Vest Prevention of Early Sudden Death Trial and VEST Registry
- Conditions
- Ventricular FibrillationVentricular DysfunctionVentricular TachycardiaMyocardial InfarctionSudden Death
- Interventions
- Device: wearable defibrillator
- Registration Number
- NCT01446965
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2348
-
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:
- If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI
- If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI
- If CABG is planned (before or within 7 days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post CABG
-
Age ≥ 18 years
- Existing ICD or indication for an ICD at the time of screening
- Existing unipolar pacemakers/leads
- Chronic renal failure requiring hemodialysis after hospital discharge
- Chest circumference too small or too large for LifeVest garment*
- Participants discharged to an institutional setting with an anticipated stay > 7 days
- Pregnancy
- Inability to consent
- Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wearable defibrillator 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
- Primary Outcome Measures
Name Time Method Sudden Death Mortality three months after myocardial infarction 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.
- Secondary Outcome Measures
Name Time Method All Cause Mortality three months after myocardial infarction All deaths, due to any cause
Compliance With Wearable Defibrillator Use three months after myocardial infarction daily wear time of the device
Trial Locations
- Locations (71)
University Hospital Case Medical Center
🇺🇸Columbus, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
St. Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Cardiovascular Consultants Heart Center
🇺🇸Fresno, California, United States
Salinas Valley Memorial Healthcare System
🇺🇸Salinas, California, United States
Watson Clinic for Research, Inc.
🇺🇸Lakeland, Florida, United States
Florida Heart Group/Florida Hospital
🇺🇸Orlando, Florida, United States
Advocate Christ Hospital
🇺🇸Oak Lawn, Illinois, United States
Lutheran General
🇺🇸Park Ridge, Illinois, United States
The Heart Group/Deaconess Hospital
🇺🇸Evansville, Indiana, United States
Western Kentucky Heart and Lung
🇺🇸Bowling Green, Kentucky, United States
University of Kentucky Gill Heart Institute
🇺🇸Lexington, Kentucky, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Albany Associates in Cardiology
🇺🇸Albany, New York, United States
United Health Services
🇺🇸Johnson City, New York, United States
Long Island Jewish Hospital
🇺🇸New Hyde Park, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Huntington Hospital
🇺🇸New York, New York, United States
University Cardiovascular Associates (Rochester)
🇺🇸Rochester, New York, United States
Stony Brook University
🇺🇸Stony Brook, New York, United States
University of North Carolina @ Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Wake Heart Research
🇺🇸Raleigh, North Carolina, United States
North Ohio Heart Center-North Ohio Research
🇺🇸Elyria, Ohio, United States
Oklahoma Heart Institute-Hillcrest
🇺🇸Tulsa, Oklahoma, United States
Cardiovascular Research Center, LLC/Mercy St Vincent
🇺🇸Toledo, Ohio, United States
Chambersburg Hospital
🇺🇸Chambersburg, Pennsylvania, United States
Geisinger Heart Institute
🇺🇸Danville, Pennsylvania, United States
The Guthrie Clinic/Guthrie Medical Group
🇺🇸Sayre, Pennsylvania, United States
Brown Medical School-Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Cardiac Study Center
🇺🇸Tacoma, Washington, United States
Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus
🇩🇪Duisburg, Nordrhein-Westfalen, Germany
Klinikum Links der Weser gGmbh Klinik
🇩🇪Bremen, Germany
Klinikum Göttingen Georg-August-Universität Göttingen
🇩🇪Göttingen, Germany
Klinikum der Stadt Ludwigshafen
🇩🇪Ludwigshafen, Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Medical University of Warsaw
🇵🇱Warsaw, Poland
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Alaska Heart Institute
🇺🇸Anchorage, Alaska, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Oregon Heart & Vascular
🇺🇸Springfield, Oregon, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Gdanski Uniwersytet Medyczny
🇵🇱Gdansk, Poland
Specjalistyczna Poradnia Kardiologiczna
🇵🇱Kielce, Poland
Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
University of Massachusetts Memorial
🇺🇸Worcester, Massachusetts, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
McLeod Health/Pee Dee Cardiology
🇺🇸Florence, South Carolina, United States
Mc Tronik
🇵🇱Lodz, Poland
Providence/South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie
🇵🇱Rzeszow, Poland
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Wellmont Holston Valley
🇺🇸Kingsport, Tennessee, United States
II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)
🇵🇱Warsaw, Poland
Institute of Cardiology
🇵🇱Warszawa, Poland
Med. Uniklinik Heidelberg
🇩🇪Heidelberg, Deutschland, Germany
University of Colorado
🇺🇸Aurora, Colorado, United States
Melbourne Cardiac Resarch Institute
🇺🇸Melbourne, Florida, United States
Presbyterian Heart Group
🇺🇸Albuquerque, New Mexico, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
St. Luke's- Roosevelt Hospital Center
🇺🇸New York, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States