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| Name | Class |
|---|---|
| Zoll Medical Corporation | INDUSTRY |
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This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.
In patients with ventricular dysfunction immediately following myocardial infarction, sudden death may be responsible for up to 50% of total mortality. Wearable defibrillators may reduce sudden death by providing immediate detection and treatment of ventricular arrhythmias. This study is design to demonstrate a reduction in sudden death measured at three months following myocardial infarction among patients who have ventricular dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable defibrillator | Experimental | subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients |
|
| Conventional treatment | No Intervention | subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wearable defibrillator | Device | LifeVest wearable defibrillator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sudden Death Mortality | For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period. | three months after myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | All deaths, due to any cause | three months after myocardial infarction |
| Compliance With Wearable Defibrillator Use | daily wear time of the device |
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Inclusion Criteria:
Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)
LV ejection fraction ≤35% determined at the following time point:
Age ≥ 18 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey E Olgin, MD | University of California, San Francisco | Principal Investigator |
| Byron K Lee, MD | University of California, San Francisco | Study Director |
| Mark J Pletcher, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Heart Institute | Anchorage | Alaska | 99508 | United States | ||
| Cardiovascular Consultants Heart Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30280654 | Result | Olgin JE, Pletcher MJ, Vittinghoff E, Wranicz J, Malik R, Morin DP, Zweibel S, Buxton AE, Elayi CS, Chung EH, Rashba E, Borggrefe M, Hue TF, Maguire C, Lin F, Simon JA, Hulley S, Lee BK; VEST Investigators. Wearable Cardioverter-Defibrillator after Myocardial Infarction. N Engl J Med. 2018 Sep 27;379(13):1205-1215. doi: 10.1056/NEJMoa1800781. |
| Label | URL |
|---|---|
| Linked to VEST/PREDICTS registration: NCT00628966 | View source |
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From July 2008 through April 2017, the investigators enrolled 2348 participants at 76 sites in the United States, at 24 in Poland, at 6 in Germany, and at 2 in Hungary. One U.S. site was dismissed on June 24, 2014, and the 46 participants at that site were excluded from the analyses, due to irregularities found by the institutional review board at the site. Thus, a total of 2302 participants were included in the analyses (1524 participants in the device group and 778 in the control group).
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| ID | Title | Description |
|---|---|---|
| FG000 | Wearable Defibrillator | subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (WCD) (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randominization |
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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 | Mar 2, 2017 |
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| three months after myocardial infarction |
| Fresno |
| California |
| 93720 |
| United States |
| Salinas Valley Memorial Healthcare System | Salinas | California | 93901 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Christiana Care Health Services | Newark | Delaware | 19718 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Watson Clinic for Research, Inc. | Lakeland | Florida | 33805 | United States |
| Melbourne Cardiac Resarch Institute | Melbourne | Florida | 32901 | United States |
| Florida Heart Group/Florida Hospital | Orlando | Florida | 32803 | United States |
| Advocate Christ Hospital | Oak Lawn | Illinois | 60453 | United States |
| Lutheran General | Park Ridge | Illinois | 60068 | United States |
| The Heart Group/Deaconess Hospital | Evansville | Indiana | 47713 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| St. Vincent Medical Group | Indianapolis | Indiana | 46260 | United States |
| Western Kentucky Heart and Lung | Bowling Green | Kentucky | 42101 | United States |
| University of Kentucky Gill Heart Institute | Lexington | Kentucky | 40536 | United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Memorial | Worcester | Massachusetts | 01655 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Presbyterian Heart Group | Albuquerque | New Mexico | 87106 | United States |
| Albany Associates in Cardiology | Albany | New York | 12205 | United States |
| United Health Services | Johnson City | New York | 13790 | United States |
| Long Island Jewish Hospital | New Hyde Park | New York | 11040 | United States |
| St. Luke's- Roosevelt Hospital Center | New York | New York | 10025 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Huntington Hospital | New York | New York | 11743 | United States |
| University Cardiovascular Associates (Rochester) | Rochester | New York | 14626 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina @ Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Heart Research | Raleigh | North Carolina | 27610 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University Hospital Case Medical Center | Columbus | Ohio | 44106 | United States |
| North Ohio Heart Center-North Ohio Research | Elyria | Ohio | 44035 | United States |
| Cardiovascular Research Center, LLC/Mercy St Vincent | Toledo | Ohio | 43608 | United States |
| Oklahoma Heart Institute-Hillcrest | Tulsa | Oklahoma | 74104 | United States |
| Oregon Heart & Vascular | Springfield | Oregon | 97477 | United States |
| Chambersburg Hospital | Chambersburg | Pennsylvania | 17201 | United States |
| Geisinger Heart Institute | Danville | Pennsylvania | 17822 | United States |
| The Guthrie Clinic/Guthrie Medical Group | Sayre | Pennsylvania | 18840 | United States |
| Brown Medical School-Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Providence/South Carolina Heart Center | Columbia | South Carolina | 29204 | United States |
| McLeod Health/Pee Dee Cardiology | Florence | South Carolina | 29506 | United States |
| Wellmont Holston Valley | Kingsport | Tennessee | 37660 | United States |
| Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | United States |
| Baylor University Medical Center | Dallas | Texas | 75226 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
| Cardiac Study Center | Tacoma | Washington | 98405 | United States |
| Med. Uniklinik Heidelberg | Heidelberg | Deutschland | 69120 | Germany |
| Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus | Duisburg | North Rhine-Westphalia | 47169 | Germany |
| Klinikum Links der Weser gGmbh Klinik | Bremen | 28277 | Germany |
| Klinikum Göttingen Georg-August-Universität Göttingen | Göttingen | 37099 | Germany |
| Klinikum der Stadt Ludwigshafen | Ludwigshafen | 67063 | Germany |
| UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Universitätsklinikum Mannheim | Mannheim | 68167 | Germany |
| Gdanski Uniwersytet Medyczny | Gdansk | 80-952 | Poland |
| Specjalistyczna Poradnia Kardiologiczna | Kielce | 25525 | Poland |
| Mc Tronik | Lodz | 90-553 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie | Rzeszów | 35111 | Poland |
| II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II) | Warsaw | 02-637 | Poland |
| Medical University of Warsaw | Warsaw | 02097 | Poland |
| Institute of Cardiology | Warsaw | 04627 | Poland |
| Conventional Treatment |
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients |
| COMPLETED |
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| NOT COMPLETED |
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| Participants Followed and Analyzed |
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| ID | Title | Description |
|---|---|---|
| BG000 | Wearable Defibrillator | subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator |
| BG001 | Conventional Treatment | subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Sex data not available for all randomized | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Left ventricular ejection fraction | Left ventricular ejection fraction is reported as percent of the total amount of blood in the left ventricle pushed out with each heartbeat. An ejection fraction of 35 percent or less was an inclusion criterion for the study. | Mean | Standard Deviation | percentage of total amount of blood |
|
| 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 | Sudden Death Mortality | For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period. | A total of 2302 participants were included in the analyses. | Posted | Count of Participants | Participants | three months after myocardial infarction |
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| Secondary | All Cause Mortality | All deaths, due to any cause | Posted | Count of Participants | Participants | three months after myocardial infarction |
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| Secondary | Compliance With Wearable Defibrillator Use | daily wear time of the device | Conventional treatment participants did not wear defibrillator. | Posted | Median | Inter-Quartile Range | hours per day | three months after myocardial infarction |
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3 months
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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 | Wearable Defibrillator | subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients wearable defibrillator: LifeVest wearable defibrillator | 48 | 1,524 | 475 | 1,524 | 1,421 | 1,524 |
| EG001 | Conventional Treatment | subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients | 38 | 778 | 253 | 778 | 714 | 778 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHD hospitalization, 1st event post-randomization | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Trouble sleeping | General disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Fainting | General disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | Non-systematic Assessment |
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| Chest pain | Cardiac disorders | Non-systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Rash in any location | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash on torso | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Itch in any location | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Itch on torso | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Olgin, MD | University of California, San Francisco | 415-476-1000 | jeffrey.olgin@ucsf.edu |
| Dec 30, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D018754 | Ventricular Dysfunction |
| D003645 | Death, Sudden |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| D016757 | Death, Sudden, Cardiac |
| D003643 | Death |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D006323 | Heart Arrest |
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