Vest Prevention of Early Sudden Death Trial and VEST Registry

Myocardial Infarction Clinical Trial

— VEST  

Official title:

Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446965
• Other study ID #: 90D0114
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00628966

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2348
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. If no PCI within the first 8 hours following the MI: = 8 hours after MI

2. If acute PCI occurs within 8 hours of MI: =8 hours after PCI

3. 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Death
• Death, Sudden
• Infarction
• Myocardial Infarction
• Sudden Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Dysfunction
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• wearable defibrillator
LifeVest wearable defibrillator

Locations

Country	Name	City	State
Germany	Klinikum Links der Weser gGmbh Klinik	Bremen
Germany	Herzzentrum Duisburg Kaiser-Wilhelm-Krankenhaus	Duisburg	Nordrhein-Westfalen
Germany	Klinikum Göttingen Georg-August-Universität Göttingen	Göttingen
Germany	Med. Uniklinik Heidelberg	Heidelberg	Deutschland
Germany	Klinikum der Stadt Ludwigshafen	Ludwigshafen
Germany	UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitätsklinikum Mannheim	Mannheim
Poland	Gdanski Uniwersytet Medyczny	Gdansk
Poland	Specjalistyczna Poradnia Kardiologiczna	Kielce
Poland	Mc Tronik	Lodz
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Rzeszowie	Rzeszow
Poland	II Klinika Choroby Wiencowej, Instytut Kardiologii (Institute of Cardiology, Clinic II)	Warsaw
Poland	Medical University of Warsaw	Warsaw
Poland	Institute of Cardiology	Warszawa
United States	Albany Associates in Cardiology	Albany	New York
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	Alaska Heart Institute	Anchorage	Alaska
United States	University of Colorado	Aurora	Colorado
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Western Kentucky Heart and Lung	Bowling Green	Kentucky
United States	Montefiore Medical Center	Bronx	New York
United States	Chambersburg Hospital	Chambersburg	Pennsylvania
United States	University of North Carolina @ Chapel Hill	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Providence/South Carolina Heart Center	Columbia	South Carolina
United States	University Hospital Case Medical Center	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Geisinger Heart Institute	Danville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	North Ohio Heart Center-North Ohio Research	Elyria	Ohio
United States	The Heart Group/Deaconess Hospital	Evansville	Indiana
United States	McLeod Health/Pee Dee Cardiology	Florence	South Carolina
United States	Cardiovascular Consultants Heart Center	Fresno	California
United States	University of Florida	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Indiana University	Indianapolis	Indiana
United States	St. Vincent Medical Group	Indianapolis	Indiana
United States	United Health Services	Johnson City	New York
United States	Wellmont Holston Valley	Kingsport	Tennessee
United States	Turkey Creek Medical Center	Knoxville	Tennessee
United States	Watson Clinic for Research, Inc.	Lakeland	Florida
United States	University of Kentucky Gill Heart Institute	Lexington	Kentucky
United States	Melbourne Cardiac Resarch Institute	Melbourne	Florida
United States	Long Island Jewish Hospital	New Hyde Park	New York
United States	Ochsner Clinic	New Orleans	Louisiana
United States	Huntington Hospital	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	St. Luke's- Roosevelt Hospital Center	New York	New York
United States	Christiana Care Health Services	Newark	Delaware
United States	Advocate Christ Hospital	Oak Lawn	Illinois
United States	Florida Heart Group/Florida Hospital	Orlando	Florida
United States	Lutheran General	Park Ridge	Illinois
United States	Brown Medical School-Rhode Island Hospital	Providence	Rhode Island
United States	Wake Heart Research	Raleigh	North Carolina
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Carilion Clinic	Roanoke	Virginia
United States	University Cardiovascular Associates (Rochester)	Rochester	New York
United States	Salinas Valley Memorial Healthcare System	Salinas	California
United States	University of California, San Francisco	San Francisco	California
United States	The Guthrie Clinic/Guthrie Medical Group	Sayre	Pennsylvania
United States	Oregon Heart & Vascular	Springfield	Oregon
United States	Stony Brook University	Stony Brook	New York
United States	Cardiac Study Center	Tacoma	Washington
United States	Cardiovascular Research Center, LLC/Mercy St Vincent	Toledo	Ohio
United States	Oklahoma Heart Institute-Hillcrest	Tulsa	Oklahoma
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

References & Publications (1)

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 Myocar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	three months after myocardial infarction
Secondary	All Cause Mortality	All deaths, due to any cause	three months after myocardial infarction
Secondary	Compliance With Wearable Defibrillator Use	daily wear time of the device	three months after myocardial infarction

External Links

•   Linked to VEST/PREDICTS registration: NCT00628966