LifeVest 4000 | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Completing 6MWT Through a Wearable Defibrillator. | Observe Compliance with completing weekly 6MWT | Up to 12-14 Weeks of WCD use |
| Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three months |
Inclusion Criteria:
Exclusion Criteria:
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Patients with heart failure who are being cared for in an outpatient environment
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| Name | Affiliation | Role |
|---|---|---|
| Steven J Szymkiewicz, MD | Zoll Medical Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Heart Institute | Orange | California | 92868 | United States | ||
| Cardiac Arrhythmia Service |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2015 |
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Observe compliance with answering daily health survey.
| Up to 12-14 Weeks of WCD use |
| Boca Raton |
| Florida |
| 33432 |
| United States |
| Gwinnett Medical Center | Lawrenceville | Georgia | 30046 | United States |
| Lexington Cardiology Consultants | Lexington | Kentucky | 40503 | United States |
| Cardiology Institute of Michigan | Flint | Michigan | 48507 | United States |
| SUNY Downstate | Brooklyn | New York | 11203 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| Erlanger Clinical Research | Chattanooga | Tennessee | 37403 | United States |
| Methodist Healthcare Foundation | Memphis | Tennessee | 38104 | United States |
| VA Beach General | Virginia Beach | Virginia | 23454 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| CAMC | Charleston | West Virginia | 25304 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| Klinische Abteilung für Kardiologie | Graz | 8036 | Austria |
| Universitats-Herzzentrum Freiburg - Bad Krozingen | Bad Krozingen | 79189 | Germany |
| Kerckhoff-Klinik | Bad Nauheim | Germany |
| Medizinische Klinik & Poliklinik II - Kardiologie | Bonn | 53105 | Germany |
| Klinikum Coburg | Coburg | 96450 | Germany |
| St. Vinzenz Hospital | Cologne | 50733 | Germany |
| Department für Herzinsuffizienz und Devicetherap | Hamburg | Germany |
| Klinik für Innere Medizin III | Villingen-Schwenningen | 78052 | Germany |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Left Ventricular Ejection Fraction | Mean | Standard Deviation | Ejection Fraction Percentage |
| |||||||||||||||||
| New York Heart Association Classification | Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. No NYHA class listed or unable to determine. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants that had at least one recorded in-clinic 6MWT | Posted | Mean | Standard Deviation | meters | Three months |
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| ||||||||||||||||||||||||||||
| Secondary | Compliance With Completing 6MWT Through a Wearable Defibrillator. | Observe Compliance with completing weekly 6MWT | All participants | Posted | Number | % of participants completing >= 1 6MWT | Up to 12-14 Weeks of WCD use |
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| ||||||||||||||||||||||||||||||
| Secondary | Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator. | Observe compliance with answering daily health survey. | All participants. | Posted | Number | % of participants completing >= 1 survey | Up to 12-14 Weeks of WCD use |
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| 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. | All participants | Posted | Median | Inter-Quartile Range | Days worn | Three months |
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During the 12-14 weeks of WCD use
All adverse events during the study period whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 198 | 5 | 198 | 0 | 198 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Medical Affairs | ZOLL LifeVest | 412-968-3333 | 14400 | stevens@zoll.com |
| Aug 13, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Germany |
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| Class II |
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| Class III |
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| Class IV |
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| Not Reported |
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